Advisory Commission on Childhood Vaccines, 23370-23371 [2020-08883]
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Federal Register / Vol. 85, No. 81 / Monday, April 27, 2020 / Notices
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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
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–5664 for ‘‘Standardized
Medicated Feed Assay Limits.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
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in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Katie Ciesienski, Center for Veterinary
Medicine (HFV–141), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0676,
Katie.Ciesienski@fda.hhs.gov.
In the
Federal Register of February 27, 2020,
FDA published a notice announcing the
availability of draft GFI #264 entitled
‘‘Standardized Medicated Feed Assay
Limits’’ with a 60-day comment period.
This draft guidance recommends a
standardized set of assay limits for
medicated feeds. Standardized
medicated feed assay limits allow
predictability in the review process as
the sponsor can determine early in the
drug development process what assay
limits they should expect to meet for
medicated feeds used in Target Animal
Safety, Effectiveness, Chemistry,
Manufacturing, and Controls,
Bioequivalence, and Human Food
Safety residue chemistry studies. Assay
limits are used pre-approval to ensure
that medicated feeds in these studies
contain the appropriate amount of drug,
and post-approval for compliance and
customer service purposes.
The Agency has received a request for
a 90-day extension of the comment
period. The request conveyed concern
that the current 60-day comment period
does not allow sufficient time to
develop a comprehensive response.
FDA has considered the request and
is extending the comment period for the
notice of availability for 60 days, until
June 26, 2020. The Agency believes that
a 60-day extension allows adequate time
for interested persons to submit
comments.
SUPPLEMENTARY INFORMATION:
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Dated: April 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–08890 Filed 4–24–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Commission on Childhood
Vaccines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
Advisory Commission on Childhood
Vaccines (ACCV) has scheduled a
public meeting. Information about
ACCV and the agenda for this meeting
can be found on the ACCV website at
https://www.hrsa.gov/advisorycommittees/vaccines.
DATES: May 18, 2020. This meeting will
begin at 9:00 a.m. ET.
ADDRESSES: This meeting will be held
by Adobe Connect webinar and
teleconference.
• Webinar link: https://
hrsa.connectsolutions.com/accv/.
• Conference call-in number: 888–
790–1734, passcode: 4177683.
FOR FURTHER INFORMATION CONTACT:
Annie Herzog, Division of Injury
Compensation Programs, HRSA, 5600
Fishers Lane, 08N186B, Rockville,
Maryland 20857; 301–443–6634; or
aherzog@HRSA.gov.
SUPPLEMENTARY INFORMATION: The ACCV
provides advice and recommendations
to the Secretary of HHS on policy,
program development, and other issues
related to implementation of the
National Vaccine Injury Compensation
Program (VICP) and concerning other
matters as described under section 2119
of the Public Health Service Act (42
U.S.C. 300aa–19).
During the May 18, 2020, meeting, the
ACCV will discuss a draft VICP Notice
of Proposed Rulemaking. Agenda items
are subject to change as priorities
dictate. Refer to the ACCV website for
any updated information concerning the
meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Oral comments will be
honored in the order they are requested
SUMMARY:
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Federal Register / Vol. 85, No. 81 / Monday, April 27, 2020 / Notices
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to ACCV should
be sent to Annie Herzog, ACCV
Principal Staff Liaison, using the contact
information above at least 5 business
days prior to the meeting. Individuals
who plan to attend and need special
assistance or another reasonable
accommodation should notify Annie
Herzog at the address and phone
number listed above at least 10 business
days prior to the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–08883 Filed 4–24–20; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0135]
Agency Information Collection
Activities; Revision, of a Currently
Approved Collection: Application for
Carrier Documentation
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: 30-Day notice.
AGENCY:
The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration Services (USCIS) will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The purpose of this notice is to
allow an additional 30 days for public
comments.
DATES: Comments are encouraged and
will be accepted until May 27, 2020.
ADDRESSES: Written comments and/or
suggestions regarding the item(s)
contained in this notice must include
the OMB Control Number 1615–0135 in
the body of the letter, the agency name
and Docket ID USCIS–2015–0004.
Submit comments via the Federal
eRulemaking Portal website at https://
www.regulations.gov under e-Docket ID
number USCIS–2015–0004.
FOR FURTHER INFORMATION CONTACT:
USCIS, Office of Policy and Strategy,
Regulatory Coordination Division,
Samantha Deshommes, Chief,
Telephone number (202) 272–8377
(This is not a toll-free number;
comments are not accepted via
telephone message.). Please note contact
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SUMMARY:
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information provided here is solely for
questions regarding this notice. It is not
for individual case status inquiries.
Applicants seeking information about
the status of their individual cases can
check Case Status Online, available at
the USCIS website at https://
www.uscis.gov, or call the USCIS
Contact Center at (800) 375–5283; TTY
(800) 767–1833.
SUPPLEMENTARY INFORMATION:
Comments
The information collection notice was
previously published in the Federal
Register on December 18, 2019, at 84 FR
69387, allowing for a 60-day public
comment period. USCIS did receive 3
comments in connection with the 60day notice.
You may access the information
collection instrument with instructions,
or additional information by visiting the
Federal eRulemaking Portal site at:
https://www.regulations.gov and enter
USCIS–2015–0004 in the search box.
The comments submitted to USCIS via
this method are visible to the Office of
Management and Budget and comply
with the requirements of 5 CFR
1320.12(c). All submissions will be
posted, without change, to the Federal
eRulemaking Portal at https://
www.regulations.gov, and will include
any personal information you provide.
Therefore, submitting this information
makes it public. You may wish to
consider limiting the amount of
personal information that you provide
in any voluntary submission you make
to DHS. DHS may withhold information
provided in comments from public
viewing that it determines may impact
the privacy of an individual or is
offensive. For additional information,
please read the Privacy Act notice that
is available via the link in the footer of
https://www.regulations.gov.
Written comments and suggestions
from the public and affected agencies
should address one or more of the
following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
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use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of This Information
Collection
(1) Type of Information Collection
Request: Revision of a Currently
Approved Collection.
(2) Title of the Form/Collection:
Application for Carrier Documentation.
(3) Agency form number, if any, and
the applicable component of the DHS
sponsoring the collection: I–131A;
USCIS.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals or
households. USCIS uses the information
provided on Form I–131A to verify the
status of (1) permanent or conditional
residents or (2) non-permanent or
conditional residents who hold an
advance parole document and
determine whether the applicant is
eligible for the requested carrier
documentation.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: The estimated total number of
respondents for the information
collection Form I–131A is 5,100 and the
estimated hour burden per response is
.92 hours; biometrics processing is 5,100
and the estimated hour burden per
response is 1.17 hours.
(6) An estimate of the total public
burden (in hours) associated with the
collection: The total estimated annual
hour burden associated with this
collection is 10,659 hours.
(7) An estimate of the total public
burden (in cost) associated with the
collection: The estimated total annual
cost burden associated with this
collection of information is $919,275.
Dated: April 21, 2020.
Samantha L. Deshommes,
Chief, Regulatory Coordination Division,
Office of Policy and Strategy, U.S. Citizenship
and Immigration Services, Department of
Homeland Security.
[FR Doc. 2020–08833 Filed 4–24–20; 8:45 am]
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]]>Agencies
[Federal Register Volume 85, Number 81 (Monday, April 27, 2020)]
[Notices]
[Pages 23370-23371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08883]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Commission on Childhood Vaccines
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, this
notice announces that the Secretary's Advisory Commission on Childhood
Vaccines (ACCV) has scheduled a public meeting. Information about ACCV
and the agenda for this meeting can be found on the ACCV website at
https://www.hrsa.gov/advisory-committees/vaccines.
DATES: May 18, 2020. This meeting will begin at 9:00 a.m. ET.
ADDRESSES: This meeting will be held by Adobe Connect webinar and
teleconference.
Webinar link: https://hrsa.connectsolutions.com/accv/.
Conference call-in number: 888-790-1734, passcode:
4177683.
FOR FURTHER INFORMATION CONTACT: Annie Herzog, Division of Injury
Compensation Programs, HRSA, 5600 Fishers Lane, 08N186B, Rockville,
Maryland 20857; 301-443-6634; or [email protected].
SUPPLEMENTARY INFORMATION: The ACCV provides advice and recommendations
to the Secretary of HHS on policy, program development, and other
issues related to implementation of the National Vaccine Injury
Compensation Program (VICP) and concerning other matters as described
under section 2119 of the Public Health Service Act (42 U.S.C. 300aa-
19).
During the May 18, 2020, meeting, the ACCV will discuss a draft
VICP Notice of Proposed Rulemaking. Agenda items are subject to change
as priorities dictate. Refer to the ACCV website for any updated
information concerning the meeting.
Members of the public will have the opportunity to provide
comments. Public participants may submit written statements in advance
of the scheduled meeting. Oral comments will be honored in the order
they are requested
[[Page 23371]]
and may be limited as time allows. Requests to submit a written
statement or make oral comments to ACCV should be sent to Annie Herzog,
ACCV Principal Staff Liaison, using the contact information above at
least 5 business days prior to the meeting. Individuals who plan to
attend and need special assistance or another reasonable accommodation
should notify Annie Herzog at the address and phone number listed above
at least 10 business days prior to the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-08883 Filed 4-24-20; 8:45 am]
BILLING CODE 4165-15-P
