Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products; Public Workshop, 44997-44998 [2024-11228]
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Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Silver Spring, MD
20993–0002, 301–796–6985,
CBERVRBPAC@fda.hhs.gov; or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). Please call the
Information Line for up-to-date
information on this meeting. For press
inquiries, please contact the Office of
Media Affairs at 301–796–4540 or
fdaoma@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 4, 2024 (89
FR 15590), FDA announced that a
meeting of the Vaccines and Related
Biological Products Advisory
Committee would be held on May 16,
2024. On page 15590, in the second
column, the SUMMARY and DATES
portions of the document are changed to
read as follows:
SUMMARY: The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Vaccines and Related
Biological Products Advisory
Committee (the Committee). The general
function of the Committee is to provide
advice and recommendations to FDA on
regulatory issues. On June 5, 2024, the
Committee will meet in open session to
discuss and make recommendations on
the selection of the 2024 to 2025
formula for COVID–19 vaccines. The
meeting will be open to the public.
DATES: The meeting will be held
virtually on June 5, 2024, from 8:30 a.m.
to 4:30 p.m. EST. This notice is issued
under the Federal Advisory Committee
Act 5 U.S.C. 1001 et seq. and 21 CFR
part 14, relating to the advisory
committees.
Dated: May 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–11216 Filed 5–21–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKJM1Z7X2PROD with NOTICES
[Docket No. FDA–2024–N–0001]
Evaluating Immunosuppressive Effects
of In Utero Exposure to Drug and
Biologic Products; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
SUMMARY:
VerDate Sep<11>2014
17:06 May 21, 2024
Jkt 262001
‘‘Evaluating Immunosuppressive Effects
of In Utero Exposure to Drug and
Biologic Products.’’ The purpose of the
public workshop is to discuss
transplacental transfer of drug and
biological products with
immunosuppressive properties and the
potential clinical impact on the
developing fetus and newborn infant,
understand the gaps in knowledge, and
consider innovative approaches to
improve collection of relevant data.
DATES: The public workshop will be
held on July 11, 2024, from 9 a.m. to 5
p.m. Eastern Time and on July 12, 2024,
from 9 a.m. to 1 p.m. Eastern Time. See
the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus
and online. Entrance for the registered
public workshop participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/about-fda/visitorinformation.
FOR FURTHER INFORMATION CONTACT:
Meshaun Payne and Michelle Pollack,
Office of New Drugs Public Meeting
Support Team, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6466, Silver Spring,
MD 20993–0002, 301–796–6668,
ONDPublicMTGSupport@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Drug and biological products are
widely used in various therapeutic areas
during pregnancy to treat various
conditions. Some products can be
actively or passively transported across
the placenta from a pregnant individual
to their fetus. When this occurs for
products with immunosuppressive
properties, it is biologically plausible
that these products can exert
immunosuppressive effects on the
developing fetus and newborn infant.
Historically, pregnant individuals have
generally been excluded from clinical
trials, resulting in a paucity of data
available on transplacental transfer and
its potential consequences to the
developing fetus and newborn infant.
This lack of data poses challenges in
providing adequate information in
product labeling to help prescribers and
patients make informed decisions about
use of these products during pregnancy.
II. Topics for Discussion at the Public
Workshop
Pregnant individuals may have
chronic and/or acute conditions that
need to be treated, and published data
PO 00000
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Fmt 4703
Sfmt 4703
44997
show that most pregnant individuals
take at least one medication (excluding
vitamins) during pregnancy. Therefore,
understanding the safety of medications
when used during pregnancy is
important. The main objective of the
‘‘Evaluating Immunosuppressive Effects
of In Utero Exposure to Drug and
Biologic Products’’ workshop is to
discuss the available data on the
placental transfer of drug and biological
products with immunosuppressive
effects and the potential clinical impact
on infants exposed in utero, identify
gaps in knowledge, and explore
innovative and practical approaches for
collection of relevant data. In addition,
the workshop will allow for an open
dialogue among regulators, academia,
industry, and patient organizations
regarding the potential safety concerns
of medicines that may need to be used
during pregnancy and approaches to
data collection.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
website: https://lu.ma/5vdmbibm.
Please register by July 10, 2024, at 11:59
p.m. Eastern time. Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by July 10, 2024, at 11:59 p.m.
Eastern time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted.
If you need special accommodations
due to a disability, please contact
Brittany Witcher, OND Public Meeting
Support Team at
ONDPublicMTGSupport@fda.hhs.gov
no later than July 1, 2024.
Streaming Webcast of the Public
Workshop: This public workshop will
also be streamed virtually via Zoom.
Virtual attendees may register at the
following website to receive the Zoom
link: https://lu.ma/5vdmbibm. Although
FDA verified the website addresses in
this document, please note that websites
are subject to change over time.
Transcripts and Recordings: Please be
advised that as soon as transcripts and
recordings of the public workshop are
available, they will be accessible on the
FDA event web page https://
www.fda.gov/drugs/news-events-
E:\FR\FM\22MYN1.SGM
22MYN1
44998
Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
human-drugs/evaluatingimmunosuppressive-effects-uteroexposure-drug-and-biologic-products07112024. The transcripts and
recordings will also be accessible at
https://www.regulations.gov and may be
viewed at the Dockets Management Staff
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Dated: May 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–11228 Filed 5–21–24; 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: National Survey of Organ
Donation Attitudes and Practices, OMB
No. 0915–0290
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
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. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than June 21, 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
khammond on DSKJM1Z7X2PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:06 May 21, 2024
Jkt 262001
Joella Roland, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
National Survey of Organ Donation
Attitudes and Practices, OMB No. 0915–
0290—Revision.
Abstract: The overall purpose of this
study is to conduct an independent
multi-mode (web and telephone) survey
of public opinion regarding various
issues related to organ donation. The
survey will measure public opinion on
issues such as willingness to become an
organ donor, financial incentives for
donation, living donation, impediments
to donation, and level of public
knowledge about donation. Previous
National Survey of Organ Donation
Attitudes and Practices were conducted
during 1993, 2005, 2012, and 2019.
Similar to the 2019 survey, the goal is
to complete 10,000 interviews with
adults (18 years of age or older)
nationwide. Specifically, this will
include 1,000 equal-probability of
selection method computer-assisted
telephone interviewing (CATI)
interviews, 1,000 ethnic oversamples
CATI interviews, and a supplemental
web panel of 8,000 respondents. The
final sample will include 1,000
interviews each with Black or African
Americans, Asian Americans, Hispanic/
Latino Americans, and American
Indian/Alaskan Natives, and a
statistically sufficient sample for
meaningful comparisons across
demographic levels of age group,
education, and income groups. A total
sample of 10,000 is necessary to achieve
sufficiently large subgroups for
statistical analysis across demographic
groups.
A 60-day notice published in the
Federal Register on January 18, 2024,
vol. 89, No. 12; pp. 3409–3410. There
were no public comments.
Need and Proposed Use of the
Information: The Division of
Transplantation, within the Health
Systems Bureau of HRSA at the
Department of Health and Human
Services, is the primary federal entity
responsible for oversight of the solid
organ and blood stem cell transplant
systems in the United States and for
initiatives to increase organ donor
registration and donation. Sponsorship
of a national survey on the American
public’s donation attitudes and
practices is one of the services that
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Division of Transplantation provides for
the larger donation community,
consistent with its legal authority to
establish a public education and
awareness program (Section 377A of the
Public Health Service Act, 42 U.S.C.
274f–1).
Patients in need of organ
transplantation in the United States face
a longstanding critical shortage of
organs. Approximately 103,000
Americans were on the waiting list for
transplantation by the end of 2022, but
only 42,000 transplants were performed,
which only meets two-fifths of the
national need. While this represents an
increase from the number of transplants
performed in 2021, the organ shortage
remains in the United States.
Understanding public attitudes about
organ donation and how the attitudes
change over time is critical to
addressing organ shortage through
public awareness and education efforts.
The information from this survey will
facilitate appropriate tailoring and
targeting of donation outreach messages
and strategies and provide an overall
assessment of the impact of previous
outreach messages and strategies. The
data will also inform the development
of policy related to organ donation and
transplantation.
Likely Respondents: A nationally
representative sample of adults over the
age of 18 with a higher number of
responses from populations of interest
such as racial-ethnic minorities,
including Black or African American,
Asian American, American Indian/
Alaskan Native, and Hispanic/Latino
American respondents, as well as
respondents of all age groups and
education levels.
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.
E:\FR\FM\22MYN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 44997-44998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11228]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0001]
Evaluating Immunosuppressive Effects of In Utero Exposure to Drug
and Biologic Products; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Evaluating Immunosuppressive
Effects of In Utero Exposure to Drug and Biologic Products.'' The
purpose of the public workshop is to discuss transplacental transfer of
drug and biological products with immunosuppressive properties and the
potential clinical impact on the developing fetus and newborn infant,
understand the gaps in knowledge, and consider innovative approaches to
improve collection of relevant data.
DATES: The public workshop will be held on July 11, 2024, from 9 a.m.
to 5 p.m. Eastern Time and on July 12, 2024, from 9 a.m. to 1 p.m.
Eastern Time. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus
and online. Entrance for the registered public workshop participants
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/about-fda/visitor-information.
FOR FURTHER INFORMATION CONTACT: Meshaun Payne and Michelle Pollack,
Office of New Drugs Public Meeting Support Team, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6466, Silver
Spring, MD 20993-0002, 301-796-6668, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Drug and biological products are widely used in various therapeutic
areas during pregnancy to treat various conditions. Some products can
be actively or passively transported across the placenta from a
pregnant individual to their fetus. When this occurs for products with
immunosuppressive properties, it is biologically plausible that these
products can exert immunosuppressive effects on the developing fetus
and newborn infant. Historically, pregnant individuals have generally
been excluded from clinical trials, resulting in a paucity of data
available on transplacental transfer and its potential consequences to
the developing fetus and newborn infant. This lack of data poses
challenges in providing adequate information in product labeling to
help prescribers and patients make informed decisions about use of
these products during pregnancy.
II. Topics for Discussion at the Public Workshop
Pregnant individuals may have chronic and/or acute conditions that
need to be treated, and published data show that most pregnant
individuals take at least one medication (excluding vitamins) during
pregnancy. Therefore, understanding the safety of medications when used
during pregnancy is important. The main objective of the ``Evaluating
Immunosuppressive Effects of In Utero Exposure to Drug and Biologic
Products'' workshop is to discuss the available data on the placental
transfer of drug and biological products with immunosuppressive effects
and the potential clinical impact on infants exposed in utero, identify
gaps in knowledge, and explore innovative and practical approaches for
collection of relevant data. In addition, the workshop will allow for
an open dialogue among regulators, academia, industry, and patient
organizations regarding the potential safety concerns of medicines that
may need to be used during pregnancy and approaches to data collection.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: https://lu.ma/5vdmbibm. Please register by July 10,
2024, at 11:59 p.m. Eastern time. Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by July 10, 2024, at 11:59 p.m. Eastern time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted.
If you need special accommodations due to a disability, please
contact Brittany Witcher, OND Public Meeting Support Team at
[email protected] no later than July 1, 2024.
Streaming Webcast of the Public Workshop: This public workshop will
also be streamed virtually via Zoom. Virtual attendees may register at
the following website to receive the Zoom link: https://lu.ma/5vdmbibm.
Although FDA verified the website addresses in this document, please
note that websites are subject to change over time.
Transcripts and Recordings: Please be advised that as soon as
transcripts and recordings of the public workshop are available, they
will be accessible on the FDA event web page https://www.fda.gov/drugs/
news-events-
[[Page 44998]]
human-drugs/evaluating-immunosuppressive-effects-utero-exposure-drug-
and-biologic-products-07112024. The transcripts and recordings will
also be accessible at https://www.regulations.gov and may be viewed at
the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: May 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11228 Filed 5-21-24; 8:45 am]
BILLING CODE 4164-01-P
