[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9329 Introduced in House (IH)]
<DOC>
117th CONGRESS
2d Session
H. R. 9329
To amend the Federal Food, Drug, and Cosmetic Act to allow waivers of
annual establishment registration fees for small businesses, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
November 17, 2022
Mr. Bucshon (for himself and Mr. Yarmuth) 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 to allow waivers of
annual establishment registration fees for small businesses, 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 ``Small Business Establishment
Registration Waiver Act''.
SEC. 2. WAIVER OF ANNUAL ESTABLISHMENT REGISTRATION FEES FOR SMALL
BUSINESSES.
Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j) is amended--
(1) in subsection (a)(3)(B)--
(A) by striking ``No fee'' and inserting the
following:
``(i) In general.--No fee''; and
(B) by adding at the end the following:
``(ii) Small businesses fee waiver.--
``(I) Definition of small
business.--For the purposes of this
clause, the term `small business' means
an entity that reported $1,000,000 or
less of gross receipts or sales in its
most recent Federal income tax return
for a taxable year, including such
returns of all of its affiliates.
``(II) Waiver.--The Secretary may
grant a waiver of the fee required
under subparagraph (A) for the annual
registration (excluding the initial
registration) of an establishment for a
year, if the Secretary finds that the
establishment is a small business and
paying the fee for such year represents
a financial hardship to the
establishment as determined on the
basis of criteria established by the
Secretary.
``(III) Firms submitting tax
returns to the united states internal
revenue service.--The establishment
shall support its claim that it meets
the definition under subclause (I) by
submission of a copy of its most recent
Federal income tax return for a taxable
year, and a copy of such returns of its
affiliates, which show an amount of
gross sales or receipts that is less
than the maximum established in
subclause (I). The establishment, and
each of such affiliates, shall certify
that the information provided is a true
and accurate copy of the actual tax
forms they submitted to the Internal
Revenue Service. If no tax forms are
submitted for any affiliate, the
establishment shall certify that the
establishment has no affiliates.
``(IV) Firms not submitting tax
returns to the united states internal
revenue service.--In the case of an
establishment that has not previously
submitted a Federal income tax return,
the establishment and each of its
affiliates shall demonstrate that it
meets the definition under subclause
(I) by submission of a signed
certification, in such form as the
Secretary may direct through a notice
published in the Federal Register, that
the establishment or affiliate meets
the criteria for a small business and a
certification, in English, from the
national taxing authority, if extant,
of the country in which the
establishment or, if applicable,
affiliate is headquartered. The
certification from such taxing
authority shall bear the official seal
of such taxing authority and shall
provide the establishment's or
affiliate's gross receipts or sales for
the most recent year in both the local
currency of such country and in United
States dollars, the exchange rate used
in converting such local currency to
dollars, and the dates during which
these receipts or sales were collected.
The establishment shall also submit a
statement signed by the head of the
establishment's firm or by its chief
financial officer that the
establishment has submitted
certifications for all of its
affiliates, or that the establishment
has no affiliates.
``(V) Request for waiver.--An
establishment seeking a fee waiver for
a year under this clause shall submit
supporting information to the Secretary
at least 60 days before the fee is
required pursuant to subparagraph (C).
The decision of the Secretary regarding
whether an entity may receive the
waiver for such year is not
reviewable.'';
(2) in subsection (d)(2)(B)(iii), by inserting ``, if
extant,'' after ``national taxing authority''; and
(3) in subsection (e)(2)(B)(iii), by inserting ``, if
extant,'' after ``national taxing authority''.
<all>