Solicitation of Nominations for Membership To Serve on the Advisory Committee on Organ Transplantation, 43569-43570 [2023-14502]
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43569
Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Notices
Based on current data from eHCTERS,
we estimate there are 2,374 HCT/P
current registrants and 157 new
registrants, for a total of 2,531
respondents annually. Information
collection provisions that include
reporting activities are identified in
table 1. The estimated burden for each
of the individual reporting activities
was calculated based on the annual
number of submissions, averaged among
respondents, and based on informal
communications with industry.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Number of
records per
recordkeeper 2
1271.47; Establishing SOPs ........................................
1271.47; Updating SOPs .............................................
1271 Subparts C & D: Establishing and maintaining
records documenting methods used in, and the facilities and controls used for, the manufacture of
HCT/Ps, including but not limited to all steps in recovery, donor screening, donor testing, processing,
storage, labeling, packaging, and distribution.
157
2,374
2,531
1
1
3,311.36
157
2,374
8,381,049
48 ...........................
24 ...........................
0.26 (∼15 minutes)
7,536
56,976
2,170,493
Total ......................................................................
........................
........................
8,383,580
................................
2,235,005
21 CFR part 1271; establish and maintain records
1 There
Average
burden per
recordkeeping 2
Total annual
records
Total hours 3
are no capital costs or operating and maintenance costs associated with this collection of information.
rounded to the nearest hundredth.
to the nearest whole number.
2 Decimals
3 Rounded
To calculate burden associated with
the establishment and maintenance of
operating procedures in accordance
with applicable CGTP requirements, we
assume twice the time is necessary for
new establishments. Burden we
attribute to recordkeeping activities
associated with the remaining
provisions in part 1271 is assumed to be
distributed among the individual
elements and averaged among
respondents.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR part 1271—human cells, tissues, and cellular
and tissue-based products; activity
Number of
respondents
Disclosing information as required under applicable
good manufacturing practices/CGTP provisions.
1 There
1,611
Number of
disclosures
per
respondent 2
Average
burden per
disclosure 2
Total annual
disclosures
4,984.75
8,030,435
0.30 (∼18 minutes)
Total hours
2,389,226
are no capital costs or operating and maintenance costs associated with this collection of information.
rounded to the nearest hundredth.
lotter on DSK11XQN23PROD with NOTICES1
2 Decimals
As part of the recordkeeping
requirements, certain provisions in part
1271 require the disclosure of
information to third parties, particularly
as it pertains to the distribution of HCT/
Ps. We estimate a proportion of the
respondents to the information
collection (1,611) will incur burden
resulting from these disclosures and
have therefore accounted for burden
that may be attributable to these distinct
activities.
Our estimated burden for the
information collection reflects an
overall reduction of 150,137 hours and
347,843 responses annually, which
corresponds to a decrease in the number
HCT/P establishments and a decrease in
the number HCT/Ps distributed since
our last evaluation.
Dated: July 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–14467 Filed 7–7–23; 8:45 am]
BILLING CODE 4164–01–P
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17:45 Jul 07, 2023
Jkt 259001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
the Committee on other proposed
policies.
Health Resources and Services
Administration
DATES:
Solicitation of Nominations for
Membership To Serve on the Advisory
Committee on Organ Transplantation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for nominations.
AGENCY:
HRSA is seeking nominations
of qualified candidates to be considered
for appointment as members of the
Advisory Committee on Organ
Transplantation (ACOT or Committee).
ACOT provides advice and
recommendations to the Secretary of
HHS (Secretary) on proposed Organ
Procurement and Transplantation
Network policies and such other matters
as the Secretary determines. The
Secretary also may seek the advice of
SUMMARY:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
Written nominations for
membership on the ACOT will be
received on a continuous basis.
Nomination packages must
be submitted to the Executive Secretary,
ACOT, Healthcare Systems Bureau,
HRSA, Room 08W67, 5600 Fishers
Lane, Rockville, Maryland 20857, or via
email to: ACOTHRSA@hrsa.gov.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Shelley Grant, Executive Secretary,
ACOT, at (301) 443–8036 or email
sgrant@hrsa.gov. A copy of the ACOT
charter and list of current members may
be obtained by accessing the ACOT
website at https://www.organdonor.gov/
about-dot/acot.html.
In
accordance with the Amended Final
Rule of the Organ Procurement and
Transplantation Network (42 CFR part
SUPPLEMENTARY INFORMATION:
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lotter on DSK11XQN23PROD with NOTICES1
43570
Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Notices
121), ACOT was established pursuant to
42 U.S.C. 217a and, in accordance with
Public Law 92–463, was first chartered
on September 1, 2000. ACOT meets up
to three times during the fiscal year.
Nominations: HRSA is requesting
nominations for voting members to
serve as Special Government Employees
(SGEs) on ACOT. The Secretary
appoints ACOT members with the
expertise needed to fulfill the duties of
the Advisory Committee. Nominees
sought are individuals involved in organ
procurement, organ transplantation
(including, but not limited to, transplant
candidates, recipients, living organ
donors, and families of deceased organ
donors), bioethics, and other medical
specialties involved in organ
transplantation and in the identification
and referral of donors. Interested
applicants may self-nominate or be
nominated by another individual or
organization.
Individuals selected for appointment
to the Committee will be invited to
serve for a term up to 3 years. Members
appointed as SGEs receive a stipend and
reimbursement for per diem and travel
expenses incurred for attending ACOT
meetings and/or conducting other
business on behalf of ACOT, as
authorized by 5 U.S.C. 5703 of the
Federal Advisory Committee Act for
persons employed intermittently in
government service.
The following information must be
included in the package of materials
submitted for each individual being
nominated for consideration: (1) A letter
of nomination stating the name,
affiliation, and contact information for
the nominee, the basis for the
nomination (e.g., what specific
attributes, perspectives, and/or skills
does the individual possess that would
benefit the workings of ACOT), and the
nominee’s field(s) of expertise; (2) a
biographical sketch of the nominee; (3)
the name, address, daytime telephone
number, and email address at which the
nominator can be contacted; and (4) a
current copy of the nominee’s
curriculum vitae. Nomination packages
may be submitted directly by the
individual being nominated or by the
person/organization recommending the
candidate. HRSA requests that
applicants who submitted a nomination
or a self-nomination in the past please
resubmit the required candidate forms.
HHS endeavors to ensure that the
membership of ACOT is fairly balanced
in terms of points of view represented
and that individuals from a broad
representation of geographic areas,
gender, and ethnic and minority groups,
as well as individuals with disabilities,
are considered for membership.
VerDate Sep<11>2014
17:45 Jul 07, 2023
Jkt 259001
Appointments shall be made without
discrimination on the basis of age,
ethnicity, gender, sexual orientation, or
cultural, religious, or socioeconomic
status.
Individuals who are selected to be
considered for appointment will be
required to provide detailed information
regarding their financial holdings,
consultancies, and research grants or
contracts. Disclosure of this information
is required for HRSA ethics officials to
determine whether there is a conflict
between the SGE’s public duties as a
member of ACOT and their private
interests, including an appearance of a
loss of impartiality as defined by federal
laws and regulations, and to identify
any required remedial action needed to
address the potential conflict.
Authority: In accordance with 42 CFR
121.12, the Secretary established ACOT
pursuant to 42 U.S.C. 217a. The
Committee is governed by the Federal
Advisory Committee Act (5 U.S.C.
appendix 2), which sets forth standards
for the formation and use of advisory
committees.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–14502 Filed 7–7–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Extension of Temporary Suspension of
Dogs Entering the United States From
Countries With a High Risk of Rabies
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
In order to protect the United
States against the potential
reintroduction of the dog-maintained
rabies virus variant (DMRVV) into the
United States, the Centers for Disease
Control and Prevention (CDC), within
the Department of Health and Human
Services (HHS), announces an extension
of the current temporary suspension of
the importation into the United States of
dogs from countries at high-risk for
enzootic rabies (DMRVV high-risk
countries). This suspension includes
dogs that have been in any DMRVV
high-risk countries during the previous
six months.
DATES: The extension of the temporary
suspension of the importation of dogs
into the United States from DMRVV
high-risk countries will be implemented
SUMMARY:
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Fmt 4703
Sfmt 4703
on August 1, 2023, when the current
suspension expires, and will remain in
effect through July 31, 2024.
FOR FURTHER INFORMATION CONTACT:
Ashley C. Altenburger, J.D., Division of
Global Migration and Quarantine,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H16–4, Atlanta, GA 30329. Telephone:
1–800–232–4636. For information
regarding CDC regulations for the
importation of dogs: Dr. Emily Pieracci,
D.V.M., Division of Global Migration
and Quarantine, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS H16–4, Atlanta, GA
30329. Telephone: 1–800–232–4636.
SUPPLEMENTARY INFORMATION: CDC is
extending, but not modifying, the terms
of the current temporary suspension of
the importation into the United States of
dogs from countries at high-risk for
enzootic rabies (DMRVV high-risk
countries), including dogs that have
been in any DMRVV high-risk countries
during the previous six months. A
suspension remains necessary to protect
the public’s health against the
reintroduction of the dog-maintained
rabies virus variant (DMRVV) into the
United States. There is a continued
threat posed by dogs from DMRVV highrisk countries which are unvaccinated
or inadequately vaccinated against
rabies. This continued threat is due to
various factors, including: a high
volume of dogs being imported into the
United States contemporaneous with
insufficient veterinary controls in
DMRVV high-risk countries to prevent
the export of inadequately vaccinated
dogs, inadequate global veterinary
supply chains for vaccines and related
materials, and persistent workforce
capacity shortages, particularly in
DMRVV high-risk countries that export
dogs to the United States. CDC
anticipates that these factors are likely
to continue over the course of the next
12 months. Considering these factors,
CDC has determined that it is necessary
to extend the temporary suspension
through July 31, 2024, to ensure dogs
imported into the United States do not
pose a public health threat of
reintroducing DMRVV into the United
States.1
1 In consideration of both the anticipated needs
for global rabies vaccine campaigns to return to prepandemic levels and to avoid disruption to
importers’ and the travel industry’s operations, CDC
has determined that a one-year extension of the
temporary suspension is required to protect the
public’s health and is therefore in the public’s
interest. In the absence of a further extension of the
temporary suspension or the adoption of an
alternate framework to mitigate the importation of
dogs infected with rabies, dog importation
requirements would return to procedures that
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]]>Agencies
[Federal Register Volume 88, Number 130 (Monday, July 10, 2023)]
[Notices]
[Pages 43569-43570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14502]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Solicitation of Nominations for Membership To Serve on the
Advisory Committee on Organ Transplantation
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Request for nominations.
-----------------------------------------------------------------------
SUMMARY: HRSA is seeking nominations of qualified candidates to be
considered for appointment as members of the Advisory Committee on
Organ Transplantation (ACOT or Committee). ACOT provides advice and
recommendations to the Secretary of HHS (Secretary) on proposed Organ
Procurement and Transplantation Network policies and such other matters
as the Secretary determines. The Secretary also may seek the advice of
the Committee on other proposed policies.
DATES: Written nominations for membership on the ACOT will be received
on a continuous basis.
ADDRESSES: Nomination packages must be submitted to the Executive
Secretary, ACOT, Healthcare Systems Bureau, HRSA, Room 08W67, 5600
Fishers Lane, Rockville, Maryland 20857, or via email to:
[email protected].
FOR FURTHER INFORMATION CONTACT: Shelley Grant, Executive Secretary,
ACOT, at (301) 443-8036 or email [email protected]. A copy of the ACOT
charter and list of current members may be obtained by accessing the
ACOT website at https://www.organdonor.gov/about-dot/acot.html.
SUPPLEMENTARY INFORMATION: In accordance with the Amended Final Rule of
the Organ Procurement and Transplantation Network (42 CFR part
[[Page 43570]]
121), ACOT was established pursuant to 42 U.S.C. 217a and, in
accordance with Public Law 92-463, was first chartered on September 1,
2000. ACOT meets up to three times during the fiscal year.
Nominations: HRSA is requesting nominations for voting members to
serve as Special Government Employees (SGEs) on ACOT. The Secretary
appoints ACOT members with the expertise needed to fulfill the duties
of the Advisory Committee. Nominees sought are individuals involved in
organ procurement, organ transplantation (including, but not limited
to, transplant candidates, recipients, living organ donors, and
families of deceased organ donors), bioethics, and other medical
specialties involved in organ transplantation and in the identification
and referral of donors. Interested applicants may self-nominate or be
nominated by another individual or organization.
Individuals selected for appointment to the Committee will be
invited to serve for a term up to 3 years. Members appointed as SGEs
receive a stipend and reimbursement for per diem and travel expenses
incurred for attending ACOT meetings and/or conducting other business
on behalf of ACOT, as authorized by 5 U.S.C. 5703 of the Federal
Advisory Committee Act for persons employed intermittently in
government service.
The following information must be included in the package of
materials submitted for each individual being nominated for
consideration: (1) A letter of nomination stating the name,
affiliation, and contact information for the nominee, the basis for the
nomination (e.g., what specific attributes, perspectives, and/or skills
does the individual possess that would benefit the workings of ACOT),
and the nominee's field(s) of expertise; (2) a biographical sketch of
the nominee; (3) the name, address, daytime telephone number, and email
address at which the nominator can be contacted; and (4) a current copy
of the nominee's curriculum vitae. Nomination packages may be submitted
directly by the individual being nominated or by the person/
organization recommending the candidate. HRSA requests that applicants
who submitted a nomination or a self-nomination in the past please
resubmit the required candidate forms.
HHS endeavors to ensure that the membership of ACOT is fairly
balanced in terms of points of view represented and that individuals
from a broad representation of geographic areas, gender, and ethnic and
minority groups, as well as individuals with disabilities, are
considered for membership. Appointments shall be made without
discrimination on the basis of age, ethnicity, gender, sexual
orientation, or cultural, religious, or socioeconomic status.
Individuals who are selected to be considered for appointment will
be required to provide detailed information regarding their financial
holdings, consultancies, and research grants or contracts. Disclosure
of this information is required for HRSA ethics officials to determine
whether there is a conflict between the SGE's public duties as a member
of ACOT and their private interests, including an appearance of a loss
of impartiality as defined by federal laws and regulations, and to
identify any required remedial action needed to address the potential
conflict.
Authority: In accordance with 42 CFR 121.12, the Secretary
established ACOT pursuant to 42 U.S.C. 217a. The Committee is governed
by the Federal Advisory Committee Act (5 U.S.C. appendix 2), which sets
forth standards for the formation and use of advisory committees.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-14502 Filed 7-7-23; 8:45 am]
BILLING CODE 4165-15-P
