Agency Information Collection Activities: Proposed Collection: Comment Request Information Collection Request Title: Survey of Eligible Users of the National Practitioner Data Bank, OMB No. 0915-0366-Reinstatement With Change, 65833-65834 [2020-22964]
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Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices
Panels
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Medical Devices Dispute Resolution Panel ........
Provides advice to the Center Director on complex or contested scientific issues between FDA
and medical device sponsors, applicants, or manufacturers relating to specific products,
marketing applications, regulatory decisions and actions by FDA, and Agency guidance and
policies.
Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro diagnostic devices for use in clinical laboratory medicine including microbiology, virology, and infectious disease and makes recommendations to the Commissioner.
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Microbiology Devices Panel ...............................
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Persons nominated for the device
panels should be full-time employees of
firms that manufacture products that
would come before the panel, or
consulting firms that represent
manufacturers, or have similar
appropriate ties to industry.
III. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current re´sume´s. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for a particular device panel.
The interested organizations are not
bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
of the Acknowledgement and Consent
form available at the FDA Advisory
Committee Membership Nomination
Portal (see ADDRESSES) within 30 days of
publication of this document (see
DATES). Nominations must also specify
the advisory panel for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the particular device panels listed in the
table. (Persons who nominate
themselves as nonvoting industry
representatives will not participate in
the selection process).
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: October 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–22911 Filed 10–15–20; 8:45 am]
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IV. Application Procedure
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65833
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Nomination
must include a current, complete
re´sume´ or curriculum vitae for each
nominee including current business
address and telephone number, email
address if available, and a signed copy
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request Information
Collection Request Title: Survey of
Eligible Users of the National
Practitioner Data Bank, OMB No. 0915–
0366—Reinstatement With Change
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than December 15,
2020.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
SUMMARY:
E:\FR\FM\16OCN1.SGM
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65834
Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices
information request collection title for
reference.
Information Collection Request Title:
Survey of Eligible Users of the National
Practitioner Data Bank, OMB No. 0915–
0366—Reinstatement With Change.
Abstract: HRSA plans to survey the
users National Practitioner Data Bank
(NPDB). The purpose of this survey is to
assess the overall satisfaction of the
eligible users of the NPDB. This survey
will evaluate the effectiveness of the
NPDB as a flagging system, source of
information, and its use in decision
making. Furthermore, this survey will
collect information from organizations
and individuals who query the NPDB to
understand and improve their user
experience. This survey is a
reinstatement of the 2012 NPDB survey
with some changes.
Need and Proposed Use of the
Information: The survey will collect
information regarding the participants’
experiences of querying and reporting to
the NPDB, perceptions of health care
practitioners with reports, impact of
NPDB reports on organizations’
decision-making, and satisfaction with
various NPDB products and services.
The survey will also be administered
to health care practitioners that use the
self-query service provided by the
NPDB. The self-queriers will be asked
about their experiences of querying, the
impact of having reports in the NPDB on
their careers and health care
organizations’ perceptions, and their
satisfaction with various NPDB products
and services. Understanding selfqueriers’ satisfaction and their use of the
information is an important component
of the survey.
Proposed changes to this ICR include
the following:
1. In the proposed entity survey, there
are 37 modules and 258 questions. From
the previous 2012 survey, there are 15
deleted questions and 13 new questions
in addition to proposed changes to 12
survey questions.
2. In the proposed self-query survey,
there are 22 modules and 88 questions.
From the previous 2012 survey, there
are 5 deleted questions and 5 new
questions in addition to proposed
changes to two survey questions.
Likely Respondents: Eligible users of
the NPDB will be asked to complete a
web-based survey. Data gathered from
the survey will be compared with
previous survey results. This survey
will provide HRSA with the information
necessary for research purposes and for
improving the usability and
effectiveness of the NPDB.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
NPDB Users Entities Respondents .....................................
NPDB Self-Query Respondents ..........................................
15,000
2,000
1
1
15,000
2,000
0.25
0.10
3,750
200
Total ..............................................................................
17,000
........................
17,000
........................
3,950
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–22964 Filed 10–15–20; 8:45 am]
BILLING CODE 4165–15–P
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Number of
responses per
respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: National
Practitioner Data Bank for Adverse
Information on Physicians and Other
Health Care Practitioners—45 CFR Part
60 Regulations and Forms, OMB No.
0915–0126—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
SUMMARY:
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18:59 Oct 15, 2020
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Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
Comments on this ICR should be
received no later than December 15,
2020.
DATES:
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 20857.
ADDRESSES:
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
FOR FURTHER INFORMATION CONTACT:
When
submitting comments or requesting
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65833-65834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22964]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request Information Collection Request Title: Survey of
Eligible Users of the National Practitioner Data Bank, OMB No. 0915-
0366--Reinstatement With Change
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than December
15, 2020.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301)
443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the
[[Page 65834]]
information request collection title for reference.
Information Collection Request Title: Survey of Eligible Users of
the National Practitioner Data Bank, OMB No. 0915-0366--Reinstatement
With Change.
Abstract: HRSA plans to survey the users National Practitioner Data
Bank (NPDB). The purpose of this survey is to assess the overall
satisfaction of the eligible users of the NPDB. This survey will
evaluate the effectiveness of the NPDB as a flagging system, source of
information, and its use in decision making. Furthermore, this survey
will collect information from organizations and individuals who query
the NPDB to understand and improve their user experience. This survey
is a reinstatement of the 2012 NPDB survey with some changes.
Need and Proposed Use of the Information: The survey will collect
information regarding the participants' experiences of querying and
reporting to the NPDB, perceptions of health care practitioners with
reports, impact of NPDB reports on organizations' decision-making, and
satisfaction with various NPDB products and services.
The survey will also be administered to health care practitioners
that use the self-query service provided by the NPDB. The self-queriers
will be asked about their experiences of querying, the impact of having
reports in the NPDB on their careers and health care organizations'
perceptions, and their satisfaction with various NPDB products and
services. Understanding self-queriers' satisfaction and their use of
the information is an important component of the survey.
Proposed changes to this ICR include the following:
1. In the proposed entity survey, there are 37 modules and 258
questions. From the previous 2012 survey, there are 15 deleted
questions and 13 new questions in addition to proposed changes to 12
survey questions.
2. In the proposed self-query survey, there are 22 modules and 88
questions. From the previous 2012 survey, there are 5 deleted questions
and 5 new questions in addition to proposed changes to two survey
questions.
Likely Respondents: Eligible users of the NPDB will be asked to
complete a web-based survey. Data gathered from the survey will be
compared with previous survey results. This survey will provide HRSA
with the information necessary for research purposes and for improving
the usability and effectiveness of the NPDB.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions, to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information, to train personnel and to be able to respond to
a collection of information, to search data sources, to complete and
review the collection of information, and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
NPDB Users Entities Respondents. 15,000 1 15,000 0.25 3,750
NPDB Self-Query Respondents..... 2,000 1 2,000 0.10 200
-------------------------------------------------------------------------------
Total....................... 17,000 .............. 17,000 .............. 3,950
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-22964 Filed 10-15-20; 8:45 am]
BILLING CODE 4165-15-P
