Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal

Issuing agencies

Abstract

The Food and Drug Administration (FDA) 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, 2028, expiration date.

Full Text

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<title>Federal Register, Volume 91 Issue 189 (Thursday, October 1, 2026)</title>
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[Federal Register Volume 91, Number 189 (Thursday, October 1, 2026)]
[Notices]
[Pages 62530-62532]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-0008]


Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory 
Committee; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of Federal advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) 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, 2028, 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: Advisory Committee Oversight and 
Management Staff, Office of the Chief Scientist, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3215, Silver 
Spring, MD 20993-0002, (301) 796-8220, <a href="/cdn-cgi/l/email-protection#b2f3f1fdffe1e1c7d0dfdbc1c1dbdddcc1f2d4d6d39cdadac19cd5ddc4"><span class="__cf_email__" data-cfemail="eeafada1a3bdbd9b8c83879d9d8781809dae888a8fc086869dc0898198">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65, 21 CFR 
14.40(b), 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.
    The Committee shall consist of a core of at least twelve voting 
members including two Chairpersons. Subject to legal and regulatory 
requirements, members and the Chairpersons are selected by and serve at 
the discretion of the Commissioner or designee. Each member, including 
the Chairpersons, will be selected from among authorities knowledgeable 
in the fields of dermatology, ophthalmology, dentistry, immunology, 
epidemiology or statistics, and related specialties.
    Members may be invited to serve for terms of up to four years, or 
for less time in the discretion of the Commissioner or designee. 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.
    In addition to the voting members, the Commissioner or designee may 
identify consumer and/or industry representatives to join the Committee 
(or serve as alternate representatives) as non-voting representative 
member(s), via a process consistent with legal and regulatory 
requirements. Individuals currently employed at FDA-regulated 
companies, such as pharmaceutical and medical device manufacturers, 
shall not be selected to serve as members of the Committee unless this 
Committee is expected to address issues for which inclusion of an 
industry representative is required by statute. If this Committee 
includes an industry representative, the Commissioner or designee will 
determine whether to invite them to participate in meetings on a case-
by-case basis, according to applicable legal and regulatory 
requirements.
    The Commissioner or designee shall have the authority to select 
members of other scientific and technical FDA advisory committees to 
serve temporarily as voting members and to designate Special Government 
Employees 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.
    A quorum for the Committee is a majority of the current voting 
members present at the time, provided that FDA may specify a quorum 
that is less than a majority of the current voting members because of 
the size of the Committee and the variety in the types of issues that 
it will consider, or other reason determined appropriate in accordance 
with legal and regulatory requirements. 21 CFR 14.22(d).
    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.
    Members appointed to an advisory committee serve for the duration 
of the committee, or until their terms expire, they resign, or they are 
removed from membership by the Commissioner or designee. Committee 
members' terms may be ended prior to their date of expiration, for 
reasons determined to be good cause. Good cause includes excessive 
absenteeism from committee meetings, a demonstrated bias that 
interferes with the ability to render objective advice, failure to 
abide by established procedures, or violation of other applicable rules 
and regulations.
    Further information regarding the most recent charter and other 
information can be found at <a href="https://www.fda.gov/advisory-committees/dermatologic-and-ophthalmic-drugs-advisory-committee/dermatologic-and-ophthalmic-drugs-advisory-committee-charter">https://www.fda.gov/advisory-committees/dermatologic-and-ophthalmic-drugs-advisory-committee/dermatologic-and-ophthalmic-drugs-advisory-committee-charter</a> or by contacting the 
Advisory Committee Oversight and Management Staff (see FOR FURTHER 
INFORMATION CONTACT). Because the committee's name and description of 
duties remain unchanged, 21 CFR 14.100 will not be amended.
    Renewal Requirements and Justification: The Commissioner has 
determined that renewal of the Dermatologic and Ophthalmic Drugs 
Advisory Committee is in the public interest. This determination is 
based on the Committee's essential role in providing independent expert 
advice on the safety and effectiveness of marketed and investigational 
human drug products for use in the treatment of dermatologic and 
ophthalmic disorders, the continued need for specialized expertise in 
this therapeutic area, and the Committee's demonstrated value in 
supporting FDA's regulatory mission. The following information supports 
this determination in accordance with applicable legal and regulatory 
requirements.

[[Page 62531]]

Public Interest Determination

    Pursuant to 41 CFR 102-3.60(a), to establish, renew, reestablish, 
or merge a discretionary (agency discretion) advisory committee, an 
agency must first consult with the General Services Administration's 
Committee Management Secretariat (the Secretariat) and, as part of the 
consultation, provide a written public interest determination approved 
by the head of the agency to the Secretariat with a copy to the Office 
of Management and Budget. In addition, pursuant to 41 CFR 102-3.35, an 
agency shall follow the same consultation process and document in 
writing the same determination of need before creating a subcommittee 
under a discretionary committee that is not made up entirely of members 
of a parent advisory committee.
    Information on the following factors for the committee is provided 
to the Secretariat to demonstrate that renewing the committee is in the 
public interest:
    1. Annual budget: The overall annual budget for this committee is 
$136,830.
    a. Federal personnel on a full-time equivalent (FTE) basis: The 
estimated person years of Federal staff support is 0.25 at an estimated 
annual cost of $43,916.
    b. Other Federal internal costs: The anticipated total value in USD 
of other internal costs, such as cost associated with IT and supplies 
for meetings, is $26,233.
    c. Proposed payments to members: The estimated payment to members 
is $15,000.
    d. Proposed number of members: The anticipated number of members is 
twelve.
    e. Reimbursable costs: The estimated annual reimbursable costs, 
including travel and related expenses for members, is $32,069.
    2. If applicable, the total dollar value of grants expected to be 
recommended during the fiscal year: N/A.
    3. Criteria for selecting members to ensure the committee has the 
necessary expertise and fairly balanced membership:
    Ensuring Necessary Expertise: Members must have background, 
education, and experience commensurate with the committee's function of 
advising FDA on the existing and relevant evidence of benefits and 
risks of marketed and investigational human drug products for use in 
the treatment of dermatologic and ophthalmic disorders and related 
specialties. Scientific and technical competence is critical. Nominees 
should be acknowledged experts with demonstrated skills in critical 
evaluation of data and effective communication. As outlined in the 
committee charter, the membership should include authorities 
knowledgeable in the fields of dermatology, ophthalmology, dentistry, 
immunology, epidemiology or statistics, and related specialties, as 
well as needed consumer and industry representation. FDA also follows 
the requirements in section 505(n)(3) of the Federal Food, Drug, and 
Cosmetic Act regarding membership of drug product advisory committees. 
(21 U.S.C. 355(n)(3)).
    Ensuring Fair Balance: Appointments are made without 
discrimination. The committee is reviewed in totality for balance, 
characterized by inclusion of necessary knowledge, insight, and 
scientific perspective from the relevant community or expertise area. 
Nominations are sought from all geographic locations within the United 
States and its territories, and from diverse sources including 
professional and scientific societies, academia, government agencies, 
industry and trade associations, consumer and patient organizations, 
and current Agency staff.
    4. List of all other Federal advisory committees of the agency:

<bullet> Anesthetic and Analgesic Drug Products Advisory Committee
<bullet> Antimicrobial Drugs Advisory Committee
<bullet> Blood Products Advisory Committee
<bullet> Cardiovascular and Renal Drugs Advisory Committee
<bullet> Cellular Tissue and Gene Therapies Advisory Committee
<bullet> Device Good Manufacturing Practice Advisory Committee
<bullet> Digital Health Advisory Committee
<bullet> Drug Safety and Risk Management Advisory Committee
<bullet> Endocrinologic and Metabolic Drugs Advisory Committee
<bullet> Genetic Metabolic Disease Advisory Committee
<bullet> Medical Devices Advisory Committee
<bullet> National Mammography Quality Assurance Advisory Committee 
(Administratively Inactive)
<bullet> Nonprescription Drugs Advisory Committee
<bullet> Obstetrics, Reproductive and Urologic Drugs Advisory Committee
<bullet> Oncologic Drugs Advisory Committee
<bullet> Pediatric Advisory Committee
<bullet> Peripheral and Central Nervous System Advisory Committee
<bullet> Pharmacy Compounding Advisory Committee
<bullet> Psychopharmacologic Drugs Advisory Committee
<bullet> Pulmonary-Allergy Drugs Advisory Committee
<bullet> Risk Communication Advisory Committee (Administratively 
Inactive)
<bullet> Science Board to the Food and Drug Administration
<bullet> Technical Electronic Product Radiation Safety Standards 
Committee
<bullet> Tobacco Products Scientific Advisory Committee
<bullet> Vaccines and Related Biological Products Advisory Committee

    5. Justification that the information or advice provided by the 
Federal advisory committee or subcommittee is not available from 
another Federal advisory committee, another Federal Government source, 
or any other more cost-effective and less burdensome source:
    The Dermatologic and Ophthalmic Drugs Advisory Committee provides 
independent expert advice to FDA on the safety and effectiveness of 
marketed and investigational human drug products for use in the in the 
practice of dermatologic and ophthalmic disorders and related 
specialties.
    The topics considered by the Dermatologic and Ophthalmic Drugs 
Advisory Committee require specialized expertise in the fields of 
dermatology, ophthalmology, dentistry, immunology, epidemiology or 
statistics, and related specialties that is not within the primary 
scope of other FDA advisory committees. Potential topics that may need 
committee input include products related to the topics outlined in 
Section (6) below. These and other issues cannot be appropriately 
addressed by another standing committee without diminishing the depth 
and relevance of the expert input provided to the Agency.
    6. If the consultation is a committee renewal, a summary of the 
previous accomplishments of the committee and the reasons it needs to 
continue:
    Summary of Previous Accomplishments:
    For the last three years, the Dermatologic and Ophthalmic Drugs 
Advisory Committee (DODAC) has held two advisory committee meetings on 
March 28-29, 2023, and January 9, 2023.
    On March 28-29, 2023, the DODAC met jointly with the Drug Safety 
and Risk Management Advisory Committee and the Anesthetic and Analgesic 
Drug Products Advisory Committee to discuss proposed changes to the 
iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements to 
minimize burden on patients, pharmacies, and prescribers while 
maintaining safe use of isotretinoin oral capsules for patients. The 
committee assembled was proposed

[[Page 62532]]

with two voting questions: (1) whether the iPLEDGE REMS should retain 
the 19-day lockout period requirement before patients can take an 
additional pregnancy test to be eligible to receive isotretinoin, and 
(2) when should the REMS require prescribers to document counseling for 
patients who cannot become pregnant in the iPLEDGE system. 
Respectively, majority of the members vote ``No'' (4 Yeses, 17 Noes, 1 
Abstention) to a 19-day lockout period requirement before patients can 
take an additional pregnancy test to be eligible to receive 
isotretinoin, and 10 members favored the first option for REMS to 
require prescribers to document counseling patients who cannot become 
pregnant with the first prescription as part of patient enrollment. 
Regarding recommendations on the pregnancy registry requirement and 
ways in which it could be streamlined to encourage more participation 
to yield high-quality data, members agreed it is not necessary to 
continue to collect ``follow-up data'' (i.e., pregnancy and fetal 
outcome information) and that more effective communication and 
transparency are needed regarding how patients' data will be used if 
they participate in the iPLEDGE Pregnancy Registry.
    Impact: On February 6, 2026, the Agency approved modification to 
the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) to minimize 
burden on patients, prescribers, and pharmacies while maintaining the 
use of isotretinoin.
    On January 9, 2023, the DODAC met to discuss supplemental biologics 
license application (sBLA) 125387, aflibercept solution for 
intravitreal injection, submitted by Regeneron Pharmaceuticals, Inc. 
The supplement was submitted in response to FDA's pediatric written 
request. FDA's written request was for studies of aflibercept in the 
treatment of retinopathy of prematurity. Two Discussion Questions were 
proposed to the panel: (1) Discuss how the studied use of aflibercept 
in the treatment of retinopathy of prematurity can best be communicated 
to physicians and the caregivers of these premature infants, and (2) 
how it should be labeled in a real-world setting. Regarding the first 
speaking point, the committee acknowledged the benefits of using anti-
vascular endothelial growth factor (anti-VEGF) for the treatment of 
retinopathy of prematurity (ROP), which is evident by the data shown 
and concluded that due to the general circumstances that the use of 
this product is made quickly in a neonatal intensive care unit, the 
instructions for administration must be clearly labeled in the package 
insert. The second discussion point, the Committee made recommendations 
on how the instructions should be centralized in the insert for easy a 
find, advised what would be classified as clear instructions for 
practitioners, appropriate dosing and safety precautions for pediatric 
use.
    Impact: The FDA officially approved Eylea (aflibercept 0.4 mg) on 
February 8, 2023, as the first pharmacologic treatment for ROP in 
preterm infants--the first pediatric approval for this indication.
    7. Explanation of why the committee/subcommittee is essential to 
the conduct of agency business:
    Reasons for Continuation:
    The committee plays a critical role in enabling FDA to meet the 
requirements of sections 505(n)(1) and (s)(1) of the Federal Food, 
Drug, and Cosmetic Act by providing expert scientific advice and 
recommendations. Without the Dermatologic and Ophthalmic Drugs Advisory 
Committee, FDA's ability to obtain external expert input on issues 
related to the approval and regulation of the safety and effectiveness 
of marketed and investigational human drug products for use in the 
treatment of dermatologic and ophthalmic disorders would be 
significantly limited.
    In conclusion, this public interest determination documents that 
renewing the committee is in the public interest, essential to the 
conduct of agency business, and that the information to be obtained is 
not already available through another advisory committee or source 
within the Federal Government.
    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 <a href="http://www.fda.gov/AdvisoryCommittees/default.htm">http://www.fda.gov/AdvisoryCommittees/default.htm</a>.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20141 Filed 9-29-26; 4:15 pm]
BILLING CODE 4164-01-P


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