Advisory Committee on Immunization Practices (ACIP); Correction, 3455-3456 [2019-01958]
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Federal Register / Vol. 84, No. 29 / Tuesday, February 12, 2019 / Notices
phases: One in December of 2016 and
one in August 2017 and a total of 61
participants were tested: 24 children
younger than 6 years, 17 children aged
6–19 years and 20 adult women. One
child younger than six years had a BLL
greater than five micrograms of lead per
deciliter of blood (mg/dL). The child’s
parents were notified by phone of the
results by the ATSDR Medical Officer
and follow-up was conducted by the
local PEHSU (Pediatric Environmental
Health Specialty Unit.
All participants received their results
by mail and the EI report was released
and presented to the community in a
public meeting in August 2018.
Example 3: Private Well Water
Sampling in Dimock, PA
Unconventional natural gas drilling
activities have been conducted in the
Dimock, PA area for approximately 10
years and local residents complain of
poor water quality. In 2012, EPA
sampled 64 private wells in the area for
contaminants that may be present due to
natural gas drilling activities. ATSDR
assisted in the analysis of the 2012 data
set and the following recommendations
were made:
Æ People with elevated levels of
inorganic analytes in their well water
should install a home treatment system,
and
Æ people with high levels of methane
in their well water should vent their
well and home and treat their water to
eliminate potential buildup of explosive
gases.
Additional water sampling was
recommended and an EI was conducted
in August 2017. For the EI, the 64
residents previously sampled were
invited to have their private wells
retested: 25 residences agreed
participate in the EI sampling. Residents
were provided the results of their
sampling and an EI report is currently
being prepared. It will be presented to
the community in a public meeting
when completed.
Example 4: Follow-Up Arsenic Urine
Testing in Hayden, Arizona
ATSDR completed an EI in 2015 at
the ASARCO Hayden Smelter Site in
Hayden, AZ. The EI included blood lead
and urine arsenic testing. Air
monitoring determined that the smelter
was not operating during the sample
collection period and that, given the
short half-life of arsenic in the body, the
arsenic results may not be valid.
In 2017, ATSDR retested the
participants from the 2015 EI to evaluate
their urinary arsenic levels. It was
determined that all urinary arsenic
levels were below the follow-up level
and air data indicate that air arsenic
levels in the two weeks prior to testing
were consistent with usual levels seen
in the community. The EI report is being
prepared and a community meeting will
be held when the document is released.
All of ATSDR’s targeted biological
assessments (e.g., urine, blood) and
some of the environmental
investigations (e.g., air, water, soil, or
food sampling) involve participants to
determine whether they are or have
been exposed to unusual levels of
pollutants at specific locations (e.g.,
where people live, spend leisure time,
or anywhere they might come into
contact with contaminants under
investigation).
Questionnaires, appropriate to the
specific contaminant, are generally
needed in about half of the EIs (at most
approximately 12 per year) to assist in
interpreting the biological or
environmental sampling results. ATSDR
collects contact information (e.g., name,
address, phone number) to provide the
participant with their individual results.
ATSDR also collects information on
other possible confounding sources of
chemical(s) exposure such as medicines
taken, foods eaten, hobbies, jobs, etc. In
addition, ATSDR asks questions on
recreational or occupational activities
that could increase a participant’s
exposure potential. That information
represents an individual’s exposure
history.
The number of questions can vary
depending on the number of chemicals
being investigated, the route of exposure
(e.g., breathing, eating, touching), and
number of other sources of the
chemical(s) (e.g., products used, jobs).
We use approximately 12–20 questions
about the pertinent environmental
exposures per investigation. Typically,
the number of participants in an
individual EI ranges from 10 to 100.
Participation is completely voluntary,
and there are no costs to participants
other than their time. Based on a
maximum of 12 EIs per year and 100
participants each, the estimated
annualized burden hours are 600.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Exposure Investigation Participants ................
Chemical Exposure Questions .......................
Jeffrey M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[FR Doc. 2019–01993 Filed 2–11–19; 8:45 am]
[Docket No. CDC–2019–0002]
BILLING CODE 4163–18–P
Advisory Committee on Immunization
Practices (ACIP); Correction
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
Notice of meeting with
comment period; correction.
ACTION:
VerDate Sep<11>2014
18:30 Feb 11, 2019
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1,200
Number of
responses per
respondent
1
Average
burden
per response
(in hrs.)
30/60
On January 28, 2019, the
Centers for Disease Control and
Prevention (CDC) in the Department of
Health and Human Services (HHS)
published a notice announcing the next
meeting of the Advisory Committee on
Immunization Practices on February 27–
28, 2019 in Atlanta, GA. The notice did
not include the docket number for
public comment or instructions for
submitting public comment. This notice
provides that information for the public.
SUMMARY:
The meeting will be held on
February 27–28, 2019 at the CDC Tom
Harkin Global Communication Center,
Centers for Disease Control and
DATES:
E:\FR\FM\12FEN1.SGM
12FEN1
3456
Federal Register / Vol. 84, No. 29 / Tuesday, February 12, 2019 / Notices
Prevention Headquarters (Building 19),
Room 232, 1600 Clifton Road NE,
Atlanta, GA 30329. Written comments
must be received on or before March 2,
2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0002 by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Centers for Disease Control
and Prevention, 1600 Clifton Rd. NE,
Mailstop A–27, Atlanta, GA 30329–
4027.
Instructions: All submissions received
must include the agency name and
Docket Number.
Instructions: All relevant comments
received will be posted without change
to https://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, National Center
for Immunization and Respiratory
Diseases, Centers for Disease Control
and Prevention, telephone 404–639–
8836, email ACIP@cdc.gov.
SUPPLEMENTARY INFORMATION: In
accordance with the Federal Advisory
Committee Act, the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
Advisory Committee on Immunization
Practices (ACIP). This meeting is open
to the public, limited only by room
seating. The meeting room
accommodates 216 for public seating.
Rooms 245, 246, and 247, adjacent to
the meeting room, will be available once
the meeting room reaches capacity,
providing up to 120 additional seats.
Time will be available for public
comment. The meeting will be webcast
live via the World Wide Web; for
instructions and more information on
ACIP please visit the ACIP website:
https://www.cdc.gov/vaccines/acip/
index.html. Written public comments
submitted by 72 hours prior to the ACIP
meeting will be provided to the ACIP
members before the meeting.
Interested persons or organizations
are invited to participate by submitting
written views, recommendations, and
data. Please note that comments
received, including attachments and
other supporting materials, are part of
the public record and are subject to
public disclosure. Comments will be
posted on https://www.regulations.gov.
Therefore, do not include any
18:30 Feb 11, 2019
Matters To Be Considered
The agenda will include discussions
on human papillomavirus vaccines,
pneumococcal vaccines, Japanese
encephalitis vaccines, influenza
vaccines, anthrax vaccine, hepatitis
vaccines, Pertussis vaccine, herpes
zoster vaccine, and meningococcal
vaccines. A recommendation vote is
scheduled for anthrax vaccine and
Japanese encephalitis vaccines. 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.
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.
Dated: January 30, 2019.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–01958 Filed 2–11–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2017–E–6728 and FDA–
2017–E–6727]
Public Participation
VerDate Sep<11>2014
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 review
and consider all comments submitted to
the docket.
Jkt 247001
Determination of Regulatory Review
Period for Purposes of Patent
Extension; XADAGO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
determined the regulatory review period
for XADAGO and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 15, 2019.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 12, 2019. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 15,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 15, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
E:\FR\FM\12FEN1.SGM
12FEN1
]]>Agencies
[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3455-3456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01958]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2019-0002]
Advisory Committee on Immunization Practices (ACIP); Correction
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting with comment period; correction.
-----------------------------------------------------------------------
SUMMARY: On January 28, 2019, the Centers for Disease Control and
Prevention (CDC) in the Department of Health and Human Services (HHS)
published a notice announcing the next meeting of the Advisory
Committee on Immunization Practices on February 27-28, 2019 in Atlanta,
GA. The notice did not include the docket number for public comment or
instructions for submitting public comment. This notice provides that
information for the public.
DATES: The meeting will be held on February 27-28, 2019 at the CDC Tom
Harkin Global Communication Center, Centers for Disease Control and
[[Page 3456]]
Prevention Headquarters (Building 19), Room 232, 1600 Clifton Road NE,
Atlanta, GA 30329. Written comments must be received on or before March
2, 2019.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0002 by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Centers for Disease Control and Prevention, 1600
Clifton Rd. NE, Mailstop A-27, Atlanta, GA 30329-4027.
Instructions: All submissions received must include the agency name
and Docket Number.
Instructions: All relevant comments received will be posted without
change to https://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, National Center for Immunization and Respiratory
Diseases, Centers for Disease Control and Prevention, telephone 404-
639-8836, email ACIP@cdc.gov.
SUPPLEMENTARY INFORMATION: In accordance with the Federal Advisory
Committee Act, the Centers for Disease Control and Prevention (CDC),
announces the following meeting of the Advisory Committee on
Immunization Practices (ACIP). This meeting is open to the public,
limited only by room seating. The meeting room accommodates 216 for
public seating. Rooms 245, 246, and 247, adjacent to the meeting room,
will be available once the meeting room reaches capacity, providing up
to 120 additional seats. Time will be available for public comment. The
meeting will be webcast live via the World Wide Web; for instructions
and more information on ACIP please visit the ACIP website: https://www.cdc.gov/vaccines/acip/. Written public comments submitted
by 72 hours prior to the ACIP meeting will be provided to the ACIP
members before the meeting.
Public Participation
Interested persons or organizations are invited to participate by
submitting written views, recommendations, and data. Please note that
comments received, including attachments and other supporting
materials, are part of the public record and are subject to public
disclosure. Comments will be posted on https://www.regulations.gov.
Therefore, 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 review and
consider all comments submitted to the docket.
Matters To Be Considered
The agenda will include discussions on human papillomavirus
vaccines, pneumococcal vaccines, Japanese encephalitis vaccines,
influenza vaccines, anthrax vaccine, hepatitis vaccines, Pertussis
vaccine, herpes zoster vaccine, and meningococcal vaccines. A
recommendation vote is scheduled for anthrax vaccine and Japanese
encephalitis vaccines. 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.
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.
Dated: January 30, 2019.
Sherri Berger,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2019-01958 Filed 2-11-19; 8:45 am]
BILLING CODE 4163-18-P
