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<title>Federal Register, Volume 91 Issue 1 (Friday, January 2, 2026)</title>
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[Federal Register Volume 91, Number 1 (Friday, January 2, 2026)]
[Proposed Rules]
[Pages 93-97]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-24153]
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 51
[REG-103430-24]
RIN 1545-BR16
Statutory Updates to Branded Prescription Drug Fee Regulations
AGENCY: Internal Revenue Service (IRS), Treasury.
ACTION: Notice of proposed rulemaking.
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SUMMARY: This document proposes amendments to regulations regarding the
annual fee imposed on covered entities engaged in the business of
manufacturing or importing certain branded prescription drugs. In
response to the replacement of the Coverage Gap Discount Program with
the new Manufacturer Discount Program by the Inflation Reduction Act of
2022, the proposed regulations would make updates regarding the
discounts, rebates, and other price concessions used to determine
branded prescription drug sales under Medicare Part D and would update
for prior statutory changes. These proposed regulations would affect
persons engaged in the business of manufacturing or importing certain
branded prescription drugs.
DATES: Written or electronic comments and requests for a public hearing
must be received by March 3, 2026. Requests for a public hearing must
be submitted as prescribed in the ``Comments and Requests for a Public
Hearing'' section.
ADDRESSES: Commenters are strongly encouraged to submit public comments
electronically via the Federal eRulemaking Portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a> (indicate IRS and REG-103430-24) by following the
online instructions for submitting comments. Once submitted to the
Federal eRulemaking Portal, comments cannot be edited or withdrawn. The
Department of the Treasury (Treasury Department) and the IRS will
publish for public availability any comments submitted to the IRS's
public docket. Send paper submissions to: CC:PA:01:PR (REG-103430-24),
Room 5503, Internal Revenue Service, P.O. Box 7604, Ben Franklin
Station, Washington, DC 20044. A plain language summary of the proposed
regulations will be made available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Concerning the proposed regulations,
contact Julia Barlow at (202) 317-6855 (not a toll-free number);
concerning the submission of comments and requests to participate in
the public hearing, contact the Publications and Regulations Section by
phone at (202) 317-6901 (not a toll-free number) or by email at
<a href="/cdn-cgi/l/email-protection#d4a4a1b6b8bdb7bcb1b5a6bdbab3a794bda6a7fab3bba2"><span class="__cf_email__" data-cfemail="e39396818f8a808b8682918a8d8490a38a9190cd848c95">[email protected]</span></a> (preferred).
SUPPLEMENTARY INFORMATION:
Authority
This document contains proposed amendments to the Branded
Prescription Drug Fee Regulations (26 CFR part 51).
The proposed regulations are issued under the express delegation of
authority under section 9008(i) of the Patient Protection and
Affordable Care Act, Public Law 111-148, 124 Stat. 119 (2010), as
amended by section 1404 of the Health Care and Education Reconciliation
Act of 2010, Public Law 111-152, 124 Stat. 1029 (2010). These acts are
collectively referred to in this preamble as the ``ACA.'' All
references in this preamble to ``section 9008'' are
[[Page 94]]
references to section 9008 of the ACA. Section 9008(i) provides that
the Secretary of the Treasury or the Secretary's delegate (Secretary)
``shall publish guidance necessary to carry out the purposes of
[section 9008].''
The proposed regulations are also issued under the express
delegation of authority under section 7805(a) of the Internal Revenue
Code (Code), which provides that the Secretary ``shall prescribe all
needful rules and regulations for the enforcement of [the Code],
including all rules and regulations as may be necessary by reason of
any alteration of law in relation to internal revenue.''
Background
I. Overview
The branded prescription drug fee was enacted by section 9008.
Section 9008 did not amend the Code but cross-references specific Code
sections.
Under section 9008(a)(1), each covered entity engaged in the
business of manufacturing or importing branded prescription drugs must
pay an annual fee to the Secretary.
Section 9008(b) provides rules for determining the amount of the
annual fee for each covered entity. Specifically, section 9008(b)(1)
provides that the annual fee for each covered entity for calendar years
2019 and thereafter shall bear the same ratio to $2.8 billion as (i)
the covered entity's branded prescription drug sales taken into account
during the preceding calendar year to (ii) the aggregate branded
prescription drug sales of all covered entities taken into account
during the same year.
Section 9008(d)(1) generally defines the term ``covered entity'' to
mean any manufacturer or importer with gross receipts from branded
prescription drug sales. Section 9008(e)(1) defines the term ``branded
prescription drug sales'' to mean sales of branded prescription drugs
to any specified government program or pursuant to coverage under such
program. Section 9008(e)(2)(A) generally defines the term ``branded
prescription drug'' to mean (i) any prescription drug the application
for which was submitted under section 505(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(b)), or (ii) any biological product the
license for which was submitted under section 351(a) of the Public
Health Service Act (42 U.S.C. 262(a)). Section 9008(e)(2)(B) defines
the term ``prescription drug'' for purposes of section 9008(e)(2)(A)(i)
to mean any drug which is subject to section 503(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)).
Section 9008(e)(4) defines the term ``specified government
programs'' as the Medicare Part D program, the Medicare Part B program,
the Medicaid program, any program under which branded prescription
drugs are procured by the Department of Veterans Affairs (VA), any
program under which branded prescription drugs are procured by the
Department of Defense (DOD), and the TRICARE retail pharmacy program,
which are collectively referred to in this preamble as the
``Programs.''
Section 9008(g) requires the Secretary of Health and Human Services
(Secretary of HHS), the Secretary of Veterans Affairs, and the
Secretary of Defense to report to the Secretary the total branded
prescription drug sales for each covered entity with respect to each
specified government program. Section 9008(g)(1) specifies the
information that the Secretary of HHS shall report for the Medicare
Part D program. Section 9008(g)(1)(A) specifies that the costs of
prescription drug plans and Medicare Advantage prescription drug plans
reported by the Secretary of HHS is reduced by ``any per-unit rebate,
discount, or other price concession provided by the covered entity.''
Section 9008(b)(3) requires the Secretary to use the data provided by
the Programs to calculate the fee.
The Branded Prescription Drug Fee Regulations (TD 9684, 79 FR 43631
(July 28, 2014), as amended by TD 9823, 82 FR 34611 (July 26, 2017)),
provide the method by which each covered entity's annual fee is
calculated. The regulations also define terms and provide rules for the
administration of the fee. See 26 CFR 51.1 through 51.11 and 51.6302.
Section 51.2 explains the terms used in 26 CFR part 51 for purposes
of the fee imposed by section 9008 on branded prescription drugs.
Section 51.2(b) defines the term ``Agencies'' to mean the Centers for
Medicare & Medicaid Services of the Department of Health and Human
Services (CMS), the VA, and the DOD. Section 51.2(i) defines
``manufacturer or importer'' as the person identified in the Labeler
Code of the National Drug Code (NDC) for a branded prescription drug.
Section 51.4 sets forth the methodologies that the Agencies are
required to use to calculate the drug sales amount for each specified
government program. Section 51.4(b)(1) requires CMS to determine
branded prescription drug sales under Medicare Part D by aggregating
the ingredient cost reported in the ``Ingredient Cost Paid'' field on
the Prescription Drug Event (PDE) records at the NDC level, reduced by
discounts, rebates, and other price concessions provided by the covered
entity, for each sales year. Under Sec. 51.2(m), the term ``sales
year'' means the second calendar year preceding the fee year.
Section 51.4(b)(2) provides that for purposes of Sec. 51.4(b)(1),
``discounts, rebates, and other price concessions'' means (A) any
direct and indirect remuneration (DIR) (within the meaning of Sec.
51.4(b)(2)(ii)), which includes any DIR reported on the PDE records at
the point of sale and any DIR reported on a Detailed DIR Report (within
the meaning of Sec. 51.4(b)(2)(iii)); and (B) any coverage gap
discount amount (within the meaning of Sec. 51.4(b)(2)(iv)).
Section 51.4(b)(2)(iv) provides that for purposes of Sec.
51.4(b)(2)(i)(B), the term ``coverage gap discount amount'' means a 50-
percent manufactured-paid (sic) discount on certain drugs under the
Coverage Gap Discount Program described in section 1860D-14A of the
Social Security Act (SSA) (42 U.S.C. 1395w-114a). The Coverage Gap
Discount Program described in section 1860D-14A of the SSA initially
required a 50-percent manufacturer-paid discount on applicable drugs in
certain instances. In section 53116(b) of the Bipartisan Budget Act of
2018 (BBA), Public Law 115-123, 132 Stat 64 (February 9, 2018),
Congress expanded the discount to 70 percent for plan years after plan
year 2018. See 42 U.S.C. 1395w-114a(g)(4)(A).
II. Inflation Reduction Act of 2022 Changes to Medicare Part D
Discounts
Section 11201 of Public Law 117-169, 136 Stat. 1818 (August 16,
2022), commonly known as the Inflation Reduction Act of 2022 (IRA),
redesigned the Medicare Part D benefit, including sunsetting the
Coverage Gap Discount Program described in section 1860D-14A of the SSA
as of January 1, 2025. Section 11201(c)(1) of the IRA amended the SSA
by adding section 1860D-14C (42 U.S.C. 1395w-114c) to establish the new
Manufacturer Discount Program beginning January 1, 2025, which requires
participating manufacturers to provide discounted prices for applicable
drugs of the manufacturer that are dispensed to applicable
beneficiaries who are in the initial and catastrophic coverage phases
of the Part D benefit. Under section 1860D-43(a) of the SSA, in order
for coverage to be available under Part D for covered Part D drugs of a
manufacturer beginning January 1, 2025, the manufacturer must
participate in the Manufacturer Discount Program by entering into and
having in effect a Manufacturer Discount Program agreement under which
the
[[Page 95]]
manufacturer agrees to provide discounted prices for applicable drugs
of the manufacturer that are dispensed to applicable beneficiaries.
Section 11201(c)(2) of the IRA amended section 1860D-14A of the SSA
to sunset the Coverage Gap Discount Program for applicable drugs
dispensed on or after January 1, 2025, but the provisions (including
all responsibilities and duties) of the Coverage Gap Discount Program
continue to apply with respect to applicable drugs dispensed before
January 1, 2025.
Explanation of Provisions
To reflect statutory changes made by the BBA, the proposed
regulations would update the percentage discount amount for the
Coverage Gap Discount Program to reflect the statutory change from a 50
percent manufacturer-paid discount to a 70 percent manufacturer-paid
discount (for plan years after plan year 2018). The proposed
regulations would also correct ``manufactured-paid'' in the current
Sec. 51.4(b)(2)(i)(B) to ``manufacturer-paid.'' To reflect statutory
changes made by the IRA, the proposed regulations would add references
to the Manufacturer Discount Program to the rules regarding the
discounts, rebates, and other price concessions that CMS uses to
determine branded prescription drug sales under Medicare Part D, for
purposes of the Branded Prescription Drug Fee.
The proposed regulations would not remove the Coverage Gap Discount
Program from the rules regarding the discounts, rebates, and other
price concessions because, due to the manner in which the fee is
calculated, the discounts that the Coverage Gap Discount Program
provides through December 31, 2024, may still be used to calculate the
fee for sales that occurred while the Coverage Gap Discount Program was
effective. Beginning in the 2027 fee year, it is expected that there
will be no Coverage Gap Discount Program discounts to take into
account.
The Treasury Department and the IRS are considering whether to
include a sunset for using the Coverage Gap Discount Program in the
final regulations. The Treasury Department and the IRS request comments
about whether the final regulations should include a sunset for using
the Coverage Gap Discount Program for applicable drugs dispensed on or
after January 1, 2025.
Proposed Applicability Date
Because these regulations reflect statutory changes that took
effect at the beginning of 2025, these regulations are proposed to
apply to fees calculated based on sales years beginning with calendar
year 2025, which will also be sales years ending on or after the date
these proposed regulations are filed in the Federal Register.
Special Analyses
I. Regulatory Planning and Review--Economic Analysis
Executive Orders 12866 and 13563 direct agencies to assess costs
and benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). Executive Order 13563
emphasizes the importance of quantifying both costs and benefits,
reducing costs, harmonizing rules, and promoting flexibility.
The proposed regulations have been designated by the Office of
Management and Budget's (OMB's) Office of Information and Regulatory
Affairs (OIRA) as subject to review under Executive Order 12866
pursuant to the Memorandum of Agreement (MOA, July 4, 2025) between the
Treasury Department and the OMB regarding review of tax regulations.
OIRA has determined that the proposed rulemaking is significant and
subject to review under Executive Order 12866 and section 1(b) of the
Memorandum of Agreement. Accordingly, the proposed regulations have
been reviewed by OMB.
A. Need for Regulation
Section 9008 of the Patient Protection and Affordable Care Act,
Public Law 111-148, 124 Stat. 119 (2010), as amended by section 1404 of
the Health Care and Education Reconciliation Act of 2010, Public Law
111-152, 124 Stat. 1029 (2010) (ACA) imposes an annual fee on covered
entities engaged in the business of manufacturing or importing branded
prescription drugs. The amount of the annual fee is set by statute. For
calendar years 2019 and thereafter, the amount of the annual fee is
$2.8 billion. See section 9008(b)(4). Each covered entity's share of
the annual fee is calculated by determining the ratio of the covered
entity's branded prescription drug sales taken into account during the
preceding calendar year to the aggregate branded prescription drug
sales of all covered entities taken into account during the same year.
Under section 9008(e)(1), branded prescription drug sales are sales of
branded prescription drugs to any specified government program or
pursuant to coverage under such program. Section 9008(g) requires the
Secretary of Health and Human Services (Secretary of HHS), the
Secretary of Veterans Affairs, and the Secretary of Defense to report
to the Secretary the total branded prescription drug sales for each
covered entity with respect to each specified government program.
Existing regulations in 26 CFR part 51 specify the method by which
each covered entity's share of the annual fee is calculated. Section
51.4(b)(1) specifies the method by which the Centers for Medicare &
Medicaid Services of the Department of Health and Human Services (CMS)
is required to determine branded prescription drug sales under Medicare
Part D. Two subsequent statutes altered inputs that CMS uses to
determine Medicare Part D sales for this purpose. First, the Bipartisan
Budget Act of 2018 (BBA), Public Law 115-123, 132, Stat. 64 (February
9, 2018), increased the Coverage Gap Discount Program manufacturer
discount rate from 50 percent to 70 percent for plan years after 2018.
Second, the Inflation Reduction Act of 2022 (IRA), Public Law 117-169,
136 Stat. 1818 (August 16, 2022), sunsets the Coverage Gap Discount
Program effective January 1, 2025, and establishes the Manufacturer
Discount Program.
The proposed regulations update existing regulations so that they
are consistent with the statute and with how the covered entities have
been calculating their share of the annual fee since enactment of the
BBA and the IRA. The proposed regulations reflect the BBA's increase to
a 70-percent manufacturer discount (as applicable) and add the IRA's
Manufacturer Discount Program discounts to the list of reductions CMS
uses when computing branded prescription drug sales under Medicare Part
D. Because fees are calculated using sales from prior years, Coverage
Gap Discount Program discounts provided through December 31, 2024, may
still enter fee computations for several sales years. Beginning in the
2027 fee year, no Coverage Gap Discount Program discounts are expected
to be taken into account. The updates are necessary to align the
regulations with statutory changes so that CMS-reported Medicare Part D
sales accurately incorporate the discount programs in effect for the
relevant sales years.
B. The Statute and the Proposed Regulations
The proposed regulations update the existing regulations regarding
the discounts, rebates, and other price
[[Page 96]]
concessions that CMS uses to determine branded prescription drug sales,
to reflect changes made by the BBA and IRA and to reflect how covered
entities are currently calculating their share of the fee. The proposed
regulations add the Manufacturer Discount Program, which was
established by the IRA, to the list of reductions that CMS uses to
calculate branded prescription drug sales. The proposed regulations
also update the percentage discount amount used for the Coverage Gap
Discount Program to reflect the statutory change made by the BBA for
plan years after plan year 2018.
C. Baseline
The Treasury Department and the IRS have assessed the benefits and
costs of the proposed regulations relative to a no-action baseline
reflecting anticipated Federal income tax-related behavior in the
absence of these proposed regulations.
D. Affected Entities and Taxpayers
The Branded Prescription Drug Fee affects manufacturers and
importers of branded prescription drugs with sales to specified
government programs (Medicare Part D, Medicare Part B, Medicaid,
Department of Veterans Affairs programs that procure branded
prescription drugs, Department of Defense programs that procure branded
prescription drugs, and TRICARE). Based on records from tax year 2024,
the Treasury Department and the IRS estimate the fee impacts roughly
300 affected entities. The proposed regulations apply to how other
Federal agencies compile and transmit data, not to new reporting
requirements for these affected entities.
E. Economic Effects of the Proposed Regulations
The primary effect of the proposed regulations would be improved
administrative alignment and clarity. Under the baseline, existing
regulations would continue to reference only the Coverage Gap Discount
Program and a 50-percent discount, which would not reflect post-2018
discount levels or the post-2024 Medicare Part D discount program. That
mismatch would increase uncertainty about how agency data should be
compiled after changes made by the IRA and BBA. The proposal clarifies
which Medicare Part D discounts reduce branded prescription drug sales
for fee computations--ensuring the regulations mirror the BBA and IRA
changes. Because the rule clarifies information-collection procedures
that already occur at other Federal agencies, Treasury and IRS expect
minimal impact on affected entity compliance costs since the covered
entities are calculating fees according to the statute. Affected
entities are expected to benefit from clearer rules that reduce policy
uncertainty and the risk of disputes about discount treatment, but, in
aggregate, Treasury and IRS expect these benefits to be small. The
regulations will also improve administrative efficiency for CMS and the
IRS through consistent data definitions across years. Minor one-time
administrative costs incurred by CMS to reflect the updated
Manufacturer Discount Program are already part of CMS's program
implementation under the IRA and are not imposed by this regulation.
F. Alternatives Considered
The Treasury Department and the IRS considered the alternative
option of taking no action to update the existing regulations in 26 CFR
part 51 to reflect the changes made by the IRA and BBA. This
alternative would leave uncertainty as to how CMS data will be reported
to the IRS for purposes of calculating each covered entity's share of
the Branded Prescription Drug Fee. Therefore, the approach to issue
proposed regulations to update the existing regulations to align with
changes made by the IRA and BBA was selected over the alternative
option of taking no action.
II. Paperwork Reduction Act
This rulemaking does not contain a collection of information from
the public, and therefore it is not required to be reviewed and
approved by the Office of Management and Budget in accordance with the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)). An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a valid control number.
III. Regulatory Flexibility Act
It is hereby certified that these regulations will not have a
significant economic impact on a substantial number of small entities.
These regulations do not affect small entities because they merely
clarify procedures that already occur at another Federal agency.
Affected entities exclude the first $5 million in sales and exclude 90
percent of sales that are over $5 million and not more than $125
million, which minimizes or completely eliminates any additional burden
these proposed regulations might impose on small businesses. Entities
engaged in pharmaceutical manufacturing or drug wholesaling with
aggregate branded drug sales more than $5 million may benefit from
clearer rules, but these impacts are not substantial. Entities with
aggregate branded drug sales not more than $5 million will not be
impacted.
IV. Section 7805(f) of the Code
Pursuant to section 7805(f) of the Code, this notice of proposed
rulemaking will be submitted to the Chief Counsel for the Office of
Advocacy of the Small Business Administration for comment on its impact
on small businesses.
V. Unfunded Mandates Reform Act
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
requires that agencies assess anticipated costs and benefits and take
certain other actions before issuing a final rule that includes any
Federal mandate that may result in expenditures in any one year by a
State, local, or Tribal government, in the aggregate, or by the private
sector, of $100 million in 1995 dollars, updated annually for
inflation. The final regulations do not include any Federal mandate
that may result in expenditures by State, local, or Tribal governments,
or by the private sector in excess of that threshold.
VI. Executive Order 13132: Federalism
Executive Order 13132 (Federalism) prohibits an agency from
publishing any rule that has federalism implications if the rule either
imposes substantial, direct compliance costs on State and local
governments, and is not required by statute, or preempts State law,
unless the agency meets the consultation and funding requirements of
section 6 of the Executive order. These proposed regulations do not
have federalism implications and do not impose substantial direct
compliance costs on State and local governments or preempt State law
within the meaning of the Executive order.
Comments and Requests for a Public Hearing
Before the proposed amendments to the regulations are adopted as
final regulations, consideration will be given to comments that are
submitted timely to the IRS as prescribed in the preamble under the
ADDRESSES section. The Treasury Department and the IRS request comments
on all aspects of the proposed regulations. All commenters are strongly
encouraged to submit comments electronically. The Treasury Department
and the IRS will publish for public availability any comment submitted
electronically or on paper to
[[Page 97]]
its public docket on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
A public hearing will be scheduled if requested in writing by any
person who timely submits electronic or written comments. Requests for
a public hearing are encouraged to be made electronically. If a public
hearing is scheduled, a notice of the date and time for the public
hearing will be published in the Federal Register. Announcement 2023-
16, 2023-20 I.R.B. 854 (May 15, 2023), provides that public hearings
will be conducted in person, although the IRS will continue to provide
a telephonic option for individuals who wish to attend or testify at a
hearing by telephone. Any telephonic hearing will be made accessible to
people with disabilities.
Statement of Availability of IRS Documents
Announcement 2023-16 is published in the Internal Revenue Bulletin
and is available from the Superintendent of Documents, U.S. Government
Publishing Office, Washington, DC 20402, or by visiting the IRS website
at <a href="http://www.irs.gov">http://www.irs.gov</a>.
Drafting Information
The principal author of these regulations is Julia Barlow of the
Office of the Associate Chief Counsel (Energy, Credit, and Excise Tax).
However, other personnel from the Treasury Department and the IRS
participated in its development.
List of Subjects in 26 CFR Part 51
Drugs, Reporting and recordkeeping requirements.
Proposed Amendment to the Regulations
Accordingly, the Treasury Department and the IRS propose to amend
26 CFR part 51 as follows:
PART 51--BRANDED PRESCRIPTION DRUG FEE
0
Paragraph 1. The authority citation for part 51 is amended by revising
the general authority to read as follows:
Authority: 26 U.S.C. 7805(a); sec. 9008(i), Pub. L. 111-148, 124
Stat. 119.
* * * * *
0
Par. 2. Section 51.4 is amended by:
0
1. Removing the word ``and'' at the end of paragraph (b)(2)(i)(A);
0
2. Removing the period at the end of paragraph (b)(2)(i)(B);
0
3. Adding the language ``; and'' at the end of paragraph (b)(2)(i)(B);
0
4. Adding paragraph (b)(2)(i)(C);
0
5. In paragraph (b)(2)(iv), by removing the word ``manufactured-paid''
and adding the word ``manufacturer-paid'' in its place, and adding the
language ``or 70-percent (as applicable)'' after the language ``50-
percent''; and
0
6. Adding paragraph (b)(2)(v).
The additions read as follows:
Sec. 51.4 Information provided by the agencies.
* * * * *
(b) * * *
(2) * * *
(i) * * *
(C) Any manufacturer discount program discount (within the meaning
of paragraph (b)(2)(v) of this section).
* * * * *
(v) Manufacturer discount program discount. For purposes of
paragraph (b)(2)(i)(C) of this section, the term manufacturer discount
program discount means a manufacturer-paid discount on certain drugs
under the Manufacturer Discount Program described in section 1860D-14C
of the Social Security Act.
* * * * *
0
Par. 3. Section 51.11 is amended by revising the section heading and
adding paragraph (c) to read as follows:
Sec. 51.11 Applicability dates.
* * * * *
(c) Section 51.4(b)(2)(i)(C) and (b)(2)(v) apply for fees
calculated based on sales years beginning on and after January 1, 2025.
Frank J. Bisignano,
Chief Executive Officer.
[FR Doc. 2025-24153 Filed 12-31-25; 8:45 am]
BILLING CODE 4831-GV-P
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Statutory Updates to Branded Prescription Drug Fee Regulations
This document proposes amendments to regulations regarding the annual fee imposed on covered entities engaged in the business of manufacturing or importing certain branded presc...
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