Agency Forms Undergoing Paperwork Reduction Act Review, 47954-47956 [2019-19632]
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47954
Federal Register / Vol. 84, No. 176 / Wednesday, September 11, 2019 / Notices
3.108(c)(2)(i) of the Patient Safety Rule
regarding notification to providers that
have reported to the PSO and of section
3.108(c)(2)(ii) regarding disposition of
PSWP consistent with section
3.108(b)(3). According to section
3.108(b)(3) of the Patient Safety Rule,
the PSO had 90 days from the effective
date of delisting and revocation to
complete the disposition of PSWP that
was currently in the PSOs’ possession.
More information on PSOs can be
obtained through AHRQ’s PSO website
at https://www.pso.ahrq.gov.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019–19581 Filed 9–10–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Common Formats for Patient Safety
Data Collection
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice of availability—new
common formats.
AGENCY:
As authorized by the
Secretary of HHS, AHRQ coordinates
the development of sets of common
definitions and reporting formats
(Common Formats or formats) for
reporting on health care quality and
patient safety. The purpose of this
notice is to announce the availability of
the Common Formats for Nursing Home
Version 1.0
DATES: Ongoing public input.
ADDRESSES: The Common Formats for
Nursing Home Version 1.0 can be
accessed electronically at the following
website: https://www.psoppc.org/
psoppc_web/publicpages/
commonFormatsOverview.
SUMMARY:
Dr.
Hamid Jalal, Center for Quality
Improvement and Patient Safety, AHRQ,
5600 Fishers Lane, Rockville, MD
20857; Telephone (toll free): (866) 403–
3697; Telephone (local): (301) 427–
1111; TTY (toll free): (866) 438–7231;
TTY (local): (301) 427–1130; Email:
pso@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
jspears on DSK3GMQ082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Background on Common Formats
Development
The Patient Safety and Quality
Improvement Act of 2005, 42 U.S.C.
299b–21 to 299b–26, (Patient Safety Act)
VerDate Sep<11>2014
18:25 Sep 10, 2019
Jkt 247001
and the related Patient Safety and
Quality Improvement Final Rule, 42
CFR part 3 (Patient Safety Rule),
published in the Federal Register on
November 21, 2008, 73 FR 70731–
70814, provide for the formation of
Patient Safety Organizations (PSOs),
which collect, and analyze confidential
and privileged information regarding
the quality and safety of health care
delivery. The collection of patient safety
work product allows the aggregation of
data that help to identify and address
underlying causal factors of patient
safety and quality issues.
Aggregation of these data enables
PSOs and others to identify and address
underlying causal factors of patient
safety and quality issues. The Patient
Safety Act provides for the development
of standardized reporting formats using
common language and definitions to
ensure that health care quality and
patient safety data collected by PSOs
and other entities are comparable. The
Common Formats facilitate aggregation
of comparable data at local, PSO,
regional and national levels. In addition,
the formats are intended to enhance the
reporting of information that is
standardized both clinically and
electronically.
AHRQ has developed Common
Formats for three settings of care—acute
care hospitals, nursing homes, and
community pharmacies—for use by
health care providers and PSOs. AHRQlisted PSOs are required to collect
patient safety work product in a
standardized manner to the extent
practical and appropriate; this is a
requirement the PSO can meet by
collecting such information using
Common Formats. Additionally,
providers and other organizations not
working with an AHRQ-listed PSO can
use the Common Formats in their work
to improve quality and safety; however,
they cannot benefit from the federal
confidentiality and privilege protections
of the Patient Safety Act.
Since February 2005, AHRQ has
convened the Federal Patient Safety
Work Group (PSWG) to assist AHRQ in
developing and maintaining the
Common Formats. The PSWG includes
major health agencies within HHS as
well as the Departments of Defense and
Veterans Affairs. The PSWG helps
assure the consistency of definitions/
formats with those of relevant
government agencies. In addition,
AHRQ has solicited comments from the
private and public sectors regarding
proposed versions of the Common
Formats through a contract, since 2008,
with the National Quality Forum (NQF),
which is a non-profit organization
focused on health care quality. After
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Fmt 4703
Sfmt 4703
receiving comments, the NQF solicits
review of the formats by its Common
Formats Expert Panel. Subsequently,
NQF provides this input to AHRQ who
then uses it to refine the Common
Formats.
The Common Formats Nursing Home
Version 1.0 include five modules:
Generic, falls, medication, pressure
injury and device. AHRQ developed
other elements of the Common Formats
for Event Reporting—Nursing Homes
including aggregate reports, data
elements and algorithims, and technical
specifications. All elements of the
Common Formats for Event Reporting—
Nursing Home will be posted at the
PSOPPC website: https://
www.psoppc.org/psoppc_web.
AHRQ is specifically interested in
receiving feedback in order to guide the
improvement of the formats.
Information on how to comment on the
Common Formats for Nursing Home
Version 1.0 is available at: https://
www.qualityforum.org/Project_Pages/
Common_Formats_for_Patient_Safety_
Data.aspx.
Additional information about the
Common Formats can be obtained
through AHRQ’s PSO website: https://
pso.ahrq.gov/.
Virginia L. Mackay-Smith,
Associate Director .
[FR Doc. 2019–19598 Filed 9–10–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[30Day–19–0041]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Agency for
Toxic Substances and Disease Registry
(ATSDR) has submitted the information
collection request titled ‘‘National
Amyotrophic Lateral Sclerosis (ALS)
Registry’’ to the Office of Management
and Budget (OMB) for review and
approval. ATSDR previously published
a ‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ notice on May 24,
2019 to obtain comments from the
public and affected agencies. ATSDR
did not receive comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
ATSDR will accept all comments for
this proposed information collection
E:\FR\FM\11SEN1.SGM
11SEN1
47955
Federal Register / Vol. 84, No. 176 / Wednesday, September 11, 2019 / Notices
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
National Amyotrophic Lateral
Sclerosis (ALS) Registry—(OMB Control
No. 0923–0041, Exp. 11/30/2019)—
Revision—Agency for Toxic Substances
and Disease Registry (ATSDR).
Background and Brief Description
The Agency for Toxic Substances and
Disease Registry (ATSDR) is requesting
a three-year Paperwork Reduction Act
(PRA) clearance for a revision
information collection request (ICR)
entitled ‘‘The National Amyotrophic
Lateral Sclerosis (ALS) Registry.’’ (OMB
Control No. 0923–0041, Expiration Date
11/30/2019). The current request is a
revision designed to strengthen the
usefulness of the National ALS Registry
for researchers. The changes to the ICR
include:
(1) Addition of an organized sports
participation survey to capture history
and current participation in physical
activities. This additional survey will
take approximately five minutes to
complete and will add an additional 63
total burden hours for respondents;
(2) Two additional questions to
capture race and ethnicity upon
registration with other basic
demographic information will be added
to ALS Case Registration Form prior to
Persons with ALS (PALS) completing
more detailed surveys.
On October 10, 2008, President Bush
signed S.1382: ALS Registry Act which
amended the Public Health Service Act
to provide for the establishment of an
Amyotrophic Lateral Sclerosis (ALS)
Registry. The activities described are
part of the ongoing effort to maintain the
National ALS Registry.
First approved in 2010 for selfregistration, the primary goal of the
surveillance system/registry remains to
obtain reliable information on the
incidence and prevalence of ALS and to
better describe the demographic
characteristics (age, race, sex, and
geographic location) of persons with
ALS. Those interested in participating
in the National ALS Registry must
answer a series of validation questions
and if determined to be eligible, they
can register.
The secondary goal of the surveillance
system/registry is to collect additional
information on potential risk factors for
ALS, including, but not limited to,
family history of ALS, smoking history,
military service, residential history,
lifetime occupational exposure, home
pesticide use, hobbies, participation in
sports, hormonal and reproductive
history (women only), caffeine use,
trauma, health insurance, open-ended
supplemental questions, and clinical
signs and symptoms. After registration,
participants complete as many as 17
voluntary survey modules, each taking
up to five minutes. In addition, in Year
1, a disease progression survey for new
registrants is completed at zero, three,
and six months. In Year 2 and Year 3,
the disease progression survey is
repeated at the yearly anniversary, and
at six months. For burden estimation,
the number of disease progression
survey responses per year has been
rounded up to three times.
A biorepository component was
added in 2016 to increase the value of
the National ALS Registry to
researchers. As part of registration the
participant can request additional
information about the biorepository and
provide additional contact information.
A geographically representative sample
is selected to provide specimens. There
are two types of specimen collections,
in-home and postmortem. The in-home
collection includes blood, urine, and
saliva. The postmortem collection
includes the brain, spinal cord, cerebral
spinal fluid (CSF), bone, muscle, and
skin.
In addition to fulfilling the two-part
Congressional mandate, the Registry is
designed to be a tool for ALS
researchers. Now that the Registry has
matured, ATSDR has made data and
specimens available to approved
researchers and has added a respondent
type. Researchers can request access to
specimens, data, or both collected by
the National ALS Registry for their
research projects. ATSDR will review
applications for scientific validity and
human subjects’ protection and make
data/specimens available to approved
researchers. ATSDR is collaborating
with ALS service organizations to
conduct outreach activities through
their local chapters and districts as well
as on a national level. They provide
ATSDR with information on their
outreach efforts in support of the
Registry on a monthly basis.
There are no costs to the respondents
other than their time. Participation in
this proposed information collection is
completely voluntary. The total number
of burden hours requested is 1,946
hours.
jspears on DSK3GMQ082PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Person with ALS ..............................
ALS Case Validation Questions ...................................
ALS Case Registration Form ........................................
Voluntary Survey Modules ............................................
Disease Progression Survey * ......................................
ALS Biorepository Specimen Processing Form and InHome Collection.
VerDate Sep<11>2014
17:44 Sep 10, 2019
Jkt 247001
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E:\FR\FM\11SEN1.SGM
1,670
1,500
750
750
325
11SEN1
Number of
responses per
respondent
1
1
1
3
1
Average
burden per
response
(in hours)
2/60
10/60
85/60
5/60
30/60
47956
Federal Register / Vol. 84, No. 176 / Wednesday, September 11, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents
Researchers .....................................
ALS Service Organization ................
ALS Biorepository Saliva Collection .............................
ALS Registry Research Application Form ....................
Annual Update ..............................................................
Chapter/District Outreach Reporting Form ...................
National Office Outreach Reporting Form ....................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–19632 Filed 9–10–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–19AUK]
jspears on DSK3GMQ082PROD with NOTICES
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 Promoting
Adolescent Health through SchoolBased HIV Prevention, National Center
for HIV/AIDS, Viral Hepatitis, STD, and
TB 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 Wednesday, June 5, 2019 to
obtain comments from the public and
affected agencies. CDC received 2
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.
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;
VerDate Sep<11>2014
17:44 Sep 10, 2019
Number of
respondents
Form name
Jkt 247001
(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
Promoting Adolescent Health through
School-Based HIV Prevention—New—
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Many young people engage in sexual
behaviors that place them at risk for HIV
infection, other sexually transmitted
diseases (STD), and pregnancy.
According to the 2017 Youth Risk
Behavior Survey (YRBS), 39.5% of high
school students in the United States had
ever had sexual intercourse and 28.7%
were currently sexually active. Among
currently sexually active students,
46.2% did not use a condom, and 13.8%
did not use any method to prevent
pregnancy the last time they had sexual
intercourse. While the proportion of
high school students who are sexually
active has steadily declined, half of the
20 million new STDs reported each year
are among young people between the
ages of 15 and 24. Young people aged
PO 00000
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Fmt 4703
Sfmt 4703
350
36
24
135
2
Number of
responses per
respondent
1
1
1
12
12
Average
burden per
response
(in hours)
10/60
30/60
15/60
5/60
20/60
13–24 account for 21% of all new HIV
diagnoses in the United States, with
most occurring among 20–24 year olds.
Establishing healthy behaviors during
childhood and adolescence is easier and
more effective than trying to change
unhealthy behaviors during adulthood.
One venue that offers valuable
opportunities for improving adolescent
health is at school. Schools have direct
contact with over 50 million students
for at least six hours a day over 13 key
years of their social, physical, and
intellectual development. In addition,
schools often have staff with knowledge
of critical health risk and protective
behaviors and have pre-existing
infrastructure that can support a varied
set of healthful interventions. This
makes schools well-positioned to help
reduce adolescents’ risk for HIV
infection and other STD through sexual
health education (SHE), access to sexual
health services (SHS), and safe and
supportive environments (SSE).
Since 1987, the Division of
Adolescent and School Health (DASH)
in the National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention
of the Centers for Disease Control and
Prevention (CDC), has worked to
support for HIV prevention efforts in the
nation’s schools. CDC requests OMB
approval to collect data over a threeyear period from funded agencies under
award PS18–1807: Promoting
Adolescent Health through SchoolBased HIV Prevention. Funded agencies
are local education agencies (LEAs), also
known as school districts. The
fundamental purposes of PS18–1807 are
to build and strengthen the capacity of
LEAs and their priority schools to
effectively contribute to the reduction of
HIV infection and other STD among
adolescents; the reduction of disparities
in HIV infection and other STD
experienced by specific adolescent subpopulation. Priority schools are middle
and high schools within the funded
LEAs in which youth are at risk for HIV
infection and other STDs. This funding
supports a multi-component, multilevel
effort to support youth reaching
E:\FR\FM\11SEN1.SGM
11SEN1
]]>Agencies
[Federal Register Volume 84, Number 176 (Wednesday, September 11, 2019)]
[Notices]
[Pages 47954-47956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19632]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[30Day-19-0041]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Agency
for Toxic Substances and Disease Registry (ATSDR) has submitted the
information collection request titled ``National Amyotrophic Lateral
Sclerosis (ALS) Registry'' to the Office of Management and Budget (OMB)
for review and approval. ATSDR previously published a ``Proposed Data
Collection Submitted for Public Comment and Recommendations'' notice on
May 24, 2019 to obtain comments from the public and affected agencies.
ATSDR did not receive comments related to the previous notice. This
notice serves to allow an additional 30 days for public and affected
agency comments.
ATSDR will accept all comments for this proposed information
collection
[[Page 47955]]
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
National Amyotrophic Lateral Sclerosis (ALS) Registry--(OMB Control
No. 0923-0041, Exp. 11/30/2019)--Revision--Agency for Toxic Substances
and Disease Registry (ATSDR).
Background and Brief Description
The Agency for Toxic Substances and Disease Registry (ATSDR) is
requesting a three-year Paperwork Reduction Act (PRA) clearance for a
revision information collection request (ICR) entitled ``The National
Amyotrophic Lateral Sclerosis (ALS) Registry.'' (OMB Control No. 0923-
0041, Expiration Date 11/30/2019). The current request is a revision
designed to strengthen the usefulness of the National ALS Registry for
researchers. The changes to the ICR include:
(1) Addition of an organized sports participation survey to capture
history and current participation in physical activities. This
additional survey will take approximately five minutes to complete and
will add an additional 63 total burden hours for respondents;
(2) Two additional questions to capture race and ethnicity upon
registration with other basic demographic information will be added to
ALS Case Registration Form prior to Persons with ALS (PALS) completing
more detailed surveys.
On October 10, 2008, President Bush signed S.1382: ALS Registry Act
which amended the Public Health Service Act to provide for the
establishment of an Amyotrophic Lateral Sclerosis (ALS) Registry. The
activities described are part of the ongoing effort to maintain the
National ALS Registry.
First approved in 2010 for self-registration, the primary goal of
the surveillance system/registry remains to obtain reliable information
on the incidence and prevalence of ALS and to better describe the
demographic characteristics (age, race, sex, and geographic location)
of persons with ALS. Those interested in participating in the National
ALS Registry must answer a series of validation questions and if
determined to be eligible, they can register.
The secondary goal of the surveillance system/registry is to
collect additional information on potential risk factors for ALS,
including, but not limited to, family history of ALS, smoking history,
military service, residential history, lifetime occupational exposure,
home pesticide use, hobbies, participation in sports, hormonal and
reproductive history (women only), caffeine use, trauma, health
insurance, open-ended supplemental questions, and clinical signs and
symptoms. After registration, participants complete as many as 17
voluntary survey modules, each taking up to five minutes. In addition,
in Year 1, a disease progression survey for new registrants is
completed at zero, three, and six months. In Year 2 and Year 3, the
disease progression survey is repeated at the yearly anniversary, and
at six months. For burden estimation, the number of disease progression
survey responses per year has been rounded up to three times.
A biorepository component was added in 2016 to increase the value
of the National ALS Registry to researchers. As part of registration
the participant can request additional information about the
biorepository and provide additional contact information. A
geographically representative sample is selected to provide specimens.
There are two types of specimen collections, in-home and postmortem.
The in-home collection includes blood, urine, and saliva. The
postmortem collection includes the brain, spinal cord, cerebral spinal
fluid (CSF), bone, muscle, and skin.
In addition to fulfilling the two-part Congressional mandate, the
Registry is designed to be a tool for ALS researchers. Now that the
Registry has matured, ATSDR has made data and specimens available to
approved researchers and has added a respondent type. Researchers can
request access to specimens, data, or both collected by the National
ALS Registry for their research projects. ATSDR will review
applications for scientific validity and human subjects' protection and
make data/specimens available to approved researchers. ATSDR is
collaborating with ALS service organizations to conduct outreach
activities through their local chapters and districts as well as on a
national level. They provide ATSDR with information on their outreach
efforts in support of the Registry on a monthly basis.
There are no costs to the respondents other than their time.
Participation in this proposed information collection is completely
voluntary. The total number of burden hours requested is 1,946 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Person with ALS....................... ALS Case Validation 1,670 1 2/60
Questions.
ALS Case Registration 1,500 1 10/60
Form.
Voluntary Survey Modules 750 1 85/60
Disease Progression 750 3 5/60
Survey *.
ALS Biorepository 325 1 30/60
Specimen Processing
Form and In-Home
Collection.
[[Page 47956]]
ALS Biorepository Saliva 350 1 10/60
Collection.
Researchers........................... ALS Registry Research 36 1 30/60
Application Form.
Annual Update........... 24 1 15/60
ALS Service Organization.............. Chapter/District 135 12 5/60
Outreach Reporting Form.
National Office Outreach 2 12 20/60
Reporting Form.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-19632 Filed 9-10-19; 8:45 am]
BILLING CODE 4163-18-P
