Charter Renewal of the Advisory Committee on Blood and Tissue Safety and Availability, 70184-70185 [2020-24404]
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70184
Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
tuberculin testing of the herds. In
addition, the regulations in part 1210
require that dairy farmers and plants
maintain pasteurization records
(§ 1210.15) and that each container of
milk or cream imported into the United
States bear a tag with the product type,
permit number, and shipper’s name and
address (§ 1210.22). Section 1210.20
requires that an application for a permit
to ship or transport milk or cream into
the United States be made by the actual
shipper. Section 1210.23 allows permits
to be granted based on certificates from
accredited officials.
Description of Respondents:
Respondents include foreign dairy farms
and plants engaged in transporting milk
and/or cream into the United States.
Respondents are from the private sector
(for-profit businesses).
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
1
1
1
1
200
1
1
1
200
1
1
1
1.5 ..........................
0.5 (30 minutes) .....
0.5 (30 minutes) .....
2 .............................
300
0.5
0.5
2
1
1
1
0.5 (30 minutes) .....
0.5
1210.23 ......
1996/Farm Inspection Report .............................
1995/Report of Physical Examination of Cows ..
1994/Report of Tuberculin Tests of Cattle .........
1997/Score Card for Sanitation Inspections of
Milk Plants.
1993/Application for Permit to Ship or Transport
Milk and/or Cream into United States.
1815/Certificate/Transmittal for an Application ...
1
1
1
0.5 (30 minutes) .....
0.5
Total ....
.............................................................................
....................
........................
....................
................................
304
21 CFR
section
1210.11
1210.12
1210.13
1210.14
......
......
......
......
1210.20 ......
1 There
Form FDA No.
Average
burden per
response
Total
hours
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
21 CFR section; activity
1210.15 Pasteurization; Equipment, and Methods .........
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1
Number of
records per
recordkeeper
1
Total
annual
records
1
Average
burden per
recordkeeping
1
Total
hours
0.05 (3 minutes) .....
0.05
There are no capital costs or operating and maintenance costs associated with this collection of information.
The Secretary of Health and Human
Services has the discretion to allow
Form FDA 1815, a duly certified
statement signed by an accredited
official of a foreign government, to be
submitted in lieu of Forms FDA 1994
and 1995. In the past, Form FDA 1815
has been submitted in lieu of these
forms. Because we have not received
any Forms FDA 1994 or 1995 in the last
3 years, we assume no more than one
will be submitted annually.
No burden has been estimated for the
tagging requirement in § 1210.22
because the information on the tag is
either supplied by us (permit number)
or is disclosed to third parties as a usual
and customary part of the shipper’s
normal business activities (type of
product, shipper’s name and address).
Under 5 CFR 1320.3(c)(2), the public
disclosure of information originally
supplied by the Federal Government to
the recipient for the purpose of
disclosure to the public is not subject to
review by OMB under the PRA. Under
5 CFR 1320.3(b)(2)), the time, effort, and
financial resources necessary to comply
with a collection of information are
excluded from the burden estimate if
the reporting, recordkeeping, or
disclosure activities needed to comply
are usual and customary because they
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would occur in the normal course of
business activities.
Based on a review of the information
collection since our last OMB approval,
we have decreased our burden estimate.
The estimated number of respondents
and hours per response are based on our
experience with the import milk permit
program and the average number of
import milk permit holders over the
past 3 years. However, we have not
received any responses in the last 3
years; therefore, we estimate that one or
fewer to be submitted annually.
Although we have not received any
responses in the last 3 years, we believe
these information collection provisions
should be extended to provide for the
potential future need for a milk
importer.
Dated: October 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–24428 Filed 11–3–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Charter Renewal of the Advisory
Committee on Blood and Tissue Safety
and Availability
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services is hereby giving notice
that the charter for the Advisory
Committee on Blood and Tissue Safety
and Availability (ACBTSA) has been
renewed.
SUMMARY:
Mr.
James Berger, Designated Federal Officer
for the ACBTSA, Senior Advisor for
Blood and Tissue Policy, Office of the
Assistant Secretary for Health,
Department of Health and Human
Services, 330 C Street SW, Suite L600,
Washington, DC 20024. Phone: (202)
795–7608. Email: ACBTSA@hhs.gov.
SUPPLEMENTARY INFORMATION: The
ACBTSA is a non-discretionary federal
advisory committee. The ACBTSA is
authorized under 42 U.S.C. 217a,
Section 222 of the Public Health Service
FOR FURTHER INFORMATION CONTACT:
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Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
(PHS) Act, as amended. The Committee
is governed by the provisions of the
Federal Advisory Committee Act
(FACA), Public Law 92–463, as
amended (5 U.S.C. App.), which sets
forth standards for the formation and
use of advisory committees. The
ACBTSA advises, assists, consults with,
and makes policy recommendations to
the Secretary, through the Assistant
Secretary for Health, regarding broad
responsibilities related to the safety of
blood, blood products, tissues, and
organs. For solid organs and blood stem
cells, the Committee’s work is limited to
policy issues related to donor derived
infectious disease complications of
transplantation.
To carry out its mission, the ACBTSA
provides advice to the Secretary through
the Assistant Secretary for Health on a
range of policy issues which includes:
(1) Identification of public health issues
through surveillance of blood and tissue
safety issues with national biovigilance
data tools; (2) identification of public
health issues that affect availability of
blood, blood products, and tissues; (3)
broad public health, ethical, and legal
issues related to the safety of blood,
blood products, and tissues; (4) the
impact of various economic factors (e.g.,
product cost and supply) on safety and
availability of blood, blood products,
and tissues; (5) risk communications
related to blood transfusion and tissue
transplantation; and (6) identification of
infectious disease transmission issues
for blood, organs, blood stem cells and
tissues.
On October 9, 2020, the Secretary
approved for the ACBTSA charter to be
renewed. The new charter was effected
and filed with the appropriate
Congressional committees and the
Library of Congress on October 9, 2020.
Renewal of the Committee’s charter
gives authorization for the Committee to
continue to operate until October 9,
2022.
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A copy of the ACBTSA charter is
available on the Committee’s website at
https://www.hhs.gov/oidp/advisorycommittee/blood-tissue-safetyavailability/charter/.
Dated: October 22, 2020.
James J. Berger,
DFO, Advisory Committee on Blood and
Safety and Availability, Office of Infectious
Disease and HIV/AIDS Policy.
[FR Doc. 2020–24404 Filed 11–3–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nominations for
Appointment to the Tick-Borne
Disease Working Group; Extension of
Nomination Period
Office of Infectious Disease and
HIV/AIDS Policy (OIDP), Office of the
Assistant Secretary for Health (OASH),
Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice; extension of nomination
period.
AGENCY:
The Office of the Assistant
Secretary for Health published a
document in the Federal Register on
October 6, 2020 seeking nominations of
non-federal public individuals who
represent diverse scientific disciplines
and views and are interested in being
considered for appointment to the TickBorne Disease Working Group
(TBDWG). Due to requests to extend the
nomination period, this document is
announcing a 30-day extension. The
October 6 notice can be accessed at
https://www.govinfo.gov/content/pkg/
FR-2020-10-06/pdf/2020-22062.pdf.
DATES: To be assured consideration,
nominations must be sent to the
TBDWG email address at
tickbornedisease@hhs.gov no later than
5:00 p.m. Eastern Standard Time on
December 5, 2020.
FOR FURTHER INFORMATION CONTACT: Mr.
James Berger, (202) 795–7608;
tickbornedisease@hhs.gov.
SUMMARY:
Dated: October 29, 2020.
James Berger,
Senior Advisor for Blood and Tissue Policy,
Designated Federal Officer, HHS Tick-Borne
Disease Working Group and the Advisory
Committee on Blood and Tissue Safety and
Availability, Office of the Assistant Secretary
for Health.
[FR Doc. 2020–24414 Filed 11–3–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; 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
Neurological Disorders and Stroke
Council.
The meeting will be open to the
public as indicated below. Individuals
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70185
who plan to participate 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.
Name of Committee: National Advisory
Neurological Disorders and Stroke Council.
Date: February 3–4, 2021.
Open: February 03, 2021, 1:00 p.m. to 6:00
p.m.
Agenda: Report by the Director, NINDS;
Report by the Director, Division of
Extramural Activities; and Administrative
and Program Developments.
Open session will be videocast from this
link: https://videocast.nih.gov/.
Closed: February 04, 2021, 1:00 p.m. to
5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NSC
Building, 6001 Executive Boulevard,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Robert Finkelstein, Ph.D.,
Director of Extramural Research, National
Institute of Neurological Disorders and
Stroke, NIH, 6001 Executive Blvd., Suite
3309, MSC 9531, Bethesda, MD 20892, (301)
496–9248, finkelsr@ninds.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:
www.ninds.nih.gov, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: October 29, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–24395 Filed 11–3–20; 8:45 am]
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Agencies
[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Pages 70184-70185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24404]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Charter Renewal of the Advisory Committee on Blood and Tissue
Safety and Availability
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services is hereby giving
notice that the charter for the Advisory Committee on Blood and Tissue
Safety and Availability (ACBTSA) has been renewed.
FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Designated Federal
Officer for the ACBTSA, Senior Advisor for Blood and Tissue Policy,
Office of the Assistant Secretary for Health, Department of Health and
Human Services, 330 C Street SW, Suite L600, Washington, DC 20024.
Phone: (202) 795-7608. Email: [email protected].
SUPPLEMENTARY INFORMATION: The ACBTSA is a non-discretionary federal
advisory committee. The ACBTSA is authorized under 42 U.S.C. 217a,
Section 222 of the Public Health Service
[[Page 70185]]
(PHS) Act, as amended. The Committee is governed by the provisions of
the Federal Advisory Committee Act (FACA), Public Law 92-463, as
amended (5 U.S.C. App.), which sets forth standards for the formation
and use of advisory committees. The ACBTSA advises, assists, consults
with, and makes policy recommendations to the Secretary, through the
Assistant Secretary for Health, regarding broad responsibilities
related to the safety of blood, blood products, tissues, and organs.
For solid organs and blood stem cells, the Committee's work is limited
to policy issues related to donor derived infectious disease
complications of transplantation.
To carry out its mission, the ACBTSA provides advice to the
Secretary through the Assistant Secretary for Health on a range of
policy issues which includes: (1) Identification of public health
issues through surveillance of blood and tissue safety issues with
national biovigilance data tools; (2) identification of public health
issues that affect availability of blood, blood products, and tissues;
(3) broad public health, ethical, and legal issues related to the
safety of blood, blood products, and tissues; (4) the impact of various
economic factors (e.g., product cost and supply) on safety and
availability of blood, blood products, and tissues; (5) risk
communications related to blood transfusion and tissue transplantation;
and (6) identification of infectious disease transmission issues for
blood, organs, blood stem cells and tissues.
On October 9, 2020, the Secretary approved for the ACBTSA charter
to be renewed. The new charter was effected and filed with the
appropriate Congressional committees and the Library of Congress on
October 9, 2020. Renewal of the Committee's charter gives authorization
for the Committee to continue to operate until October 9, 2022.
A copy of the ACBTSA charter is available on the Committee's
website at https://www.hhs.gov/oidp/advisory-committee/blood-tissue-safety-availability/charter/.
Dated: October 22, 2020.
James J. Berger,
DFO, Advisory Committee on Blood and Safety and Availability, Office of
Infectious Disease and HIV/AIDS Policy.
[FR Doc. 2020-24404 Filed 11-3-20; 8:45 am]
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