Agency Forms Undergoing Paperwork Reduction Act Review, 28820-28822 [2019-13054]
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28820
Federal Register / Vol. 84, No. 119 / Thursday, June 20, 2019 / Notices
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
The Maternal Mortality Review
Information Application (MMRIA)
–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) seeks OMB approval
to collect information through the
Maternal Mortality Review Information
Application (MMRIA) for three years.
MMRIA is a standardized data
collection system that allows Maternal
Mortality Review Committees (MMRCs)
across the country to abstract relevant
data (clinical and non-clinical) from a
variety of sources, document committee
decisions, and analyze data in order to
better understand the contributing
factors and preventability of maternal
deaths and thus to develop
recommendations for prevention.
About 700 women die each year in
the United States as a result of
pregnancy or delivery complications, a
chain of events initiated by pregnancy,
or the aggravation of an unrelated
condition by the physiologic effects of
pregnancy. Furthermore, considerable
racial disparities exist, with black
women almost four times more likely to
die from pregnancy-related
complications than white women.
Findings from MMRCs indicate that
from various sources, including death
certificates, autopsy reports, birth
certificates, prenatal care records,
emergency room visit records,
hospitalization records, records from
other medical office visits, medical
transport records, social and
environmental profiles, mental health
profiles, and informant interviews. Case
narratives for committee reviews are
auto-populated from the abstracted data
entered into MMRIA to facilitate
committee review, and committee
decisions will also be entered into
MMRIA.
The data collected in MMRIA will be
used to facilitate an understanding of
the drives of maternal mortality and
complications of pregnancy and
associated disparities; determine what
interventions at patient, provider,
facility, system, and community levels
will have the most impact; and
implement data driven
recommendations.
The burden estimates presented here
are applicable to the estimated 25
awardees of the cooperative agreement
Preventing Maternal Deaths: Supporting
Maternal Mortality Review Committees
(CDC–RFA–DP19–1908); these awardees
are required to compile a defined set of
information about maternal deaths into
MMRIA. It is estimated that information
will be collected for a total of 740
pregnancy-associated deaths on average,
annually, among the 25 awardees.
Burden is estimated based on each
awardee’s total staff time to enter the
abstracted data into MMRIA and enter
the committee decision.
more than half of maternal deaths are
preventable.
Maternal Mortality Review is a
process by which a multidisciplinary
committee at the jurisdiction level
identifies and reviews cases of maternal
death within one year of end of
pregnancy. Members of MMRCs
typically represent public health,
obstetrics and gynecology, maternalfetal medicine, nursing, midwifery,
forensic pathology, mental and
behavioral health, and other relevant
stakeholders. Through a partnership
among the MMRC, state vital records
office, and epidemiologists, deaths
among women of reproductive age are
examined to determine if they occurred
during pregnancy or within one year of
the end of pregnancy (i.e., pregnancyassociated deaths). Through this
process, potential cases of pregnancyrelated deaths (i.e., maternal death from
any cause related to or aggravated by
pregnancy or its management) are then
identified. Review committees access
multiple sources of clinical and nonclinical information to understand the
circumstances surrounding a maternal
death in order to develop
recommendations for action to prevent
similar deaths in the future.
MMRIA is a standardized data
collection system designed to collect
timely, accurate, and standardized
information about deaths to women
during pregnancy and within one year
of end of pregnancy, including
opportunities for prevention, within and
across jurisdictions. Data will be
abstracted and entered into MMRIA
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Awardees ..........................................
Data abstraction ...............................
Committee decision ..........................
Total ...........................................
...........................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–13055 Filed 6–19–19; 8:45 am]
jbell on DSK3GLQ082PROD with NOTICES
BILLING CODE 4163–18–P
Number of
responses per
respondent
Average hours
per response
(in hours)
25
25
30
30
15
24/60
11,250
300
........................
........................
........................
11,550
Number of
respondents
Types of respondents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–1108]
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 Paul Coverdell
VerDate Sep<11>2014
18:52 Jun 19, 2019
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Frm 00033
Fmt 4703
Sfmt 4703
Total burden
hours
National Acute Stroke Program
(PCNASP) 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 February
7, 2019 to obtain comments from the
public and affected agencies. CDC did
not receive comments 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.
E:\FR\FM\20JNN1.SGM
20JNN1
Federal Register / Vol. 84, No. 119 / Thursday, June 20, 2019 / Notices
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.
jbell on DSK3GLQ082PROD with NOTICES
Proposed Project
Paul Coverdell National Acute Stroke
Program (PCNASP) (OMB No. 0920–
1108, exp. 03/31/2019)—Reinstatement
with Change—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Stroke is the fifth leading cause of
death in the United States and results in
approximately 145,000 deaths per year.
Additionally, approximately 800,000
stroke events are reported each year,
including approximately 185,000
recurrent strokes. However, many
strokes are preventable, and patient
outcomes can be improved through
coordinated care that begins at stroke
onset and is delivered in a timely
manner.
Stroke outcomes depend upon the
rapid recognition of signs and
VerDate Sep<11>2014
17:47 Jun 19, 2019
Jkt 247001
symptoms of stroke, prompt transport to
a treatment facility, and early
rehabilitation. Improving outcomes
requires a coordinated systems
approach involving pre-hospital care,
emergency department and hospital
care, prevention of complications, poststroke rehabilitation, and ongoing
secondary prevention. Through the Paul
Coverdell National Acute Stroke
Program (PCNASP), CDC has been
continuously working to measure and
improve acute stroke care using wellknown quality improvement strategies
coupled with frequent evaluation of
results. PCNASP awardees are state
health departments who work with
participating hospitals, Emergency
Medical Services (EMS) agencies, and
other healthcare partners (e.g., poststroke recovery facilities) in their
jurisdictions to improve quality of care
and transitions of care for stroke
patients. During initial cooperative
agreement cycles, PCNASP awardees
focused on improving in-hospital
quality of care (QoC) with technical
assistance provided by CDC. Through
lessons learned during this process and
other supporting evidence in the field,
it has become evident that it is also
important to examine pre- and posthospital transitions of care to link the
entire continuum of stroke care when
improving QoC for stroke patients.
The PCNASP’s current five-year
cooperative agreement started on July 1,
2015 and includes nine awardees and
their selected partners (hospitals, EMS
agencies, other healthcare facilities).
This current funding reflects additional
emphasis on pre-hospital quality of care
as well as the post-hospital transition of
care setting from hospital to home or
other healthcare facility. With technical
assistance provided by CDC, awardees
have worked on identifying and using
data systems to systematically collect
and report data on all three phases of
the stroke care continuum and on
hospital capacity.
PCNASP had OMB approval for the
collection of pre-hospital (EMS), inhospital, and post-hospital patient care
data, as well as hospital inventory data
(OMB No. 0920–1108). This approval
expired on 3/31/2019, and awardees
have discontinued data submission. The
lapsed information collection will
resume after OMB approval of a
reinstatement package.
When possible, in-hospital patient
care data continues to align with
standards set by The Joint Commission
(TJC) and the American Heart
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Fmt 4703
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28821
Association’s Get With The Guidelines
(GWTG) program. There are no changes
to the estimated burden for the
collection of in-hospital data. The
average burden per response remains 30
minutes for awardees, for a total of 18
hours annually.
Data collection methods for pre- and
post-hospital care data are revised to
allow for information collection through
existing data systems, including GWTG
and the National Emergency Medical
Services Information System (NEMSIS).
CDC has worked with awardees, the
American Heart Association and
NEMSIS to identify areas of alignment
and new collaboration to reduce the
burden of pre-hospital data collection.
The average burden per response will
vary from 30 minutes to two hours.
Thus, the burden for pre-hospital data is
being reduced from 96 to 60 burden
hours annually. Similarly, the burden
for post-hospital data is reduced from 38
to 22 burden hours annually, because
data collection will occur using GWTG
or another similar mechanism, and data
will be transmitted automatically to
awardees. The average burden per
response will vary from 30 minutes to
two hours per quarter for post-hospital
data collection.
Primary data collection of hospital
inventory data is collected to
understand the capacity and
infrastructure of the hospitals that admit
and treat stroke patients. The average
burden per response remains 30
minutes for hospitals, and eight hours
for each PCNASP awardee to prepare an
aggregate hospital inventory file. The
number of respondents is increasing
from 315 to 378 hospital partners due to
increased participation in PCNASP.
Thus, the burden for hospital inventory
data is increasing from 230 to 261 hours
annually.
These requested changes will result in
a net decrease in total average burden
from 382 to 361 hours. All patient,
hospital, and EMS provider data that is
submitted to CDC by PCNASP awardees
will be de-identified and transmitted
through secure data systems. Proposed
data elements and quality indicators
may be updated over time to include
new or revised items based on evolving
recommendations and standards in the
field to improve the quality of stroke
care.
OMB approval is requested for three
years. Participation is voluntary and
there are no costs to respondents other
than their time.
E:\FR\FM\20JNN1.SGM
20JNN1
28822
Federal Register / Vol. 84, No. 119 / Thursday, June 20, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
PCNASP Awardee ..........................................
—
Hospital inventory ...........................................
In-hospital care data ......................................
Pre-hospital care data ....................................
7
Post-hospital transition of care data ..............
2
Hospital Inventory ..........................................
PCNASP Hospital Partners ............................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–13054 Filed 6–19–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–1482]
Scientific Data and Information About
Products Containing Cannabis or
Cannabis-Derived Compounds;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of comment
period.
The Food and Drug
Administration (FDA or we) is
extending the comment period for the
notice that appeared in the Federal
Register of April 3, 2019. The notice
announced a public hearing to obtain
scientific data and information about
the safety, manufacturing, product
quality, marketing, labeling, and sale of
products containing cannabis or
cannabis-derived compounds. In
addition, it notified the public that FDA
was establishing a docket for public
comment on this hearing and that the
docket would close on July 2, 2019. We
are extending the comment period to
give interested parties more time to
comment.
DATES: FDA is extending the comment
period on the notice published in the
Federal Register of April 3, 2019 (84 FR
12969). Submit either electronic or
written comments by July 16, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 16, 2019.
The https://www.regulations.gov
electronic filing system will accept
SUMMARY:
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Number of
respondents
Type of respondents
VerDate Sep<11>2014
17:47 Jun 19, 2019
Jkt 247001
comments until 11:59 p.m. Eastern Time
at the end of July 16, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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
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
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
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Frm 00035
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9
9
2
4
7
4
378
Number of
responses per
respondent
1
4
4
2
4
1
1
Average
burden per
response
(in hours)
8
30/60
30/60
30/60
30/60
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–1482 for ‘‘Scientific Data and
Information About Products Containing
Cannabis or Cannabis-Derived
Compounds.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ We
will review this copy, including the
claimed confidential information, in our
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
E:\FR\FM\20JNN1.SGM
20JNN1
Agencies
[Federal Register Volume 84, Number 119 (Thursday, June 20, 2019)]
[Notices]
[Pages 28820-28822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13054]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-1108]
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 Paul Coverdell National Acute Stroke Program
(PCNASP) 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 February
7, 2019 to obtain comments from the public and affected agencies. CDC
did not receive comments 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.
[[Page 28821]]
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
Paul Coverdell National Acute Stroke Program (PCNASP) (OMB No.
0920-1108, exp. 03/31/2019)--Reinstatement with Change--National Center
for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
Stroke is the fifth leading cause of death in the United States and
results in approximately 145,000 deaths per year. Additionally,
approximately 800,000 stroke events are reported each year, including
approximately 185,000 recurrent strokes. However, many strokes are
preventable, and patient outcomes can be improved through coordinated
care that begins at stroke onset and is delivered in a timely manner.
Stroke outcomes depend upon the rapid recognition of signs and
symptoms of stroke, prompt transport to a treatment facility, and early
rehabilitation. Improving outcomes requires a coordinated systems
approach involving pre-hospital care, emergency department and hospital
care, prevention of complications, post-stroke rehabilitation, and
ongoing secondary prevention. Through the Paul Coverdell National Acute
Stroke Program (PCNASP), CDC has been continuously working to measure
and improve acute stroke care using well-known quality improvement
strategies coupled with frequent evaluation of results. PCNASP awardees
are state health departments who work with participating hospitals,
Emergency Medical Services (EMS) agencies, and other healthcare
partners (e.g., post-stroke recovery facilities) in their jurisdictions
to improve quality of care and transitions of care for stroke patients.
During initial cooperative agreement cycles, PCNASP awardees focused on
improving in-hospital quality of care (QoC) with technical assistance
provided by CDC. Through lessons learned during this process and other
supporting evidence in the field, it has become evident that it is also
important to examine pre- and post-hospital transitions of care to link
the entire continuum of stroke care when improving QoC for stroke
patients.
The PCNASP's current five-year cooperative agreement started on
July 1, 2015 and includes nine awardees and their selected partners
(hospitals, EMS agencies, other healthcare facilities). This current
funding reflects additional emphasis on pre-hospital quality of care as
well as the post-hospital transition of care setting from hospital to
home or other healthcare facility. With technical assistance provided
by CDC, awardees have worked on identifying and using data systems to
systematically collect and report data on all three phases of the
stroke care continuum and on hospital capacity.
PCNASP had OMB approval for the collection of pre-hospital (EMS),
in-hospital, and post-hospital patient care data, as well as hospital
inventory data (OMB No. 0920-1108). This approval expired on 3/31/2019,
and awardees have discontinued data submission. The lapsed information
collection will resume after OMB approval of a reinstatement package.
When possible, in-hospital patient care data continues to align
with standards set by The Joint Commission (TJC) and the American Heart
Association's Get With The Guidelines (GWTG) program. There are no
changes to the estimated burden for the collection of in-hospital data.
The average burden per response remains 30 minutes for awardees, for a
total of 18 hours annually.
Data collection methods for pre- and post-hospital care data are
revised to allow for information collection through existing data
systems, including GWTG and the National Emergency Medical Services
Information System (NEMSIS). CDC has worked with awardees, the American
Heart Association and NEMSIS to identify areas of alignment and new
collaboration to reduce the burden of pre-hospital data collection. The
average burden per response will vary from 30 minutes to two hours.
Thus, the burden for pre-hospital data is being reduced from 96 to 60
burden hours annually. Similarly, the burden for post-hospital data is
reduced from 38 to 22 burden hours annually, because data collection
will occur using GWTG or another similar mechanism, and data will be
transmitted automatically to awardees. The average burden per response
will vary from 30 minutes to two hours per quarter for post-hospital
data collection.
Primary data collection of hospital inventory data is collected to
understand the capacity and infrastructure of the hospitals that admit
and treat stroke patients. The average burden per response remains 30
minutes for hospitals, and eight hours for each PCNASP awardee to
prepare an aggregate hospital inventory file. The number of respondents
is increasing from 315 to 378 hospital partners due to increased
participation in PCNASP. Thus, the burden for hospital inventory data
is increasing from 230 to 261 hours annually.
These requested changes will result in a net decrease in total
average burden from 382 to 361 hours. All patient, hospital, and EMS
provider data that is submitted to CDC by PCNASP awardees will be de-
identified and transmitted through secure data systems. Proposed data
elements and quality indicators may be updated over time to include new
or revised items based on evolving recommendations and standards in the
field to improve the quality of stroke care.
OMB approval is requested for three years. Participation is
voluntary and there are no costs to respondents other than their time.
[[Page 28822]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
PCNASP Awardee........................ Hospital inventory...... 9 1 8
-- In-hospital care data... 9 4 30/60
Pre-hospital care data.. 2 4 30/60
7 4 2
Post-hospital transition 7 4 30/60
of care data.
2 4 1
PCNASP Hospital Partners.............. Hospital Inventory...... 378 1 30/60
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-13054 Filed 6-19-19; 8:45 am]
BILLING CODE 4163-18-P