[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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