Advisory Committee on Immunization Practices (ACIP), 43841-43842 [2020-15614]
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43841
Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Notices
completion of the SAF, their requests
for approval are evaluated. A total of
375 applications were submitted in
CY2019. To date, 300 applications have
been submitted in CY2020. The
increased submission rate is due to the
publication of a new respirator class,
PAPR100, as well certification requests
due to COVID–19. No survey was
conducted to more thoroughly analyze
the reasons for the change in number of
respondents. The applications are
submitted at will, and taking into
account both historical conditions, as
well as the current situation, our
prediction of the number of respondents
each year between CY2020 and CY2022
is 140. A $200 fee is required for each
application. Respondents requesting
respirator approval or certain extensions
of approval are required to submit
standards, it is not expected that
requiring approved quality standards
will impose an additional cost burden
over similarly effective quality
standards that are not approved under
42 CFR part 84.
Manufacturers with current approvals
are subject to site audits by the Institute
or its agents. Audits may occur
periodically, typically every second
year, or as a result of a reported issue.
Sixty-four site audits from 90 respirator
approval holders were scheduled for the
2020 fiscal year. There is an average fee
of $12,656 for each audit to align with
fee collection provisions of the
Independent Offices Appropriations Act
of 1952 (31 U.S.C. 9701), and OMB
Circular A–25 Revised. It is estimated
that the average over the next three
years (FY21–FY23) will be 70.
additional fees for necessary testing and
evaluation as specified in 42 CFR parts
84.20–22, 84.66, 84.258 and 84.1102.
Applicants are required to provide
test data that shows the manufacturer is
capable of ensuring the respirator is
capable of meeting the specified
requirements in 42 CFR part 84. The
requirement for submitted test data is
likely to be satisfied by standard testing
performed by the manufacturer, and is
not required to follow the relevant
NIOSH Standard Test Procedures. As
additional testing is not required,
providing proof that an adequate test
has been performed is limited to
providing existing paperwork.
42 CFR part 84 approvals offer
corroboration that approved respirators
are produced to certain quality
standards. Although 42 CFR part 84
Subpart E prescribes certain quality
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondents
Form name
Business or other for-profit ...............
140
4
229
128,240
Business or other for-profit ...............
Standard Application Form for the
Approval of Respirators.
Audit .................................................
70
1
24
1,680
Total ...........................................
..........................................................
........................
........................
........................
129,920
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–15658 Filed 7–17–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee on Breast Cancer
in Young Women (ACBCYW); Notice of
Charter Renewal
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of charter renewal.
AGENCY:
This gives notice under the
Federal Advisory Committee Act of
October 6, 1972, that the Advisory
Committee on Breast Cancer in Young
Women (ACBCYW), Centers for Disease
Control and Prevention, Department of
Health and Human Services, has been
renewed for a 2-year period through
June 17, 2022.
FOR FURTHER INFORMATION CONTACT:
Jeremy McCallister, Designated Federal
SUMMARY:
VerDate Sep<11>2014
18:30 Jul 17, 2020
Jkt 250001
Officer, National Center for Chronic
Disease Prevention and Health
Promotion, CDC, 4770 Buford Highway
NE, Mailstop S107–4, Atlanta, Georgia
30341, Telephone (404) 639–7989, Fax
(770) 488–4760; Email: acbcyw@
cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–15616 Filed 7–17–20; 8:45 am]
BILLING CODE 4163–18–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2020–0083]
Advisory Committee on Immunization
Practices (ACIP)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting and request
for comment.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
CDC, announces the following meeting
of the Advisory Committee on
Immunization Practices (ACIP). This
meeting is open to the public. Time will
be available for public comment. The
meeting will be webcast live via the
World Wide Web.
DATES: The meeting will be held on
August 26, 2020 from 10:00 a.m. to 4:00
p.m., EDT (times subject to change).
Written comments must be received
on or before August 27, 2020.
ADDRESSES: For more information on
ACIP please visit the ACIP website:
SUMMARY:
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43842
Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Notices
https://www.cdc.gov/vaccines/acip/
index.html.
You may submit comments, identified
by Docket No. CDC–2020–0083, by
either of the following methods below.
CDC does not accept comment by email.
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Docket No. CDC–2020–0083,
c/o Attn: August ACIP Meeting, Centers
for Disease Control and Prevention,
1600 Clifton Road NE, MS H24–8,
Atlanta, GA 30329–4027.
Instructions: All submissions received
must include the Agency name and
Docket Number. All relevant comments
received in conformance with the
https://www.regulations.gov suitability
policy will be posted without change to
https://www.regulations.gov, including
any personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Stephanie Thomas, ACIP Committee
Management Specialist, Centers for
Disease Control and Prevention,
National Center for Immunization and
Respiratory Diseases, 1600 Clifton Road
NE, MS–H24–8, Atlanta, GA 30329–
4027; Telephone: 404–639–8367; Email:
ACIP@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: The committee is charged
with advising the Director, CDC, on the
use of immunizing agents. In addition,
under 42 U.S.C. 1396s, the committee is
mandated to establish and periodically
review and, as appropriate, revise the
list of vaccines for administration to
vaccine-eligible children through the
Vaccines for Children (VFC) program,
along with schedules regarding dosing
interval, dosage, and contraindications
to administration of vaccines. Further,
under provisions of the Affordable Care
Act, section 2713 of the Public Health
Service Act, immunization
recommendations of the ACIP that have
been approved by the Director of the
Centers for Disease Control and
Prevention and appear on CDC
immunization schedules must be
covered by applicable health plans.
Matters to be Considered: The agenda
will include discussions on COVID–19
vaccines. No recommendation votes are
scheduled. Agenda items are subject to
change as priorities dictate. For more
information on the meeting agenda visit
https://www.cdc.gov/vaccines/acip/
meetings/meetings-info.html.
Meeting Information: The meeting
will be webcast live via the World Wide
Web; for more information on ACIP
please visit the ACIP website: https://
www.cdc.gov/vaccines/acip/.
VerDate Sep<11>2014
18:30 Jul 17, 2020
Jkt 250001
Public Participation
Interested persons or organizations
are invited to participate by submitting
written views, recommendations, and
data. Comments received are part of the
public record and are subject to public
disclosure. Do not include any
information in your comment or
supporting materials that you consider
confidential or inappropriate for public
disclosure. If you include your name,
contact information, or other
information that identifies you in the
body of your comments, that
information will be on public display.
CDC will review all submissions and
may choose to redact, or withhold,
submissions containing private or
proprietary information such as Social
Security numbers, medical information,
inappropriate language, or duplicate/
near duplicate examples of a mass-mail
campaign. CDC will carefully consider
all comments submitted into the docket.
CDC does not accept comment by email.
Oral Public Comment: This meeting
will include time for members of the
public to make an oral comment. Oral
public comment will occur before any
scheduled votes including all votes
relevant to the ACIP’s Affordable Care
Act and Vaccines for Children Program
roles. Priority will be given to
individuals who submit a request to
make an oral public comment before the
meeting according to the procedures
below.
Procedure for Oral Public Comment:
All persons interested in making an oral
public comment at the August ACIP
meeting must submit a request at https://
www.cdc.gov/vaccines/acip/meetings/
no later than 11:59 p.m., EDT, August
19, 2020 according to the instructions
provided.
If the number of persons requesting to
speak is greater than can be reasonably
accommodated during the scheduled
time, CDC will conduct a lottery to
determine the speakers for the
scheduled public comment session.
CDC staff will notify individuals
regarding their request to speak by email
by August 20, 2020. To accommodate
the significant interest in participation
in the oral public comment session of
ACIP meetings, each speaker will be
limited to 3 minutes, and each speaker
may only speak once per meeting.
Written Public Comment: Written
comments must be received on or before
August 27, 2020. Written public
comments submitted by 72 hours prior
to the ACIP meeting will be provided to
ACIP members before the meeting.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
PO 00000
Frm 00037
Fmt 4703
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Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–15614 Filed 7–17–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–20QD; Docket No. CDC–2020–
0076]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled ‘‘Reducing Fatigue Among Taxi
Drivers’’ with the goal of evaluating two
interventions, a training and a wristdevice that provides personalized daily
fatigue scores, designed to enable taxi
drivers to reduce their fatigue levels.
This research study involves two parts:
Development of a fatigue management
eLearning training tool designed for
drivers-for-hire (e.g., taxi drivers; ride
sourcing drivers); and an evaluation of
the effectiveness of this training alone
and paired with the wrist-device that
provides personalized daily fatigue
scores.
SUMMARY:
CDC must receive written
comments on or before September 18,
2020.
DATES:
You may submit comments,
identified by Docket No. CDC–2020–
0076 by any of the following methods:
ADDRESSES:
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]]>Agencies
[Federal Register Volume 85, Number 139 (Monday, July 20, 2020)]
[Notices]
[Pages 43841-43842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15614]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2020-0083]
Advisory Committee on Immunization Practices (ACIP)
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting and request for comment.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, the
CDC, announces the following meeting of the Advisory Committee on
Immunization Practices (ACIP). This meeting is open to the public. Time
will be available for public comment. The meeting will be webcast live
via the World Wide Web.
DATES: The meeting will be held on August 26, 2020 from 10:00 a.m. to
4:00 p.m., EDT (times subject to change).
Written comments must be received on or before August 27, 2020.
ADDRESSES: For more information on ACIP please visit the ACIP website:
[[Page 43842]]
https://www.cdc.gov/vaccines/acip/.
You may submit comments, identified by Docket No. CDC-2020-0083, by
either of the following methods below. CDC does not accept comment by
email.
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Docket No. CDC-2020-0083, c/o Attn: August ACIP
Meeting, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H24-8, Atlanta, GA 30329-4027.
Instructions: All submissions received must include the Agency name
and Docket Number. All relevant comments received in conformance with
the https://www.regulations.gov suitability policy will be posted
without change to https://www.regulations.gov, including any personal
information provided. For access to the docket to read background
documents or comments received, go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Stephanie Thomas, ACIP Committee
Management Specialist, Centers for Disease Control and Prevention,
National Center for Immunization and Respiratory Diseases, 1600 Clifton
Road NE, MS-H24-8, Atlanta, GA 30329-4027; Telephone: 404-639-8367;
Email: [email protected].
SUPPLEMENTARY INFORMATION:
Purpose: The committee is charged with advising the Director, CDC,
on the use of immunizing agents. In addition, under 42 U.S.C. 1396s,
the committee is mandated to establish and periodically review and, as
appropriate, revise the list of vaccines for administration to vaccine-
eligible children through the Vaccines for Children (VFC) program,
along with schedules regarding dosing interval, dosage, and
contraindications to administration of vaccines. Further, under
provisions of the Affordable Care Act, section 2713 of the Public
Health Service Act, immunization recommendations of the ACIP that have
been approved by the Director of the Centers for Disease Control and
Prevention and appear on CDC immunization schedules must be covered by
applicable health plans.
Matters to be Considered: The agenda will include discussions on
COVID-19 vaccines. No recommendation votes are scheduled. Agenda items
are subject to change as priorities dictate. For more information on
the meeting agenda visit https://www.cdc.gov/vaccines/acip/meetings/meetings-info.html.
Meeting Information: The meeting will be webcast live via the World
Wide Web; for more information on ACIP please visit the ACIP website:
https://www.cdc.gov/vaccines/acip/.
Public Participation
Interested persons or organizations are invited to participate by
submitting written views, recommendations, and data. Comments received
are part of the public record and are subject to public disclosure. Do
not include any information in your comment or supporting materials
that you consider confidential or inappropriate for public disclosure.
If you include your name, contact information, or other information
that identifies you in the body of your comments, that information will
be on public display. CDC will review all submissions and may choose to
redact, or withhold, submissions containing private or proprietary
information such as Social Security numbers, medical information,
inappropriate language, or duplicate/near duplicate examples of a mass-
mail campaign. CDC will carefully consider all comments submitted into
the docket. CDC does not accept comment by email.
Oral Public Comment: This meeting will include time for members of
the public to make an oral comment. Oral public comment will occur
before any scheduled votes including all votes relevant to the ACIP's
Affordable Care Act and Vaccines for Children Program roles. Priority
will be given to individuals who submit a request to make an oral
public comment before the meeting according to the procedures below.
Procedure for Oral Public Comment: All persons interested in making
an oral public comment at the August ACIP meeting must submit a request
at https://www.cdc.gov/vaccines/acip/meetings/ no later than 11:59 p.m.,
EDT, August 19, 2020 according to the instructions provided.
If the number of persons requesting to speak is greater than can be
reasonably accommodated during the scheduled time, CDC will conduct a
lottery to determine the speakers for the scheduled public comment
session. CDC staff will notify individuals regarding their request to
speak by email by August 20, 2020. To accommodate the significant
interest in participation in the oral public comment session of ACIP
meetings, each speaker will be limited to 3 minutes, and each speaker
may only speak once per meeting.
Written Public Comment: Written comments must be received on or
before August 27, 2020. Written public comments submitted by 72 hours
prior to the ACIP meeting will be provided to ACIP members before the
meeting.
The Director, Strategic Business Initiatives Unit, Office of the
Chief Operating Officer, Centers for Disease Control and Prevention,
has been delegated the authority to sign Federal Register notices
pertaining to announcements of meetings and other committee management
activities, for both the Centers for Disease Control and Prevention and
the Agency for Toxic Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2020-15614 Filed 7-17-20; 8:45 am]
BILLING CODE 4163-18-P
