Agency Information Collection Activities: Proposed Collection; Comment Request, 18548-18549 [2023-06421]
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18548
Federal Register / Vol. 88, No. 60 / Wednesday, March 29, 2023 / Notices
patterns, devices, manufacturing
processes, or customer names.
Josephine Liu,
Assistant General Counsel for Legal Counsel.
[FR Doc. 2023–06451 Filed 3–28–23; 8:45 am]
BILLING CODE 6750–01–P
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, 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) approve the proposed
information collection project ‘‘AHRQ
Research Reporting System (ARRS).’’
The purpose of this notice is to allow 60
days for public comment.
DATES: Comments on this notice must be
received by May 30, 2023.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Proposed Project
AHRQ Research Reporting System
(ARRS)
AHRQ has developed a systematic
method for its grantees to report project
progress and important preliminary
findings for grants funded by the
Agency. This system, the AHRQ
Research Reporting System (ARRS),
previously known as the Grants
Reporting System (GRS), was last
approved by OMB on August 31, 2020.
The system addressed the shortfalls in
the previous reporting process and
established a consistent and
comprehensive reporting solution for
grants in AHRQ. The ARRS provides a
centralized repository of grants research
progress and additional information that
can be used to support initiatives within
the Agency. This includes future
research planning and support for
administrative activities such as
performance monitoring, budgeting, and
knowledge transfer, as well as for
strategic planning.
This Project has the following goals:
(1) To promote the transfer of critical
information more frequently and
efficiently and enhance the Agency’s
ability to support research designed to
improve the outcomes and quality of
health care, reduce its costs, and
broaden access to effective services.
(2) To increase the efficiency of the
Agency in responding to ad-hoc
information requests.
(3) To support Executive Branch
requirements for increased transparency
and public reporting.
(4) To establish a consistent approach
throughout the Agency for information
collection regarding grant progress and
a systematic basis for oversight and for
facilitating potential collaborations
among grantees.
(5) To decrease the inconvenience and
burden on grantees of unanticipated adhoc requests for information by the
Agency in response to particular (onetime) internal and external requests for
information.
This project is being conducted by
AHRQ through its contractor, Science
Applications International Corporation,
Inc, 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 quality
measurement and improvement. 42
U.S.C 299a(a)(1) and (2)
Method of Collection
Grantees use the ARRS system to
report project progress and important
preliminary findings for grants funded
by the Agency. Grantees submit progress
reports on a monthly or quarterly basis,
which are reviewed by AHRQ
personnel. All users access the ARRS
system through a secure online interface
which requires a user id and password
entered through the ARRS Login screen.
When status reports are due AHRQ
notifies Principal Investigators (PI) via
email.
The ARRS is an automated userfriendly resource that is utilized by
AHRQ staff for preparing, distributing,
and reviewing reporting requests to
grantees for the purpose of information
sharing. AHRQ personnel are able to
systematically search the information
collected and stored in the ARRS
database. Personnel will also use the
information to address internal and/or
external requests for information
regarding grant progress, preliminary
findings, and other requests, such as
Freedom of Information Act requests,
and producing responses related to
federally mandated programs and
regulations.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents. It will take grantees an
estimated 15 minutes to enter the
necessary data into the ARRS System.
Frequency of reporting varies from
monthly to once a year. The total
number of responses submitted for the
past year is considered for this
estimation. Based on that, the total
annualized burden hours are estimated
to be 125 hours.
Exhibit 2 shows the estimated
annualized cost burden for the
respondents. The total estimated cost
burden for respondents is $5,475.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses
ddrumheller on DSK120RN23PROD with NOTICES1
Form name
Hours per
response
Total burden
hours
Data entry into ARRS ..................................................................................................................
500
15/60
125
Total ......................................................................................................................................
500
N/A
125
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19:20 Mar 28, 2023
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18549
Federal Register / Vol. 88, No. 60 / Wednesday, March 29, 2023 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
responses
Form name
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
Data entry into ARRS ......................................................................................
500
125
$43.80
$5,475
Total ..........................................................................................................
500
125
N/A
5,475
* Based upon the average wages for Healthcare Practitioner and Technical Occupations (29–0000), ‘‘National Compensation Survey: Occupational Wages in the United States, May 2021,’’ U.S. Department of Labor, Bureau of Labor Statistics, https://www.bls.gov/oes/current/oes_
nat.htm#29-0000.
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: March 21, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023–06421 Filed 3–28–23; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2023–D–0488]
Orthopedic Non-Spinal Bone Plates,
Screws, and Washers—Premarket
Notification (510(k)) Submissions;
Draft Guidance for Industry and Food
and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
VerDate Sep<11>2014
19:20 Mar 28, 2023
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Orthopedic NonSpinal Bone Plates, Screws, and
Washers—Premarket Notification
(510(k)) Submissions.’’ This draft
guidance document provides
recommendations for information to
include in 510(k) submissions for nonresorbable bone plate, screw, and
washer devices. The scope of this draft
guidance includes devices that are
indicated for orthopedic bone fixation
but does not include devices indicated
for spinal, mandibular, maxillofacial,
cranial, and orbital fracture fixation.
This draft guidance is not final nor is it
for implementation at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by May 30, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Jkt 259001
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
PO 00000
Frm 00038
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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
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–D–0488] for ‘‘Orthopedic NonSpinal Bone Plates, Screws, and
Washers—Premarket Notification
(510(k)) Submissions.’’ Received
comments 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, 240–402–7500.
• 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.’’ The
Agency will review this copy, including
the claimed confidential information, in
its 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
E:\FR\FM\29MRN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 60 (Wednesday, March 29, 2023)]
[Notices]
[Pages 18548-18549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06421]
=======================================================================
-----------------------------------------------------------------------
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, 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) approve the proposed information collection
project ``AHRQ Research Reporting System (ARRS).'' The purpose of this
notice is to allow 60 days for public comment.
DATES: Comments on this notice must be received by May 30, 2023.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at
[email protected].
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
AHRQ Research Reporting System (ARRS)
AHRQ has developed a systematic method for its grantees to report
project progress and important preliminary findings for grants funded
by the Agency. This system, the AHRQ Research Reporting System (ARRS),
previously known as the Grants Reporting System (GRS), was last
approved by OMB on August 31, 2020. The system addressed the shortfalls
in the previous reporting process and established a consistent and
comprehensive reporting solution for grants in AHRQ. The ARRS provides
a centralized repository of grants research progress and additional
information that can be used to support initiatives within the Agency.
This includes future research planning and support for administrative
activities such as performance monitoring, budgeting, and knowledge
transfer, as well as for strategic planning.
This Project has the following goals:
(1) To promote the transfer of critical information more frequently
and efficiently and enhance the Agency's ability to support research
designed to improve the outcomes and quality of health care, reduce its
costs, and broaden access to effective services.
(2) To increase the efficiency of the Agency in responding to ad-
hoc information requests.
(3) To support Executive Branch requirements for increased
transparency and public reporting.
(4) To establish a consistent approach throughout the Agency for
information collection regarding grant progress and a systematic basis
for oversight and for facilitating potential collaborations among
grantees.
(5) To decrease the inconvenience and burden on grantees of
unanticipated ad-hoc requests for information by the Agency in response
to particular (one-time) internal and external requests for
information.
This project is being conducted by AHRQ through its contractor,
Science Applications International Corporation, Inc, 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 quality measurement
and improvement. 42 U.S.C 299a(a)(1) and (2)
Method of Collection
Grantees use the ARRS system to report project progress and
important preliminary findings for grants funded by the Agency.
Grantees submit progress reports on a monthly or quarterly basis, which
are reviewed by AHRQ personnel. All users access the ARRS system
through a secure online interface which requires a user id and password
entered through the ARRS Login screen. When status reports are due AHRQ
notifies Principal Investigators (PI) via email.
The ARRS is an automated user-friendly resource that is utilized by
AHRQ staff for preparing, distributing, and reviewing reporting
requests to grantees for the purpose of information sharing. AHRQ
personnel are able to systematically search the information collected
and stored in the ARRS database. Personnel will also use the
information to address internal and/or external requests for
information regarding grant progress, preliminary findings, and other
requests, such as Freedom of Information Act requests, and producing
responses related to federally mandated programs and regulations.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondents. It will take grantees an estimated 15 minutes to enter the
necessary data into the ARRS System. Frequency of reporting varies from
monthly to once a year. The total number of responses submitted for the
past year is considered for this estimation. Based on that, the total
annualized burden hours are estimated to be 125 hours.
Exhibit 2 shows the estimated annualized cost burden for the
respondents. The total estimated cost burden for respondents is $5,475.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Hours per Total burden
Form name responses response hours
----------------------------------------------------------------------------------------------------------------
Data entry into ARRS............................................ 500 15/60 125
-----------------------------------------------
Total....................................................... 500 N/A 125
----------------------------------------------------------------------------------------------------------------
[[Page 18549]]
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Average
Form name Number of Total burden hourly wage Total cost
responses hours rate * burden
----------------------------------------------------------------------------------------------------------------
Data entry into ARRS............................ 500 125 $43.80 $5,475
---------------------------------------------------------------
Total....................................... 500 125 N/A 5,475
----------------------------------------------------------------------------------------------------------------
* Based upon the average wages for Healthcare Practitioner and Technical Occupations (29-0000), ``National
Compensation Survey: Occupational Wages in the United States, May 2021,'' U.S. Department of Labor, Bureau of
Labor Statistics, https://www.bls.gov/oes/current/oes_nat.htm#29-0000.
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: March 21, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-06421 Filed 3-28-23; 8:45 am]
BILLING CODE 4160-90-P
