National Biodefense Science Board Public Meeting, 48490 [2022-16978]
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48490
Federal Register / Vol. 87, No. 152 / Tuesday, August 9, 2022 / Notices
may have already undergone eSTAR set
up for other types of submission, e.g.,
premarket notification, fewer
respondents may need to undergo
eSTAR setup than estimated.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’
Q-Submissions:
CDRH ...............................................................
CBER ...............................................................
2,160
60
1
1
2,160
60
137 .....................
137 .....................
295,920
8,220
Q-Submissions Using eSTAR (21 CFR Part 814, Subparts A Through E; Section 745A(b) of the FD&C Act)
CDRH ......................................................................
CBER ......................................................................
eSTAR setup ...........................................................
Manufacturer request to participate in EPFP .........
1,440
40
1,480
30
1
1
1
1
1,440
40
1,480
30
69 .......................
69 .......................
0.08 (5 minutes)
2 .........................
99,360
2,760
118
60
Total ..........................................................
........................
........................
........................
............................
406,438
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Including the EPFP form represents a
revision to this information collection
request. Our estimated burden for the
information collection reflects the
availability of eSTAR to assist electronic
preparation of Q-submissions and
addition of the EPFP form, resulting in
an overall decrease of 85,803 hours.
Dated: August 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17058 Filed 8–8–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Biodefense Science Board
Public Meeting
Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The National Biodefense
Science Board (NBSB or the Board),
authorized under Section 319M of the
Public Health Service (PHS) Act, as
added by Section 402 of the Pandemic
and All-Hazards Preparedness Act of
2006 and amended by Section 404 of the
Pandemic and All-Hazards
Preparedness Reauthorization Act, will
hold a public meeting. The NBSB
provides expert advice and guidance to
the Department of Health and Human
Services (HHS) regarding current and
future chemical, biological, radiological,
and nuclear threats, as well as other
matters related to disaster preparedness
and response. The Assistant Secretary
jspears on DSK121TN23PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:04 Aug 08, 2022
Jkt 256001
for Preparedness and Response (ASPR)
manages and convenes the NBSB on
behalf the Secretary. A detailed agenda
and Zoom registration instructions will
be posted on the ASPR website at least
two weeks in advance.
DATES: The public meeting will be held
on September 29, 2022 beginning at 11
a.m. Eastern time.
FOR FURTHER INFORMATION CONTACT:
CAPT Christopher Perdue, NBSB
Designated Federal Official, NBSB@
hhs.gov, 202–401–5837.
SUPPLEMENTARY INFORMATION: Those
interested may attend the meeting via a
toll-free phone number or Zoom
teleconference, which requires preregistration. The meeting link to preregister will be posted on the meeting
website. The online meeting will
include American Sign Language
interpretation and live captioning.
Members of the public may provide
written comments or submit questions
at any time via email to NBSB@hhs.gov.
Additionally, the NBSB invites
stakeholders to request up to seven
minutes to address the Board in-person
during the meeting. The Board wishes to
hear from experts from relevant
biomedical, biodefense, or health
industries; faculty or researchers at
academic institutions; health
professionals, health system experts, or
those who work in health care consumer
organizations; or experts in state, Tribal,
territorial, or local government agencies.
Requests to provide remarks to the
NBSB during the public meeting must
be sent to NBSB@hhs.gov by September
15, 2022. In that request, please provide
the speaker’s name, title, position, and
organization with a brief description of
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
the topic that they will address.
Requests to speak to the Board will be
approved in consultation with the Board
Chair and based on time available
during the meeting. Obvious
commercial bias, to include any form of
advertising, marketing, or solicitation,
will not be allowed.
Dawn O’Connell,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2022–16978 Filed 8–8–22; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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.
Name of Committee: National Institute on
Aging Special Emphasis Panel SARS–CoV–2
infection and genetic variations effects on
Risk of Cognitive Decline.
E:\FR\FM\09AUN1.SGM
09AUN1
Agencies
[Federal Register Volume 87, Number 152 (Tuesday, August 9, 2022)]
[Notices]
[Page 48490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16978]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Biodefense Science Board Public Meeting
AGENCY: Office of the Assistant Secretary for Preparedness and Response
(ASPR), Department of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Biodefense Science Board (NBSB or the Board),
authorized under Section 319M of the Public Health Service (PHS) Act,
as added by Section 402 of the Pandemic and All-Hazards Preparedness
Act of 2006 and amended by Section 404 of the Pandemic and All-Hazards
Preparedness Reauthorization Act, will hold a public meeting. The NBSB
provides expert advice and guidance to the Department of Health and
Human Services (HHS) regarding current and future chemical, biological,
radiological, and nuclear threats, as well as other matters related to
disaster preparedness and response. The Assistant Secretary for
Preparedness and Response (ASPR) manages and convenes the NBSB on
behalf the Secretary. A detailed agenda and Zoom registration
instructions will be posted on the ASPR website at least two weeks in
advance.
DATES: The public meeting will be held on September 29, 2022 beginning
at 11 a.m. Eastern time.
FOR FURTHER INFORMATION CONTACT: CAPT Christopher Perdue, NBSB
Designated Federal Official, [email protected], 202-401-5837.
SUPPLEMENTARY INFORMATION: Those interested may attend the meeting via
a toll-free phone number or Zoom teleconference, which requires pre-
registration. The meeting link to pre-register will be posted on the
meeting website. The online meeting will include American Sign Language
interpretation and live captioning.
Members of the public may provide written comments or submit
questions at any time via email to [email protected]. Additionally, the NBSB
invites stakeholders to request up to seven minutes to address the
Board in-person during the meeting. The Board wishes to hear from
experts from relevant biomedical, biodefense, or health industries;
faculty or researchers at academic institutions; health professionals,
health system experts, or those who work in health care consumer
organizations; or experts in state, Tribal, territorial, or local
government agencies. Requests to provide remarks to the NBSB during the
public meeting must be sent to [email protected] by September 15, 2022. In
that request, please provide the speaker's name, title, position, and
organization with a brief description of the topic that they will
address. Requests to speak to the Board will be approved in
consultation with the Board Chair and based on time available during
the meeting. Obvious commercial bias, to include any form of
advertising, marketing, or solicitation, will not be allowed.
Dawn O'Connell,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2022-16978 Filed 8-8-22; 8:45 am]
BILLING CODE 4150-37-P