Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation OMB No. 0906-0034-Extension, 13723-13724 [2024-03759]
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Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
also receiving misbranded prescription
drugs from overseas suppliers.
As a result of this conviction, FDA
sent Mr. McLaren, by certified mail, on
November 30, 2023, a notice proposing
to debar him for a 5-year period from
importing or offering for import any
drug into the United States. The
proposal was based on a finding under
section 306(b)(3)(C) of the FD&C Act
that Mr. McLaren’s felony conviction
under Federal law for conspiracy to
smuggle goods into the United States in
violation of 18 U.S.C. 371 and 545, was
for conduct relating to the importation
into the United States of any drug or
controlled substance because he was
involved in a scheme to illegally import
and introduce prescription drugs into
the United States. In proposing a
debarment period, FDA weighed the
considerations set forth in section
306(c)(3) of the FD&C Act that it
considered applicable to Mr. McLaren’s
offense and concluded that the offense
warranted the imposition of a 5-year
period of debarment.
The proposal informed Mr. McLaren
of the proposed debarment and offered
him an opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Mr.
McLaren received the proposal and
notice of opportunity for a hearing on
December 9, 2023. Mr. McLaren failed
to request a hearing within the
timeframe prescribed by regulation and
has, therefore, waived his opportunity
for a hearing and waived any
contentions concerning his debarment
(21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Taylor
McLaren has been convicted of a felony
under Federal law for conduct relating
to the importation into the United States
of any drug or controlled substance.
FDA finds that the offense should be
accorded a debarment period of 5 years
as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding,
Mr. McLaren is debarred for a period of
5 years from importing or offering for
import any drug into the United States,
effective (see DATES). Pursuant to section
301(cc) of the FD&C Act (21 U.S.C.
331(cc)), the importing or offering for
import into the United States of any
VerDate Sep<11>2014
17:19 Feb 22, 2024
Jkt 262001
drug by, with the assistance of, or at the
direction of Mr. McLaren is a prohibited
act.
Dated: February 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–03650 Filed 2–22–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Scientific Registry of
Transplant Recipients Information
Collection Effort for Potential Donors
for Living Organ Donation OMB No.
0906–0034—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. The initial notice
was published on November 17, 2023,
with a 60-day comment period. No
comments were received. OMB will
accept comments from the public during
the 30-day comment period for this
notice. OMB may act on HRSA’s ICR
only after the 30-day comment period
for this notice has closed.
DATES: Comments on this ICR should be
received no later than March 25, 2024.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Joella Roland, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Scientific Registry of Transplant
Recipients Information Collection Effort
for Potential Donors for Living Organ
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
13723
Donation, OMB No. 0906–0034—
Extension.
Abstract: The Scientific Registry of
Transplant Recipients (SRTR) is
administered under contract with
HRSA, an agency within HHS. HHS is
authorized to establish and maintain
mechanisms to evaluate the long-term
effects associated with living organ
donations (42 U.S.C. 273a) and is
required to submit to Congress an
annual report on the long-term health
effects of living donation (42 U.S.C.
273b). The Organ Procurement and
Transplantation Network final rule, 42
CFR part 121.11(b)(2), requires organ
procurement organizations and
transplant hospitals, ‘‘as specified from
time to time by the Secretary,’’ to submit
to the SRTR, as appropriate, information
regarding ‘‘donors of organs’’ and ‘‘other
information that the Secretary deems
appropriate.’’
In 2018, a pilot living donor registry
was implemented by the SRTR, and
each participating transplant program
registered all potential candidates for
living donation who provided informed
consent to enroll. In 2019, an updated
version of the data collection instrument
was approved, followed by the latest
data collection forms which were
approved on February 26, 2021. These
data collection modifications were
intended to improve the quality of the
data and reduce the administrative
burden for respondents. This Federal
Register notice requests an extension of
the last approved data collection forms
(February 2021) with no changes to the
total estimated annualized burden
hours.
A 60-day notice published in the
Federal Register on November 17, 2023,
vol. 88, No. 221; pp. 80318–19. There
were no public comments.
Need and Proposed Use of the
Information: The transplant programs
submit health information collected at
the time of donation evaluation through
a secure web-based data collection tool
developed by the SRTR contractor. The
SRTR contractor maintains contact with
registry participants and collects data on
long-term health outcomes through
surveys. The data collection includes
outcomes of evaluation, including
reasons for non-donation. The living
donor registry is an ongoing effort, and
the goal is to continue to collect data on
living organ donor transplant programs
in the United States over time.
Monitoring and reporting of long-term
health outcomes of living organ donors
post-donation will continue to provide
useful information to transplant
programs for their future donor
selection process and to aid potential
E:\FR\FM\23FEN1.SGM
23FEN1
13724
Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices
living organ donors in their decision to
pursue living donation.
Likely Respondents: Potential and
actual living donors, transplant
programs, medical and scientific
organizations, and public organizations,
including patient advocacy groups.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total
burden hours
Potential Living Donor Registration Form ............................
Potential Living Donor Follow-up Form ...............................
Reasons Did Not Donate Form (Liver or Kidney) ...............
a 16
c 112
c 1,792
e 0.27
b 754
d 754
f 0.50
a 16
1
c 106
c 1,696
g 0.23
484
377
390
Total ..............................................................................
a 786
........................
4,242
........................
1,251
a Number
of respondents is based on the current number of transplant programs and is likely to increase as additional programs decide to par-
ticipate.
b Number of living donor candidates that submitted follow-up forms in 2019.
c Derived from the number of forms submitted by transplant programs in 2019.
d Total number of Living Donor Collective follow-up forms submitted by living donor candidates in 2019.
e Based on a 2019 survey of transplant programs submitting data to the Living Donor Collective.
f Based on internal testing and user feedback.
g Based on discussion and interviews with staff at participating transplant programs in 2019–2020.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024–03759 Filed 2–22–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
ddrumheller on DSK120RN23PROD with NOTICES1
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following 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 Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Allergy, Immunology, and
Transplantation Research Committee (AITC)
Special Emphasis Panel.
Date: March 18, 2024.
Time: 10:00 a.m. to 5:00 p.m.
VerDate Sep<11>2014
17:19 Feb 22, 2024
Jkt 262001
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G31B,
Rockville, MD 20852 (Video Assisted
Meeting).
Contact Person: James T. Snyder, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G31B, Rockville, MD
20852, (240) 669–5060, james.snyder@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: February 16, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–03669 Filed 2–22–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Center for Scientific
Review Advisory Council.
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
This will be held in-person and will
be open to the public as indicated
below. Individuals who plan to attend
and need special assistance, such as
sign language interpretation or other
reasonable accommodations, should
register at: https://public.csr.nih.gov/
AboutCSR/Organization/CSRAdvisory
Council/Registration.
The meeting can be viewed remotely
via the NIH Videocasting website:
https://videocast.nih.gov/watch=54186.
Name of Committee: Center for Scientific
Review Advisory Council.
Date: March 25, 2024.
Time: 9:30 a.m. to 3:30 p.m.
Agenda: Provide advice to the Director,
Center for Scientific Review (CSR), on
matters related to planning, execution,
conduct, support, review, evaluation, and
receipt and referral of grant applications at
CSR.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Conference Room 160–A, Bethesda, MD
20892.
Contact Person: Bruce Reed, Ph.D., Deputy
Director, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD 20892, (301) 594–9159,
reedbr@mail.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. In
the interest of security, NIH has
E:\FR\FM\23FEN1.SGM
23FEN1
]]>Agencies
[Federal Register Volume 89, Number 37 (Friday, February 23, 2024)]
[Notices]
[Pages 13723-13724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03759]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Scientific Registry of
Transplant Recipients Information Collection Effort for Potential
Donors for Living Organ Donation OMB No. 0906-0034--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. The initial notice
was published on November 17, 2023, with a 60-day comment period. No
comments were received. OMB will accept comments from the public during
the 30-day comment period for this notice. OMB may act on HRSA's ICR
only after the 30-day comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than March 25,
2024.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Joella Roland, the HRSA
Information Collection Clearance Officer, at [email protected] or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Scientific Registry of
Transplant Recipients Information Collection Effort for Potential
Donors for Living Organ Donation, OMB No. 0906-0034--Extension.
Abstract: The Scientific Registry of Transplant Recipients (SRTR)
is administered under contract with HRSA, an agency within HHS. HHS is
authorized to establish and maintain mechanisms to evaluate the long-
term effects associated with living organ donations (42 U.S.C. 273a)
and is required to submit to Congress an annual report on the long-term
health effects of living donation (42 U.S.C. 273b). The Organ
Procurement and Transplantation Network final rule, 42 CFR part
121.11(b)(2), requires organ procurement organizations and transplant
hospitals, ``as specified from time to time by the Secretary,'' to
submit to the SRTR, as appropriate, information regarding ``donors of
organs'' and ``other information that the Secretary deems
appropriate.''
In 2018, a pilot living donor registry was implemented by the SRTR,
and each participating transplant program registered all potential
candidates for living donation who provided informed consent to enroll.
In 2019, an updated version of the data collection instrument was
approved, followed by the latest data collection forms which were
approved on February 26, 2021. These data collection modifications were
intended to improve the quality of the data and reduce the
administrative burden for respondents. This Federal Register notice
requests an extension of the last approved data collection forms
(February 2021) with no changes to the total estimated annualized
burden hours.
A 60-day notice published in the Federal Register on November 17,
2023, vol. 88, No. 221; pp. 80318-19. There were no public comments.
Need and Proposed Use of the Information: The transplant programs
submit health information collected at the time of donation evaluation
through a secure web-based data collection tool developed by the SRTR
contractor. The SRTR contractor maintains contact with registry
participants and collects data on long-term health outcomes through
surveys. The data collection includes outcomes of evaluation, including
reasons for non-donation. The living donor registry is an ongoing
effort, and the goal is to continue to collect data on living organ
donor transplant programs in the United States over time. Monitoring
and reporting of long-term health outcomes of living organ donors post-
donation will continue to provide useful information to transplant
programs for their future donor selection process and to aid potential
[[Page 13724]]
living organ donors in their decision to pursue living donation.
Likely Respondents: Potential and actual living donors, transplant
programs, medical and scientific organizations, and public
organizations, including patient advocacy groups.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Potential Living Donor \a\ 16 \c\ 112 \c\ 1,792 \e\ 0.27 484
Registration Form..............
Potential Living Donor Follow-up \b\ 754 1 \d\ 754 \f\ 0.50 377
Form...........................
Reasons Did Not Donate Form \a\ 16 \c\ 106 \c\ 1,696 \g\ 0.23 390
(Liver or Kidney)..............
-------------------------------------------------------------------------------
Total....................... \a\ 786 .............. 4,242 .............. 1,251
----------------------------------------------------------------------------------------------------------------
\a\ Number of respondents is based on the current number of transplant programs and is likely to increase as
additional programs decide to participate.
\b\ Number of living donor candidates that submitted follow-up forms in 2019.
\c\ Derived from the number of forms submitted by transplant programs in 2019.
\d\ Total number of Living Donor Collective follow-up forms submitted by living donor candidates in 2019.
\e\ Based on a 2019 survey of transplant programs submitting data to the Living Donor Collective.
\f\ Based on internal testing and user feedback.
\g\ Based on discussion and interviews with staff at participating transplant programs in 2019-2020.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-03759 Filed 2-22-24; 8:45 am]
BILLING CODE 4165-15-P
