[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4256 Introduced in Senate (IS)]
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117th CONGRESS
2d Session
S. 4256
To amend the Federal Food, Drug, and Cosmetic Act to prevent food
shortages, including shortages of infant formula and certain medical
foods.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 18 (legislative day, May 17), 2022
Mr. Casey (for himself, Mr. Brown, Ms. Duckworth, Mrs. Gillibrand, and
Ms. Warren) introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to prevent food
shortages, including shortages of infant formula and certain medical
foods.
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 ``Protecting Infants from Formula
Shortages Act of 2022''.
SEC. 2. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF ESSENTIAL
SOURCES OF NUTRITION.
(a) Discontinuance or Interruption in the Production of Essential
Food.--The Federal Food, Drug, and Cosmetic Act is amended by inserting
after section 412 (21 U.S.C. 350a) the following new section:
``SEC. 412A. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF FOOD,
INCLUDING INFANT FORMULA AND CERTAIN MEDICAL FOODS FOR
INBORN ERRORS OF METABOLISM.
``(a) In General.--A manufacturer of an essential source of
nutrition shall notify the Secretary, in accordance with subsection
(b), of a permanent discontinuance in the manufacture of such food or
an interruption of the manufacture of an essential source of nutrition
or any other circumstance that is likely to lead to a meaningful
disruption in the supply of such food in the United States, and the
reasons for such discontinuance or interruption.
``(b) Timing.--Except as provided in subsection (g), a notice
required under subsection (a) shall be submitted to the Secretary--
``(1) at least 6 months prior to the date of the
discontinuance or interruption; or
``(2) if compliance with paragraph (1) is not possible, as
soon as practicable.
``(c) Distribution.--To the maximum extent practicable, the
Secretary shall distribute, to the Secretary of Agriculture and to
appropriate organizations, as determined by the Secretary, through such
means as the Secretary determines appropriate, information on the
discontinuance or interruption of the manufacture of an essential
source of nutrition, or other circumstance, reported under subsection
(a).
``(d) Confidentiality.--Nothing in this section authorizes the
Secretary to disclose any information that 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.
``(e) Failure To Meet Requirements.--If a person fails to submit
information required under subsection (a) in accordance with subsection
(b)--
``(1) the Secretary shall issue to such person a letter
that--
``(A) informs such person of the failure to comply;
``(B) describes the basis for noncompliance; and
``(C) requires the person to comply not later than
30 calendar days after the date on which the letter was
issued;
``(2) not later than 30 calendar days after the issuance of
a letter under paragraph (1), the person who receives such
letter shall submit to the Secretary a written response to such
letter that provides the information required under subsection
(a); and
``(3) not later than 45 calendar days after the issuance of
a letter under paragraph (1), the Secretary shall make such
letter and any response to such letter under paragraph (2)
available to the public on the website of the Food and Drug
Administration, with appropriate redactions made to protect
information described in subsection (d), except that, if the
Secretary determines that the letter under paragraph (1) was
issued in error or, after review of such response, the person
had a reasonable basis for not notifying as required under
subsection (a), the requirements of this paragraph shall not
apply.
``(f) Regulations.--
``(1) In general.--Not later than 1 year after the date of
enactment of the Protecting Infants from Formula Shortages Act
of 2022, the Secretary shall promulgate regulations regarding
the requirements under this section.
``(2) Contents.--Such regulations--
``(A) shall include a list of each category of food
for which a manufacturer is required to notify the
Secretary in accordance with subsection (a); and
``(B) may--
``(i) designate foods not otherwise defined
as an essential source of nutrition, giving
special consideration to foods--
``(I) upon which individuals with
certain diseases or conditions may be
particularly reliant; or
``(II) that are administered under
medical supervision;
``(ii) designate additional categories of
foods for which the Secretary determines
notification described in subsection (a) is
appropriate during a public health emergency
declared under section 319 of the Public Health
Service Act; and
``(iii) prescribe additional conditions on
the timing and manner of such notifications as
are reasonable and appropriate during such a
public health emergency.
``(g) Order.--During a public health emergency declared under
section 319 of the Public Health Service Act, the Secretary may order
any manufacturer of an essential source of nutrition to provide
notification required by this section. Such order may--
``(1) impose additional conditions on the timing and manner
of notification as are reasonable and appropriate in light of
the circumstances of the public health emergency; and
``(2) designate additional categories of food for which the
Secretary determines notification is appropriate during the
public health emergency.
``(h) Risk Management Plans.--Each manufacturer of an essential
source of nutrition shall develop, maintain, and, as appropriate,
implement a redundancy risk management plan that identifies and
evaluates risks to the supply of the food, as applicable, for each
establishment in which such food is manufactured. A risk management
plan under this subsection--
``(1) may identify and evaluate risks to the supply of more
than one food, or food category, manufactured at the same
establishment; and
``(2) shall be subject to inspection and copying by the
Secretary pursuant to section 704 or at the request of the
Secretary.
``(i) Definitions.--In this section:
``(1) Essential source of nutrition.--The term `essential
source of nutrition' means--
``(A) an infant formula;
``(B) a food that--
``(i) meets the definition of `medical
food' in section 5(b) of the Orphan Drug Act;
and
``(ii) is intended for use by individuals
with--
``(I) certain inborn errors of
metabolism; or
``(II) other conditions requiring a
medical food, as determined by the
Secretary in guidance issued under
subsection (f); or
``(C) a food so designated pursuant to subsection
(f).
``(2) Meaningful disruption.--The term `meaningful
disruption'--
``(A) means a change in production that is
reasonably likely to lead to a reduction in the supply
of an essential source of nutrition by a manufacturer
that is more than negligible and affects the ability of
the manufacturer to fulfill contractual obligations or
meet expected demand for its product; and
``(B) does not include interruptions in
manufacturing due to matters such as routine
maintenance or insignificant changes in manufacturing
so long as the manufacturer expects to resume
operations in a short period of time.''.
(b) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following new subsection:
``(fff) The failure to provide information as required under
section 412A after receipt of a letter from the Secretary under
subsection (e) of such section.''.
SEC. 3. REMOTE RECORDS ASSESSMENT FOR ESSENTIAL SOURCES OF NUTRITION.
(a) Factory Inspection.--Section 704(a)(4)(A) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is amended in the first
sentence by inserting ``or the manufacturing, processing, packing, or
holding of an essential source of nutrition (as defined in section
412A)'' after ``processing of a drug''.
(b) Regulations.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') shall promulgate regulations
describing circumstances in which the Secretary may issue requests for
records or other information in advance of, or in lieu of, an
inspection pursuant to section 704(a)(4)(A) of the Federal Food, Drug,
and Cosmetic Act, as amended by subsection (a), processes for
responding to such requests electronically or in physical form, and
factors the Secretary may consider in evaluating whether such records
are provided within a reasonable timeframe, within reasonable limits,
and in a reasonable manner, accounting for resource and other
limitations that may exist, including for small businesses.
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