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Federal Register / Vol. 85, No. 38 / Wednesday, February 26, 2020 / Notices

such as abdominal pain and distension.
Finally, FDA considered additional
available mitigations for the spread of
uterine tissue. Since 2014, FDA has
provided marketing authorization for
LPM containment systems intended to
isolate and contain tissue that is
considered benign. These products have
been shown, through bench testing and
simulated use testing, to contain such
tissue during morcellation.
For these reasons, FDA is proposing
in this draft guidance to update its
recommendations, as originally
described in the 2014 guidance
document, concerning the content and
format of certain labeling information
for LPMs. Specifically, FDA is
recommending that manufacturers
incorporate into the labeling for these
devices information providing greater
specificity regarding the risks of use as
it relates to age, information regarding
the risk of spreading benign uterine
tissue, and information regarding the
use of LPM containment systems.

FDA considered comments received
on the final guidance document that
appeared in the Federal Register of
November 25, 2014 (79 FR 70193). FDA
revised the guidance as appropriate in
response to the comments.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Product Labeling for Laparoscopic
Power Morcellators.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological

IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collections of information in the
following FDA regulations have been
approved by OMB as listed in the
following table:

21 CFR part

Topic

807, subpart E ..............................................................................................................
800, 801, and 809 ........................................................................................................
803 ................................................................................................................................

Premarket notification ...............................
Medical Device Labeling Regulations ......
Medical Devices; Medical Device Reporting; Manufacturer reporting, importer
reporting, user facility reporting, distributor reporting.

Dated: February 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03827 Filed 2–25–20; 8:45 am]
BILLING CODE 4164–01–P

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 April 27, 2020.

DATES:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Shortage
Designation Management System
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
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

SUMMARY:

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17:22 Feb 25, 2020

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Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.

ADDRESSES:

Health Resources and Services
Administration

khammond on DSKJM1Z7X2PROD with NOTICES

Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Product Labeling for Laparoscopic
Power Morcellators’’ may send an email
request to [email protected]
to receive an electronic copy of the
document. Please use the document
number 1400052 to identify the
guidance you are requesting.

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.

FOR FURTHER INFORMATION CONTACT:

When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Shortage Designation Management
System OMB No. 0906–0029—Revision.

SUPPLEMENTARY INFORMATION:

PO 00000

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OMB control
No.
0910–0120
0910–0485
0910–0437

Abstract: HRSA’s Bureau of Health
Workforce is committed to improving
the health of the Nation’s underserved
communities and vulnerable
populations by developing,
implementing, evaluating, and refining
programs that strengthen the nation’s
health workforce. HHS relies on two
federal shortage designations to identify
and dedicate resources to areas and
populations in greatest need of
providers: Health Professional Shortage
Area (HPSA) designations and
Medically Underserved Area/Medically
Underserved Population (MUA/P)
designations. HPSA designations are
geographic areas, population groups,
and facilities that are experiencing a
shortage of health professionals. The
authorizing statute for the National
Health Service Corps (NHSC) created
HPSAs to fulfill the statutory
requirement that NHSC personnel be
directed to areas of greatest need. To
further differentiate areas of greatest
need, HRSA calculates a score for each
HPSA. There are three categories of
HPSAs based on health discipline:
Primary care, dental health, and mental
health. Scores range from 1 to 25 for

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Federal Register / Vol. 85, No. 38 / Wednesday, February 26, 2020 / Notices
primary care and mental health and
from 1 to 26 for dental, with higher
scores indicating greater need. They are
used to prioritize applications for NHSC
Loan Repayment Program award
funding, and determine service sites
eligible to receive NHSC Scholarship
and Students-to-Service participants.
MUA/P designations are geographic
areas, or population groups within
geographic areas, that are experiencing
a shortage of primary care health care
services based on the Index of Medical
Underservice. MUAs are designated for
the entire population of a particular
geographic area. MUA/P designations
are limited to particular subset of the
population within a geographic area.
Both designations were created to aid
the federal government in identifying
areas with healthcare workforce
shortages.
As part of HRSA’s cooperative
agreement with the State Primary Care
Offices (PCOs), the State PCOs conduct
needs assessment in their states,
determine what areas are eligible for
designations, and submit designation
applications for HRSA review via the
Shortage Designation Management
System (SDMS). Requests that come
from other sources are referred to the
PCOs for their review, concurrence, and
submission via SDMS. In order to obtain
a federal shortage designation for an
area, population, or facility, PCOs must
submit a shortage designation
application through SDMS for review
and approval by HRSA. Both the HPSA
and MUA/P application request local,
state, and national data on the
population that is experiencing a
shortage of health professionals and the
number of health professionals relative
to the population covered by the

proposed designation. The information
collected on the applications is used to
determine which areas, populations,
and facilities have qualifying shortages.
In addition, interested parties, including
the Governor, the State Primary Care
Association, state professional
associations, etc. are notified of each
designation request submitted via SDMS
for their comments and
recommendations.
Previously, PCOs were required to
provide HRSA with Census, American
Community Survey, and Centers for
Disease Control and Prevention data
specific to the intended geographic area
for designation known as a rational
service area. With the development of
the SDMS, PCOs are no longer required
to provide this information as it is
automatically populated in the system
when they select the service area for
designation.
HRSA reviews the HPSA applications
submitted by the State PCOs, and—if
they meet the designation eligibility
criteria for the type of HPSA or MUA/
P the application is for—designates the
HPSA or MUA/P on behalf of the
Secretary. HPSAs are statutorily
required to be annually reviewed and
revised as necessary after initial
designation to reflect current data.
HPSAs scores, therefore, may and do
change from time to time. Currently,
MUA/Ps do not have a statutorily
mandated review period.
The lists of designated HPSAs are
published annually in the Federal
Register. In addition, lists of HPSAs are
updated on the HRSA website, https://
data.hrsa.gov/tools/shortage-area, so
that interested parties can access the
information.
Need and Proposed Use of the
Information: In 2014, SDMS was

launched to facilitate the collection of
information needed to designate HPSAs
and MUA/Ps. The information obtained
from the SDMS Application is used to
determine which areas, populations,
and facilities have critical shortages of
health professionals per PCO
application submission. The SDMS
HPSA application and SDMS MUA/P
Application are used for these
designation determinations. Applicants
must submit a SDMS application to
HRSA to obtain a federal shortage
designation. The application asks for
local, state, and national data required
to determine the application’s eligibility
to obtain a federal shortage designation.
In addition, applicants must enter in
detailed information explaining how the
area, population, or facility faces a
critical shortage of health professionals.
Likely Respondents: State Primary
Care Offices interested in obtaining a
primary care, dental, or mental HPSA
designation or a MUA/P in their state.
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 ICR are
summarized in the table below.

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

khammond on DSKJM1Z7X2PROD with NOTICES

Form name

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
responses

Total burden
hours

Designation Planning and Preparation ................................
SDMS Application ................................................................

54
54

48
83

2,592
4,482

8.00
4.00

20,736
17,928

Total ..............................................................................

54

........................

7,074

........................

38,664

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

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technology to minimize the information
collection burden.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Maria G. Button,
Director, Executive Secretariat.

[Document Identifier: OS–0990–0438–60D]

[FR Doc. 2020–03783 Filed 2–25–20; 8:45 am]
BILLING CODE 4165–15–P

PO 00000

Agency Information Collection
Request; 60-Day Public Comment
Request
AGENCY:

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Office of the Secretary, HHS.

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