DEPARTMENT OF HEALTH AND HUMAN SERVICES, 42934 [2019-17689]
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42934
Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
disclosures
per respondent
Number of
respondents
Activity/21 CFR section
Information regarding compromised quality; AB 4—
900.12(j)(1).
Patient notification of serious risk—900.12(j)(2) ......
Reconsideration of accreditation—900.15(c) ...........
Notification of requirement to correct major deficiencies—900.24(a).
Notification of loss of approval; major deficiencies—900.24(a)(2).
Notification of probationary status—900.24(b)(1) ....
Notification of loss of approval; minor deficiencies—900.24(b)(3).
Total ..................................................................
Total annual
disclosures
Average burden
per disclosure
Total hours 2
Total
operating and
maintenance
costs
20
1
20
320 ..............................
6,400
646
5
5
0.4
1
1
1
5
5
0.4
100 ..............................
2 ..................................
200 ..............................
500
10
80
20,878
..........................
73
0.15
1
0.15
100 ..............................
15
27
0.3
0.15
1
1
0.3
0.15
200 ..............................
100 ..............................
60
15
55
27
........................
..........................
........................
.....................................
3,691,842
26,141,344
1 There
are no capital costs associated with the collection of information.
2 Total hours have been rounded.
3 Refers to the facility component of the burden for this requirement.
4 Refers to the AB component of the burden for this requirement.
5 Refers to the situation where a patient specifically does not want to receive the lay summary of her exam.
FDA has adjusted the number of
respondents for § 900.3(c) ‘‘AB renewal
of approval’’ to one. This adjustment
resulted in a 14-hour increase to the
hour-burden estimate. Additionally, we
updated the capital costs and operating
and maintenance costs by adjusting
them for inflation since the last update
to those estimates. This adjustment
resulted in a $1,893,071 increase to the
estimated capital and operating and
maintenance costs ($24,410,106
previously; $26,303,177 current
extension request).
Dated: August 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17734 Filed 8–16–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Tick-Borne Disease
Working Group
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the Tick-Borne Disease Working
Group (TBDWG) will hold a meeting.
The meeting will be open to the public.
For this meeting, the Working Group
will receive updates from the eight
subcommittees formed at the June 4,
2019, meeting and continue to focus on
plans to develop the next report to the
jspears on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:29 Aug 16, 2019
Jkt 247001
HHS Secretary and Congress on federal
tick-borne activities and research, taking
into consideration the 2018 report. The
2020 report will address a wide range of
federal activities and research related to
tick-borne diseases, such as,
surveillance, prevention, diagnosis,
diagnostics, and treatment; identify gaps
in tick-borne disease research; and
provide recommendations to the HHS
Secretary regarding changes or
improvements to such activities and
research. In developing the report, the
TBDWG will solicit stakeholder input.
DATES: The meeting will be online via
webcast and will be held on September
12, 2019, from 8:30 a.m. to 5 p.m. ET
(times are tentative and subject to
change). The confirmed times and
agenda items for the meeting will be
posted on the website for the TBDWG at
https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/
2019-9-12/ when this
information becomes available.
ADDRESSES: Members of the public may
also attend the meeting via webcast.
Instructions for attending the virtual
meeting will be posted one week prior
to the meeting at https://www.hhs.gov/
ash/advisory-committees/
tickbornedisease/meetings/2019-9-12/
index.html.
FOR FURTHER INFORMATION CONTACT:
James Berger, Designated Federal Officer
for the TBDWG; Office of Infectious
Disease and HIV/AIDS Policy, Office of
the Assistant Secretary for Health,
Department of Health and Human
Services, Mary E Switzer Building, 330
C Street SW, Suite L100, Washington,
DC 20024. Email: tickbornedisease@
hhs.gov; Phone: 202–795–7697.
SUPPLEMENTARY INFORMATION: The
public will have an opportunity to
present their views to the TBDWG
PO 00000
Frm 00047
Fmt 4703
Sfmt 9990
during the meeting’s public comment
session or by submitting their views in
writing. Comments should be pertinent
to the meeting discussion. Persons who
wish to provide verbal or written public
comment should review instructions at
https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/
2019-9-12/ and respond by
midnight Wednesday, September 4,
2019, ET. Verbal comments will be
limited to three minutes each to
accommodate as many speakers as
possible during the 30 minute session.
Written public comments will be
accessible to the TBDWG members and
public on the TBDWG web page prior to
the meeting.
Background and Authority: The TickBorne Disease Working Group was
established on August 10, 2017, in
accordance with Section 2062 of the
21st Century Cures Act, and the Federal
Advisory Committee Act, 5 U.S.C. App.,
as amended, to provide expertise and
review federal efforts related to tickborne diseases to help ensure
interagency coordination and minimize
overlap, examine research priorities,
and identify and address unmet needs.
The TBDWG is required to submit a
report to the HHS Secretary and
Congress on their findings and any
recommendations for the federal
response to tick-borne disease every two
years.
Dated: August 6, 2019.
James Berger,
Designated Federal Officer, Tick-Borne
Disease Working Group, Senior Advisor for
Blood and Tissue Policy, Office of Infectious
Disease and HIV/AIDS Policy.
[FR Doc. 2019–17689 Filed 8–16–19; 8:45 am]
BILLING CODE 4150–28–P
E:\FR\FM\19AUN1.SGM
19AUN1
]]>[Federal Register Volume 84, Number 160 (Monday, August 19, 2019)]
[Notices]
[Page 42934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17689]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Tick-Borne Disease Working Group
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act, the
Department of Health and Human Services (HHS) is hereby giving notice
that the Tick-Borne Disease Working Group (TBDWG) will hold a meeting.
The meeting will be open to the public. For this meeting, the Working
Group will receive updates from the eight subcommittees formed at the
June 4, 2019, meeting and continue to focus on plans to develop the
next report to the HHS Secretary and Congress on federal tick-borne
activities and research, taking into consideration the 2018 report. The
2020 report will address a wide range of federal activities and
research related to tick-borne diseases, such as, surveillance,
prevention, diagnosis, diagnostics, and treatment; identify gaps in
tick-borne disease research; and provide recommendations to the HHS
Secretary regarding changes or improvements to such activities and
research. In developing the report, the TBDWG will solicit stakeholder
input.
DATES: The meeting will be online via webcast and will be held on
September 12, 2019, from 8:30 a.m. to 5 p.m. ET (times are tentative
and subject to change). The confirmed times and agenda items for the
meeting will be posted on the website for the TBDWG at https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/2019-9-12/ when this information becomes available.
ADDRESSES: Members of the public may also attend the meeting via
webcast. Instructions for attending the virtual meeting will be posted
one week prior to the meeting at https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/2019-9-12/.
FOR FURTHER INFORMATION CONTACT: James Berger, Designated Federal
Officer for the TBDWG; Office of Infectious Disease and HIV/AIDS
Policy, Office of the Assistant Secretary for Health, Department of
Health and Human Services, Mary E Switzer Building, 330 C Street SW,
Suite L100, Washington, DC 20024. Email: [email protected];
Phone: 202-795-7697.
SUPPLEMENTARY INFORMATION: The public will have an opportunity to
present their views to the TBDWG during the meeting's public comment
session or by submitting their views in writing. Comments should be
pertinent to the meeting discussion. Persons who wish to provide verbal
or written public comment should review instructions at https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/2019-9-12/ and respond by midnight Wednesday, September 4, 2019, ET.
Verbal comments will be limited to three minutes each to accommodate as
many speakers as possible during the 30 minute session. Written public
comments will be accessible to the TBDWG members and public on the
TBDWG web page prior to the meeting.
Background and Authority: The Tick-Borne Disease Working Group was
established on August 10, 2017, in accordance with Section 2062 of the
21st Century Cures Act, and the Federal Advisory Committee Act, 5
U.S.C. App., as amended, to provide expertise and review federal
efforts related to tick-borne diseases to help ensure interagency
coordination and minimize overlap, examine research priorities, and
identify and address unmet needs. The TBDWG is required to submit a
report to the HHS Secretary and Congress on their findings and any
recommendations for the federal response to tick-borne disease every
two years.
Dated: August 6, 2019.
James Berger,
Designated Federal Officer, Tick-Borne Disease Working Group, Senior
Advisor for Blood and Tissue Policy, Office of Infectious Disease and
HIV/AIDS Policy.
[FR Doc. 2019-17689 Filed 8-16-19; 8:45 am]
BILLING CODE 4150-28-P
