[House Report 119-300]
[From the U.S. Government Publishing Office]
119th Congress } { Report
HOUSE OF REPRESENTATIVES
1st Session } { 119-300
=======================================================================
OVER-THE-COUNTER MONOGRAPH DRUG USER FEE
AMENDMENTS
----------------
September 17, 2025.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
----------------
Mr. Guthrie, from the Committee on Energy and Commerce,
submitted the following
R E P O R T
[To accompany H.R. 4273]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 4273) to amend the Federal Food, Drug, and
Cosmetic Act to revise and extend the user fee program for
over-the-counter monograph drugs, and for other purposes,
having considered the same, reports favorably thereon with an
amendment and recommends that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 5
Background and Need for Legislation.............................. 6
Committee Action................................................. 6
Committee Votes.................................................. 6
Oversight Findings and Recommendations........................... 8
New Budget Authority, Entitlement Authority, and Tax Expenditures 8
Congressional Budget Office Estimate............................. 8
Federal Mandates Statement....................................... 8
Statement of General Performance Goals and Objectives............ 8
Duplication of Federal Programs.................................. 8
Related Committee and Subcommittee Hearings...................... 8
Committee Cost Estimate.......................................... 9
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 9
Advisory Committee Statement..................................... 9
Applicability to Legislative Branch.............................. 9
Section-by-Section Analysis of the Legislation................... 9
Changes in Existing Law Made by the Bill, as Reported............ 10
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Over-the-Counter Monograph Drug User
Fee Amendments''.
SEC. 2. FINDING.
Congress finds that the fees authorized by the amendments made in
this Act will be dedicated to OTC monograph drug activities, as set
forth in the goals identified for purposes of part 10 of subchapter C
of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-71 et seq.), in the letters from the Secretary of Health and Human
Services to the Chairman of the Committee on Energy and Commerce of the
House of Representatives and the Chairman of the Committee on Health,
Education, Labor, and Pensions of the Senate, as set forth in the
Congressional Record.
SEC. 3. DEFINITIONS.
Section 744L(9)(A) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-71(9)(A)) is amended--
(1) in clause (v), by striking ``; or'' and inserting a
semicolon;
(2) in clause (vi)--
(A) by striking ``addition'' and inserting ``the
addition''; and
(B) by striking the period and inserting ``; or'';
and
(3) by adding at the end the following:
``(vii) the addition or modification of a testing
procedure applicable to one or more OTC monograph
drugs, provided that such additional or modified
testing procedure reflects a voluntary consensus
standard with respect to pharmaceutical quality that
is--
``(I) established by a national or
international standards development
organization; and
``(II) recognized by the Secretary through a
process described in guidance for industry,
initially published in July 2023, or any
successor guidance, publicly available on the
website of the Food and Drug Administration,
which addresses voluntary consensus standards
for pharmaceutical quality.''.
SEC. 4. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH FEES.
(a) Types of Fees.--Section 744M(a)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-72(a)(1)) is amended--
(1) in subparagraph (A)--
(A) by striking ``on December 31 of the fiscal year
or at any time during the preceding 12-month period''
and inserting ``at any time during the applicable
period specified in clause (ii) for a fiscal year'';
(B) by striking ``Each person'' and inserting the
following:
``(i) Assessment of fees.--Each person''; and
(C) by adding at the end the following:
``(ii) Applicable period.--For purposes of
clause (i), the applicable period is--
``(I) for fiscal year 2026, the 12-
month period ending on December 31,
2025;
``(II) for fiscal year 2027, the 9-
month period ending on September 30,
2026; and
``(III) for fiscal year 2028 and each
subsequent fiscal year, the 12-month
period ending on September 30 of the
preceding fiscal year.'';
(2) in subparagraph (B)(i), by amending subclause (I) to read
as follows:
``(I) has ceased all activities
related to OTC monograph drugs prior
to--
``(aa) for purposes of fiscal
year 2026, January 1, 2025;
``(bb) for purposes of fiscal
year 2027, January 1, 2026; and
``(cc) for purposes of fiscal
year 2028 and each subsequent
fiscal year, October 1 of the
preceding fiscal year; and'';
and
(3) by amending subparagraph (D) to read as follows:
``(D) Due date.--
``(i) Fiscal year 2026.--For fiscal year
2026, the facility fees required under
subparagraph (A) shall be due on the later of--
``(I) the first business day of June
of such year; or
``(II) the first business day after
the enactment of an appropriations Act
providing for the collection and
obligation of fees under this section
for such year.
``(ii) Fiscal year 2027.--For fiscal year
2027, the facility fees required under
subparagraph (A) shall be due--
``(I) in a first installment
representing 50 percent of such fee, on
the later of--
``(aa) October 1, 2026; or
``(bb) the first business day
after the enactment of an
appropriations Act providing
for the collection and
obligation of fees under this
section for such year; and
``(II) in a second installment
representing the remaining 50 percent
of such fee, on--
``(aa) February 1, 2027; or
``(bb) if an appropriations
Act described in subclause
(I)(bb) is not in effect on
February 1, 2027, the first
business day after enactment of
such an appropriations Act.
``(iii) Subsequent fiscal years.--For fiscal
year 2028 and each subsequent fiscal year, the
facility fees required under subparagraph (A)
shall be due on the later of--
``(I) the first business day on or
after October 1 of the fiscal year; or
``(II) the first business day after
the date of enactment of an
appropriations Act providing for the
collection and obligation of fees under
this section for the fiscal year.''.
(b) Fee Revenue Amounts.--Section 744M(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-72(b)) is amended to read as follows:
``(b) Fee Revenue Amounts.--
``(1) In general.--For each of the fiscal years 2026 through
2030, fees under subsection (a)(1) shall be established to
generate a total facility fee revenue amount equal to the sum
of--
``(A) the annual base revenue for the fiscal year (as
determined under paragraph (2));
``(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined under
subsection (c)(1));
``(C) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(2));
``(D) additional direct cost adjustments (as
determined under subsection (c)(3));
``(E) an additional dollar amount equal to--
``(i) $2,373,000 for fiscal year 2026;
``(ii) $1,233,000 for fiscal year 2027; and
``(iii) $854,000 for fiscal year 2028; and
``(F) in the case of a fiscal year for which the
Secretary applies the one-time facility fee workload
adjustment under subsection (c)(4), the dollar amount
equal to such adjustment.
``(2) Annual base revenue.--For purposes of paragraph (1),
the dollar amount of the annual base revenue for a fiscal year
shall be--
``(A) for fiscal year 2026, the dollar amount of the
total revenue amount established for fiscal year 2025
under this subsection as in effect on the day before
the date of enactment of the Over-the-Counter Monograph
Drug User Fee Amendments, not including any adjustments
made for such fiscal year 2025 under subsection (c)(2),
as so in effect; and
``(B) for fiscal years 2027 through 2030, the dollar
amount of the total revenue amount established under
this subsection for the previous fiscal year, not
including any adjustments made for such previous fiscal
year under subsection (c)(2) or (c)(3).''.
(c) Adjustments; Annual Fee Setting.--Section 744M(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A), in the matter preceding
clause (i)--
(i) by striking ``subsection (b)(2)(B)'' and
inserting ``subsection (b)(1)(B)''; and
(ii) by striking ``fiscal year 2022 and each
subsequent fiscal year'' and inserting ``each
fiscal year'';
(B) in subparagraph (B), by striking ``fiscal year
2022'' and all that follows through the period at the
end and inserting the following: ``a fiscal year shall
be equal to the product of--
``(i) for fiscal year 2026--
``(I) the fee for fiscal year 2025
under subsection (a)(2); and
``(II) the inflation adjustment
percentage under subparagraph (C); and
``(ii) for each of fiscal years 2027 through
2030--
``(I) the applicable fee under
subsection (a)(2) for the preceding
fiscal year; and
``(II) the inflation adjustment
percentage under subparagraph (C).'';
and
(C) in subparagraph (C)--
(i) in the matter preceding clause (i), by
inserting ``the sum of'' after ``is equal to'';
(ii) by striking clause (i);
(iii) by redesignating subclauses (I) and
(II) of clause (ii) as clauses (i) and (ii),
respectively, and adjusting the margins
accordingly;
(iv) by striking ``(ii) for each of fiscal
years 2024 and 2025, the sum of--''; and
(v) in clause (ii), as so redesignated, by
striking ``Washington-Baltimore, DC-MD-VA-WV''
and inserting ``Washington-Arlington-
Alexandria-DC-VA-MD-WV'';
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) by striking ``fiscal year 2021 and
subsequent fiscal years'' and inserting ``each
fiscal year'';
(ii) by striking ``subsections (b)(1)(B) and
(b)(2)(C)'' and inserting ``subsection
(b)(1)(C)''; and
(iii) by striking ``the number of weeks
specified in subparagraph (B)'' and inserting
``10 weeks'';
(B) by striking subparagraph (B);
(C) by redesignating subparagraphs (C) and (D) as
subparagraphs (B) and (C), respectively; and
(D) in subparagraph (C), as so redesignated, by
striking ``paragraph (4) establishing'' and inserting
``paragraph (5) publishing'';
(3) in paragraph (3)--
(A) in the matter preceding subparagraph (A), by
striking ``subsection (b)(2)(D)'' and inserting
``subsection (b)(1)(D)''; and
(B) by striking subparagraphs (A) through (E) and
inserting the following:
``(A) $135,000 for fiscal year 2026;
``(B) $300,000 for fiscal year 2027;
``(C) $55,000 for fiscal year 2028;
``(D) $30,000 for fiscal year 2029; and
``(E) $0 for fiscal year 2030.''; and
(4) by striking paragraph (4) and inserting the following:
``(4) One-time facility fee workload adjustment.--
``(A) In general.--In addition to the adjustments
under paragraphs (1), (2), and (3), the Secretary may
further increase the fee revenues and fees through a
one-time adjustment made for fiscal year 2028, 2029, or
2030, in accordance with this paragraph.
``(B) Adjustment described.--
``(i) Conditions for adjustment.--An
adjustment under this paragraph may be made for
a fiscal year only if--
``(I) an adjustment under this
paragraph had not been made for any
prior fiscal year;
``(II) the average number of OTC
monograph drug facilities subject to a
facility fee under subsection (a)(1)
over the period of the preceding 3
fiscal years exceeds 1,625; and
``(III) with respect to facilities
described in subclause (II), the
average number of such facilities
(expressed as a percentage) that
appeared on the arrears lists pursuant
to subsection (e)(1)(A)(i) over the
period of the preceding 3 fiscal years
is less than 30 percent.
``(ii) Amount of adjustment.--An adjustment
under this paragraph for a fiscal year shall
equal the product of--
``(I) the total facility revenue
amount determined under subsection (b)
for the fiscal year, exclusive of the
adjustment under this paragraph for
such fiscal year; and
``(II) the excess facility percentage
described in clause (iii).
``(iii) Excess facility percentage.--The
excess facility percentage described in this
clause is--
``(I) the amount by which the average
number of OTC monograph drug facilities
subject to a facility fee under
subsection (a)(1) over the preceding 3
fiscal years exceeds 1,625; divided by
``(II) 1,625.
``(5) Annual fee setting.--The Secretary shall, not later
than 60 days before the first day of each fiscal year--
``(A) establish for such fiscal year, based on the
revenue amounts under subsection (b) and the
adjustments provided under this subsection--
``(i) OTC monograph drug facility fees under
subsection (a)(1); and
``(ii) OTC monograph order request fees under
subsection (a)(2); and
``(B) publish such fee revenue amounts, facility
fees, and OTC monograph order request fees in the
Federal Register.''.
(d) Crediting and Availability of Fees.--Section 744M(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72(f)) is
amended--
(1) in paragraph (2)(D)--
(A) in the subparagraph heading, by striking ``in
subsequent years''; and
(B) by striking ``(after fiscal year 2021)''; and
(2) in paragraph (3), by striking ``2021 through 2025'' and
inserting ``2026 through 2030''.
SEC. 5. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744N of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-73) is amended--
(1) in subsection (a)--
(A) by striking ``Beginning with fiscal year 2021,
and not later than 120 calendar days after the end of
each fiscal year thereafter'' and inserting ``Not later
than 120 calendar days after the end of each fiscal
year''; and
(B) by striking ``section 3861(b) of the CARES Act''
and inserting ``section 2 of the Over-the-Counter
Monograph Drug User Fee Amendments'';
(2) in subsection (b), by striking ``fiscal year 2021 and
each subsequent fiscal year'' and inserting ``each fiscal
year''; and
(3) in subsection (d), by striking ``2025'' each place it
appears and inserting ``2030''.
SEC. 6. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE MARKETED
WITHOUT AN APPROVED DRUG APPLICATION.
(a) Development Advice to Sponsors or Requestors.--Section 505G(h) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h(h)) is amended
by striking ``sponsors or requestors'' and inserting ``sponsors,
requestors, or organizations nominated by sponsors or requestors to
represent their interests in a proceeding''.
(b) Technical Correction.--Section 505G(b)(2)(A)(iv)(III) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h(b)(2)(A)(iv)(III))
is amended by striking ``requestors'' and inserting ``sponsors or
requestors''.
SEC. 7. SUNSET DATES.
(a) Authorization.--Sections 744L and 744M of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-71; 379j-72) shall cease to be
effective October 1, 2030.
(b) Reporting Requirements.--Section 744N of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-73) shall cease to be effective
January 31, 2031.
SEC. 8. EFFECTIVE DATE.
The amendments made by this Act shall take effect on October 1, 2025,
or the date of the enactment of this Act, whichever is later, except
that fees under part 10 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-71 et seq.) shall be
assessed beginning October 1, 2025, regardless of the date of the
enactment of this Act.
SEC. 9. SAVINGS CLAUSE.
Notwithstanding the amendments made by this Act, part 10 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-71 et seq.), as in effect on the day before the date of
enactment of this Act, shall continue to be in effect with respect to
assessing and collecting any fee required by such part for a fiscal
year prior to fiscal year 2026.
Purpose and Summary
H.R. 4273 reauthorizes the Over-the-Counter Monograph Drug
User Fee Program (OMUFA) for fiscal years 2026 to 2030.
Background and Need for Legislation
The Coronavirus Aid, Relief, and Economic Security Act
(CARES Act), signed into law in March 2020, authorized the Food
and Drug Administration (FDA) to assess and collect user fees
dedicated to over-the-counter (OTC) monograph drug activities
through the OTC Monograph Drug User Fee Program (OMUFA I).
Under OMUFA, fees paid by the regulated industry support
FDA's regulatory activities related to OTC monograph drugs,
while the FDA commits to adhere to certain negotiated
performance goals and procedures related to various OTC
monograph activities.\1\
---------------------------------------------------------------------------
\1\U.S. Food and Drug Admin., Over-The-Counter Monograph Drug User
Fee Program (OMUFA) (2025), https://www.fda.gov/industry/fda-user-fee-
programs/over-counter-monograph-drug-user-fee-program-omufa.
---------------------------------------------------------------------------
Reauthorization of this program would include the
negotiated agreement on performance goals and procedures
between FDA and industry for the upcoming five-year period.
This would be the first reauthorization of OMUFA (OMUFA II).
Committee Action
On July 16, 2025, the Subcommittee on Health held a hearing
on H.R. 4273. The title of the hearing was ``Legislative
Proposals to Maintain and Improve the Public Health Workforce,
Rural Health, and Over-the-Counter Medicines.'' The
Subcommittee received testimony from:
Dr. Jacqueline Corrigan-Curay, JD, MD,
Acting Director for Center for Drug Evaluation and
Research (CDER), U.S. Food and Drug Administration;
Dr. Candice Chen, MD, MPH, Acting Associate
Administrator for Health Workforce, U.S. Health
Resources and Services Administration; and
Tom Morris, MPA, Associate Administrator for
Rural Health Policy, U.S. Health Resources and Services
Administration.
On July 23, 2025, the full Committee on Energy and Commerce
met in open markup session and ordered H.R. 4273, as amended,
favorably reported to the House by a record vote of 51 yeas and
0 nays.
Committee Votes
Clause 3(b) of rule XIII requires the Committee to list the
record votes on the motion to report legislation and amendments
thereto. The following reflects the record votes taken during
the Committee consideration:
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Oversight Findings and Recommendations
Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of
rule XIII, the Committee held hearings and made findings that
are reflected in this report.
New Budget Authority, Entitlement Authority, and Tax
Expenditures
Pursuant to clause 3(c)(2) of rule XIII, the Committee
finds that H.R. 4273 would result in no new or increased budget
authority, entitlement authority, or tax expenditures or
revenues.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII, at the time this
report was filed, the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974 was not available.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to
reauthorize the Over-the-Counter Monograph Drug User Fee
Program (OMUFA) for fiscal years 2026 to 2030.
Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 4273 is known to be duplicative of another Federal
program, including any program that was included in a report to
Congress pursuant to section 21 of Public Law 111-139 or the
most recent Catalog of Federal Domestic Assistance.
Related Committee and Subcommittee Hearings
Pursuant to clause 3(c)(6) of rule XIII, the following
related hearings were used to develop or consider H.R. 4273:
On April 1, 2025, the Subcommittee on Health
held a hearing on H.R. 4273. The title of the hearing
was ``Examining the FDA's Regulation of Over-the-
Counter Monograph Drugs.'' The Subcommittee received
testimony from:
Kevin Menzel, Member, Board of
Directors, Consumer Healthcare Products
Association; President, Focus Consumer
Healthcare;
Douglas M. Troutman, Interim Co-
Chief Executive Officer, American Cleaning
Institute;
Kim Wezik, MPH, Director of
Advocacy, Melanoma Research Foundation;
Scott Faber, Senior Vice
President, Government Affairs, Environmental
Working Group; and
Carl D'Ruiz, MPH, Senior
Science, Advocacy, and Business Development
Manager for Beauty and Care, North America,
dsm-firmenich.
On July 16, 2025, the Subcommittee on Health
held a hearing on H.R. 4273. The title of the hearing
was ``Legislative Proposals to Maintain and Improve the
Public Health Workforce, Rural Health, and Over-the-
Counter Medicines.'' The Subcommittee received
testimony from:
Dr. Jacqueline Corrigan-Curay,
JD, MD, Acting Director for Center for Drug
Evaluation and Research (CDER), U.S. Food and
Drug Administration;
Dr. Candice Chen, MD, MPH,
Acting Associate Administrator for Health
Workforce, U.S. Health Resources and Services
Administration; and
Tom Morris, MPA, Associate
Administrator for Rural Health Policy, U.S.
Health Resources and Services Administration.
Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974. At the time this report was
filed, the estimate was not available.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 4273 contains no earmarks, limited
tax benefits, or limited tariff benefits.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 provides a short title of ``Over-the-Counter
Monograph Drug User Fee Amendments.''
Section 2. Finding
Section 2 reports that Congress finds the fees authorized
in this legislation will be dedicated to OTC monograph drug
activities.
Section 3. Definitions
Section 3 amends the definition of a Tier 2 OTC monograph
order request to add a new category of such requests,
specifically for the addition or modification of certain
testing procedures in the applicable monograph(s).
Section 4. Authority to assess and use OTC monograph fees
Section 4 authorizes the Secretary to continue to assess
and collect fees as determined by an annual base revenue amount
with certain permitted adjustments, as well as to continue the
10-week operating reserve. This Section also makes certain
changes to the process of setting annual facility fees,
including changes to the required timelines.
Section 5. Reauthorization; reporting requirements
Section 5 reauthorizes the requirements included in OMUFA I
for the Secretary to prepare and issue certain reports to
Congress related to OTC monograph drug activities, including
progress made towards the negotiated performance goals.
Section 6. Regulation of certain nonprescription drugs that are
marketed without an approved drug application
Section 6 clarifies that organizations nominated by
sponsors or requestors to represent their interests are
permitted to meet with FDA officials related to obtaining
advice on certain information to support submissions relevant
to nonprescription drugs. This section also makes a technical
correction to clarify that both sponsors and requestors are
permitted to pursue formal dispute resolutions related to
certain administrative orders.
Section 7. Sunset dates
Section 7 establishes sunsets for certain authorities
outlined within this legislation.
Section 8. Effective date
Section 8 specifies the effective date for the amendments
in this legislation and ensures that certain fees can be
assessed and collected beginning October 1, 2025.
Section 9. Savings clause
Section 9 preserves the applicability of the previous OMUFA
I fee authority with respect to fees due and payable prior to
enactment of the amendments made by this legislation.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules
of the House of Representatives, changes in existing law made
by the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, and existing law in which no
change is proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
* * * * * * *
SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE
MARKETED WITHOUT AN APPROVED DRUG APPLICATION.
(a) Nonprescription Drugs Marketed Without an Approved
Application.--Nonprescription drugs marketed without an
approved drug application under section 505, as of the date of
the enactment of this section, shall be treated in accordance
with this subsection.
(1) Drugs subject to a final monograph; category i
drugs subject to a tentative final monograph.--A drug
is deemed to be generally recognized as safe and
effective under section 201(p)(1), not a new drug under
section 201(p), and not subject to section 503(b)(1),
if--
(A) the drug is--
(i) in conformity with the
requirements for nonprescription use of
a final monograph issued under part 330
of title 21, Code of Federal
Regulations (except as provided in
paragraph (2)), the general
requirements for nonprescription drugs,
and conditions or requirements under
subsections (b), (c), and (k); and
(ii) except as permitted by an order
issued under subsection (b) or, in the
case of a minor change in the drug, in
conformity with an order issued under
subsection (c), in a dosage form that,
immediately prior to the date of the
enactment of this section, has been
used to a material extent and for a
material time under section 201(p)(2);
or
(B) the drug is--
(i) classified in category I for
safety and effectiveness under a
tentative final monograph that is the
most recently applicable proposal or
determination issued under part 330 of
title 21, Code of Federal Regulations;
(ii) in conformity with the proposed
requirements for nonprescription use of
such tentative final monograph, any
applicable subsequent determination by
the Secretary, the general requirements
for nonprescription drugs, and
conditions or requirements under
subsections (b), (c), and (k); and
(iii) except as permitted by an order
issued under subsection (b) or, in the
case of a minor change in the drug, in
conformity with an order issued under
subsection (c), in a dosage form that,
immediately prior to the date of the
enactment of this section, has been
used to a material extent and for a
material time under section 201(p)(2).
(2) Treatment of sunscreen drugs.--With respect to
sunscreen drugs subject to this section, the applicable
requirements in terms of conformity with a final
monograph, for purposes of paragraph (1)(A)(i), shall
be the requirements specified in part 352 of title 21,
Code of Federal Regulations, as published on May 21,
1999, beginning on page 27687 of volume 64 of the
Federal Register, except that the applicable
requirements governing effectiveness and labeling shall
be those specified in section 201.327 of title 21, Code
of Federal Regulations.
(3) Category iii drugs subject to a tentative final
monograph; category i drugs subject to proposed
monograph or advance notice of proposed rulemaking.--A
drug that is not described in paragraph (1), (2), or
(4) is not required to be the subject of an application
approved under section 505, and is not subject to
section 503(b)(1), if--
(A) the drug is--
(i) classified in category III for
safety or effectiveness in the preamble
of a proposed rule establishing a
tentative final monograph that is the
most recently applicable proposal or
determination for such drug issued
under part 330 of title 21, Code of
Federal Regulations;
(ii) in conformity with--
(I) the conditions of use,
including indication and dosage
strength, if any, described for
such category III drug in such
preamble or in an applicable
subsequent proposed rule;
(II) the proposed
requirements for drugs
classified in such tentative
final monograph in category I
in the most recently proposed
rule establishing requirements
related to such tentative final
monograph and in any final rule
establishing requirements that
are applicable to the drug; and
(III) the general
requirements for
nonprescription drugs and
conditions or requirements
under subsection (b) or (k);
and
(iii) in a dosage form that,
immediately prior to the date of the
enactment of this section, had been
used to a material extent and for a
material time under section 201(p)(2);
or
(B) the drug is--
(i) classified in category I for
safety and effectiveness under a
proposed monograph or advance notice of
proposed rulemaking that is the most
recently applicable proposal or
determination for such drug issued
under part 330 of title 21, Code of
Federal Regulations;
(ii) in conformity with the
requirements for nonprescription use of
such proposed monograph or advance
notice of proposed rulemaking, any
applicable subsequent determination by
the Secretary, the general requirements
for nonprescription drugs, and
conditions or requirements under
subsection (b) or (k); and
(iii) in a dosage form that,
immediately prior to the date of the
enactment of this section, has been
used to a material extent and for a
material time under section 201(p)(2).
(4) Category ii drugs deemed new drugs.--A drug that
is classified in category II for safety or
effectiveness under a tentative final monograph or that
is subject to a determination to be not generally
recognized as safe and effective in a proposed rule
that is the most recently applicable proposal issued
under part 330 of title 21, Code of Federal
Regulations, shall be deemed to be a new drug under
section 201(p), misbranded under section 502(ee), and
subject to the requirement for an approved new drug
application under section 505 beginning on the day that
is 180 calendar days after the date of the enactment of
this section, unless, before such day, the Secretary
determines that it is in the interest of public health
to extend the period during which the drug may be
marketed without such an approved new drug application.
(5) Drugs not grase deemed new drugs.--A drug that
the Secretary has determined not to be generally
recognized as safe and effective under section
201(p)(1) under a final determination issued under part
330 of title 21, Code of Federal Regulations, shall be
deemed to be a new drug under section 201(p),
misbranded under section 502(ee), and subject to the
requirement for an approved new drug application under
section 505.
(6) Other drugs deemed new drugs.--Except as provided
in subsection (m), a drug is deemed to be a new drug
under section 201(p) and misbranded under section
502(ee) if the drug--
(A) is not subject to section 503(b)(1); and
(B) is not described in paragraph (1), (2),
(3), (4), or (5), or subsection (b)(1)(B).
(b) Administrative Orders.--
(1) In general.--
(A) Determination.--The Secretary may, on the
initiative of the Secretary or at the request
of one or more requestors, issue an
administrative order determining whether there
are conditions under which a specific drug, a
class of drugs, or a combination of drugs, is
determined to be--
(i) not subject to section 503(b)(1);
and
(ii) generally recognized as safe and
effective under section 201(p)(1).
(B) Effect.--A drug or combination of drugs
shall be deemed to not require approval under
section 505 if such drug or combination of
drugs--
(i) is determined by the Secretary to
meet the conditions specified in
clauses (i) and (ii) of subparagraph
(A);
(ii) is marketed in conformity with
an administrative order under this
subsection;
(iii) meets the general requirements
for nonprescription drugs; and
(iv) meets the requirements under
subsections (c) and (k).
(C) Standard.--The Secretary shall find that
a drug is not generally recognized as safe and
effective under section 201(p)(1) if--
(i) the evidence shows that the drug
is not generally recognized as safe and
effective under section 201(p)(1); or
(ii) the evidence is inadequate to
show that the drug is generally
recognized as safe and effective under
section 201(p)(1).
(2) Administrative orders initiated by the
secretary.--
(A) In general.--In issuing an administrative
order under paragraph (1) upon the Secretary's
initiative, the Secretary shall--
(i) make reasonable efforts to notify
informally, not later than 2 business
days before the issuance of the
proposed order, the sponsors of drugs
who have a listing in effect under
section 510(j) for the drugs or
combination of drugs that will be
subject to the administrative order;
(ii) after any such reasonable
efforts of notification--
(I) issue a proposed
administrative order by
publishing it on the website of
the Food and Drug
Administration and include in
such order the reasons for the
issuance of such order; and
(II) publish a notice of
availability of such proposed
order in the Federal Register;
(iii) except as provided in
subparagraph (B), provide for a public
comment period with respect to such
proposed order of not less than 45
calendar days; and
(iv) if, after completion of the
proceedings specified in clauses (i)
through (iii), the Secretary determines
that it is appropriate to issue a final
administrative order--
(I) issue the final
administrative order, together
with a detailed statement of
reasons, which order shall not
take effect until the time for
requesting judicial review
under paragraph (3)(D)(ii) has
expired;
(II) publish a notice of such
final administrative order in
the Federal Register;
(III) afford [requestors]
sponsors or requestors of drugs
that will be subject to such
order the opportunity for
formal dispute resolution up to
the level of the Director of
the Center for Drug Evaluation
and Research, which initially
must be requested within 45
calendar days of the issuance
of the order, and, for
subsequent levels of appeal,
within 30 calendar days of the
prior decision; and
(IV) except with respect to
drugs described in paragraph
(3)(B), upon completion of the
formal dispute resolution
procedure, inform the persons
which sought such dispute
resolution of their right to
request a hearing.
(B) Exceptions.--When issuing an
administrative order under paragraph (1) on the
Secretary's initiative proposing to determine
that a drug described in subsection (a)(3) is
not generally recognized as safe and effective
under section 201(p)(1), the Secretary shall
follow the procedures in subparagraph (A),
except that--
(i) the proposed order shall include
notice of--
(I) the general categories of
data the Secretary has
determined necessary to
establish that the drug is
generally recognized as safe
and effective under section
201(p)(1); and
(II) the format for
submissions by interested
persons;
(ii) the Secretary shall provide for
a public comment period of no less than
180 calendar days with respect to such
proposed order, except when the
Secretary determines, for good cause,
that a shorter period is in the
interest of public health; and
(iii) any person who submits data in
such comment period shall include a
certification that the person has
submitted all evidence created,
obtained, or received by that person
that is both within the categories of
data identified in the proposed order
and relevant to a determination as to
whether the drug is generally
recognized as safe and effective under
section 201(p)(1).
(3) Hearings; judicial review.--
(A) In general.--Only a person who
participated in each stage of formal dispute
resolution under subclause (III) of paragraph
(2)(A)(iv) of an administrative order with
respect to a drug may request a hearing
concerning a final administrative order issued
under such paragraph with respect to such drug.
If a hearing is sought, such person must submit
a request for a hearing, which shall be based
solely on information in the administrative
record, to the Secretary not later than 30
calendar days after receiving notice of the
final decision of the formal dispute resolution
procedure.
(B) No hearing required with respect to
orders relating to certain drugs.--
(i) In general.--The Secretary shall
not be required to provide notice and
an opportunity for a hearing pursuant
to paragraph (2)(A)(iv) if the final
administrative order involved relates
to a drug--
(I) that is described in
subsection (a)(3)(A); and
(II) with respect to which no
human or non-human data studies
relevant to the safety or
effectiveness of such drug have
been submitted to the
administrative record since the
issuance of the most recent
tentative final monograph
relating to such drug.
(ii) Human data studies and non-human
data defined.--In this subparagraph:
(I) The term ``human data
studies'' means clinical trials
of safety or effectiveness
(including actual use studies),
pharmacokinetics studies, or
bioavailability studies.
(II) The term ``non-human
data'' means data from testing
other than with human subjects
which provides information
concerning safety or
effectiveness.
(C) Hearing procedures.--
(i) Denial of request for hearing.--
If the Secretary determines that
information submitted in a request for
a hearing under subparagraph (A) with
respect to a final administrative order
issued under paragraph (2)(A)(iv) does
not identify the existence of a genuine
and substantial question of material
fact, the Secretary may deny such
request. In making such a
determination, the Secretary may
consider only information and data that
are based on relevant and reliable
scientific principles and
methodologies.
(ii) Single hearing for multiple
related requests.--If more than one
request for a hearing is submitted with
respect to the same administrative
order under subparagraph (A), the
Secretary may direct that a single
hearing be conducted in which all
persons whose hearing requests were
granted may participate.
(iii) Presiding officer.--The
presiding officer of a hearing
requested under subparagraph (A)
shall--
(I) be designated by the
Secretary;
(II) not be an employee of
the Center for Drug Evaluation
and Research; and
(III) not have been
previously involved in the
development of the
administrative order involved
or proceedings relating to that
administrative order.
(iv) Rights of parties to hearing.--
The parties to a hearing requested
under subparagraph (A) shall have the
right to present testimony, including
testimony of expert witnesses, and to
cross-examine witnesses presented by
other parties. Where appropriate, the
presiding officer may require that
cross-examination by parties
representing substantially the same
interests be consolidated to promote
efficiency and avoid duplication.
(v) Final decision.--
(I) At the conclusion of a
hearing requested under
subparagraph (A), the presiding
officer of the hearing shall
issue a decision containing
findings of fact and
conclusions of law. The
decision of the presiding
officer shall be final.
(II) The final decision may
not take effect until the
period under subparagraph
(D)(ii) for submitting a
request for judicial review of
such decision expires.
(D) Judicial review of final administrative
order.--
(i) In general.--The procedures
described in section 505(h) shall apply
with respect to judicial review of
final administrative orders issued
under this subsection in the same
manner and to the same extent as such
section applies to an order described
in such section except that the
judicial review shall be taken by
filing in an appropriate district court
of the United States in lieu of the
appellate courts specified in such
section.
(ii) Period to submit a request for
judicial review.--A person eligible to
request a hearing under this paragraph
and seeking judicial review of a final
administrative order issued under this
subsection shall file such request for
judicial review not later than 60
calendar days after the latest of--
(I) the date on which notice
of such order is published;
(II) the date on which a
hearing with respect to such
order is denied under
subparagraph (B) or (C)(i);
(III) the date on which a
final decision is made
following a hearing under
subparagraph (C)(v); or
(IV) if no hearing is
requested, the date on which
the time for requesting a
hearing expires.
(4) Expedited procedure with respect to
administrative orders initiated by the secretary.--
(A) Imminent hazard to the public health.--
(i) In general.--In the case of a
determination by the Secretary that a
drug, class of drugs, or combination of
drugs subject to this section poses an
imminent hazard to the public health,
the Secretary, after first making
reasonable efforts to notify, not later
than 48 hours before issuance of such
order under this subparagraph, sponsors
who have a listing in effect under
section 510(j) for such drug or
combination of drugs--
(I) may issue an interim
final administrative order for
such drug, class of drugs, or
combination of drugs under
paragraph (1), together with a
detailed statement of the
reasons for such order;
(II) shall publish in the
Federal Register a notice of
availability of any such order;
and
(III) shall provide for a
public comment period of at
least 45 calendar days with
respect to such interim final
order.
(ii) Nondelegation.--The Secretary
may not delegate the authority to issue
an interim final administrative order
under this subparagraph.
(B) Safety labeling changes.--
(i) In general.--In the case of a
determination by the Secretary that a
change in the labeling of a drug, class
of drugs, or combination of drugs
subject to this section is reasonably
expected to mitigate a significant or
unreasonable risk of a serious adverse
event associated with use of the drug,
the Secretary may--
(I) make reasonable efforts
to notify informally, not later
than 48 hours before the
issuance of the interim final
order, the sponsors of drugs
who have a listing in effect
under section 510(j) for such
drug or combination of drugs;
(II) after reasonable efforts
of notification, issue an
interim final administrative
order in accordance with
paragraph (1) to require such
change, together with a
detailed statement of the
reasons for such order;
(III) publish in the Federal
Register a notice of
availability of such order; and
(IV) provide for a public
comment period of at least 45
calendar days with respect to
such interim final order.
(ii) Content of order.--An interim
final order issued under this
subparagraph with respect to the
labeling of a drug may provide for new
warnings and other information required
for safe use of the drug.
(C) Effective date.--An order under
subparagraph (A) or (B) shall take effect on a
date specified by the Secretary.
(D) Final order.--After the completion of the
proceedings in subparagraph (A) or (B), the
Secretary shall--
(i) issue a final order in accordance
with paragraph (1);
(ii) publish a notice of availability
of such final administrative order in
the Federal Register; and
(iii) afford sponsors of such drugs
that will be subject to such an order
the opportunity for formal dispute
resolution up to the level of the
Director of the Center for Drug
Evaluation and Research, which must
initially be within 45 calendar days of
the issuance of the order, and for
subsequent levels of appeal, within 30
calendar days of the prior decision.
(E) Hearings.--A sponsor of a drug subject to
a final order issued under subparagraph (D) and
that participated in each stage of formal
dispute resolution under clause (iii) of such
subparagraph may request a hearing on such
order. The provisions of subparagraphs (A),
(B), and (C) of paragraph (3), other than
paragraph (3)(C)(v)(II), shall apply with
respect to a hearing on such order in the same
manner and to the same extent as such
provisions apply with respect to a hearing on
an administrative order issued under paragraph
(2)(A)(iv).
(F) Timing.--
(i) Final order and hearing.--The
Secretary shall--
(I) not later than 6 months
after the date on which the
comment period closes under
subparagraph (A) or (B), issue
a final order in accordance
with paragraph (1); and
(II) not later than 12 months
after the date on which such
final order is issued, complete
any hearing under subparagraph
(E).
(ii) Dispute resolution request.--The
Secretary shall specify in an interim
final order issued under subparagraph
(A) or (B) such shorter periods for
requesting dispute resolution under
subparagraph (D)(iii) as are necessary
to meet the requirements of this
subparagraph.
(G) Judicial review.--A final order issued
pursuant to subparagraph (F) shall be subject
to judicial review in accordance with paragraph
(3)(D).
(5) Administrative order initiated at the request of
a requestor.--
(A) In general.--In issuing an administrative
order under paragraph (1) at the request of a
requestor with respect to certain drugs,
classes of drugs, or combinations of drugs--
(i) the Secretary shall, after
receiving a request under this
subparagraph, determine whether the
request is sufficiently complete and
formatted to permit a substantive
review;
(ii) if the Secretary determines that
the request is sufficiently complete
and formatted to permit a substantive
review, the Secretary shall--
(I) file the request; and
(II) initiate proceedings
with respect to issuing an
administrative order in
accordance with paragraphs (2)
and (3); and
(iii) except as provided in paragraph
(6), if the Secretary determines that a
request does not meet the requirements
for filing or is not sufficiently
complete and formatted to permit a
substantive review, the requestor may
demand that the request be filed over
protest, and the Secretary shall
initiate proceedings to review the
request in accordance with paragraph
(2)(A).
(B) Request to initiate proceedings.--
(i) In general.--A requestor seeking
an administrative order under paragraph
(1) with respect to certain drugs,
classes of drugs, or combinations of
drugs, shall submit to the Secretary a
request to initiate proceedings for
such order in the form and manner as
specified by the Secretary. Such
requestor may submit a request under
this subparagraph for the issuance of
an administrative order--
(I) determining whether a
drug is generally recognized as
safe and effective under
section 201(p)(1), exempt from
section 503(b)(1), and not
required to be the subject of
an approved application under
section 505; or
(II) determining whether a
change to a condition of use of
a drug is generally recognized
as safe and effective under
section 201(p)(1), exempt from
section 503(b)(1), and not
required to be the subject of
an approved application under
section 505, if, absent such a
changed condition of use, such
drug is--
(aa) generally
recognized as safe and
effective under section
201(p)(1) in accordance
with subsection (a)(1),
(a)(2), or an order
under this subsection;
or
(bb) subject to
subsection (a)(3), but
only if such requestor
initiates such request
in conjunction with a
request for the
Secretary to determine
whether such drug is
generally recognized as
safe and effective
under section
201(p)(1), which is
filed by the Secretary
under subparagraph
(A)(ii).
(ii) Exception.--The Secretary is not
required to complete review of a
request for a change described in
clause (i)(II) if the Secretary
determines that there is an inadequate
basis to find the drug is generally
recognized as safe and effective under
section 201(p)(1) under paragraph (1)
and issues a final order announcing
that determination.
(iii) Withdrawal.--The requestor may
withdraw a request under this
paragraph, according to the procedures
set forth pursuant to subsection
(d)(2)(B). Notwithstanding any other
provision of this section, if such
request is withdrawn, the Secretary may
cease proceedings under this
subparagraph.
(C) Exclusivity.--
(i) In general.--A final
administrative order issued in response
to a request under this section shall
have the effect of authorizing solely
the order requestor (or the licensees,
assignees, or successors in interest of
such requestor with respect to the
subject of such order), for a period of
18 months following the effective date
of such final order and beginning on
the date the requestor may lawfully
market such drugs pursuant to the
order, to market drugs--
(I) incorporating changes
described in clause (ii); and
(II) subject to the
limitations under clause (iv).
(ii) Changes described.--A change
described in this clause is a change
subject to an order specified in clause
(i), which--
(I) provides for a drug to
contain an active ingredient
(including any ester or salt of
the active ingredient) not
previously incorporated in a
drug described in clause (iii);
or
(II) provides for a change in
the conditions of use of a
drug, for which new human data
studies conducted or sponsored
by the requestor (or for which
the requestor has an exclusive
right of reference) were
essential to the issuance of
such order.
(iii) Drugs described.--The drugs
described in this clause are drugs--
(I) specified in subsection
(a)(1), (a)(2), or (a)(3);
(II) subject to a final order
issued under this section;
(III) subject to a final
sunscreen order (as defined in
section 586(2)(A)); or
(IV) described in subsection
(m)(1), other than drugs
subject to an active
enforcement action under
chapter III of this Act.
(iv) Limitations on exclusivity.--
(I) In general.--Only one 18-
month period under this
subparagraph shall be granted,
under each order described in
clause (i), with respect to
changes (to the drug subject to
such order) which are either--
(aa) changes
described in clause
(ii)(I), relating to
active ingredients; or
(bb) changes
described in clause
(ii)(II), relating to
conditions of use.
(II) No exclusivity
allowed.--No exclusivity shall
apply to changes to a drug
which are--
(aa) the subject of a
Tier 2 OTC monograph
order request (as
defined in section
744L);
(bb) safety-related
changes, as defined by
the Secretary, or any
other changes the
Secretary considers
necessary to assure
safe use; or
(cc) changes related
to methods of testing
safety or efficacy.
(v) New human data studies defined.--
In this subparagraph, the term ``new
human data studies'' means clinical
trials of safety or effectiveness
(including actual use studies),
pharmacokinetics studies, or
bioavailability studies, the results of
which--
(I) have not been relied on
by the Secretary to support--
(aa) a proposed or
final determination
that a drug described
in subclause (I), (II),
or (III) of clause
(iii) is generally
recognized as safe and
effective under section
201(p)(1); or
(bb) approval of a
drug that was approved
under section 505; and
(II) do not duplicate the
results of another study that
was relied on by the Secretary
to support--
(aa) a proposed or
final determination
that a drug described
in subclause (I), (II),
or (III) of clause
(iii) is generally
recognized as safe and
effective under section
201(p)(1); or
(bb) approval of a
drug that was approved
under section 505.
(vi) Notification of drug not
available for sale.--A requestor that
is granted exclusivity with respect to
a drug under this subparagraph shall
notify the Secretary in writing within
1 year of the issuance of the final
administrative order if the drug that
is the subject of such order will not
be available for sale within 1 year of
the date of issuance of such order. The
requestor shall include with such
notice the--
(I) identity of the drug by
established name and by
proprietary name, if any;
(II) strength of the drug;
(III) date on which the drug
will be available for sale, if
known; and
(IV) reason for not marketing
the drug after issuance of the
order.
(6) Information regarding safe nonprescription
marketing and use as condition for filing a generally
recognized as safe and effective request.--
(A) In general.--In response to a request
under this section that a drug described in
subparagraph (B) be generally recognized as
safe and effective, the Secretary--
(i) may file such request, if the
request includes information specified
under subparagraph (C) with respect to
safe nonprescription marketing and use
of such drug; or
(ii) if the request fails to include
information specified under
subparagraph (C), shall refuse to file
such request and require that
nonprescription marketing of the drug
be pursuant to a new drug application
as described in subparagraph (D).
(B) Drug described.--A drug described in this
subparagraph is a nonprescription drug which
contains an active ingredient not previously
incorporated in a drug--
(i) specified in subsection (a)(1),
(a)(2), or (a)(3);
(ii) subject to a final order under
this section; or
(iii) subject to a final sunscreen
order (as defined in section
586(2)(A)).
(C) Information demonstrating prima facie
safe nonprescription marketing and use.--
Information specified in this subparagraph,
with respect to a request described in
subparagraph (A)(i), is--
(i) information sufficient for a
prima facie demonstration that the drug
subject to such request has a
verifiable history of being marketed
and safely used by consumers in the
United States as a nonprescription drug
under comparable conditions of use;
(ii) if the drug has not been
previously marketed in the United
States as a nonprescription drug,
information sufficient for a prima
facie demonstration that the drug was
marketed and safely used under
comparable conditions of marketing and
use in a country listed in section
802(b)(1)(A) or designated by the
Secretary in accordance with section
802(b)(1)(B)--
(I) for such period as needed
to provide reasonable
assurances concerning the safe
nonprescription use of the
drug; and
(II) during such time was
subject to sufficient
monitoring by a regulatory body
considered acceptable by the
Secretary for such monitoring
purposes, including for adverse
events associated with
nonprescription use of the
drug; or
(iii) if the Secretary determines
that information described in clause
(i) or (ii) is not needed to provide a
prima facie demonstration that the drug
can be safely marketed and used as a
nonprescription drug, such other
information the Secretary determines is
sufficient for such purposes.
(D) Marketing pursuant to new drug
application.--In the case of a request
described in subparagraph (A)(ii), the drug
subject to such request may be resubmitted for
filing only if--
(i) the drug is marketed as a
nonprescription drug, under conditions
of use comparable to the conditions
specified in the request, for such
period as the Secretary determines
appropriate (not to exceed 5
consecutive years) pursuant to an
application approved under section 505;
and
(ii) during such period, 1,000,000
retail packages of the drug, or an
equivalent quantity as determined by
the Secretary, were distributed for
retail sale, as determined in such
manner as the Secretary finds
appropriate.
(E) Rule of application.--Except in the case
of a request involving a drug described in
section 586(9), as in effect on January 1,
2017, if the Secretary refuses to file a
request under this paragraph, the requestor may
not file such request over protest under
paragraph (5)(A)(iii).
(7) Packaging.--An administrative order issued under
paragraph (2), (4)(A), or (5) may include requirements
for the packaging of a drug to encourage use in
accordance with labeling. Such requirements may include
unit dose packaging, requirements for products intended
for use by pediatric populations, requirements to
reduce risk of harm from unsupervised ingestion, and
other appropriate requirements. This paragraph does not
authorize the Food and Drug Administration to require
standards or testing procedures as described in part
1700 of title 16, Code of Federal Regulations.
(8) Final and tentative final monographs for category
i drugs deemed final administrative orders.--
(A) In general.--A final monograph or
tentative final monograph described in
subparagraph (B) shall be deemed to be a final
administrative order under this subsection and
may be amended, revoked, or otherwise modified
in accordance with the procedures of this
subsection.
(B) Monographs described.--For purposes of
subparagraph (A), a final monograph or
tentative final monograph is described in this
subparagraph if it--
(i) establishes conditions of use for
a drug described in paragraph (1) or
(2) of subsection (a); and
(ii) represents the most recently
promulgated version of such conditions,
including as modified, in whole or in
part, by any proposed or final rule.
(C) Deemed orders include harmonizing
technical amendments.--The deemed establishment
of a final administrative order under
subparagraph (A) shall be construed to include
any technical amendments to such order as the
Secretary determines necessary to ensure that
such order is appropriately harmonized, in
terms of terminology or cross-references, with
the applicable provisions of this Act (and
regulations thereunder) and any other orders
issued under this section.
(c) Procedure for Minor Changes.--
(1) In general.--Minor changes in the dosage form of
a drug that is described in paragraph (1) or (2) of
subsection (a) or the subject of an order issued under
subsection (b) may be made by a requestor without the
issuance of an order under subsection (b) if--
(A) the requestor maintains such information
as is necessary to demonstrate that the
change--
(i) will not affect the safety or
effectiveness of the drug; and
(ii) will not materially affect the
extent of absorption or other exposure
to the active ingredient in comparison
to a suitable reference product; and
(B) the change is in conformity with the
requirements of an applicable administrative
order issued by the Secretary under paragraph
(3).
(2) Additional information.--
(A) Access to records.--A sponsor shall
submit records requested by the Secretary
relating to such a minor change under section
704(a)(4), within 15 business days of receiving
such a request, or such longer period as the
Secretary may provide.
(B) Insufficient information.--If the
Secretary determines that the information
contained in such records is not sufficient to
demonstrate that the change does not affect the
safety or effectiveness of the drug or
materially affect the extent of absorption or
other exposure to the active ingredient, the
Secretary--
(i) may so inform the sponsor of the
drug in writing; and
(ii) if the Secretary so informs the
sponsor, shall provide the sponsor of
the drug with a reasonable opportunity
to provide additional information.
(C) Failure to submit sufficient
information.--If the sponsor fails to provide
such additional information within a time
prescribed by the Secretary, or if the
Secretary determines that such additional
information does not demonstrate that the
change does not--
(i) affect the safety or
effectiveness of the drug; or
(ii) materially affect the extent of
absorption or other exposure to the
active ingredient in comparison to a
suitable reference product,
the drug as modified is a new drug under
section 201(p) and shall be deemed to be
misbranded under section 502(ee).
(3) Determining whether a change will affect safety
or effectiveness.--
(A) In general.--The Secretary shall issue
one or more administrative orders specifying
requirements for determining whether a minor
change made by a sponsor pursuant to this
subsection will affect the safety or
effectiveness of a drug or materially affect
the extent of absorption or other exposure to
an active ingredient in the drug in comparison
to a suitable reference product, together with
guidance for applying those orders to specific
dosage forms.
(B) Standard practices.--The orders and
guidance issued by the Secretary under
subparagraph (A) shall take into account
relevant public standards and standard
practices for evaluating the quality of drugs,
and may take into account the special needs of
populations, including children.
(d) Confidentiality of Information Submitted to the
Secretary.--
(1) In general.--Subject to paragraph (2), any
information, including reports of testing conducted on
the drug or drugs involved, that is submitted by a
requestor in connection with proceedings on an order
under this section (including any minor change under
subsection (c)) and is a trade secret or confidential
information subject to section 552(b)(4) of title 5,
United States Code, or section 1905 of title 18, United
States Code, shall not be disclosed to the public
unless the requestor consents to that disclosure.
(2) Public availability.--
(A) In general.--Except as provided in
subparagraph (B), the Secretary shall--
(i) make any information submitted by
a requestor in support of a request
under subsection (b)(5)(A) available to
the public not later than the date on
which the proposed order is issued; and
(ii) make any information submitted
by any other person with respect to an
order requested (or initiated by the
Secretary) under subsection (b),
available to the public upon such
submission.
(B) Limitations on public availability.--
Information described in subparagraph (A) shall
not be made public if--
(i) the information pertains to
pharmaceutical quality information,
unless such information is necessary to
establish standards under which a drug
is generally recognized as safe and
effective under section 201(p)(1);
(ii) the information is submitted in
a requestor-initiated request, but the
requestor withdraws such request, in
accordance with withdrawal procedures
established by the Secretary, before
the Secretary issues the proposed
order;
(iii) the Secretary requests and
obtains the information under
subsection (c) and such information is
not submitted in relation to an order
under subsection (b); or
(iv) the information is of the type
contained in raw datasets.
(e) Updates to Drug Listing Information.--A sponsor who makes
a change to a drug subject to this section shall submit updated
drug listing information for the drug in accordance with
section 510(j) within 30 calendar days of the date when the
drug is first commercially marketed, except that a sponsor who
was the order requestor with respect to an order subject to
subsection (b)(5)(C) (or a licensee, assignee, or successor in
interest of such requestor) shall submit updated drug listing
information on or before the date when the drug is first
commercially marketed.
(f) Approvals Under Section 505.--The provisions of this
section shall not be construed to preclude a person from
seeking or maintaining the approval of an application for a
drug under sections 505(b)(1), 505(b)(2), and 505(j). A
determination under this section that a drug is not subject to
section 503(b)(1), is generally recognized as safe and
effective under section 201(p)(1), and is not a new drug under
section 201(p) shall constitute a finding that the drug is safe
and effective that may be relied upon for purposes of an
application under section 505(b)(2), so that the applicant
shall be required to submit for purposes of such application
only information needed to support any modification of the drug
that is not covered by such determination under this section.
(g) Public Availability of Administrative Orders.--The
Secretary shall establish, maintain, update (as determined
necessary by the Secretary but no less frequently than
annually), and make publicly available, with respect to orders
issued under this section--
(1) a repository of each final order and interim
final order in effect, including the complete text of
the order; and
(2) a listing of all orders proposed and under
development under subsection (b)(2), including--
(A) a brief description of each such order;
and
(B) the Secretary's expectations, if
resources permit, for issuance of proposed
orders over a 3-year period.
(h) Development Advice to Sponsors or Requestors.--The
Secretary shall establish procedures under which [sponsors or
requestors] sponsors, requestors, or organizations nominated by
sponsors or requestors to represent their interests in a
proceeding may meet with appropriate officials of the Food and
Drug Administration to obtain advice on the studies and other
information necessary to support submissions under this section
and other matters relevant to the regulation of nonprescription
drugs and the development of new nonprescription drugs under
this section.
(i) Participation of Multiple Sponsors or Requestors.--The
Secretary shall establish procedures to facilitate efficient
participation by multiple sponsors or requestors in proceedings
under this section, including provision for joint meetings with
multiple sponsors or requestors or with organizations nominated
by sponsors or requestors to represent their interests in a
proceeding.
(j) Electronic Format.--All submissions under this section
shall be in electronic format.
(k) Effect on Existing Regulations Governing Nonprescription
Drugs.--
(1) Regulations of general applicability to
nonprescription drugs.--Except as provided in this
subsection, nothing in this section supersedes
regulations establishing general requirements for
nonprescription drugs, including regulations of general
applicability contained in parts 201, 250, and 330 of
title 21, Code of Federal Regulations, or any successor
regulations. The Secretary shall establish or modify
such regulations by means of rulemaking in accordance
with section 553 of title 5, United States Code.
(2) Regulations establishing requirements for
specific nonprescription drugs.--
(A) The provisions of section 310.545 of
title 21, Code of Federal Regulations, as in
effect on the day before the date of the
enactment of this section, shall be deemed to
be a final order under subsection (b).
(B) Regulations in effect on the day before
the date of the enactment of this section,
establishing requirements for specific
nonprescription drugs marketed pursuant to this
section (including such requirements in parts
201 and 250 of title 21, Code of Federal
Regulations), shall be deemed to be final
orders under subsection (b), only as they apply
to drugs--
(i) subject to paragraph (1), (2),
(3), or (4) of subsection (a); or
(ii) otherwise subject to an order
under this section.
(3) Withdrawal of regulations.--The Secretary shall
withdraw regulations establishing final monographs and
the procedures governing the over-the-counter drug
review under part 330 and other relevant parts of title
21, Code of Federal Regulations (as in effect on the
day before the date of the enactment of this section),
or make technical changes to such regulations to ensure
conformity with appropriate terminology and cross
references. Notwithstanding subchapter II of chapter 5
of title 5, United States Code, any such withdrawal or
technical changes shall be made without public notice
and comment and shall be effective upon publication
through notice in the Federal Register (or upon such
date as specified in such notice).
(l) Guidance.--The Secretary shall issue guidance that
specifies--
(1) the procedures and principles for formal meetings
between the Secretary and sponsors or requestors for
drugs subject to this section;
(2) the format and content of data submissions to the
Secretary under this section;
(3) the format of electronic submissions to the
Secretary under this section;
(4) consolidated proceedings for appeal and the
procedures for such proceedings where appropriate; and
(5) for minor changes in drugs, recommendations on
how to comply with the requirements in orders issued
under subsection (c)(3).
(m) Rule of Construction.--
(1) In general.--This section shall not affect the
treatment or status of a nonprescription drug--
(A) that is marketed without an application
approved under section 505 as of the date of
the enactment of this section;
(B) that is not subject to an order issued
under this section; and
(C) to which paragraph (1), (2), (3), (4), or
(5) of subsection (a) do not apply.
(2) Treatment of products previously found to be
subject to time and extent requirements.--
(A) Notwithstanding subsection (a), a drug
described in subparagraph (B) may only be
lawfully marketed, without an application
approved under section 505, pursuant to an
order issued under this section.
(B) A drug described in this subparagraph is
a drug which, prior to the date of the
enactment of this section, the Secretary
determined in a proposed or final rule to be
ineligible for review under the OTC drug review
(as such phrase ``OTC drug review'' was used in
section 330.14 of title 21, Code of Federal
Regulations, as in effect on the day before the
date of the enactment of this section).
(3) Preservation of authority.--
(A) Nothing in paragraph (1) shall be
construed to preclude or limit the
applicability of any provision of this Act
other than this section.
(B) Nothing in subsection (a) shall be
construed to prohibit the Secretary from
issuing an order under this section finding a
drug to be not generally recognized as safe and
effective under section 201(p)(1), as the
Secretary determines appropriate.
(n) Investigational New Drugs.--A drug is not subject to this
section if an exemption for investigational use under section
505(i) is in effect for such drug.
(o) Inapplicability of Paperwork Reduction Act.--Chapter 35
of title 44, United States Code, shall not apply to collections
of information made under this section.
(p) Inapplicability of Notice and Comment Rulemaking and
Other Requirements.--The requirements of subsection (b) shall
apply with respect to orders issued under this section instead
of the requirements of subchapter II of chapter 5 of title 5,
United States Code.
(q) Definitions.--In this section:
(1) The term ``nonprescription drug'' refers to a
drug not subject to the requirements of section
503(b)(1).
(2) The term ``sponsor'' refers to any person
marketing, manufacturing, or processing a drug that--
(A) is listed pursuant to section 510(j); and
(B) is or will be subject to an
administrative order under this section of the
Food and Drug Administration.
(3) The term ``requestor'' refers to any person or
group of persons marketing, manufacturing, processing,
or developing a drug.
* * * * * * *
CHAPTER VII--GENERAL AUTHORITY
* * * * * * *
Subchapter C--Fees
* * * * * * *
PART 10--FEES RELATING TO OVER-THE-COUNTER DRUGS
SEC. 744L. DEFINITIONS.
In this part:
(1) The term ``affiliate'' means a business entity
that has a relationship with a second business entity
if, directly or indirectly--
(A) one business entity controls, or has the
power to control, the other business entity; or
(B) a third party controls, or has power to
control, both of the business entities.
(2) The term ``contract manufacturing organization
facility'' means an OTC monograph drug facility where
neither the owner of such manufacturing facility nor
any affiliate of such owner or facility sells the OTC
monograph drug produced at such facility directly to
wholesalers, retailers, or consumers in the United
States.
(3) The term ``costs of resources allocated for OTC
monograph drug activities'' means the expenses in
connection with OTC monograph drug activities for--
(A) officers and employees of the Food and
Drug Administration, contractors of the Food
and Drug Administration, advisory committees,
and costs related to such officers, employees,
and committees and costs related to contracts
with such contractors;
(B) management of information, and the
acquisition, maintenance, and repair of
computer resources;
(C) leasing, maintenance, renovation, and
repair of facilities and acquisition,
maintenance, and repair of fixtures, furniture,
scientific equipment, and other necessary
materials and supplies; and
(D) collecting fees under section 744M and
accounting for resources allocated for OTC
monograph drug activities.
(4) The term ``FDA establishment identifier'' is the
unique number automatically generated by Food and Drug
Administration's Field Accomplishments and Compliance
Tracking System (FACTS) (or any successor system).
(5) The term ``OTC monograph drug'' means a
nonprescription drug without an approved new drug
application which is governed by the provisions of
section 505G.
(6) The term ``OTC monograph drug activities'' means
activities of the Secretary associated with OTC
monograph drugs and inspection of facilities associated
with such products, including the following activities:
(A) The activities necessary for review and
evaluation of OTC monographs and OTC monograph
order requests, including--
(i) orders proposing or finalizing
applicable conditions of use for OTC
monograph drugs;
(ii) orders affecting status
regarding general recognition of safety
and effectiveness of an OTC monograph
ingredient or combination of
ingredients under specified conditions
of use;
(iii) all OTC monograph drug
development and review activities,
including intra-agency collaboration;
(iv) regulation and policy
development activities related to OTC
monograph drugs;
(v) development of product standards
for products subject to review and
evaluation;
(vi) meetings referred to in section
505G(i);
(vii) review of labeling prior to
issuance of orders related to OTC
monograph drugs or conditions of use;
and
(viii) regulatory science activities
related to OTC monograph drugs.
(B) Inspections related to OTC monograph
drugs.
(C) Monitoring of clinical and other research
conducted in connection with OTC monograph
drugs.
(D) Safety activities with respect to OTC
monograph drugs, including--
(i) collecting, developing, and
reviewing safety information on OTC
monograph drugs, including adverse
event reports;
(ii) developing and using improved
adverse event data-collection systems,
including information technology
systems; and
(iii) developing and using improved
analytical tools to assess potential
safety risks, including access to
external databases.
(E) Other activities necessary for
implementation of section 505G.
(7) The term ``OTC monograph order request'' means a
request for an order submitted under section
505G(b)(5).
(8) The term ``Tier 1 OTC monograph order request''
means any OTC monograph order request not determined to
be a Tier 2 OTC monograph order request.
(9)(A) The term ``Tier 2 OTC monograph order
request'' means, subject to subparagraph (B), an OTC
monograph order request for--
(i) the reordering of existing information in
the drug facts label of an OTC monograph drug;
(ii) the addition of information to the other
information section of the drug facts label of
an OTC monograph drug, as limited by section
201.66(c)(7) of title 21, Code of Federal
Regulations (or any successor regulations);
(iii) modification to the directions for use
section of the drug facts label of an OTC
monograph drug, if such changes conform to
changes made pursuant to section 505G(c)(3)(A);
(iv) the standardization of the concentration
or dose of a specific finalized ingredient
within a particular finalized monograph;
(v) a change to ingredient nomenclature to
align with nomenclature of a standards-setting
organization[; or];
(vi) [addition] the addition of an
interchangeable term in accordance with section
330.1 of title 21, Code of Federal Regulations
(or any successor regulations)[.]; or
(vii) the addition or modification of a
testing procedure applicable to one or more OTC
monograph drugs, provided that such additional
or modified testing procedure reflects a
voluntary consensus standard with respect to
pharmaceutical quality that is--
(I) established by a national or
international standards development
organization; and
(II) recognized by the Secretary
through a process described in guidance
for industry, initially published in
July 2023, or any successor guidance,
publicly available on the website of
the Food and Drug Administration, which
addresses voluntary consensus standards
for pharmaceutical quality.
(B) The Secretary may, based on program
implementation experience or other factors found
appropriate by the Secretary, characterize any OTC
monograph order request as a Tier 2 OTC monograph order
request (including recharacterizing a request from Tier
1 to Tier 2) and publish such determination in a
proposed order issued pursuant to section 505G.
(10)(A) The term ``OTC monograph drug facility''
means a foreign or domestic business or other entity
that--
(i) is--
(I) under one management, either
direct or indirect; and
(II) at one geographic location or
address engaged in manufacturing or
processing the finished dosage form of
an OTC monograph drug;
(ii) includes a finished dosage form
manufacturer facility in a contractual
relationship with the sponsor of one or more
OTC monograph drugs to manufacture or process
such drugs; and
(iii) does not include a business or other
entity whose only manufacturing or processing
activities are one or more of the following:
production of clinical research supplies,
testing, or placement of outer packaging on
packages containing multiple products, for such
purposes as creating multipacks, when each
monograph drug product contained within the
overpackaging is already in a final packaged
form prior to placement in the outer
overpackaging.
(B) For purposes of subparagraph (A)(i)(II), separate
buildings or locations within close proximity are
considered to be at one geographic location or address
if the activities conducted in such buildings or
locations are--
(i) closely related to the same business
enterprise;
(ii) under the supervision of the same local
management; and
(iii) under a single FDA establishment
identifier and capable of being inspected by
the Food and Drug Administration during a
single inspection.
(C) If a business or other entity would meet criteria
specified in subparagraph (A), but for being under
multiple management, the business or other entity is
deemed to constitute multiple facilities, one per
management entity, for purposes of this paragraph.
(11) The term ``OTC monograph drug meeting'' means
any meeting regarding the content of a proposed OTC
monograph order request.
(12) The term ``person'' includes an affiliate of a
person.
(13) The terms ``requestor'' and ``sponsor'' have the
meanings given such terms in section 505G.
SEC. 744M. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH FEES.
(a) Types of Fees.--Beginning with fiscal year 2021, the
Secretary shall assess and collect fees in accordance with this
section as follows:
(1) Facility fee.--
(A) In general.--[Each person]
(i) Assessment of fees._Each person
that owns a facility identified as an
OTC monograph drug facility [on
December 31 of the fiscal year or at
any time during the preceding 12-month
period] at any time during the
applicable period specified in clause
(ii) for a fiscal year shall be
assessed an annual fee for each such
facility as determined under subsection
(c).
(ii) Applicable period.--For purposes
of clause (i), the applicable period
is--
(I) for fiscal year 2026, the
12-month period ending on
December 31, 2025;
(II) for fiscal year 2027,
the 9-month period ending on
September 30, 2026; and
(III) for fiscal year 2028
and each subsequent fiscal
year, the 12-month period
ending on September 30 of the
preceding fiscal year.
(B) Exceptions.--
(i) Facilities that cease
activities.--A fee shall not be
assessed under subparagraph (A) if the
identified OTC monograph drug
facility--
[(I) has ceased all
activities related to OTC
monograph drugs prior to
December 31 of the year
immediately preceding the
applicable fiscal year; and]
(I) has ceased all activities
related to OTC monograph drugs
prior to--
(aa) for purposes of
fiscal year 2026,
January 1, 2025;
(bb) for purposes of
fiscal year 2027,
January 1, 2026; and
(cc) for purposes of
fiscal year 2028 and
each subsequent fiscal
year, October 1 of the
preceding fiscal year;
and
(II) has updated its
registration to reflect such
change under the requirements
for drug establishment
registration set forth in
section 510.
(ii) Contract manufacturing
organizations.--The amount of the fee
for a contract manufacturing
organization facility shall be equal to
two-thirds of the amount of the fee for
an OTC monograph drug facility that is
not a contract manufacturing
organization facility.
(C) Amount.--The amount of fees established
under subparagraph (A) shall be established
under subsection (c).
[(D) Due date.--
[(i) For first program year.--For
fiscal year 2021, the facility fees
required under subparagraph (A) shall
be due on the later of--
[(I) the first business day
of July of 2020; or
[(II) 45 calendar days after
publication of the Federal
Register notice provided for
under subsection (c)(4)(A).
[(ii) Subsequent fiscal years.--For
each fiscal year after fiscal year
2021, the facility fees required under
subparagraph (A) shall be due on the
later of--
[(I) the first business day
of June of such year; or
[(II) the first business day
after the enactment of an
appropriations Act providing
for the collection and
obligation of fees under this
section for such year.]
(D) Due date.--
(i) Fiscal year 2026.--For fiscal
year 2026, the facility fees required
under subparagraph (A) shall be due on
the later of--
(I) the first business day of
June of such year; or
(II) the first business day
after the enactment of an
appropriations Act providing
for the collection and
obligation of fees under this
section for such year.
(ii) Fiscal year 2027.--For fiscal
year 2027, the facility fees required
under subparagraph (A) shall be due--
(I) in a first installment
representing 50 percent of such
fee, on the later of--
(aa) October 1, 2026;
or
(bb) the first
business day after the
enactment of an
appropriations Act
providing for the
collection and
obligation of fees
under this section for
such year; and
(II) in a second installment
representing the remaining 50
percent of such fee, on--
(aa) February 1,
2027; or
(bb) if an
appropriations Act
described in subclause
(I)(bb) is not in
effect on February 1,
2027, the first
business day after
enactment of such an
appropriations Act.
(iii) Subsequent fiscal years.--For
fiscal year 2028 and each subsequent
fiscal year, the facility fees required
under subparagraph (A) shall be due on
the later of--
(I) the first business day on
or after October 1 of the
fiscal year; or
(II) the first business day
after the date of enactment of
an appropriations Act providing
for the collection and
obligation of fees under this
section for the fiscal year.
(2) OTC monograph order request fee.--
(A) In general.--Each person that submits an
OTC monograph order request shall be subject to
a fee for an OTC monograph order request. The
amount of such fee shall be--
(i) for a Tier 1 OTC monograph order
request, $500,000, adjusted for
inflation for the fiscal year (as
determined under subsection (c)(1)(B));
and
(ii) for a Tier 2 OTC monograph order
request, $100,000, adjusted for
inflation for the fiscal year (as
determined under subsection (c)(1)(B)).
(B) Due date.--The OTC monograph order
request fees required under subparagraph (A)
shall be due on the date of submission of the
OTC monograph order request.
(C) Exception for certain safety changes.--A
person who is named as the requestor in an OTC
monograph order shall not be subject to a fee
under subparagraph (A) if the Secretary finds
that the OTC monograph order request seeks to
change the drug facts labeling of an OTC
monograph drug in a way that would add to or
strengthen--
(i) a contraindication, warning, or
precaution;
(ii) a statement about risk
associated with misuse or abuse; or
(iii) an instruction about dosage and
administration that is intended to
increase the safe use of the OTC
monograph drug.
(D) Refund of fee if order request is
recategorized as a tier 2 otc monograph order
request.--If the Secretary determines that an
OTC monograph request initially characterized
as Tier 1 shall be re-characterized as a Tier 2
OTC monograph order request, and the requestor
has paid a Tier 1 fee in accordance with
subparagraph (A)(i), the Secretary shall refund
the requestor the difference between the Tier 1
and Tier 2 fees determined under subparagraphs
(A)(i) and (A)(ii), respectively.
(E) Refund of fee if order request refused
for filing or withdrawn before filing.--The
Secretary shall refund 75 percent of the fee
paid under subparagraph (B) for any order
request which is refused for filing or was
withdrawn before being accepted or refused for
filing.
(F) Fees for order requests previously
refused for filing or withdrawn before
filing.--An OTC monograph order request that
was submitted but was refused for filing, or
was withdrawn before being accepted or refused
for filing, shall be subject to the full fee
under subparagraph (A) upon being resubmitted
or filed over protest.
(G) Refund of fee if order request
withdrawn.--If an order request is withdrawn
after the order request was filed, the
Secretary may refund the fee or a portion of
the fee if no substantial work was performed on
the order request after the application was
filed. The Secretary shall have the sole
discretion to refund a fee or a portion of the
fee under this subparagraph. A determination by
the Secretary concerning a refund under this
subparagraph shall not be reviewable.
(3) Refunds.--
(A) In general.--Other than refunds provided
pursuant to any of subparagraphs (D) through
(G) of paragraph (2), the Secretary shall not
refund any fee paid under paragraph (1) except
as provided in subparagraph (B).
(B) Disputes concerning fees.--To qualify for
the return of a fee claimed to have been paid
in error under paragraph (1) or (2), a person
shall submit to the Secretary a written request
justifying such return within 180 calendar days
after such fee was paid.
(4) Notice.--Within the timeframe specified in
subsection (c), the Secretary shall publish in the
Federal Register the amount of the fees under paragraph
(1) for such fiscal year.
[(b) Fee Revenue Amounts.--
[(1) Fiscal year 2021.--For fiscal year 2021, fees
under subsection (a)(1) shall be established to
generate a total facility fee revenue amount equal to
the sum of--
[(A) the annual base revenue for fiscal year
2021 (as determined under paragraph (3));
[(B) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if
applicable (as determined under subsection
(c)(2)); and
[(C) additional direct cost adjustments (as
determined under subsection (c)(3)).
[(2) Subsequent fiscal years.--For each of the fiscal
years 2022 through 2025, fees under subsection (a)(1)
shall be established to generate a total facility fee
revenue amount equal to the sum of--
[(A) the annual base revenue for the fiscal
year (as determined under paragraph (3));
[(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined
under subsection (c)(1));
[(C) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if
applicable (as determined under subsection
(c)(2));
[(D) additional direct cost adjustments (as
determined under subsection (c)(3)); and
[(E) additional dollar amounts for each
fiscal year as follows:
[(i) $7,000,000 for fiscal year 2022.
[(ii) $6,000,000 for fiscal year
2023.
[(iii) $7,000,000 for fiscal year
2024.
[(iv) $3,000,000 for fiscal year
2025.
[(3) Annual base revenue.--For purposes of paragraphs
(1)(A) and (2)(A), the dollar amount of the annual base
revenue for a fiscal year shall be--
[(A) for fiscal year 2021, $8,000,000; and
[(B) for fiscal years 2022 through 2025, the
dollar amount of the total revenue amount
established under this subsection for the
previous fiscal year, not including any
adjustments made under subsection (c)(2) or
(c)(3).]
(b) Fee Revenue Amounts.--
(1) In general.--For each of the fiscal years 2026
through 2030, fees under subsection (a)(1) shall be
established to generate a total facility fee revenue
amount equal to the sum of--
(A) the annual base revenue for the fiscal
year (as determined under paragraph (2));
(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined
under subsection (c)(1));
(C) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if
applicable (as determined under subsection
(c)(2));
(D) additional direct cost adjustments (as
determined under subsection (c)(3));
(E) an additional dollar amount equal to--
(i) $2,373,000 for fiscal year 2026;
(ii) $1,233,000 for fiscal year 2027;
and
(iii) $854,000 for fiscal year 2028;
and
(F) in the case of a fiscal year for which
the Secretary applies the one-time facility fee
workload adjustment under subsection (c)(4),
the dollar amount equal to such adjustment.
(2) Annual base revenue.--For purposes of paragraph
(1), the dollar amount of the annual base revenue for a
fiscal year shall be--
(A) for fiscal year 2026, the dollar amount
of the total revenue amount established for
fiscal year 2025 under this subsection as in
effect on the day before the date of enactment
of the Over-the-Counter Monograph Drug User Fee
Amendments, not including any adjustments made
for such fiscal year 2025 under subsection
(c)(2), as so in effect; and
(B) for fiscal years 2027 through 2030, the
dollar amount of the total revenue amount
established under this subsection for the
previous fiscal year, not including any
adjustments made for such previous fiscal year
under subsection (c)(2) or (c)(3).
(c) Adjustments; Annual Fee Setting.--
(1) Inflation adjustment.--
(A) In general.--For purposes of [subsection
(b)(2)(B)] subsection (b)(1)(B), the dollar
amount of the inflation adjustment to the
annual base revenue for [fiscal year 2022 and
each subsequent fiscal year] each fiscal year
shall be equal to the product of--
(i) such annual base revenue for the
fiscal year under subsection (b)(2);
and
(ii) the inflation adjustment
percentage under subparagraph (C).
(B) OTC monograph order request fees.--For
purposes of subsection (a)(2), the dollar
amount of the inflation adjustment to the fee
for OTC monograph order requests for [fiscal
year 2022 and each subsequent fiscal year shall
be equal to the product of--] a fiscal year
shall be equal to the product of--
[(i) the applicable fee under
subsection (a)(2) for the preceding
fiscal year; and
[(ii) the inflation adjustment
percentage under subparagraph (C).]
(i) for fiscal year 2026--
(I) the fee for fiscal year
2025 under subsection (a)(2);
and
(II) the inflation adjustment
percentage under subparagraph
(C); and
(ii) for each of fiscal years 2027
through 2030--
(I) the applicable fee under
subsection (a)(2) for the
preceding fiscal year; and
(II) the inflation adjustment
percentage under subparagraph
(C).
(C) Inflation adjustment percentage.--The
inflation adjustment percentage under this
subparagraph for a fiscal year is equal to the
sum of--
[(i) for each of fiscal years 2022
and 2023, the average annual percent
change that occurred in the Consumer
Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not
Seasonally Adjusted; All items; Annual
Index) for the first 3 years of the
preceding 4 years of available data;
and]
[(ii) for each of fiscal years 2024
and 2025, the sum of--]
[(I)] (i) the average annual percent
change in the cost, per full-time
equivalent position of the Food and
Drug Administration, of all personnel
compensation and benefits paid with
respect to such positions for the first
3 years of the preceding 4 fiscal
years, multiplied by the proportion of
personnel compensation and benefits
costs to total costs of OTC monograph
drug activities for the first 3 years
of the preceding 4 fiscal years; and
[(II)] (ii) the average annual
percent change that occurred in the
Consumer Price Index for urban
consumers ([Washington-Baltimore, DC-
MD-VA-WV] Washington-Arlington-
Alexandria-DC-VA-MD-WV; Not Seasonally
Adjusted; All items; Annual Index) for
the first 3 years of the preceding 4
years of available data multiplied by
the proportion of all costs other than
personnel compensation and benefits
costs to total costs of OTC monograph
drug activities for the first 3 years
of the preceding 4 fiscal years.
(2) Operating reserve adjustment.--
(A) In general.--For [fiscal year 2021 and
subsequent fiscal years] each fiscal year, for
purposes of [subsections (b)(1)(B) and
(b)(2)(C)] subsection (b)(1)(C), the Secretary
may, in addition to adjustments under paragraph
(1), further increase the fee revenue and fees
if such an adjustment is necessary to provide
operating reserves of carryover user fees for
OTC monograph drug activities for not more than
[the number of weeks specified in subparagraph
(B)] 10 weeks.
[(B) Number of weeks.--The number of weeks
specified in this subparagraph is--
[(i) 3 weeks for fiscal year 2021;
[(ii) 7 weeks for fiscal year 2022;
[(iii) 10 weeks for fiscal year 2023;
[(iv) 10 weeks for fiscal year 2024;
and
[(v) 10 weeks for fiscal year 2025.]
[(C)] (B) Decrease.--If the Secretary has
carryover balances for such process in excess
of 10 weeks of the operating reserves referred
to in subparagraph (A), the Secretary shall
decrease the fee revenue and fees referred to
in such subparagraph to provide for not more
than 10 weeks of such operating reserves.
[(D)] (C) Rationale for adjustment.--If an
adjustment under this paragraph is made, the
rationale for the amount of the increase or
decrease (as applicable) in fee revenue and
fees shall be contained in the annual Federal
Register notice under [paragraph (4)
establishing] paragraph (5) publishing fee
revenue and fees for the fiscal year involved.
(3) Additional direct cost adjustment.--The Secretary
shall, in addition to adjustments under paragraphs (1)
and (2), further increase the fee revenue and fees for
purposes of [subsection (b)(2)(D)] subsection (b)(1)(D)
by an amount equal to--
[(A) $14,000,000 for fiscal year 2021;
[(B) $7,000,000 for fiscal year 2022;
[(C) $4,000,000 for fiscal year 2023;
[(D) $3,000,000 for fiscal year 2024; and
[(E) $3,000,000 for fiscal year 2025.]
(A) $135,000 for fiscal year 2026;
(B) $300,000 for fiscal year 2027;
(C) $55,000 for fiscal year 2028;
(D) $30,000 for fiscal year 2029; and
(E) $0 for fiscal year 2030.
[(4) Annual fee setting.--
[(A) Fiscal year 2021.--The Secretary shall,
not later than the second Monday in May of
2020--
[(i) establish OTC monograph drug
facility fees for fiscal year 2021
under subsection (a), based on the
revenue amount for such year under
subsection (b) and the adjustments
provided under this subsection; and
[(ii) publish fee revenue, facility
fees, and OTC monograph order requests
in the Federal Register.
[(B) Subsequent fiscal years.--The Secretary
shall, for each fiscal year that begins after
September 30, 2021, not later than the second
Monday in March that precedes such fiscal
year--
[(i) establish for such fiscal year,
based on the revenue amounts under
subsection (b) and the adjustments
provided under this subsection--
[(I) OTC monograph drug
facility fees under subsection
(a)(1); and
[(II) OTC monograph order
request fees under subsection
(a)(2); and
[(ii) publish such fee revenue
amounts, facility fees, and OTC
monograph order request fees in the
Federal Register.]
(4) One-time facility fee workload adjustment.--
(A) In general.--In addition to the
adjustments under paragraphs (1), (2), and (3),
the Secretary may further increase the fee
revenues and fees through a one-time adjustment
made for fiscal year 2028, 2029, or 2030, in
accordance with this paragraph.
(B) Adjustment described.--
(i) Conditions for adjustment.--An
adjustment under this paragraph may be
made for a fiscal year only if--
(I) an adjustment under this
paragraph had not been made for
any prior fiscal year;
(II) the average number of
OTC monograph drug facilities
subject to a facility fee under
subsection (a)(1) over the
period of the preceding 3
fiscal years exceeds 1,625; and
(III) with respect to
facilities described in
subclause (II), the average
number of such facilities
(expressed as a percentage)
that appeared on the arrears
lists pursuant to subsection
(e)(1)(A)(i) over the period of
the preceding 3 fiscal years is
less than 30 percent.
(ii) Amount of adjustment.--An
adjustment under this paragraph for a
fiscal year shall equal the product
of--
(I) the total facility
revenue amount determined under
subsection (b) for the fiscal
year, exclusive of the
adjustment under this paragraph
for such fiscal year; and
(II) the excess facility
percentage described in clause
(iii).
(iii) Excess facility percentage.--
The excess facility percentage
described in this clause is--
(I) the amount by which the
average number of OTC monograph
drug facilities subject to a
facility fee under subsection
(a)(1) over the preceding 3
fiscal years exceeds 1,625;
divided by
(II) 1,625.
(5) Annual fee setting.--The Secretary shall, not
later than 60 days before the first day of each fiscal
year--
(A) establish for such fiscal year, based on
the revenue amounts under subsection (b) and
the adjustments provided under this
subsection--
(i) OTC monograph drug facility fees
under subsection (a)(1); and
(ii) OTC monograph order request fees
under subsection (a)(2); and
(B) publish such fee revenue amounts,
facility fees, and OTC monograph order request
fees in the Federal Register.
(d) Identification of Facilities.--Each person that owns an
OTC monograph drug facility shall submit to the Secretary the
information required under this subsection each year. Such
information shall, for each fiscal year--
(1) be submitted as part of the requirements for drug
establishment registration set forth in section 510;
and
(2) include for each such facility, at a minimum,
identification of the facility's business operation as
that of an OTC monograph drug facility.
(e) Effect of Failure to Pay Fees.--
(1) OTC monograph drug facility fee.--
(A) In general.--Failure to pay the fee under
subsection (a)(1) within 20 calendar days of
the due date as specified in subparagraph (D)
of such subsection shall result in the
following:
(i) The Secretary shall place the
facility on a publicly available
arrears list.
(ii) All OTC monograph drugs
manufactured in such a facility or
containing an ingredient manufactured
in such a facility shall be deemed
misbranded under section 502(ff).
(B) Application of penalties.--The penalties
under this paragraph shall apply until the fee
established by subsection (a)(1) is paid.
(2) Order requests.--An OTC monograph order request
submitted by a person subject to fees under subsection
(a) shall be considered incomplete and shall not be
accepted for filing by the Secretary until all fees
owed by such person under this section have been paid.
(3) Meetings.--A person subject to fees under this
section shall be considered ineligible for OTC
monograph drug meetings until all such fees owed by
such person have been paid.
(f) Crediting and Availability of Fees.--
(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to
the extent and in the amount provided in advance in
appropriations Acts. Such fees are authorized to remain
available until expended. Such sums as may be necessary
may be transferred from the Food and Drug
Administration salaries and expenses appropriation
account without fiscal year limitation to such
appropriation account for salaries and expenses with
such fiscal year limitation. The sums transferred shall
be available solely for OTC monograph drug activities.
(2) Collections and appropriation acts.--
(A) In general.--Subject to subparagraph (C),
the fees authorized by this section shall be
collected and available in each fiscal year in
an amount not to exceed the amount specified in
appropriation Acts, or otherwise made available
for obligation, for such fiscal year.
(B) Use of fees and limitation.--The fees
authorized by this section shall be available
to defray increases in the costs of the
resources allocated for OTC monograph drug
activities (including increases in such costs
for an additional number of full-time
equivalent positions in the Department of
Health and Human Services to be engaged in such
activities), only if the Secretary allocates
for such purpose an amount for such fiscal year
(excluding amounts from fees collected under
this section) no less than $12,000,000,
multiplied by the adjustment factor applicable
to the fiscal year involved under subsection
(c)(1).
(C) Compliance.--The Secretary shall be
considered to have met the requirements of
subparagraph (B) in any fiscal year if the
costs funded by appropriations and allocated
for OTC monograph drug activities are not more
than 15 percent below the level specified in
such subparagraph.
(D) Provision for early payments [in
subsequent years].--Payment of fees authorized
under this section for a fiscal year [(after
fiscal year 2021)], prior to the due date for
such fees, may be accepted by the Secretary in
accordance with authority provided in advance
in a prior year appropriations Act.
(3) Authorization of appropriations.--For each of the
fiscal years [2021 through 2025] 2026 through 2030,
there is authorized to be appropriated for fees under
this section an amount equal to the total amount of
fees assessed for such fiscal year under this section.
(g) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 calendar days after it is due, such
fee shall be treated as a claim of the United States Government
subject to subchapter II of chapter 37 of title 31, United
States Code.
(h) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employers, and advisory committees not engaged in OTC monograph
drug activities, be reduced to offset the number of officers,
employees, and advisory committees so engaged.
SEC. 744N. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Report.--[Beginning with fiscal year 2021,
and not later than 120 calendar days after the end of each
fiscal year thereafter] Not later than 120 calendar days after
the end of each fiscal year for which fees are collected under
this part, the Secretary shall prepare and submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a report concerning the progress of
the Food and Drug Administration in achieving the goals
identified in the letters described in [section 3861(b) of the
CARES Act] section 2 of the Over-the-Counter Monograph Drug
User Fee Amendments during such fiscal year and the future
plans of the Food and Drug Administration for meeting such
goals.
(b) Fiscal Report.--Not later than 120 calendar days after
the end of [fiscal year 2021 and each subsequent fiscal year]
each fiscal year for which fees are collected under this part,
the Secretary shall prepare and submit to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate a report on the implementation of the authority for such
fees during such fiscal year and the use, by the Food and Drug
Administration, of the fees collected for such fiscal year.
(c) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to the
public on the internet website of the Food and Drug
Administration.
(d) Reauthorization.--
(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals
described in subsection (a), and plans for meeting the
goals, for OTC monograph drug activities for the first
5 fiscal years after fiscal year [2025] 2030, and for
the reauthorization of this part for such fiscal years,
the Secretary shall consult with--
(A) the Committee on Energy and Commerce of
the House of Representatives;
(B) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer
advocacy groups; and
(F) the regulated industry.
(2) Public review of recommendations.--After
negotiations with the regulated industry, the Secretary
shall--
(A) present the recommendations developed
under paragraph (1) to the congressional
committees specified in such paragraph;
(B) publish such recommendations in the
Federal Register;
(C) provide for a period of 30 calendar days
for the public to provide written comments on
such recommendations;
(D) hold a meeting at which the public may
present its views on such recommendations; and
(E) after consideration of such public views
and comments, revise such recommendations as
necessary.
(3) Transmittal of recommendations.--Not later than
January 15, [2025] 2030, the Secretary shall transmit
to the Congress the revised recommendations under
paragraph (2), a summary of the views and comments
received under such paragraph, and any changes made to
the recommendations in response to such views and
comments.
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