118 HR 5486 IH: Access to Donor Milk Act of 2023
U.S. House of Representatives
2023-09-14
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I
118th CONGRESS
1st Session
H. R. 5486
IN THE HOUSE OF REPRESENTATIVES
September 14, 2023
Ms. Houlahan (for herself, Mrs. Bice, Ms. Salazar, Ms. Mace, and Mrs. Lesko) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and the Workforce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
A BILL
To protect and expand access to pasteurized, donor human milk, and for other purposes.
1.

Short title
This Act may be cited as the “Access to Donor Milk Act of 2023”.
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)).
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.”.
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.
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.
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.