Agency Information Collection Activities: Proposed Collection: Public Comment Request SHIP COVID-19 Testing and Mitigation Program Data Collection, 74095-74096 [2021-28268]
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Federal Register / Vol. 86, No. 247 / Wednesday, December 29, 2021 / Notices
consider comments on the proposed
order (section 515(b) of the FD&C Act,
as amended by FDASIA).
Under the FD&C Act, FDA’s call for
PMAs must, among other things,
contain an opportunity for interested
persons to request a change in the
classification of the device based on
new information (section 515(b)(2) of
the FD&C Act). After consideration of
comments on the proposed order and
findings, FDA must either: (1) Finalize
the call for PMAs by issuing an
administrative order requiring approval
of a PMA and publishing in the Federal
Register findings with respect to: (i) The
degree of risk of illness or injury
designed to be eliminated or reduced by
requiring the device to have an
approved PMA or a declared completed
product development protocol and (ii)
the benefit to the public from the use of
the device; or (2) publish a notice in the
Federal Register terminating the
proceeding and initiate a reclassification
proceeding based on new information
(section 515(b)(3) of the FD&C Act, as
amended by FDASIA; see section 513(e)
of the FD&C Act).
The FD&C Act, as amended by
FDASIA, now requires the use of
administrative orders, rather than
rulemaking, when FDA calls for PMAs
for a preamendments device remaining
in class III (section 515(b) of the FD&C
Act, as amended by FDASIA).
FDA refers to a device that was not in
commercial distribution before the 1976
Amendments as a postamendments
device. Postamendments devices are
classified automatically into class III by
statute, without any rulemaking process
(section 513(f)(1) of the FD&C Act). A
postamendments device remains in
class III and is subject to the PMA
requirements unless and until: (1) FDA
reclassifies the device into class I or II;
(2) FDA issues an order classifying the
device into class I or II via the De Novo
classification process (see section
513(f)(2) of the FD&C Act); or (3) FDA
issues an order finding the device to be
substantially equivalent to a predicate
device that does not require the filing of
a PMA (see section 513(i) of the FD&C
Act).
FDA may initiate, or the manufacturer
or importer of a device may petition for,
the reclassification of a
postamendments device classified into
class III by operation of law (section
513(f)(3) of the FD&C Act). This FDAinitiated reclassification process
consists of a proposed reclassification
order, optional panel consultation, and
a final reclassification order published
in the Federal Register following
consideration of comments and any
panel recommendations or comments
(§ 860.134(c) (21 CFR 860.134(c))). The
reclassification order may, as
appropriate, establish special controls to
provide reasonable assurance of the
safety and effectiveness of the device
(§ 860.134(d)).
Under the 1976 Amendments,
Congress classified all those devices
previously regulated as new drugs into
class III (generally referred to as
transitional devices). Under the FD&C
Act, FDA may initiate, or the
manufacturer or importer of a device
may petition for, the reclassification of
a transitional device remaining in class
III (section 520(l)(2) of the FD&C Act (21
U.S.C. 360j(l)(2)). The process for
reclassification of transitional devices
initiated by FDA is detailed in 21 CFR
?860.136(c). This process consists of a
proposed reclassification order, optional
panel consultation, and a final
reclassification order published in the
Federal Register following
consideration of comments and any
panel recommendations or comments.
In the Federal Register of September
7, 2021 (86 FR 50132), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
§ 860.123; supporting data for reclassification petitions ......
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section; information collection activity
6
1
6
Total hours
497
2,982
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: December 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–28305 Filed 12–28–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0906–0066—Extension]
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request SHIP COVID–19
Testing and Mitigation Program Data
Collection
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
khammond on DSKJM1Z7X2PROD with NOTICES
Average
burden per
response
Total annual
responses
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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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 February 28,
2022.
DATES:
Submit your comments to
paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 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 Samantha Miller, the acting
HRSA Information Collection Clearance
Officer at (301) 443–9094.
FOR FURTHER INFORMATION CONTACT:
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Federal Register / Vol. 86, No. 247 / Wednesday, December 29, 2021 / Notices
When
submitting comments or requesting
information, please include the
information collection request title for
reference.
Information Collection Request Title:
Small Rural Hospital Improvement
Program (SHIP) COVID–19 Testing and
Mitigation Program Data Collection
OMB No. 0906–0066—Extension.
Abstract: The American Rescue Plan
Act of 2021 (Pub. L. 117–2) provided
one-time funding for awards that will be
carried out under Section 711 of the
Social Security Act (42 U.S.C.
912(b)(5)). The SHIP is requesting an
extension of an information collection
request. State grantees will improve
health care in rural areas by using the
funding to provide support to eligible
SUPPLEMENTARY INFORMATION:
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.
rural hospitals to increase COVID–19
testing efforts, expand access to testing
in rural communities, and expand the
range of mitigation activities.
Need and Proposed Use of the
Information: The terms and conditions
for this program specify that, ‘‘hospitals
will be required to report on the number
of tests provided and categories in
which the funding is spent.’’ The data
will allow HRSA to ensure SHIP
COVID–19 recipients are meeting the
terms and conditions of their funding,
while providing HRSA with information
on the effectiveness of funds distributed
through this program.
Likely Respondents: The respondents
will be hospital staff and designated
Representatives, and State Office of
Rural Health Staff.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of respondents
Number of respondents
per respondent
1,540 .......................................
Number of unique organizations funded through the
program.
6 ..............................................
Reported on a quarterly basis
during the 18 month program or until the end of the
public health emergency
(whichever is first).
..................................................
Form name
SHIP COVID–19 Testing and
Mitigation Data Reporting.
1,540 .......................................
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. 2021–28268 Filed 12–28–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
VerDate Sep<11>2014
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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 cooperative agreement
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the cooperative agreement applications,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Initial
Review Group; Neurological Sciences and
Disorders C Study Section Translational
Neural, Brain, and Pain Relief Devices.
Date: February 8–9, 2022.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Diana M. Cummings,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute of
Neurological Disorders and Stroke, NIH,
NSC, 6001 Executive Blvd., Suite 3208,
Bethesda, MD 20892, cummingsdi@
ninds.nih.gov.
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Average burden per response (in
hours)
Total responses
9,240
.25
9,240
........................
Total burden hours
2,310
Total hours spend on responses for all funded organization over a 2-year period.
2,310
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; NSD–C Member Conflict
Special Emphasis Panel.
Date: February 15, 2022.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Diana M. Cummings,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute of
Neurological Disorders and Stroke, NIH,
NSC, 6001 Executive Blvd., Suite 3208,
Bethesda, MD 20892, cummingsdi@
ninds.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: December 22, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–28277 Filed 12–28–21; 8:45 am]
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]]>Agencies
[Federal Register Volume 86, Number 247 (Wednesday, December 29, 2021)]
[Notices]
[Pages 74095-74096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28268]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
[OMB No. 0906-0066--Extension]
Agency Information Collection Activities: Proposed Collection:
Public Comment Request SHIP COVID-19 Testing and Mitigation Program
Data Collection
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 February
28, 2022.
ADDRESSES: Submit your comments to [email protected] or by mail to 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 Samantha Miller,
the acting HRSA Information Collection Clearance Officer at (301) 443-
9094.
[[Page 74096]]
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information collection request title
for reference.
Information Collection Request Title: Small Rural Hospital
Improvement Program (SHIP) COVID-19 Testing and Mitigation Program Data
Collection OMB No. 0906-0066--Extension.
Abstract: The American Rescue Plan Act of 2021 (Pub. L. 117-2)
provided one-time funding for awards that will be carried out under
Section 711 of the Social Security Act (42 U.S.C. 912(b)(5)). The SHIP
is requesting an extension of an information collection request. State
grantees will improve health care in rural areas by using the funding
to provide support to eligible rural hospitals to increase COVID-19
testing efforts, expand access to testing in rural communities, and
expand the range of mitigation activities.
Need and Proposed Use of the Information: The terms and conditions
for this program specify that, ``hospitals will be required to report
on the number of tests provided and categories in which the funding is
spent.'' The data will allow HRSA to ensure SHIP COVID-19 recipients
are meeting the terms and conditions of their funding, while providing
HRSA with information on the effectiveness of funds distributed through
this program.
Likely Respondents: The respondents will be hospital staff and
designated Representatives, and State Office of Rural Health Staff.
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 respondents per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
SHIP COVID-19 Testing and 1,540.......... 6.............. 9,240 .25 2,310
Mitigation Data Reporting. Number of Reported on a Total hours
unique quarterly spend on
organizations basis during responses for
funded through the 18 month all funded
the program. program or organization
until the end over a 2-year
of the public period.
health
emergency
(whichever is
first).
1,540.......... ............... 9,240 .............. 2,310
----------------------------------------------------------------------------------------------------------------
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. 2021-28268 Filed 12-28-21; 8:45 am]
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