Agency Forms Undergoing Paperwork Reduction Act Review, 14857-14859 [2018-07016]
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Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices
(NCEZID), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) Division of Global
Migration and Quarantine (DGMQ) is
requesting a three-year revision of a
currently approved generic clearance to
conduct evaluation research. This will
help CDC plan and implement health
communication, education, and training
activities to improve health and prevent
the spread of disease. These activities
include communicating, educating, and
training with international travelers and
other mobile populations, training
healthcare providers, and educating
public health departments, federal
partners, and other stakeholders.
The information collection for which
the revision is sought is in accordance
with DGMQ’s mission to reduce
morbidity and mortality among
immigrants, refugees, travelers,
expatriates, and other globally mobile
populations, and to prevent the
introduction, transmission, or spread of
communicable diseases from foreign
countries into the United States. This
mission is supported by delegated legal
authorities outlined in the Public Health
Service (PHS) Act (42 U.S.C. 264) and
in regulations that are codified in 42
Code of Federal Regulations (CFR) parts
70 and 71, and 34.
Approval of this revision request will
allow DGMQ to continue collecting, in
an expedited manner, information about
the knowledge, attitudes, and behaviors
of key audiences (such as refugees,
immigrants, migrants, international
travelers, travel industry partners,
healthcare providers, non-profit
agencies, customs brokers and
forwarders, schools, state and local
health departments) to help improve
and inform these activities during both
routine and emergency public health
events. This generic OMB clearance will
help DGMQ continue to refine these
efforts in a timely manner, and will be
especially valuable for communication
activities that must occur quickly in
response to public health emergencies.
DGMQ staff will use a variety of data
collection methods for this proposed
project: interviews, focus groups,
surveys, and pre/post-tests. Depending
on the research questions and audiences
involved, data may be gathered inperson, by telephone, online, or using
some combination of these formats. Data
may be collected in quantitative and/or
14857
qualitative forms. Numerous audience
variables will be assessed under the
auspices of this generic OMB clearance.
These include, but are not limited to,
knowledge, attitudes, beliefs, behavioral
intentions, practices, behaviors, skills,
self-efficacy, and information needs and
sources. Insights gained from evaluation
research will assist in the development,
refinement, implementation, and
demonstration of outcomes and impact
of communication, education, and
training activities.
DGMQ estimates that 17,500
respondents and 7,982 hours of burden
will be involved in evaluation research
activities each year. The information
being collected will not impose a cost
burden on the respondents beyond that
associated with their time to provide the
required data.
For this submission, requested burden
has been reduced from 37,500
respondents and 17,835 burden hours to
17,500 respondents and 7,982 burden
hours due to a reduction in the number
of estimated number of collections per
year from ten to five and a two thirds
reduction in pre- and post-tests
requested for both types of respondents:
healthcare professionals and the general
public.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
General Public ................................................
Healthcare Professionals ................................
General Public ................................................
Healthcare Professionals ................................
General Public ................................................
Healthcare Professionals ................................
General Public ................................................
Healthcare Professionals Interviews ...............
General Public ................................................
Healthcare Professionals ................................
General Public ................................................
Healthcare Professionals ................................
General Public ................................................
Healthcare Professionals ................................
Focus Groups Screening form .......................
Focus Groups Screening form .......................
Focus Groups .................................................
Focus Groups .................................................
Interview Screening Form ..............................
Interview Screening Form ..............................
Interviews .......................................................
Interviews .......................................................
Survey Screening Forms ...............................
Survey Screening Forms ...............................
Surveys ..........................................................
Surveys ..........................................................
Pre/Post Tests ................................................
Pre/Post Tests ................................................
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–07017 Filed 4–5–18; 8:45 am]
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Leroy A. Richardson,
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.
[30Day–18–0943]
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
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
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1,050
450
525
225
700
300
350
150
5,250
2,250
2,625
1,125
1,750
750
Number of
responses per
respondent
1
1
1
1
1
1
1
1
1
1
1
........................
1
1
Average
burden per
response
(in hours)
10/60
10/60
90/60
90/60
10/60
10/60
1
1
10/60
10/60
45/60
45/60
45/60
45/60
collection request titled Data Collection
for the Residential Care Community and
Adult Day Services Center Components
of the National Study of Long-Term Care
Providers 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
19, 2017 to obtain comments from the
public and affected agencies. CDC
received three comments related to the
previous notice. This notice serves to
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14858
Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices
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
Data Collection for the Residential
Care Community and Adult Day
Services Center Components of the
National Study of Long-Term Care
Providers (OMB Control Number 0920–
0943, Exp. Date 05/31/2019)—
Revision—National Center for Health
Statistics, Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, ‘‘shall collect
statistics on health resources. . . [and]
utilization of health care, including
extended care facilities, and other
institutions.’’
NCHS seeks approval to collect data
for the residential care community
(RCC) and adult day services center
(ADSC) survey components of the 2018
National Study of Long-Term Care
Providers (NSLTCP). A one year
clearance is requested.
Details on the complete study design
are as follows. The NSLTCP is designed
to (1) broaden NCHS’ ongoing coverage
of paid, regulated long-term care (LTC)
providers; (2) merge with existing
administrative data on LTC providers
and service users (i.e. Centers for
Medicare and Medicaid Services (CMS)
data on nursing homes and residents,
home health agencies and patients, and
hospices and patients); (3) update data
more frequently on LTC providers and
service users for which nationally
representative administrative data do
not exist; and (4) enable comparisons
across LTC sectors and timely
monitoring of supply, use, and
characteristics of these sectors over
time. Data will be collected from two
types of LTC providers in the 50 states
and the District of Columbia: 2,090
RCCs and 1,650 ADSCs. Data were
collected in 2012, 2014, and 2016. The
data to be collected in 2018 include the
basic characteristics, services, staffing,
and practices of RCCs and ADSCs, and
demographics, selected health
conditions and health care utilization,
physical functioning, and cognitive
functioning of RCC residents and ADSC
participants. The 2018 NSLTCP will
include the addition of a contact
confirmation call, a call to screen and
set an appointment for the services user
data collection, and sampling and
services user questionnaires. The
provider-level data collection has been
consolidated into one version of a
questionnaire for each setting rather
than two versions, and a data retrieval
call has been eliminated.
Expected users of data from this
collection effort include, but are not
limited to CDC; other Department of
Health and Human Services (DHHS)
agencies, such as the Office of the
Assistant Secretary for Planning and
Evaluation, The Administration for
Community Living, and the Agency for
Healthcare Research and Quality;
associations, such as LeadingAge,
National Center for Assisted Living,
American Seniors Housing Association,
Argentum (formerly Assisted Living
Federation of America), and National
Adult Day Services Association;
universities; foundations; and other
private sector organizations such as the
Alzheimer’s Association and the AARP
Public Policy Institute.
Expected burden from data collection
for eligible cases is 80 minutes per
respondent: 5 Minutes for a contact
confirmation call; 15 minutes for a
screener and appointment setting call;
30 minutes for a provider questionnaire;
and 30 minutes for a sampling and
services user questionnaire. We estimate
an eligibility rate for ADSCs of 86% and
for RCCs of 76%. One year clearance is
requested to cover the collection of data.
The burden for the collection is shown
in the table below. There is no cost to
respondents other than their time to
participate.
ESTIMATED ANNUALIZED BURDEN HOURS
No. of
respondents
Form name
RCC/ADSC Director/Designated Staff Member ......
RCC/ADSC Director/Designated Staff Member ......
RCC Director/Designated Staff Member .................
daltland on DSKBBV9HB2PROD with NOTICES
Type of respondents
No. of
responses per
respondent
3,740
3,740
1,589
1
1
1
5/60
15/60
30/60
1,419
3,008
1
1
30/60
30/60
Contact Confirmation Call .........................
Screener and Appointment Setting Call ....
RCC ...........................................................
Provider Questionnaire ..............................
ADSC Provider Questionnaire ...................
RCC/ADSC ................................................
Sampling and Services User Questionnaire.
ADSC Director/Designated Staff Member ...............
RCC/ADSC Director/Designated Staff Member ......
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Avg. burden
per response
(in hours)
Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices
14859
Leroy A. Richardson,
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Food and Drug Administration
[FR Doc. 2018–07016 Filed 4–5–18; 8:45 am]
Notice of Closed Meeting
Exposure-Response Analysis in Drug
Development and Regulatory Decision
Making; Establishment of a Public
Docket; Request for Comments
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Closed Meeting
daltland on DSKBBV9HB2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Management Analysis and
Services Office, CDC, pursuant to Public
Law 92–463. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)—RFA–CE–18–002,
Evaluation of Policies for the Primary
Prevention of Multiple Forms of Violence.
Dates: May 23, 2018 and May 24, 2018.
Time: 9:00 a.m.–5:00 p.m., EDT.
Place: DoubleTree by Hilton Hotel
Atlanta—Buckhead, 3342 Peachtree Road NE,
Atlanta, GA 30326.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Mikel L.
Walters, M.A., Ph.D., Scientific Review
Official, NCIPC, CDC, 4770 Buford Highway
NE, Mailstop F–63, Atlanta, Georgia 30341,
Telephone: (404)639–0913; Email: mwalters@
cdc.gov.
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 the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Management Analysis and
Services Office, CDC, pursuant to Public
Law 92–463. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)—CK18–001,
Epicenters for the Prevention of HealthcareAssociated Infections (HAIs); Cycle II
Multicenter Program Studies and CK18–003,
Determining and Monitoring Health
Conditions Among US-Bound Refugees and
Other Globally Mobile Populations.
Date: May 9, 2018.
Time: 10:00 a.m.–3:00 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Gregory
Anderson, M.S., M.P.H., Scientific Review
Officer, CDC, 1600 Clifton Road NE, Mailstop
E60, Atlanta, Georgia 30329, (404) 718–8833,
gca5@cdc.gov.
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 the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2018–07053 Filed 4–5–18; 8:45 am]
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[FR Doc. 2018–07051 Filed 4–5–18; 8:45 am]
BILLING CODE 4163–18–P
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[Docket No. FDA–2018–N–0791]
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Prescription Drug User
Fee Act of 2017 (PDUFA VI), part of the
FDA Reauthorization Act of 2017
(FDARA, highlights the goal of
advancing model-informed drug
development (MIDD). Exposureresponse analysis is a MIDD strategy
that has been used in drug development
and regulatory decision making. The
Food and Drug Administration (FDA or
Agency) is opening a docket to receive
public comments on experience
leveraging exposure-response analysis
since publishing the guidance for
industry (GFI) entitled ‘‘ExposureResponse Relationships—Study Design,
Data Analysis, and Regulatory
Applications,’’ which was announced in
the Federal Register on May 6, 2003.
Specifically, the Agency wants to
identify areas of scientific policy that
may need further clarity or elaboration,
as well as any obstacles that prevent use
of exposure-response analyses in drug
development and regulatory review.
DATES: To ensure that the Agency
considers your input, submit either
electronic or written comments by July
5, 2018.
ADDRESSES: You may submit comments
as follows. Electronic comments must
be submitted on or before July 5, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
date service acceptance receipt is on or
before that date:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• 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
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]]>Agencies
[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Notices]
[Pages 14857-14859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07016]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-0943]
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 Data Collection for the Residential Care
Community and Adult Day Services Center Components of the National
Study of Long-Term Care Providers 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 19, 2017 to obtain comments from
the public and affected agencies. CDC received three comments related
to the previous notice. This notice serves to
[[Page 14858]]
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 [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
Data Collection for the Residential Care Community and Adult Day
Services Center Components of the National Study of Long-Term Care
Providers (OMB Control Number 0920-0943, Exp. Date 05/31/2019)--
Revision--National Center for Health Statistics, Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health Service (PHS) Act (42 U.S.C.
242k), as amended, authorizes that the Secretary of Health and Human
Services (DHHS), acting through NCHS, ``shall collect statistics on
health resources. . . [and] utilization of health care, including
extended care facilities, and other institutions.''
NCHS seeks approval to collect data for the residential care
community (RCC) and adult day services center (ADSC) survey components
of the 2018 National Study of Long-Term Care Providers (NSLTCP). A one
year clearance is requested.
Details on the complete study design are as follows. The NSLTCP is
designed to (1) broaden NCHS' ongoing coverage of paid, regulated long-
term care (LTC) providers; (2) merge with existing administrative data
on LTC providers and service users (i.e. Centers for Medicare and
Medicaid Services (CMS) data on nursing homes and residents, home
health agencies and patients, and hospices and patients); (3) update
data more frequently on LTC providers and service users for which
nationally representative administrative data do not exist; and (4)
enable comparisons across LTC sectors and timely monitoring of supply,
use, and characteristics of these sectors over time. Data will be
collected from two types of LTC providers in the 50 states and the
District of Columbia: 2,090 RCCs and 1,650 ADSCs. Data were collected
in 2012, 2014, and 2016. The data to be collected in 2018 include the
basic characteristics, services, staffing, and practices of RCCs and
ADSCs, and demographics, selected health conditions and health care
utilization, physical functioning, and cognitive functioning of RCC
residents and ADSC participants. The 2018 NSLTCP will include the
addition of a contact confirmation call, a call to screen and set an
appointment for the services user data collection, and sampling and
services user questionnaires. The provider-level data collection has
been consolidated into one version of a questionnaire for each setting
rather than two versions, and a data retrieval call has been
eliminated.
Expected users of data from this collection effort include, but are
not limited to CDC; other Department of Health and Human Services
(DHHS) agencies, such as the Office of the Assistant Secretary for
Planning and Evaluation, The Administration for Community Living, and
the Agency for Healthcare Research and Quality; associations, such as
LeadingAge, National Center for Assisted Living, American Seniors
Housing Association, Argentum (formerly Assisted Living Federation of
America), and National Adult Day Services Association; universities;
foundations; and other private sector organizations such as the
Alzheimer's Association and the AARP Public Policy Institute.
Expected burden from data collection for eligible cases is 80
minutes per respondent: 5 Minutes for a contact confirmation call; 15
minutes for a screener and appointment setting call; 30 minutes for a
provider questionnaire; and 30 minutes for a sampling and services user
questionnaire. We estimate an eligibility rate for ADSCs of 86% and for
RCCs of 76%. One year clearance is requested to cover the collection of
data. The burden for the collection is shown in the table below. There
is no cost to respondents other than their time to participate.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
No. of Avg. burden
Type of respondents Form name No. of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
RCC/ADSC Director/Designated Staff Contact Confirmation Call. 3,740 1 5/60
Member.
RCC/ADSC Director/Designated Staff Screener and Appointment 3,740 1 15/60
Member. Setting Call.
RCC Director/Designated Staff Member... RCC....................... 1,589 1 30/60
Provider Questionnaire....
ADSC Director/Designated Staff Member.. ADSC Provider 1,419 1 30/60
Questionnaire.
RCC/ADSC Director/Designated Staff RCC/ADSC.................. 3,008 1 30/60
Member. Sampling and Services User
Questionnaire.
----------------------------------------------------------------------------------------------------------------
[[Page 14859]]
Leroy A. Richardson,
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. 2018-07016 Filed 4-5-18; 8:45 am]
BILLING CODE 4163-18-P
