[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2819 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
1st Session
S. 2819
To protect and expand access to pasteurized, donor human milk, and for
other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 14, 2023
Mr. Durbin for (Ms. Duckworth (for herself and Mr. Rubio)) introduced
the following bill; which was read twice and referred to the Committee
on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To protect and expand access to pasteurized, donor human milk, 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 ``Access to Donor Milk Act of 2023''.
SEC. 2. DEFINITIONS.
In this Act:
(1) The term ``donor human milk'' means human milk that is
collected, pasteurized, and dispensed without additives.
(2) The term ``donor human milk bank'' means an
organization that--
(A) meets standards established by the Food and
Drug Administration for purposes of ensuring the safety
of donor human milk and human milk banks; and
(B) collects, tests, processes, pasteurizes, and
distributes donor human milk, in compliance with
applicable law.
(3) The term ``nonprofit donor human milk bank'' means a
donor human milk bank (as defined in paragraph (2)) that is an
organization described in section 501(c)(3) of the Internal
Revenue Code of 1986 (26 U.S.C. 501(c)(3)) and exempt from tax
under section 501(a) of such Code (26 U.S.C. 501(a)).
SEC. 3. SUPPORT FOR DONOR HUMAN MILK ACTIVITIES.
Section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786) is
amended--
(1) in subsection (b)(4), by inserting ``(including support
for donor human milk (as defined in section 2 of the Access to
Donor Milk Act of 2023) activities)'' after ``promotion''; and
(2) in subsection (h)(1)(C)--
(A) in clause (i), by striking ``clause (ii)'' and
inserting ``clauses (ii) and (iii)''; and
(B) by adding at the end the following:
``(iii) Donor human milk.--A State agency
may use amounts made available under clause (i)
for--
``(I) collecting and storing
donations of unprocessed human milk;
and
``(II) the transfer of the milk
described in subclause (I) to a
nonprofit donor human milk bank (as
defined in section 2 of the Access to
Donor Milk Act of 2023) registered with
the Food and Drug Administration.''.
SEC. 4. EMERGENCY CAPACITY FUNDING FOR HUMAN MILK BANKS.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall award
competitive grants, subject to subsection (f), to eligible entities for
expanding emergency capacity with respect to banking donor human milk.
(b) Application.--An eligible entity seeking a grant under this
section shall submit an application to the Secretary at such time, in
such manner, and containing such information as the Secretary may
require.
(c) Use of Funds.--Expanding emergency capacity pursuant to a grant
under this section may include--
(1) publicizing the need for donor human milk, especially
for high-risk infants;
(2) raising awareness and providing resources to families,
especially families of high-risk infants, about donor human
milk;
(3) covering donor human milk collection, storage,
pasteurization, transfer, and processing fees;
(4) increasing staffing and supplies needed at donor human
milk banks;
(5) purchasing consumable products needed for donor human
milk processing; and
(6) acquiring equipment for safe and quality processing of
donor human milk.
(d) Eligible Entity.--For purposes of this section, the term
``eligible entity'' means an entity that--
(1) is a nonprofit donor human milk bank registered with
the Food and Drug Administration; and
(2) in the application submitted under subsection (b),
demonstrates, with respect to such entity--
(A) a rapid increase in demand for donor human
milk; or
(B) a shortage of supplies needed to operate a
donor human milk bank.
(e) Authorization of Appropriations.--For the purposes of carrying
out this section, there are authorized to be appropriated $3,000,000
for fiscal year 2024, and such sums as may be necessary for each fiscal
year thereafter.
(f) Criteria.--The Secretary may award grants under subsection (a)
only in the event of any of the following:
(1) The Secretary determines that expanded capacity is
necessary to respond to any major disaster declared by the
President under section 401 of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act (42 U.S.C. 5170) or to any
public health emergency declared under section 319 of the
Public Health Service Act (42 U.S.C. 247d).
(2) The Secretary determines that Federal assistance is
needed to supplement State and local efforts and capabilities
to save lives and to protect property and public health and
safety, or to lessen or avert the threat of a catastrophe in
any part of the United States.
(3) The Secretary determines emergency capacity is needed
to ensure adequate supply is available to meet the demand for
donor human milk from an eligible entity.
SEC. 5. PUBLIC AWARENESS CAMPAIGN WITH RESPECT TO DONOR HUMAN MILK.
(a) In General.--The Secretary of Health and Human Services--
(1) shall, acting through the Administrator of the Health
Resources and Services Administration, develop a public
awareness campaign with respect to the benefits and safety of
donor human milk from donor human milk banks registered with
the Food and Drug Administration; and
(2) is encouraged to work with nonprofit donor human milk
banks registered with the Food and Drug Administration.
(b) Distribution of Educational Materials.--The public awareness
campaign under subsection (a) shall include the distribution of
educational materials to--
(1) clinicians, such as pediatric specialists,
pediatricians, obstetricians, pediatric nutritionists,
midwives, and lactation consultants, including international
board-certified lactation consultants;
(2) expectant and new parents, with a focus on expectant
and new parents that are participating in the special
supplemental nutrition program for women, infants, and children
program under section 17 of the Child Nutrition Act of 1966 (42
U.S.C. 1786); and
(3) community-based organizations.
SEC. 6. REGULATORY STATUS OF DONOR HUMAN MILK.
(a) Public Meeting.--Not later than 180 days after the date of the
enactment of this Act, the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall convene a
public meeting to inform the draft guidance required under subsection
(b).
(b) Guidance.--Not later than 18 months after the date of enactment
of this Act, the Secretary shall issue draft guidance that--
(1) addresses the appropriate standards for the collection
and preparation, storage, handling, processes used in
pasteurization, and transfer of donor human milk and donor
human-milk derived products; and
(2) considers the appropriateness of screening and other
processes, as determined by the Secretary.
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