Notice2026-05313
Advisory Committee; Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Renewal
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Published
March 18, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the renewal of the Obstetrics, Reproductive and Urologic 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 Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the March 23, 2028, expiration date.
Full Text
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<title>Federal Register, Volume 91 Issue 52 (Wednesday, March 18, 2026)</title>
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[Federal Register Volume 91, Number 52 (Wednesday, March 18, 2026)]
[Notices]
[Pages 13031-13034]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05313]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0008]
Advisory Committee; Obstetrics, Reproductive and Urologic 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 Obstetrics, Reproductive and Urologic 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 Obstetrics, Reproductive and Urologic Drugs Advisory Committee for
an additional 2 years beyond the charter expiration date. The new
charter will be in effect until the March 23, 2028, expiration date.
DATES: Authority for the Obstetrics, Reproductive and Urologic Drugs
Advisory Committee will expire on March 23, 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. 31, Rm. 2417, Silver
Spring, MD 20993-0002, (301) 796-7973, <a href="/cdn-cgi/l/email-protection#7435373b3927270116191d07071d1b1a07341210155a1c1c075a131b02"><span class="__cf_email__" data-cfemail="dd9c9e92908e8ea8bfb0b4aeaeb4b2b3ae9dbbb9bcf3b5b5aef3bab2ab">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Pursuant to 21 CFR 14.40(b) and 41 CFR 102-
3.65, and following approval by the Department of Health and Human
Services and review by the General Services Administration, FDA is
[[Page 13032]]
announcing the renewal of the Obstetrics, Reproductive and Urologic
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 data on the safety and
effectiveness of marketed and investigational human drug products for
use in the practice of obstetrics, gynecology, urology and related
specialties, and makes appropriate recommendations to the Commissioner.
The Committee shall consist of a core of at least six voting
members including the Chair. Subject to legal and regulatory
requirements, members and the Chair are selected by and serve at the
discretion of the Commissioner or designee. Each member, including the
Chair, will be selected from among authorities knowledgeable in the
fields of obstetrics, gynecology, urology, 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).
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/human-drug-advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee-formerly-bone-reproductive-and">https://www.fda.gov/advisory-committees/human-drug-advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee-formerly-bone-reproductive-and</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 Obstetrics, Reproductive and Urologic
Drugs Advisory Committee is in the public interest. This determination
is based on the Committee's essential role in providing independent
expert advice on complex scientific and regulatory matters related to
obstetrics, gynecology, urology and related specialties, 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.
Public Interest Determination
FDA estimates the following annual operating costs and staff years
associated with this committee.
(1) Annual budget and expected costs: $88,775.
(i) Federal personnel (based on full-time equivalent (FTE) usage
basis) and other Federal internal costs.
The estimated person years of Federal staff support required is
0.25 at an estimated annual cost of $50,739.
(ii) Proposed payments to members and number of members; and
The estimated annual payment to members is $9,212 for twelve (12)
committee members.\1\
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\1\ This number of committee members is an estimate that
includes potential additional temporary voting members who may
participate in specific advisory committee meetings.
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(iii) Reimbursable costs.
The estimated annual reimbursable costs, including travel and
related expenses for members, is $16,140.
(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 practice of
obstetrics, gynecology, urology 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
obstetrics, gynecology, urology, epidemiology, or statistics and
related specialties, as well as needed consumer and industry
representation. FDA also follows the requirements in section 505(n)(3)
regarding membership of drug product advisory committees. (21 U.S.C.
355(n)(3)).
[[Page 13033]]
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.
Selection Process
A Federal Register Notice is published annually soliciting
nominations for vacancies. Agency Designated Federal Officers and
Office/Division Directors review and evaluate prospective members for
competence and suitability. Anyone may nominate an individual,
including themselves, for committee membership.
(4) List of all other Federal advisory committees of the agency.
FDA maintains the following Federal advisory committees:
<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> Dermatologic and Ophthalmic Drugs 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> Gastrointestinal Drugs Advisory Committee
<bullet> Genetic and Metabolic Disease Advisory Committee
<bullet> Medical Devices Advisory Committee
<bullet> National Mammography Quality Assurance Advisory Committee
(Administratively Inactive)
<bullet> Nonprescription Drugs Advisory Committee
<bullet> Oncologic Drugs Advisory Committee
<bullet> Patient Engagement Advisory Committee
<bullet> Pediatrics Advisory Committee
<bullet> Peripheral and Central Nervous System Advisory Committee
<bullet> Pharmacy Compounding Advisory Committee
<bullet> Pharmacy Compounding Drugs AC
<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 and Electronic Products Safety Standards Advisory
Committee
<bullet> Tobacco Products Scientific Advisory Committee
(5) Justification that the information or advice provided by the
Federal advisory committee is not available from another Federal
advisory committee, another Federal Government source, or any other
more cost-effective and less burdensome source.
The Obstetrics, Reproductive and Urologic 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 practice of obstetrics, gynecology, urology and related
specialties.
The topics considered by the Obstetrics, Reproductive and Urologic
Drugs Advisory Committee require specialized expertise in the practice
of obstetrics, gynecology, urology 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 justification relates to a renewal, a summary of the
previous accomplishments of the committee and the reasons it needs to
continue.
Summary of Previous Accomplishments
In 2022, the committee discussed the Makena (hydroxyprogesterone
caproate injection) application. Approved in 2011 under accelerated
approval, Makena was the only drug product approved to reduce the risk
of recurrent preterm birth in women with a singleton pregnancy who have
a history of singleton spontaneous preterm birth. As a condition of
Makena's approval, the applicant was required to conduct a confirmatory
clinical trial (``the PROLONG'' trial) to verify and describe the
predicted clinical benefit to newborns. The committee discussed whether
the PROLONG trial verified the clinical benefit of Makena and whether
available evidence demonstrated that Makena was effective for its
approved indication. The Committee discussed whether FDA should allow
Makena to remain on the market while an appropriate confirmatory study
was being designed. Their recommendations informed FDA's decision to
withdraw approval for Makena in 2023.
Patients benefit from this committee's review and evaluation of
obstetrics, reproductive and urologic drugs. Topics on which FDA may
seek input from this committee include the following:
<bullet> Contraception and family planning
<bullet> Treatment for endometriosis and adenomyosis
<bullet> Treatment of menstrual disorders
<bullet> Prevention of preterm birth
<bullet> Female and male infertility
<bullet> Female and male sexual dysfunction
<bullet> Testosterone for hypogonadism in men
<bullet> Lactation disorders
<bullet> Treatment of menopausal symptoms
<bullet> Medical treatment of cervical dysplasia associated with human
papilloma virus infection
<bullet> Treatment of preeclampsia
<bullet> Bladder pain disorders
<bullet> Overactive bladder disorders
<bullet> Treatment of benign prostate disease
(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 Obstetrics, Reproductive and Urologic
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 practice of obstetrics, gynecology, urology and related
specialties 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
[[Page 13034]]
<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. 2026-05313 Filed 3-17-26; 8:45 am]
BILLING CODE 4164-01-P
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