Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal, 107148-107149 [2024-31363]
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107148
Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Notices
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FOR FURTHER INFORMATION CONTACT:
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and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 240–
402–8717.
SUPPLEMENTARY INFORMATION:
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I. Background
In the Federal Register of July 25,
2024 (89 FR 60436), FDA requested
information and comments. Interested
persons were originally given until
September 23, 2024, to comment on
evaluating and mitigating the
immunogenicity risk of host cell
proteins.
Following publication of the July 25,
2024, notice, FDA received a request to
allow interested persons additional time
to comment. The requester asserted that
the time period of 60 days was
insufficient to respond fully to FDA’s
specific requests for comments and to
allow potential respondents to
thoroughly evaluate and address
pertinent issues.
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18:31 Dec 30, 2024
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II. Electronic Access
Persons with access to the internet
may obtain relevant guidance at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
clinical-pharmacology-considerationspeptide-drug-products.
Dated: December 23, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–31365 Filed 12–30–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–5830]
Advisory Committee; Dermatologic
and Ophthalmic Drugs Advisory
Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the renewal of the
Dermatologic and Ophthalmic Drugs
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Dermatologic and
Ophthalmic Drugs Advisory Committee
for an additional 2 years beyond the
charter expiration date. The new charter
will be in effect until the October 7,
2026, expiration date.
DATES: Authority for the Dermatologic
and Ophthalmic Drugs Advisory
Committee will expire on October 7,
2026, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
LaToya Bonner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–2855, DODAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Dermatologic and
Ophthalmic Drugs Advisory Committee
(the Committee). The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Committee
SUMMARY:
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advises the Commissioner or designee
in discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of dermatologic and
ophthalmic disorders and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
Pursuant to its charter, the Committee
shall consist of a core of 12 voting
members including 2 Chairpersons.
Members and the Chairpersons are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
dermatology, ophthalmology, dentistry,
immunology, epidemiology or statistics,
and other related professions. Members
will be invited to serve for overlapping
terms of up to 4 years. Non-Federal
members of this committee will serve as
Special Government Employees or
representatives. Federal members will
serve as Regular Government Employees
or Ex-Officios. The core of voting
members may include one technically
qualified member, selected by the
Commissioner or designee, who is
identified with consumer interests and
is recommended by either a consortium
of consumer-oriented organizations or
other interested persons. In addition to
the voting members, the Committee may
include one non-voting representative
member who is identified with industry
interests. There may also be an alternate
industry representative.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members), or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
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31DEN1
Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Notices
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, an additional non-voting
representative member of consumer
interests and an additional non-voting
representative member of industry
interests will be included in addition to
the voting members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
dermatologic-and-ophthalmic-drugsadvisory-committee/dermatologic-andophthalmic-drugs-advisory-committeecharter or by contacting the Designated
Federal Officer (see FOR FURTHER
INFORMATION CONTACT). In light of the
fact that no change has been made to the
committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This notice is issued under the
Federal Advisory Committee Act as
amended (5 U.S.C. 1001 et seq.). For
general information related to FDA
advisory committees, please visit us at
https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: December 23, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–31363 Filed 12–30–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Statement of Organization, Functions,
and Delegations of Authority
Advanced Research Projects
Agency for Health, Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
This document announces
that the Establishment of the Advanced
Research Projects Agency for Health
(ARPA–H) is being amended to reflect a
revised organizational structure for
ARPA–H that aligns with current
statutory requirements. See 42 U.S.C.
290c(a)(2).
SUPPLEMENTARY INFORMATION: The
Establishment of the Advanced
Research Projects Agency for Health
(ARPA–H) (May 24, 2022, at 87 FR
32174) should now read as follows:
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SUMMARY:
Section I. Mission
The mission of ARPA–H is to (1)
expand technical possibilities for the
future of health, (2) forge a resilient
health ecosystem to ensure optimal
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ARPA–H consists of the following
offices and personnel:
progress toward new solutions for the
health care of the future. (2) Cultivate
novel, agile tools that will facilitate
revolutionary advances in medical care.
(3) Leverage the latest scientific
breakthroughs and invests in the
development of platforms and
technologies that do not yet exist. (4)
Propose agency-sponsored research
programs to the ARPA–H Director,
ensuring they align with strategic
objectives.
The ARPA–H Office of the Director
The Resilient Systems Office
The ARPA–H Office of the Director
(Director’s Office (DIRO)) is comprised
of:
1. The ARPA–H Director
2. Deputy Director
3. Chief of Staff
4. Such other staff as necessary to
support the Office of the Director.
The ARPA–H Director is appointed by
the President (42 U.S.C. 290c (1)) and
reports directly to the Secretary of
Health and Human Services. 42 U.S.C.
290c (3). The Secretary has delegated all
determinations regarding ARPA–H
programs and operations to be in the
sole authority and discretion of the
Director. Consistent with 42 U.S.C.
290c(c)(4)(B), this includes all decisions
regarding the approval, termination and
funding of all ARPA–H projects and
programs.
DIRO’s functions and responsibilities
are as follows: (1) Oversee the creation
of agency technical strategy, program
approval, prioritization and
implementation (2) Lead all aspects of
internal Director’s Office operations,
including ongoing management of the
agency’s communications, legislative,
governmental, legal, international, and
mission office activities (3) Serve as the
primary liaison for all Executive and
Legislative functions of the
organization, and fulfills principal level
duties across HHS, including
engagement with the Secretary and
counselors (4) Serve as the primary
liaison to Technical Staff, including
program managers and their teams, and
the Director’s Advisory staff to ensure
consistent and effective coordination
and communication.
The Resilient Systems Office (RSO) is
comprised of is comprised of:
1. Director
2. Deputy Director
3. Such other staff as necessary to
support the RSO
RSO’s mission and responsibilities are
as follows: (1) Drive advances in health
systems to improve their resilience,
robustness, and interoperability, as well
as their ability to adapt to unforeseen
events, such as cyber-attacks, hospital
closures, staffing shortages, emerging
pathogens, and natural disasters. (2)
Improve the continuity of care during
regional and national emergencies,
provides time savings to healthcare
workforces, enhances quality of care
across geographies, improves the
robustness of clinical artificial
intelligence (AI) applications, makes it
easier for patients and clinicians to
make informed decisions, and reduces
gaps between advanced research and
clinical care (3) Develop, implement,
and manage novel, innovative scientific
and technical programs aimed at
improving health outcomes. (4) Propose
agency-sponsored research programs to
the ARPA–H Director, ensuring they
align with strategic objectives.
well-being for all, (3) drive scalable
solutions to improve health care access
and affordability, (4) build proactive
health capacity to keep people from
becoming patients, (5) foster data-driven
innovation across the health ecosystem,
and (6) increase the probability of
successful transition.
Section II. Organization
The Health Science Futures Office
The Health Science Futures Office
(HSFO) is comprised of:
1. Director
2. Deputy Director
3. Such other staff as necessary to
support the HSF Director.
The HSFO’s functions and
responsibilities are as follows: (1)
Remove scientific and technological
limitations that stymie our nation’s
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The Scalable Solutions Office
The Scalable Solutions Office (SSO) is
comprised of:
1. Director
2. Deputy Director
3. Such other staff as necessary to
support the SSO.
SSO’s functions and responsibilities
are as follows: (1) Aim to improve
health care access and affordability for
all Americans by working with partners
to streamline manufacturing processes,
optimize distribution networks, and
develop innovative delivery methods to
bring critical health technologies and
treatments to underserved communities
and remote areas. (2) Focus on
advancing research and development to
create scalable health solutions,
expanding the reach of proven
technologies, and accelerating their
integration into the healthcare system.
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]]>Agencies
[Federal Register Volume 89, Number 250 (Tuesday, December 31, 2024)]
[Notices]
[Pages 107148-107149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31363]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5830]
Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory
Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the renewal of the Dermatologic and Ophthalmic Drugs
Advisory Committee by the Commissioner of Food and Drugs (the
Commissioner). The Commissioner has determined that it is in the public
interest to renew the Dermatologic and Ophthalmic Drugs Advisory
Committee for an additional 2 years beyond the charter expiration date.
The new charter will be in effect until the October 7, 2026, expiration
date.
DATES: Authority for the Dermatologic and Ophthalmic Drugs Advisory
Committee will expire on October 7, 2026, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-2855, [email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Dermatologic and
Ophthalmic Drugs Advisory Committee (the Committee). The Committee is a
discretionary Federal advisory committee established to provide advice
to the Commissioner. The Committee advises the Commissioner or designee
in discharging responsibilities as they relate to helping to ensure
safe and effective drugs for human use and, as required, any other
product for which FDA has regulatory responsibility.
The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of dermatologic and ophthalmic
disorders and makes appropriate recommendations to the Commissioner of
Food and Drugs.
Pursuant to its charter, the Committee shall consist of a core of
12 voting members including 2 Chairpersons. Members and the
Chairpersons are selected by the Commissioner or designee from among
authorities knowledgeable in the fields of dermatology, ophthalmology,
dentistry, immunology, epidemiology or statistics, and other related
professions. Members will be invited to serve for overlapping terms of
up to 4 years. Non-Federal members of this committee will serve as
Special Government Employees or representatives. Federal members will
serve as Regular Government Employees or Ex-Officios. The core of
voting members may include one technically qualified member, selected
by the Commissioner or designee, who is identified with consumer
interests and is recommended by either a consortium of consumer-
oriented organizations or other interested persons. In addition to the
voting members, the Committee may include one non-voting representative
member who is identified with industry interests. There may also be an
alternate industry representative.
The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to exceed 10 members) to serve temporarily as voting
members and to designate consultants to serve temporarily as voting
members when: (1) expertise is required that is not available among
current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members), or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize
[[Page 107149]]
a committee charter to specify quorum requirements.
If functioning as a medical device panel, an additional non-voting
representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in
addition to the voting members.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/dermatologic-and-ophthalmic-drugs-advisory-committee/dermatologic-and-ophthalmic-drugs-advisory-committee-charter or by contacting the
Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In
light of the fact that no change has been made to the committee name or
description of duties, no amendment will be made to 21 CFR 14.100.
This notice is issued under the Federal Advisory Committee Act as
amended (5 U.S.C. 1001 et seq.). For general information related to FDA
advisory committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: December 23, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31363 Filed 12-30-24; 8:45 am]
BILLING CODE 4164-01-P
