Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients With Renal Impairment; Public Workshop, 66008-66009 [2023-20903]
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66008
Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
Annual
number of
responses per
respondent
47
47
47
1
1
2
Applications ......................................................................................................
State Plans ......................................................................................................
Performance Progress Reports .......................................................................
Estimated Total Annual Burden
Hours: 4,512.
Authority: Section 510 of the Social
Security Act (42 U.S.C. 710), as
amended by section 50502 of the
Bipartisan Budget Act of 2018 (Pub. L.
115–123) and extended by Division CC,
title III, section 303 of the Consolidated
Appropriations Act, 2022 (Pub. L. 117–
103).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–20758 Filed 9–25–23; 8:45 am]
BILLING CODE 4184–83–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0001]
Advancing the Development of
Pediatric Therapeutics on Drug Dosing
in Pediatric Patients With Renal
Impairment; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Advancing the
Development of Pediatric Therapeutics
(ADEPT 8) on Drug Dosing in Pediatric
Patients With Renal Impairment.’’ The
purpose of the public workshop is to
discuss the current landscape of drug
dosing in pediatric patients with renal
impairment, understand the gaps in
knowledge, and consider innovative
approaches to improve the current
paradigm for dosing in pediatric
patients with renal impairment.
DATES: The public workshop will be
held on November 30, 2023, and
December 1, 2023, from 9 a.m. to 5 p.m.
eastern time each day. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held at the FDA White Oak Campus
Great Room and online. Entrance for the
registered public workshop participants
(non-FDA employees) is through
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:18 Sep 25, 2023
Jkt 259001
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: Julie
Levin, Office of New Drugs Public
Meeting Support, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6481, Silver Spring,
MD 20993–0002, 202–567–7565,
ONDPublicMTGSupport@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The pharmacokinetics of drugs
excreted by the kidneys may be altered
by renal (kidney) impairment, requiring
dosing adjustments. However, the
majority of drugs that are predominantly
renally excreted and have dosage
recommendations for adults with renal
impairment lack dose adjustment
recommendations for pediatric patients
with renal impairment. This is largely
due to the lack of generation of
pharmacokinetic data in pediatric
patients with renal impairment, which
is attributable to both the ethical and the
practical limitations of conducting
dedicated renal impairment studies in
pediatric patients, as well as the
exclusion of pediatric patients with
renal impairment from most clinical
efficacy and safety studies. For drugs
that are renally cleared, exposures can
be impacted by both the maturation of
kidney function and the renal
impairment due to kidney disease.
II. Topics for Discussion at the Public
Workshop
The main objective of the ‘‘Advancing
the Development of Pediatric
Therapeutics (ADEPT 8) on Drug Dosing
in Pediatric Patients With Renal
Impairment’’ workshop is to discuss
current approaches to classifying renal
impairment in the pediatric population,
identify data gaps, and explore
scientifically supported approaches and
methods for providing information on
dosing adjustment. The workshop will
specifically focus on measurements of
renal function, extrapolation of adult
data, and approaches to generating
clinical trial data to assess the impact of
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
Average
burden hours
per response
Annual
burden hours
24
40
16
1,128
1,880
1,504
renal impairment on the
pharmacokinetics of drugs in pediatric
patients. In addition, the workshop will
allow for an open dialogue around the
use of these approaches among
regulators, industry, academia, and
patient organizations.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
website: https://www.eventbrite.com/e/
adept-8-pediatric-renal-impairmentworkshop-tickets-687423571407. 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 November 15, 2023, 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 Julie
Levin at ONDPublicMTGSupport@
fda.hhs.gov no later than November 15,
2023.
Streaming Webcast of the Public
Workshop: This public workshop will
also be via Zoom. A link will be
provided via email to registered
participants. If you have never attended
a Zoom event before, test your internet
connection by joining a test meeting at
https://zoom.us/test. FDA has verified
the website addresses in this document,
as of the date this document is
published in the Federal Register, but
websites are subject to change over time.
Transcripts: Please be advised that
when a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
E:\FR\FM\26SEN1.SGM
26SEN1
Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices
Dated: September 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–20903 Filed 9–25–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–2925]
Defining Durations of Use for
Approved Medically Important
Antimicrobial Drugs Fed to FoodProducing Animals; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry (GFI) #273
entitled ‘‘Defining Durations of Use for
Approved Medically Important
Antimicrobial Drugs Fed to FoodProducing Animals.’’ This draft
guidance document, when finalized,
will provide recommendations on how
sponsors may voluntarily establish
defined durations of use for certain
antimicrobial new animal drugs used in
or on the medicated feed of foodproducing animals that are currently
approved with one or more indications
that lack a defined duration of use.
Establishing defined durations of use
within the approved new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) is intended to mitigate
development of antimicrobial resistance
for these antimicrobial drugs, which are
important to human medicine. It also,
when finalized, will propose timelines
for stakeholders wishing to voluntarily
align their affected applications with
this guidance.
DATES: Submit either electronic or
written comments on the draft guidance
by December 26, 2023, to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
VerDate Sep<11>2014
18:18 Sep 25, 2023
Jkt 259001
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
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–
2023–D–2925 for ‘‘Defining Durations of
Use for Approved Medically Important
Antimicrobial Drugs Fed to FoodProducing Animals.’’ 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, 240–402–7500.
• 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
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66009
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
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, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT: John
Mussman, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0589,
John.Mussman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft GFI #273 entitled ‘‘Defining
Durations of Use for Approved
Medically Important Antimicrobial
Drugs Fed to Food-Producing Animals.’’
This draft guidance, when finalized,
will provide information to sponsors of
certain antimicrobial animal drug
products who are interested in
establishing appropriately defined
durations of therapeutic administration
to food-producing animals where none
currently exist. The draft guidance,
when finalized, will also propose
timelines for stakeholders wishing to
comply voluntarily with this guidance.
E:\FR\FM\26SEN1.SGM
26SEN1
]]>Agencies
[Federal Register Volume 88, Number 185 (Tuesday, September 26, 2023)]
[Notices]
[Pages 66008-66009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20903]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0001]
Advancing the Development of Pediatric Therapeutics on Drug
Dosing in Pediatric Patients With Renal Impairment; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Advancing the
Development of Pediatric Therapeutics (ADEPT 8) on Drug Dosing in
Pediatric Patients With Renal Impairment.'' The purpose of the public
workshop is to discuss the current landscape of drug dosing in
pediatric patients with renal impairment, understand the gaps in
knowledge, and consider innovative approaches to improve the current
paradigm for dosing in pediatric patients with renal impairment.
DATES: The public workshop will be held on November 30, 2023, and
December 1, 2023, from 9 a.m. to 5 p.m. eastern time each day. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public workshop will be held at the FDA White Oak Campus
Great Room 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: Julie Levin, Office of New Drugs
Public Meeting Support, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6481, Silver Spring, MD 20993-0002, 202-
567-7565, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The pharmacokinetics of drugs excreted by the kidneys may be
altered by renal (kidney) impairment, requiring dosing adjustments.
However, the majority of drugs that are predominantly renally excreted
and have dosage recommendations for adults with renal impairment lack
dose adjustment recommendations for pediatric patients with renal
impairment. This is largely due to the lack of generation of
pharmacokinetic data in pediatric patients with renal impairment, which
is attributable to both the ethical and the practical limitations of
conducting dedicated renal impairment studies in pediatric patients, as
well as the exclusion of pediatric patients with renal impairment from
most clinical efficacy and safety studies. For drugs that are renally
cleared, exposures can be impacted by both the maturation of kidney
function and the renal impairment due to kidney disease.
II. Topics for Discussion at the Public Workshop
The main objective of the ``Advancing the Development of Pediatric
Therapeutics (ADEPT 8) on Drug Dosing in Pediatric Patients With Renal
Impairment'' workshop is to discuss current approaches to classifying
renal impairment in the pediatric population, identify data gaps, and
explore scientifically supported approaches and methods for providing
information on dosing adjustment. The workshop will specifically focus
on measurements of renal function, extrapolation of adult data, and
approaches to generating clinical trial data to assess the impact of
renal impairment on the pharmacokinetics of drugs in pediatric
patients. In addition, the workshop will allow for an open dialogue
around the use of these approaches among regulators, industry,
academia, and patient organizations.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: https://www.eventbrite.com/e/adept-8-pediatric-renal-impairment-workshop-tickets-687423571407. 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 November 15, 2023, 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 Julie Levin at [email protected] no later than
November 15, 2023.
Streaming Webcast of the Public Workshop: This public workshop will
also be via Zoom. A link will be provided via email to registered
participants. If you have never attended a Zoom event before, test your
internet connection by joining a test meeting at https://zoom.us/test.
FDA has verified the website addresses in this document, as of the date
this document is published in the Federal Register, but websites are
subject to change over time.
Transcripts: Please be advised that when a transcript of the public
workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
[[Page 66009]]
Dated: September 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20903 Filed 9-25-23; 8:45 am]
BILLING CODE 4164-01-P
