Meeting of the Advisory Commission on Childhood Vaccines; Correction, 22692-22693 [2021-08942]
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Federal Register / Vol. 86, No. 81 / Thursday, April 29, 2021 / Notices
waivers regarding expedited reporting of
certain serious events; therefore, FDA
has estimated one respondent per year
to account for the rare instance a request
may be made. Based on FDA’s
experience with clinical trials using
DMCs, FDA estimates that the sponsor
on average would issue two interim
reports per clinical trial to the DMC.
FDA estimates that the DMCs would
hold two meetings per year per clinical
trial resulting in the issuance of two
DMC reports of meeting minutes to the
sponsor. One set of both of the meeting
records should be maintained per
clinical trial.
The ‘‘Average Burden per Response’’
and ‘‘Average Burden per
Recordkeeping’’ are based on FDA’s
experience with comparable
recordkeeping and reporting provisions
applicable to FDA regulated industry.
The ‘‘Average Burden per Response’’
includes the time the respondent would
spend reviewing, gathering, and
preparing the information to be
submitted to the DMC, FDA, or the
sponsor. The ‘‘Average Burden per
Recordkeeping’’ includes the time to
record, gather, and maintain the
information.
The information collection provisions
in the guidance for 21 CFR 312.30,
312.32, 312.38, 312.55, and 312.56 have
been approved under OMB control
number 0910–0014; 21 CFR 314.50 has
been approved under OMB control
number 0910–0001; and 21 CFR 812.35
and 812.150 have been approved under
OMB control number 0910–0078.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Section of guidance/reporting activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
5. Sponsor reporting to FDA on DMC recommendations related to safety.
37
1
37
0.50 (30 minutes) ..
18.5
Total ......................................................................
........................
........................
........................
................................
18.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Section of guidance/recordkeeping activity
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
4.1. and 6.4. SOPs for DMCs ..............................................
4.4.3.2. DMC meeting records .............................................
37
370
1
1
37
370
8
2
296
740
Total ..............................................................................
........................
........................
........................
........................
1,036
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
4.4.1.2. Sponsor notification to the DMC regarding
waivers.
4.4.3.2. DMC reports of meeting minutes to the
sponsor.
Total ....................................................................
1 There
Total annual
disclosures
Average burden
per disclosure
Total hours
1
1
1
0.25 (15 minutes) ...
0.25
370
2
740
1 .............................
740
........................
..........................
........................
................................
740.25
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: April 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
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Number of
disclosures per
respondent
Number of
respondents
Section of guidance/disclosure activity
[FR Doc. 2021–08963 Filed 4–28–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Commission
on Childhood Vaccines; Correction
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice; correction.
AGENCY:
HRSA published a document
in the Federal Register of January 28,
2021, concerning a meeting of the
SUMMARY:
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18:32 Apr 28, 2021
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Advisory Commission on Childhood
Vaccines. The document contained
incorrect dates. The date of the June
2021 Advisory Commission on
Childhood Vaccines (ACCV) meeting
has changed. The original date for the
June 2021 ACCV meeting was June 3,
2021. The new date for the June 2021
ACCV meeting is June 18, 2021.
FOR FURTHER INFORMATION CONTACT:
Annie Herzog, Division of Injury
Compensation Programs, HRSA, 5600
Fishers Lane, Rockville, Maryland,
20857, (301) 443–6634; or ACCV@
HRSA.gov.
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Federal Register / Vol. 86, No. 81 / Thursday, April 29, 2021 / Notices
For the
latest information regarding the
meeting, including its start time and the
agenda, please access the ACCV
website: https://www.hrsa.gov/advisorycommittees/vaccines/meetings.html.
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of January 28,
2021, FR Doc. 2021–01879, page 7402,
column 3, section 1, paragraph 2,
correct the DATES caption to read:
DATES: ACCV meetings will be held on:
• March 4, 2021, 10:00 a.m. Eastern
Time (ET)–4:00 p.m. ET;
• June 18, 2021, 10:00 a.m. ET–4:00
p.m. ET;
• September 2, 2021, 10:00 a.m. ET–
4:00 p.m. ET;
• December 2, 2021, 10:00 a.m. ET–
4:00 p.m. ET.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–08942 Filed 4–28–21; 8:45 am]
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Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS).
ACTION: Notice.
The National Biodefense
Science Board (NBSB) provides expert
advice and guidance on scientific,
technical, and other matters of special
interest to the Department regarding
current and future chemical, biological,
nuclear, and radiological agents,
whether naturally occurring, accidental,
or deliberate.
DATES: The May 26, 2021, public
teleconference will include a general
discussion of strategic priorities for
public health and medical preparedness
and a possible vote on
recommendations. A more detailed
agenda will be available on the NBSB
meeting website https://www.phe.gov/
nbsb.
SUMMARY:
Members of the public may
attend the meeting via a toll-free call-in
phone number or Web-ex enabled
teleconference, which will be posted on
https://www.phe.gov/nbsb. Members of
the public may provide written
comments for consideration by the
NBSB at any time via email to NBSB@
hhs.gov. If such comments are specific
to the agenda for the current meeting,
please use ‘‘NBSB Public Comment for
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The
National Biodefense Science Board
(NBSB) is authorized under Section
319M of the Public PHS Act, as added
by Section 402 of the Pandemic and AllHazards Preparedness Act of 2006 and
amended by Section 404 of the
Pandemic and All-Hazards
Preparedness Reauthorization Act. The
Board is governed by the Federal
Advisory Committee Act (5 U.S.C.
App.), which sets forth standards for the
formation and use of advisory
committees.
SUPPLEMENTARY INFORMATION:
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AGENCY:
18:32 Apr 28, 2021
CAPT Christopher L. Perdue, MD, MPH,
Executive Director, National Advisory
Committees; NBSB Designated Federal
Officer, Washington, DC, Office NBSB@
hhs.gov, (202) 401–5837.
[FR Doc. 2021–08951 Filed 4–28–21; 8:45 am]
National Biodefense Science Board
Public Teleconference
VerDate Sep<11>2014
FOR FURTHER INFORMATION CONTACT:
Nikki Bratcher-Bowman,
Acting Assistant Secretary for Preparedness
and Response.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ADDRESSES:
05/26/2021 in the subject line. Members
of the public are encouraged to provide
additional comments after the meeting
as well.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research;
Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council for Nursing Research.
The meeting will be open to the
public as indicated below via videocast.
The URL link to this meeting is https://
videocast.nih.gov/watch=41947.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the 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.
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22693
Name of Committee: National Advisory
Council for Nursing Research.
Date: May 18, 2021.
Open: 10:30 a.m. to 3:15 p.m.
Agenda: Discussion of Program Policies
and Issues.
Place: National Institute of Nursing
Research, National Institutes of Health, 6701
Democracy Boulevard, One Democracy Plaza,
Bethesda, MD 20892, https://
videocast.nih.gov/watch=41947 (Virtual
Meeting).
Closed: 3:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Nursing
Research, National Institutes of Health, 6701
Democracy Boulevard, One Democracy Plaza,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Susan E. Old, Ph.D.,
Acting Deputy Director, National Institute of
Nursing Research, 31 Center Drive, Room
5B05, Bethesda, MD 20892, 301.496.7291,
oldse@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.ninr.nih.gov/, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.361, Nursing Research,
National Institutes of Health, HHS)
Dated: April 23, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–08887 Filed 4–28–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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 Division of Intramural
Research Board of Scientific Counselors,
NIAID.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended for the review, discussion,
and evaluation of individual intramural
programs and projects conducted by the
National Institute of Allergy and
Infectious Diseases, including
consideration of personnel
qualifications and performance, and the
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[Federal Register Volume 86, Number 81 (Thursday, April 29, 2021)]
[Notices]
[Pages 22692-22693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08942]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the Advisory Commission on Childhood Vaccines;
Correction
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: HRSA published a document in the Federal Register of January
28, 2021, concerning a meeting of the Advisory Commission on Childhood
Vaccines. The document contained incorrect dates. The date of the June
2021 Advisory Commission on Childhood Vaccines (ACCV) meeting has
changed. The original date for the June 2021 ACCV meeting was June 3,
2021. The new date for the June 2021 ACCV meeting is June 18, 2021.
FOR FURTHER INFORMATION CONTACT: Annie Herzog, Division of Injury
Compensation Programs, HRSA, 5600 Fishers Lane, Rockville, Maryland,
20857, (301) 443-6634; or [email protected].
[[Page 22693]]
SUPPLEMENTARY INFORMATION: For the latest information regarding the
meeting, including its start time and the agenda, please access the
ACCV website: https://www.hrsa.gov/advisory-committees/vaccines/meetings.html.
Correction
In the Federal Register of January 28, 2021, FR Doc. 2021-01879,
page 7402, column 3, section 1, paragraph 2, correct the Dates caption
to read:
DATES: ACCV meetings will be held on:
March 4, 2021, 10:00 a.m. Eastern Time (ET)-4:00 p.m. ET;
June 18, 2021, 10:00 a.m. ET-4:00 p.m. ET;
September 2, 2021, 10:00 a.m. ET- 4:00 p.m. ET;
December 2, 2021, 10:00 a.m. ET- 4:00 p.m. ET.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021-08942 Filed 4-28-21; 8:45 am]
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