Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health, 55300-55301 [2020-19563]
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Federal Register / Vol. 85, No. 173 / Friday, September 4, 2020 / Notices
include 2 states and 10 tribes, which are
listed in the table below. Grantees
submitted the FY 2019 Carryover and
Reallotment Reports to the OCS, as
required by regulations applicable to
LIHEAP at 45 CFR 96.81(b). After
publication of this notice DEA will
redetermine the final reallotment
amounts and make adjustments where
necessary.
The LIHEAP statute allows grantees
who have funds unobligated at the end
of the federal fiscal year for which they
are awarded to request that they be
allowed to carry over up to 10 percent
of their full-year allotments to the next
federal fiscal year. Funds in excess of
this amount must be returned to HHS
and are subject to reallotment under
section 2607(b)(1) of the Low Income
Home Energy Assistance Act, (42 U.S.C.
8626(b)(1)). The amount described in
this notice was reported by grantees as
unobligated FY 2019 funds in excess of
the amount that these grantees could
carry over to FY 2020. In accordance
with section 2607(b)(3) of the Act (42
U.S.C. 8626(b)(3)), HHS has notified
each grantee of any balance that will be
de-obligated for purpose of this
anticipated reallotment and has given
30 days to provide comments directly to
HHS. Public comments will be accepted
for a period of 30 days from the date of
publication of this notice.
All current LIHEAP grantees will be
notified of the final reallotment amount
redistributed to them for obligation in
FY 2020. This decision will also be
published in the Federal Register and in
a Dear Colleague Letter that is posted to
ACF’s website at https://
www.acf.hhs.gov/ocs/resource/dearcolleagues.
If funds are reallotted, they will be
allocated in accordance with section
2604 of the Act (42 U.S.C. 8623) and
must be treated by LIHEAP grantees
receiving them as an amount
appropriated for FY 2020. As FY 2020
funds, they will be subject to all
requirements of the Act, including
section 2607(b)(2) (42 U.S.C. 8626(b)(2)),
which requires that a grantee obligate at
least 90 percent of its total block grant
allocation for a fiscal year by the end of
the fiscal year for which the funds are
appropriated, that is, by September 30,
2020.
ESTIMATED REALLOTMENT AMOUNTS OF FY 2019 LIHEAP FUNDS
Grantee
reported
reallotment
amount
Grantee name
Ohio .........................................................................................................................................................................
Utah .........................................................................................................................................................................
Chippewa Cree Tribe ...............................................................................................................................................
Coeur d’Alene Tribe .................................................................................................................................................
Colorado River Indian Tribes ...................................................................................................................................
Hoh Indian Tribe ......................................................................................................................................................
Karuk Tribe ..............................................................................................................................................................
Little River Band of Ottawa Indians .........................................................................................................................
Northern Cheyenne Tribe ........................................................................................................................................
Paiute Tribe of Utah ................................................................................................................................................
Quinault Indian Nation .............................................................................................................................................
Sac and Fox Nation of Oklahoma ...........................................................................................................................
Sitka Tribe ................................................................................................................................................................
$206,951
540,516
13,302
1,328
595
2,472
9,337
32,069
5,704
95,125
1,285
30,768
41,606
$206,951
540,516
13,302
1,328
595
0
9,337
3,247
5,704
95,125
7
30,767
41,606
Total ..................................................................................................................................................................
981,058
948,485
Statutory Authority: 42 U.S.C. 8626.
Karen Shields,
Senior Grants Policy Specialist, Office of
Grants Policy.
[FR Doc. 2020–19578 Filed 9–3–20; 8:45 am]
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SUMMARY:
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Submit written comments
(including recommendations) on the
collection of information by October 5,
2020.
SUPPLEMENTARY INFORMATION:
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Submission Process for Voluntary
Allegations to the Center for Devices
and Radiological Health
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
16:42 Sep 03, 2020
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To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0769. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
[Docket No. FDA–2017–N–1095]
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Amount
available for
redistribution
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Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Electronic Submission Process for
Voluntary Allegations to the Center for
Devices and Radiological Health
OMB Control Number 0910–0769—
Extension
This information collection request
collects information voluntarily
submitted to the Center for Devices and
Radiological Health (CDRH) on actual or
potential health risk concerns about a
medical device or radiological product
or its use. Because, prior to the
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Federal Register / Vol. 85, No. 173 / Friday, September 4, 2020 / Notices
establishment of the electronic
submission process for voluntary
allegations to CDRH, there had been no
established guidelines or instructions on
how to submit an allegation to CDRH,
allegations often contained minimal
information and were received via
phone calls, emails, or conversationally.
CDRH has established a consistent
format and process for the submission of
device allegations that enhances our
timeliness in receiving, assessing, and
evaluating voluntary allegations. The
information provided in the allegations
received by CDRH may be used to
clarify the recurrence or emergence of
significant device-related risks to the
general public and the need to initiate
educational outreach or regulatory
action to minimize or mitigate identified
risks.
In the Federal Register of February
10, 2020 (85 FR 7562), we published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received two
comments.
The first comment was not relevant to
the information collection.
The second comment stated that the
rule does not state whether people
submitting allegations of regulatory
misconduct are required to redact their
contact information.
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We disagree with the comment.
Anyone may file a complaint reporting
an allegation of regulatory misconduct.
FDA encourages people submitting
allegations to include supporting
information and contact information in
case additional information is needed
for FDA to understand the allegation
and act on the report; however, you can
choose to submit a report anonymously.
FDA will not share your identity or
contact information with anyone
outside FDA unless required to do so by
law, regulation, or court order.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Electronic submission of voluntary allegations to
CDRH.
1 There
Dated: August 26, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–19563 Filed 9–3–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1767]
Joint Meeting of the
Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
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1,600
1
Total annual
responses
1,600
Average burden
per response
0.25 (15 minutes) .........
Total hours
400
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 225 hours and a
corresponding increase of 900
responses/records. We attribute this
adjustment to an increase in the number
of submissions we received over the last
few years.
AGENCY:
Number of
responses per
respondent
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Joint Meeting of the
Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and Risk
SUMMARY:
VerDate Sep<11>2014
16:42 Sep 03, 2020
Jkt 250001
Management Advisory Committee. The
general function of the committees is to
provide advice and recommendations to
FDA on regulatory issues. The meeting
will be open to the public. FDA is
establishing a docket for public
comment on this document.
DATES: The meeting will be held on
October 8, 2020, from 8 a.m. Eastern
Time to 5 p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2020–N–1767.
The docket will close on October 7,
2020. Submit either electronic or
written comments on this public
meeting by October 7, 2020. Please note
that late, untimely filed comments will
not be considered. Electronic comments
must be submitted on or before October
7, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 7, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
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acceptance receipt is on or before that
date.
Comments received on or before
September 25, 2020, will be provided to
the committees. Comments received
after that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
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]]>Agencies
[Federal Register Volume 85, Number 173 (Friday, September 4, 2020)]
[Notices]
[Pages 55300-55301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19563]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1095]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic Submission
Process for Voluntary Allegations to the Center for Devices and
Radiological Health
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by October 5, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0769. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Electronic Submission Process for Voluntary Allegations to the Center
for Devices and Radiological Health
OMB Control Number 0910-0769--Extension
This information collection request collects information
voluntarily submitted to the Center for Devices and Radiological Health
(CDRH) on actual or potential health risk concerns about a medical
device or radiological product or its use. Because, prior to the
[[Page 55301]]
establishment of the electronic submission process for voluntary
allegations to CDRH, there had been no established guidelines or
instructions on how to submit an allegation to CDRH, allegations often
contained minimal information and were received via phone calls,
emails, or conversationally. CDRH has established a consistent format
and process for the submission of device allegations that enhances our
timeliness in receiving, assessing, and evaluating voluntary
allegations. The information provided in the allegations received by
CDRH may be used to clarify the recurrence or emergence of significant
device-related risks to the general public and the need to initiate
educational outreach or regulatory action to minimize or mitigate
identified risks.
In the Federal Register of February 10, 2020 (85 FR 7562), we
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments.
The first comment was not relevant to the information collection.
The second comment stated that the rule does not state whether
people submitting allegations of regulatory misconduct are required to
redact their contact information.
We disagree with the comment. Anyone may file a complaint reporting
an allegation of regulatory misconduct. FDA encourages people
submitting allegations to include supporting information and contact
information in case additional information is needed for FDA to
understand the allegation and act on the report; however, you can
choose to submit a report anonymously. FDA will not share your identity
or contact information with anyone outside FDA unless required to do so
by law, regulation, or court order.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Electronic submission of 1,600 1 1,600 0.25 (15 400
voluntary allegations to CDRH. minutes).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimated burden for the information collection reflects an
overall increase of 225 hours and a corresponding increase of 900
responses/records. We attribute this adjustment to an increase in the
number of submissions we received over the last few years.
Dated: August 26, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-19563 Filed 9-3-20; 8:45 am]
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