Agency Information Collection Activities: Proposed Collection; Comment Request, 12562-12563 [2020-04277]
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Federal Register / Vol. 85, No. 42 / Tuesday, March 3, 2020 / Notices
If sign language interpretation or other
reasonable accommodation for a
disability is needed, please contact the
Food and Drug Administration (FDA)
Office of Equal Employment
Opportunity and Diversity Management
on (301) 827–4840, no later than
Thursday, March 12, 2020. The agenda,
roster, and minutes will be available
from Ms. Heather Phelps, Committee
Management Officer, Agency for
Healthcare Research and Quality, 5600
Fishers Lane, Rockville, Maryland
20857. Ms. Phelps’ phone number is
(301) 427–1128.
Dated: February 26, 2020.
Virginia L. Mackay-Smith,
Associate Director.
SUPPLEMENTARY INFORMATION:
AGENCY:
In accordance with section 10(a) of
the Federal Advisory Committee Act, 5
U.S.C. App., this notice announces a
meeting of the National Advisory
Council for Healthcare Research and
Quality (the Council). The Council is
authorized by Section 941 of the Public
Health Service Act, 42 U.S.C. 299c. In
accordance with its statutory mandate,
the Council is to advise the Secretary of
the Department of Health and Human
Services and the Director of AHRQ on
matters related to AHRQ’s conduct of its
mission including providing guidance
on (A) priorities for health care research,
(B) the field of health care research
including training needs and
information dissemination on health
care quality, and (C) the role of the
Agency in light of private sector activity
and opportunities for public private
partnerships. The Council is composed
of members of the public, appointed by
the Secretary, and Federal ex-officio
members specified in the authorizing
legislation.
lotter on DSKBCFDHB2PROD with NOTICES
II. Agenda
On Thursday, March 26, 2020, the
Council meeting will convene at 8:30
a.m., with the call to order by the
Council Chair and approval of previous
Council summary notes. The meeting is
open to the public and will be available
via webcast at
www.webconferences.com/ahrq. The
meeting will begin with an update on
AHRQ’s recent accomplishments and
budget. The agenda will also include a
discussion about 21st Century Care,
AHRQ’s Digital Healthcare Research
Agenda, and Synthetic Data. The
meeting will adjourn at 2:45 p.m. The
final agenda will be available on the
AHRQ website at www.AHRQ.gov no
later than Thursday, March 19, 2020.
17:19 Mar 02, 2020
Jkt 250001
BILLING CODE 4160–90–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.
I. Purpose
VerDate Sep<11>2014
[FR Doc. 2020–04293 Filed 3–2–20; 8:45 am]
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).’’
DATES: Comments on this notice must be
received by 60 days after date of
publication.
SUMMARY:
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:
ADDRESSES:
Proposed Project
AHRQ Research Reporting System
(ARRS)
AHRQ has developed a systematic
method for its grantees and vendors to
report project progress and important
preliminary findings for grants and
contracts 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 May 22nd,
2017. The system addressed the
shortfalls in the previous reporting
process and established a consistent and
comprehensive grants reporting solution
for AHRQ. The ARRS provides a
centralized repository of grant and
contract research progress and
additional information that can be used
to support initiatives within the Agency.
This includes future research planning
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and support for administrative activities
such as performance monitoring,
budgeting, knowledge transfer and
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
and contract progress and a
systematic basis for oversight and for
facilitating potential collaborations
among grantees
(5) To decrease the inconvenience and
burden on grantees and vendors 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 pursuant to AHRQ’s statutory
authority to conduct and support
research on healthcare 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
To achieve the goals of this project the
following data collections will be
implemented:
AHRQ Research Reporting System
(ARRS)—Grantees and vendors use the
ARRS system to report project progress
and important preliminary findings for
grants and contracts funded by the
Agency. Grantees and vendors 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 I.D. and
password entered through the ARRS
login screen. When status reports are
due AHRQ notifies principal
investigators and vendors via email.
The ARRS is an automated userfriendly resource that is utilized by
AHRQ staff for preparing, distributing,
and reviewing reporting requests to
grantees and vendors for the purpose of
E:\FR\FM\03MRN1.SGM
03MRN1
12563
Federal Register / Vol. 85, No. 42 / Tuesday, March 3, 2020 / Notices
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 and
vendors an estimated 15 minutes to
enter the necessary data into the ARRS
System and reporting will occur four
Number of
respondents
Form name
times annually. The total annualized
burden hours are estimated to be 500
hours.
Exhibit 2 shows the estimated
annualized cost burden for the
respondents. The total estimated cost
burden for respondents is $19,710.
Exhibit 1 Estimated Annualized
Burden Hours
Number of
responses per
respondent
Hours per
response
Total burden
hours
Data entry into ARRS ......................................................................................
500
4
15/60
500
Total ..........................................................................................................
500
N/A
N/A
500
Exhibit 2
Burden
Estimated Annualized Cost
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
Data entry into ARRS ......................................................................................
500
500
$39.42
$19,710
Total ..........................................................................................................
500
500
N/A
19,710
* Based upon the average wages for Healthcare Practitioner and Technical Occupations (29–0000), ‘‘National Compensation Survey: Occupational Wages in the United States, May 2015,’’ U.S. Department of Labor, Bureau of Labor Statistics, https://www.bls.gov/oes/current/oes_
nat.htm#29-0000.
lotter on DSKBCFDHB2PROD with NOTICES
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
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.
VerDate Sep<11>2014
17:19 Mar 02, 2020
Jkt 250001
Dated: February 26, 2020.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2020–04277 Filed 3–2–20; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–4436]
Bone Anchors—Premarket Notification
(510(k)) Submissions; Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Bone Anchors—
Premarket Notification (510(k))
Submissions.’’ This guidance document
provides recommendations for 510(k)
submissions for bone anchor (suture
anchor) devices. FDA is clarifying and
providing current thinking on the
recommended content for a bone anchor
510(k) submission, including
performance testing recommendations
and device description.
SUMMARY:
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The announcement of the
guidance is published in the Federal
Register on March 3, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
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
E:\FR\FM\03MRN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 42 (Tuesday, March 3, 2020)]
[Notices]
[Pages 12562-12563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04277]
-----------------------------------------------------------------------
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).''
DATES: Comments on this notice must be received by 60 days after date
of publication.
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:
Proposed Project
AHRQ Research Reporting System (ARRS)
AHRQ has developed a systematic method for its grantees and vendors
to report project progress and important preliminary findings for
grants and contracts 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 May 22nd, 2017. The
system addressed the shortfalls in the previous reporting process and
established a consistent and comprehensive grants reporting solution
for AHRQ. The ARRS provides a centralized repository of grant and
contract 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, knowledge transfer and 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 and contract progress and a
systematic basis for oversight and for facilitating potential
collaborations among grantees
(5) To decrease the inconvenience and burden on grantees and vendors 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 pursuant to AHRQ's statutory
authority to conduct and support research on healthcare 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
To achieve the goals of this project the following data collections
will be implemented:
AHRQ Research Reporting System (ARRS)--Grantees and vendors use the
ARRS system to report project progress and important preliminary
findings for grants and contracts funded by the Agency. Grantees and
vendors 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 I.D. and
password entered through the ARRS login screen. When status reports are
due AHRQ notifies principal investigators and vendors 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 and vendors for the purpose of
[[Page 12563]]
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 and vendors an estimated 15 minutes
to enter the necessary data into the ARRS System and reporting will
occur four times annually. The total annualized burden hours are
estimated to be 500 hours.
Exhibit 2 shows the estimated annualized cost burden for the
respondents. The total estimated cost burden for respondents is
$19,710.
Exhibit 1 Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Data entry into ARRS............................ 500 4 15/60 500
---------------------------------------------------------------
Total....................................... 500 N/A N/A 500
----------------------------------------------------------------------------------------------------------------
Exhibit 2 Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Form name respondents hours wage rate * burden
----------------------------------------------------------------------------------------------------------------
Data entry into ARRS............................ 500 500 $39.42 $19,710
---------------------------------------------------------------
Total....................................... 500 500 N/A 19,710
----------------------------------------------------------------------------------------------------------------
* Based upon the average wages for Healthcare Practitioner and Technical Occupations (29-0000), ``National
Compensation Survey: Occupational Wages in the United States, May 2015,'' 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-
3521, 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: February 26, 2020.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2020-04277 Filed 3-2-20; 8:45 am]
BILLING CODE 4160-90-P
