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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9791 Introduced in House (IH)]
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119th CONGRESS
2d Session
H. R. 9791
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
requirements for the small business waiver from device fees related to
annual establishment registration, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 20, 2026
Mr. Perry introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
requirements for the small business waiver from device fees related to
annual establishment registration, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Nullifying Overbearing Federal
Expenditures and Exorbitant Spending Act of 2026'' or the ``NO FEES Act
of 2026''.
SEC. 2. SMALL BUSINESS FEE WAIVER.
(a) Small Businesses Fee Waiver.--
(1) Definition of small business.--Section
738(a)(3)(B)(ii)(I) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j(a)(3)(B)(ii)(I)) is amended to read as follows:
``(I) Definition of small
business.--For purposes of this clause,
the term `small business' means an
entity that employs less than 20 full-
time equivalent employees, including
such employees of all of its
affiliates.''.
(2) Waiver.--Section 738(a)(3)(B)(ii)(II) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)(3)(B)(ii)(II))
is amended to read as follows:
``(II) Waiver.--
``(aa) In general.--Subject
to subclause (V), the Secretary
shall grant a waiver of the fee
required under subparagraph (A)
for the annual registration of
an establishment for a year if
the Secretary finds that such
establishment is a small
business.
``(bb) Prohibition on
secretary considering payment
history.--In determining
whether to grant a waiver under
this clause, the Secretary may
not consider whether an
establishment paid the fee
required under subparagraph (A)
for any year prior to the year
for which the establishment
requests such waiver.
``(cc) Size and affiliation
standards.--For purposes of
determining whether an
establishment is a small
business under this clause, the
Secretary shall apply the
standards of the Small Business
Administration related to size
eligibility and affiliation, as
described in sections 121.103
and 121.106 of title 13, Code
of Federal Regulations (or
successor regulations).
``(dd) Information
demonstrating establishment
size.--For purposes of
demonstrating that an
establishment requesting a
waiver is a small business
under this clause, such
establishment shall submit to
the Secretary, at least 60 days
before the fee is due pursuant
to subparagraph (C), a copy of
its most recent Federal income
tax return for a taxable year
or its most recent payroll
register.''.
(3) Exclusion of foreign companies.--Section
738(a)(3)(B)(ii)(III) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j(a)(3)(B)(ii)(III)) is amended to read as
follows:
``(III) Exclusion of foreign
companies.--An entity that is organized
under the laws of a foreign government
may not--
``(aa) apply for a waiver
under this clause; or
``(bb) form an entity under
the laws of the United States
for purposes of applying for a
waiver under this clause.''.
(4) Waiver amount; expiration of eligibility.--Section
738(a)(3)(B)(ii) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j(a)(3)(B)(ii)) is amended by striking subclause
(IV) and inserting the following:
``(IV) Waiver amount.--A waiver
granted by the Secretary to an
establishment under this clause shall
cover--
``(aa) with respect to the
3-year period beginning on the
date on which the Secretary
first determines that such
establishment qualifies for
such waiver, 100 percent of the
amount of the fee required
under subparagraph (A); and
``(bb) with respect to the
subsequent 2-year period, 50
percent of such amount.
``(V) Expiration of eligibility.--
The Secretary may not grant a waiver to
an establishment under this clause
following--
``(aa) the date of a
determination by the Secretary,
if any, that such establishment
is not a small business; or
``(bb) the expiration of
the 5-year period of coverage
applicable to such
establishment under subclause
(IV).''.
(5) Non-reviewability.--Section 738(a)(3)(B)(ii)(V) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j(a)(3)(B)(ii)(V)) is amended by striking ``Request for
waiver.--'' and all that follows through ``subparagraph (C).''
and inserting ``Non-reviewability.--''.
SEC. 3. ANNUAL REGISTRATION FEE FOR FOREIGN COMPANIES.
Section 738(a)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j(a)(3)) is amended by adding at the end the following:
``(D) Annual registration fee for foreign
companies.--With respect to an establishment owned or
operated by an entity organized under the laws of a
foreign government, the fee for an initial or annual
registration under section 510 shall be equal to the
fee required under subparagraph (A) multiplied by 8.''.
SEC. 4. EFFECTIVE DATE.
The amendments made by this Act shall apply beginning on the date
that is 90 days after the date of enactment of this Act.
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