Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments; Postponement
| Published date | 17 April 2020 |
| Citation | 85 FR 21445 |
| Record Number | 2020-08167 |
| Section | Notices |
| Court | Food And Drug Administration |
21445
Federal Register / Vol. 85, No. 75 / Friday, April 17, 2020 / Notices
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
Management Information Systems for
Comprehensive Cancer Control
Programs (OMB Control No. 0920–0841,
Exp. 6/30/2019)—Reinstatement with
Change—National Center for Chronic
Disease and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
In 2017, 66 awardees, representing all
50 states, the District of Columbia, seven
United States Association Pacific
Islands and territories, and eight tribes
and tribal organizations, were selected
for funding under NOFO (DP17–1701,
‘‘Cancer Prevention and Control
Programs for State, Territorial, and
Tribal Organizations’’). Under this
cooperative agreement, awardees
implement cancer prevention and
control programs to reduce cancer
morbidity, mortality, and disparities. To
facilitate program monitoring,
performance assessment, and
evaluation, a web-based management
information system (MIS) is needed for
collection and abstraction of
information about program resources,
partnerships, work plan activities, and
evaluation efforts. Information
collection is organized into eight areas
(MIS tabs): (1) FOA & Recipients; (2)
Program Information; (3) Resources; (4)
Leadership Team; (5) Financial; (6)
Planning; (7) Action Plan; and (8)
Reports. The Leadership Team tab is
new. CDC conducted user acceptability
testing of the leadership team tab data
elements which allowed for an accurate
estimate of burden per response. All
information collected by CDC will be
analyzed and used in aggregate to
describe program efforts.
OMB approval is requested for three
years, which coincides with the last
three years of the program. All awardees
will submit information to CDC
annually. Participation is required as a
condition of funding under the
cooperative agreement. The estimated
burden per response is one hour and the
total estimated annualized burden is 66
hours.
E
STIMATED
A
NNUALIZED
B
URDEN
H
OURS
Type of respondents Form name Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Program Director for State- Tribal-, or
Territorial- based Cancer Prevention and
Control Program.
Data Elements for All CPC Programs: An-
nual Reporting. 66 1 1
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–08164 Filed 4–16–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0907]
Medical Device User Fee Amendments
for Fiscal Years 2023 Through 2027;
Public Meeting; Request for
Comments; Postponement
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice of public meeting;
postponed.
SUMMARY
: The Food and Drug
Administration (FDA) is announcing
that the public meeting entitled
‘‘Medical Device User Fee Amendments
for Fiscal Years 2023 Through 2027;
Public Meeting; Request for Comments’’
that was scheduled in the Federal
Register on April 3, 2020, to take place
on May 5, 2020, is postponed until
further notice.
DATES
: The public meeting will be
rescheduled for a future date.
Information about the rescheduled
meeting will be provided when
available. Submit either electronic or
written comments on the medical
device user fee program and suggestions
regarding the commitments FDA should
propose for the next reauthorized
program.
FOR FURTHER INFORMATION CONTACT
:
Ellen Olson, Center for Devices and
Radiological Health, Food and Drug
Administration, Bldg. 66, Rm. 1664,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–4322,
ellen.olson@fda.hhs.gov or CDRH-
OPEQ-StrategicInitiatives@fda.hhs.gov.
SUPPLEMENTARY INFORMATION
: The
public meeting entitled ‘‘Medical Device
User Fee Amendments for Fiscal Years
2023 Through 2027; Public Meeting;
Request for Comments’’ was originally
announced in the Federal Register of
March 6, 2020 (85 FR 13165), and was
initially scheduled for April 7, 2020. On
April 3, 2020, the meeting was
postponed to May 5, 2020, and was
planned to take place by webcast only
due to extenuating circumstances (85 FR
18992). FDA continues to evaluate
whether and how to proceed with
upcoming scheduled meetings while
our day-to-day operations are impacted
by the COVID–19 public health
emergency, and we have decided to
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21446
Federal Register / Vol. 85, No. 75 / Friday, April 17, 2020 / Notices
postpone this public meeting until
further notice. Information on the
rescheduled meeting will be provided in
the future when available. The web page
for the ‘‘Medical Device User Fee
Amendments for Fiscal Years 2023
Through 2027; Public Meeting’’ is
available at https://www.fda.gov/
medical-devices/workshops-
conferences-medical-devices/2020-
medical-device-meetings-and-
workshops. Interested persons may
continue to submit comments on the
medical device user fee program and
suggestions regarding the commitments
FDA should propose for the next
reauthorized program to the public
docket.
Dated: April 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–08167 Filed 4–16–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Advanced Nursing
Education Workforce, OMB No. 0915–
0375 Extension
AGENCY
: Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION
: Notice.
SUMMARY
: In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR have been provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this Notice has
closed.
DATES
: Comments on this ICR should be
received no later than May 18, 2020.
ADDRESSES
: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT
: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION
:
Information Collection Request Title:
Advanced Nursing Education Workforce
Program-Specific Data Collection Forms,
OMB No. 0915–0375 Extension.
Abstract: HRSA provides advanced
education nursing training grants to
educational institutions to increase the
numbers of advanced education nurses
through the Advanced Nursing
Education Workforce (ANEW) Program.
The ANEW Program is authorized by
Section 811 of the Public Health Service
Act (42 U.S.C. 296j), as amended. This
request is to extend the use of ANEW
Program Specific forms, specifically
Tables #1 and #2. There are no proposed
changes to these tables. ANEW Table #1
collects information on the types of
practice settings where graduates, who
received ANEW support as students, are
currently employed. The data on
graduates’ employment practice settings
demonstrate the distribution of
specialties, i.e., nurse practitioners,
clinical nurse specialists and nurse
midwives, who are practicing in rural,
underserved, public health nursing, and
Health Professional Shortage Areas
(HPSA) practice settings. ANEW Table
#2 requests information on the projected
number of primary care advanced
practice registered nursing student
enrollees/trainees who will receive
traineeship support for each upcoming
budget year over the entire project
period. This data provides a baseline for
comparison to data collected on the
numbers of students/enrollees/trainees
supported that are reported on the
Annual Performance Reports.
A 60-day notice published in the
Federal Register on January 22, 2020,
vol. 85, No. 14; pp. 3697–3698. There
were no public comments.
Need and Proposed Use of the
Information: ANEW Program-Specific
Table #1 captures data on the number of
graduates of the academic partner
applicant who received HRSA support
and are currently employed in rural
areas, undeserved areas, public health
nursing, and HPSA practice settings.
The graduate data collected measure the
impact of the ANEW Program in
meeting the legislative and program
goals. ANEW Program-Specific Table #2
collects information on the projected
number of students/enrollees to receive
traineeship support each budget year of
the project period and provides a
baseline for student/enrollee support
that is reported in the Annual
Performance Reports. Collecting this
data assists HRSA in carrying out the
most impactful program and ensuring
resources are used responsibly.
Likely Respondents: Likely
respondents will be current ANEW
awardees, who will submit the data
tables as part of a Noncompeting
Continuation progress report, and
applicants for the ANEW program,
including schools of nursing, nursing
centers, academic health centers, state
or local governments, and other public
or private nonprofit entities determined
appropriate by the Secretary that are
accredited to carry out primary care
nurse practitioner and nurse midwifery
programs by a national nurse education
accrediting agency recognized by the
Secretary of the U.S. Department of
Education. The school must be located
in one of the 50 U.S. States, the District
of Columbia, Guam, the Commonwealth
of Puerto Rico, the Northern Mariana
Islands, the Virgin Islands, American
Samoa, the U.S. Virgin Islands, the
Federated States of Micronesia, the
Republic of the Marshall Islands, or the
Republic of Palau.
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.
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