Agency Information Collection Activities: Submission to OMB for Review and Approval; Nurse Anesthetist Traineeship (NAT) Program Specific Data Forms, OMB Control No. 0915-0374-Revision, 57878-57879 [2019-23564]
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Federal Register / Vol. 84, No. 209 / Tuesday, October 29, 2019 / Notices
Constituent Parts With Electronics or
Software.’’ Some CDER-led combination
products feature a device constituent
part with electronics and/or software
that may be used as a platform across
multiple products. An application for
such a combination product may
necessitate review by multiple centers,
offices, and divisions within FDA. In
addition, because the device constituent
part may be used as a platform in
multiple CDER-led combination
products, the same device information
may be applicable to and used to
support multiple CDER submissions.
For such combination products, a Type
V DMF can be an efficient mechanism
to provide information regarding the
device constituent part when the same
information is applicable to several
CDER applications, and additional
measures to ensure consistency are
needed.
Further, because of rapid advances in
technology, the device constituent part
of these types of combination products
could be modified frequently.
Knowledge of these modifications is
important in determining whether they
have any impact on the safety and
effectiveness of the combination
product or its indications for use.
Amendments to the Type V DMF
provide a regulatory pathway for the
DMF holder to report device
modifications and for FDA to be notified
of and to review device modifications.
Once FDA reviews the Type V DMF
device information for one CDER
application, its review may be
applicable to other CDER applications if
the device information remains
unchanged and is pertinent to products
in other CDER applications that also
incorporate the DMF by reference.
FDA’s ability to use previously
completed scientific reviews for a DMF
can contribute to an efficient FDA
review process and help ensure
consistency across CDER applications
referencing the same information.
This draft guidance applies to Type V
DMF submissions as described above for
CDER-led combination products.
Specifically, the information in this
draft guidance may be appropriate for
device constituent parts with electronics
and/or software that meet the statutory
definition of a device and perform
functions such as the following:
• Facilitate drug delivery in a manner
that may include patient input or
analysis (e.g., an electromechanically
driven pen injector with software that
allows input of patient or dosing
information or that analyzes dosing or
device use information).
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• Provide information that is used in
making a decision regarding treatment,
therapy, or drug delivery.
• Interface with other devices or
systems to provide patient use or other
information to the user or health care
provider (e.g., physiological
parameters).
• Control or drive the features of the
user interface.
This draft guidance addresses process
and general content expectations for
Type V DMFs for such device
constituent parts. It does not address
FDA premarket review standards or
expectations for such constituent parts
or the combination products that
include them. This draft guidance is
also not intended to suggest that a Type
V DMF should be submitted to CDER if
the sponsor has rights of reference to a
device master file located in another
center containing the same information.
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 ‘‘Type V DMFs for CDER-Led
Combination Products Using Device
Constituent Parts With Electronics or
Software.’’ 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.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
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. 3501–3520). The collections
of information in 21 CFR 314.420 have
been approved under OMB control
number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: October 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Nurse
Anesthetist Traineeship (NAT)
Program Specific Data Forms, OMB
Control No. 0915–0374—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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.
DATES: Comments on this ICR should be
received no later than November 29,
2019.
SUMMARY:
Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806.
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:
Nurse Anesthetist Traineeship (NAT)
Program Specific Data Forms, OMB
Control No. 0915–0374—Revision.
Abstract: HRSA provides advanced
education nursing training grants to
educational institutions to increase the
numbers of Certified Registered Nurse
Anesthetists through the NAT Program.
The NAT Program is authorized by
Section 811 of the Public Health Service
(PHS) Act (42 U.S.C. 296j). The NAT
Tables request information on program
participants such as the number of
enrollees/trainees, number of enrollees/
trainees supported, number of
graduates, number of graduates
supported, number of projected
enrollees/trainees, degree program
(Master’s and Doctoral), and the
distribution of Nurse Anesthetists who
practice in underserved, rural, and/or
public health practice settings.
ADDRESSES:
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Federal Register / Vol. 84, No. 209 / Tuesday, October 29, 2019 / Notices
Need and Proposed Use of the
Information: Funds appropriated for the
NAT Program are distributed among
eligible institutions based on a formula,
as permitted by PHS Act section
806(e)(1). HRSA uses the data from the
NAT Tables to determine if the Funding
Factors (either the Statutory Funding
Preference or Special Consideration) are
met, determine the award amount,
ensure compliance with programmatic
and grant requirements, and provide
information to the public and Congress.
The NAT Tables currently collect one
year of data, which allows HRSA to
calculate award amounts for a singleyear project period. For fiscal year 2020,
HRSA is revising the forms that
previously collected one year of data on
prospective students to capture three
years of data, thereby allowing HRSA to
calculate award amounts for a multiyear project period. Table 1 will add
columns to collect Year 2 and Year 3
data for the number of prospective
students. While Table 2 data collection
elements will not change, the header
will change to provide further
clarification about the data being
collected.
Likely Respondents: Respondents will
be applicants to HRSA’s NAT Program.
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
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Table 1—NAT: Enrollment, Traineeship Support, Graduate, Graduates Supported and Projected Data .............
Table 2—NAT: Graduate Data—Rural, Underserved, or
Public Health ....................................................................
100
1
100
3.5
350
100
1
100
2.8
280
Total ..............................................................................
* 100
........................
100
........................
630
* The same respondents are completing Tables 1 and Table 2.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019–23564 Filed 10–28–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Special Emphasis Panel; Conference Support
(R13) Review.
Date: November 19, 2019.
Time: 12:30 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Rockville,
MD 20850 (Telephone Conference Call).
Contact Person: John P. Holden, Ph.D.,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707
Democracy Boulevard, Suite 920, Bethesda,
MD 20892, (301) 496–8775, john.holden@
nih.gov.
Dated: October 23, 2019.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–23553 Filed 10–28–19; 8:45 am]
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Biomedical Imaging and Bioengineering
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Immigration and Customs
Enforcement
[OMB Control Number 1653–0042]
Agency Information Collection
Activities: Extension of a Currently
Approved Collection: Obligor Change
of Address
U.S. Immigration and Customs
Enforcement, Department of Homeland
Security.
ACTION: 30-Day notice.
AGENCY:
In accordance with the
Paperwork Reductions Act (PRA) of
1995 the Department of Homeland
Security (DHS), U.S. Immigration and
Customs Enforcement (ICE) will submit
the following Information Collection
Request (ICR) to the Office of
Management and Budget (OMB) for
review and clearance. This information
collection was previously published in
the Federal Register on July 24, 2019,
allowing for a 60-day comment period.
ICE received no comments in
connection with the 60-day notice.
Based on better estimates, ICE is making
an adjustment from the 60-day notice to
reflect a decrease in the number of
respondents. The purpose of this notice
SUMMARY:
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[Federal Register Volume 84, Number 209 (Tuesday, October 29, 2019)]
[Notices]
[Pages 57878-57879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23564]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Nurse Anesthetist Traineeship (NAT) Program
Specific Data Forms, OMB Control No. 0915-0374--Revision
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.
DATES: Comments on this ICR should be received no later than November
29, 2019.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to [email protected] or by
fax to (202) 395-5806.
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 [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Nurse Anesthetist Traineeship
(NAT) Program Specific Data Forms, OMB Control No. 0915-0374--Revision.
Abstract: HRSA provides advanced education nursing training grants
to educational institutions to increase the numbers of Certified
Registered Nurse Anesthetists through the NAT Program. The NAT Program
is authorized by Section 811 of the Public Health Service (PHS) Act (42
U.S.C. 296j). The NAT Tables request information on program
participants such as the number of enrollees/trainees, number of
enrollees/trainees supported, number of graduates, number of graduates
supported, number of projected enrollees/trainees, degree program
(Master's and Doctoral), and the distribution of Nurse Anesthetists who
practice in underserved, rural, and/or public health practice settings.
[[Page 57879]]
Need and Proposed Use of the Information: Funds appropriated for
the NAT Program are distributed among eligible institutions based on a
formula, as permitted by PHS Act section 806(e)(1). HRSA uses the data
from the NAT Tables to determine if the Funding Factors (either the
Statutory Funding Preference or Special Consideration) are met,
determine the award amount, ensure compliance with programmatic and
grant requirements, and provide information to the public and Congress.
The NAT Tables currently collect one year of data, which allows HRSA to
calculate award amounts for a single-year project period. For fiscal
year 2020, HRSA is revising the forms that previously collected one
year of data on prospective students to capture three years of data,
thereby allowing HRSA to calculate award amounts for a multi-year
project period. Table 1 will add columns to collect Year 2 and Year 3
data for the number of prospective students. While Table 2 data
collection elements will not change, the header will change to provide
further clarification about the data being collected.
Likely Respondents: Respondents will be applicants to HRSA's NAT
Program.
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 Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Table 1--NAT: Enrollment, 100 1 100 3.5 350
Traineeship Support, Graduate,
Graduates Supported and
Projected Data.................
Table 2--NAT: Graduate Data-- 100 1 100 2.8 280
Rural, Underserved, or Public
Health.........................
-------------------------------------------------------------------------------
Total....................... * 100 .............. 100 .............. 630
----------------------------------------------------------------------------------------------------------------
* The same respondents are completing Tables 1 and Table 2.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-23564 Filed 10-28-19; 8:45 am]
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