Agency Information Collection Activities: Proposed Collection; Comment Request, 28111-28112 [2021-10938]
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Federal Register / Vol. 86, No. 99 / Tuesday, May 25, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) reapprove the proposed
information collection project
‘‘Ambulatory Surgery Center Survey on
Patient Safety Culture Database.’’
DATES: Comments on this notice must be
received by July 26, 2021.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection plans,
data collection instruments, and specific
details on the estimated burden can be
obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality (AHRQ) requests that the Office
of Management and Budget (OMB)
reapprove, under the Paperwork
Reduction Act of 1995, AHRQ’s
collection of information for the AHRQ
Ambulatory Surgery Center (ASC)
Survey on Patient Safety (SOPS)
Database; OMB NO. 0935–0242;
Approved September 10, 2018.
In 1999, the Institute of Medicine
called for health care organizations to
develop a ‘‘culture of safety’’ such that
their workforce and processes focus on
improving the reliability and safety of
care for patients (IOM, 1999; To Err is
Human: Building a Safer Health
System). To respond to the need for
tools to assess patient safety culture in
health care, AHRQ developed and pilot
tested the ASC Survey on Patient Safety
Culture (OMB NO. 0935–0216;
approved October 31, 2013).
The survey is designed to enable
ASCs to assess provider and staff
perspectives about patient safety issues,
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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18:09 May 24, 2021
Jkt 253001
medical error, and error reporting. The
survey includes 27 items that measure
8 composites of patient safety culture. In
addition to the composite items, the
survey includes one item measuring
how often ASCs document near-misses;
one item asking whether the respondent
is in the room during surgeries,
procedures, or treatments; and three
items about communication before and
after surgeries, procedures, or
treatments. The survey also includes an
overall rating item on patient safety, two
items about respondent characteristics,
and a section for open-ended comments.
AHRQ made the survey publicly
available along with a Survey User’s
Guide and other toolkit materials in
May 2015 on the AHRQ website.
The AHRQ ASC SOPS Database
consists of data from the AHRQ ASC
Survey on Patient Safety Culture.
Ambulatory surgery centers in the U.S.
can voluntarily submit data from the
survey to AHRQ, through its contractor,
Westat. The ASC SOPS Database (OMB
NO. 0935–0242; Approved September
10, 2018) was developed by AHRQ in
response to requests from ASCs
interested in tracking their own survey
results. Organizations submitting data
receive a feedback report, as well as a
report of the aggregated, de-identified
findings of the other ASCs submitting
data. These reports are used to assist
ASC staff in their efforts to improve
patient safety culture in their
organizations.
This database:
1. Presents results from ASCs that
voluntarily submit their data;
2. Provides data to ASCs to facilitate
internal assessment and learning in the
patient safety improvement process; and
3. Provides supplemental information
to help ASCs identify their strengths
and areas with potential for
improvement in patient safety culture.
This study is being conducted by
AHRQ through its contractor, Westat,
pursuant to AHRQ’s statutory authority
to conduct and support research on
health care and on systems for the
delivery of such care, including
activities with respect to the quality,
effectiveness, efficiency,
appropriateness and value of healthcare
services and with respect to health
statistics, surveys, and database
development. 42 U.S.C. 299a(a)(1) and
(8).
Method of Collection
To achieve the goal of this project the
following activities and data collections
will be implemented:
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Fmt 4703
Sfmt 4703
28111
1. Eligibility and Registration Form—
The point-of-contact (POC), often the
manager of the ASC, completes a
number of data submission steps and
forms, beginning with completion of an
online Eligibility and Registration Form.
The purpose of this form is to collect
basic demographic information about
the ASC and initiate the registration
process.
2. Data Use Agreement—The purpose
of the data use agreement, completed by
the ASC manager, is to state how data
submitted by ASCs will be used and
provides privacy assurances.
3. ASC Site Information—The
purpose of the site level specifications,
completed by the ASC POC, is to collect
background characteristics of the ASC.
This information will be used to analyze
data collected with the ASC SOPS
survey.
4. Data Files Submission—POCs
upload their data file(s), using ASC
survey data file specifications, to ensure
that users submit standardized and
consistent data in the way variables are
named, coded, and formatted. The
number of submissions to the database
is likely to vary each year because ASCs
do not administer the survey and submit
data every year. Data submission is
typically handled by one POC who is
either an ASC administrative manager
or a survey vendor who contracts with
an ASC to collect and submit its data.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in the
database. An estimated 100 ASC
managers (i.e., POCs from ASCs) will
complete the database submission steps
and forms. Each POC will submit the
following:
• Eligibility and registration form
(completion is estimated to take about 5
minutes).
• Data use agreement (completion is
estimated to take about 3 minutes).
• ASC Site Information Form
(completion is estimated to take about 5
minutes).
• Survey data submission will take an
average of one hour.
The total burden is estimated to be
121 hours.
Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to submit their data.
The cost burden is estimated to be
$5,804.37
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28112
Federal Register / Vol. 86, No. 99 / Tuesday, May 25, 2021 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents/POCs
Number of
responses per
POC
Eligibility and Registration Form ..............................................................
Data Use Agreement ...............................................................................
ASC Site Information Form .....................................................................
Data Files Submission .............................................................................
100
100
100
100
1
1
1
1
5/60
3/60
5/60
1
8
5
8
100
Total ..................................................................................................
NA
NA
NA
121
Form name
Hours per
response
Total burden
hours
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents/POCs
Form name
Total
burden
hours
Average
hourly wage
rate *
Total cost
burden
Eligibility and Registration Form ..............................................................
Data Use Agreement ...............................................................................
ASC Site Information ...............................................................................
Data Files Submission .............................................................................
100
100
100
100
8
5
8
100
$47.97
47.97
47.97
47.97
$383.76
239.85
383.76
4,797.00
Total ..................................................................................................
NA
121
NA
5,804.37
* Based on the mean hourly wage for 100 ASC Administrative Services Managers (11–3010; $47.97) obtained from the May 2019 National Industry-Specific Occupational Employment and Wage Estimates: NAICS 621400—Outpatient Care Centers (located at https://www.bls.gov/oes/
current/naics4_621400.htm#11-00000).
Request for Comments
jbell on DSKJLSW7X2PROD with NOTICES
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: May 19, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–10938 Filed 5–24–21; 8:45 am]
BILLING CODE 4160–90–P
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18:09 May 24, 2021
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–P–2048]
Determination That MANGANESE
SULFATE, Injectable, Equivalent 0.1
Milligram Manganese/Milliliter, 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 MANGANESE
SULFATE, injectable, equivalent (Eq)
0.1 milligram (mg) manganese/milliliter
(mL), was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for MANGANESE
SULFATE, injectable, Eq 0.1 mg
manganese/mL, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Sungjoon Chi, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6216,
Silver Spring, MD 20993–0002, 240–
402–9674, Sungjoon.Chi@fda.hhs.gov.
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
SUMMARY:
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Fmt 4703
Sfmt 4703
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
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]]>Agencies
[Federal Register Volume 86, Number 99 (Tuesday, May 25, 2021)]
[Notices]
[Pages 28111-28112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10938]
[[Page 28111]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) reapprove the proposed information
collection project ``Ambulatory Surgery Center Survey on Patient Safety
Culture Database.''
DATES: Comments on this notice must be received by July 26, 2021.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at
[email protected]. Copies of the proposed collection plans,
data collection instruments, and specific details on the estimated
burden can be obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
[email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality (AHRQ) requests that the Office of Management and Budget (OMB)
reapprove, under the Paperwork Reduction Act of 1995, AHRQ's collection
of information for the AHRQ Ambulatory Surgery Center (ASC) Survey on
Patient Safety (SOPS) Database; OMB NO. 0935-0242; Approved September
10, 2018.
In 1999, the Institute of Medicine called for health care
organizations to develop a ``culture of safety'' such that their
workforce and processes focus on improving the reliability and safety
of care for patients (IOM, 1999; To Err is Human: Building a Safer
Health System). To respond to the need for tools to assess patient
safety culture in health care, AHRQ developed and pilot tested the ASC
Survey on Patient Safety Culture (OMB NO. 0935-0216; approved October
31, 2013).
The survey is designed to enable ASCs to assess provider and staff
perspectives about patient safety issues, medical error, and error
reporting. The survey includes 27 items that measure 8 composites of
patient safety culture. In addition to the composite items, the survey
includes one item measuring how often ASCs document near-misses; one
item asking whether the respondent is in the room during surgeries,
procedures, or treatments; and three items about communication before
and after surgeries, procedures, or treatments. The survey also
includes an overall rating item on patient safety, two items about
respondent characteristics, and a section for open-ended comments. AHRQ
made the survey publicly available along with a Survey User's Guide and
other toolkit materials in May 2015 on the AHRQ website.
The AHRQ ASC SOPS Database consists of data from the AHRQ ASC
Survey on Patient Safety Culture. Ambulatory surgery centers in the
U.S. can voluntarily submit data from the survey to AHRQ, through its
contractor, Westat. The ASC SOPS Database (OMB NO. 0935-0242; Approved
September 10, 2018) was developed by AHRQ in response to requests from
ASCs interested in tracking their own survey results. Organizations
submitting data receive a feedback report, as well as a report of the
aggregated, de-identified findings of the other ASCs submitting data.
These reports are used to assist ASC staff in their efforts to improve
patient safety culture in their organizations.
This database:
1. Presents results from ASCs that voluntarily submit their data;
2. Provides data to ASCs to facilitate internal assessment and
learning in the patient safety improvement process; and
3. Provides supplemental information to help ASCs identify their
strengths and areas with potential for improvement in patient safety
culture.
This study is being conducted by AHRQ through its contractor,
Westat, pursuant to AHRQ's statutory authority to conduct and support
research on health care and on systems for the delivery of such care,
including activities with respect to the quality, effectiveness,
efficiency, appropriateness and value of healthcare services and with
respect to health statistics, surveys, and database development. 42
U.S.C. 299a(a)(1) and (8).
Method of Collection
To achieve the goal of this project the following activities and
data collections will be implemented:
1. Eligibility and Registration Form--The point-of-contact (POC),
often the manager of the ASC, completes a number of data submission
steps and forms, beginning with completion of an online Eligibility and
Registration Form. The purpose of this form is to collect basic
demographic information about the ASC and initiate the registration
process.
2. Data Use Agreement--The purpose of the data use agreement,
completed by the ASC manager, is to state how data submitted by ASCs
will be used and provides privacy assurances.
3. ASC Site Information--The purpose of the site level
specifications, completed by the ASC POC, is to collect background
characteristics of the ASC. This information will be used to analyze
data collected with the ASC SOPS survey.
4. Data Files Submission--POCs upload their data file(s), using ASC
survey data file specifications, to ensure that users submit
standardized and consistent data in the way variables are named, coded,
and formatted. The number of submissions to the database is likely to
vary each year because ASCs do not administer the survey and submit
data every year. Data submission is typically handled by one POC who is
either an ASC administrative manager or a survey vendor who contracts
with an ASC to collect and submit its data.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondents' time to participate in the database. An estimated 100 ASC
managers (i.e., POCs from ASCs) will complete the database submission
steps and forms. Each POC will submit the following:
Eligibility and registration form (completion is estimated
to take about 5 minutes).
Data use agreement (completion is estimated to take about
3 minutes).
ASC Site Information Form (completion is estimated to take
about 5 minutes).
Survey data submission will take an average of one hour.
The total burden is estimated to be 121 hours.
Exhibit 2 shows the estimated annualized cost burden based on the
respondents' time to submit their data. The cost burden is estimated to
be $5,804.37
[[Page 28112]]
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Total burden
respondents/POCs POC response hours
----------------------------------------------------------------------------------------------------------------
Eligibility and Registration Form........... 100 1 5/60 8
Data Use Agreement.......................... 100 1 3/60 5
ASC Site Information Form................... 100 1 5/60 8
Data Files Submission....................... 100 1 1 100
-------------------------------------------------------------------
Total................................... NA NA NA 121
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Average
Form name Number of Total burden hourly wage Total cost
respondents/POCs hours rate * burden
----------------------------------------------------------------------------------------------------------------
Eligibility and Registration Form........... 100 8 $47.97 $383.76
Data Use Agreement.......................... 100 5 47.97 239.85
ASC Site Information........................ 100 8 47.97 383.76
Data Files Submission....................... 100 100 47.97 4,797.00
-------------------------------------------------------------------
Total................................... NA 121 NA 5,804.37
----------------------------------------------------------------------------------------------------------------
* Based on the mean hourly wage for 100 ASC Administrative Services Managers (11-3010; $47.97) obtained from the
May 2019 National Industry-Specific Occupational Employment and Wage Estimates: NAICS 621400--Outpatient Care
Centers (located at https://www.bls.gov/oes/current/naics4_621400.htm#11-00000).
Request for Comments
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3520, comments on AHRQ's information collection are requested with
regard to any of the following: (a) Whether the proposed collection of
information is necessary for the proper performance of AHRQ's health
care research and health care information dissemination functions,
including whether the information will have practical utility; (b) the
accuracy of AHRQ's estimate of burden (including hours and costs) of
the proposed collection(s) of information; (c) ways to enhance the
quality, utility and clarity of the information to be collected; and
(d) ways to minimize the burden of the collection of information upon
the respondents, including the use of automated collection techniques
or other forms of information technology.
Comments submitted in response to this notice will be summarized
and included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Dated: May 19, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-10938 Filed 5-24-21; 8:45 am]
BILLING CODE 4160-90-P
