[Congressional Record Volume 169, Number 153 (Thursday, September 21, 2023)]
[Senate]
[Pages S4657-S4658]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Mr. PADILLA (for himself, Mr. Welch, Mr. Heinrich, Mr. Wyden, 
        Mrs. Shaheen, Mr. Bennet, and Mr. Fetterman):
  S. 2881. A bill to amend the Higher Education Act of 1965 to require 
institutions of higher education to provide notice to students 
participating in a State or federally financed work-study program about 
potential eligibility for participation in the supplemental nutrition 
assistance program, and for other purposes; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. PADILLA. Madam President, I rise to speak in support of the 
Opportunity to Address College Hunger Act, which I introduced today.
  According to a 2018 GAO study, roughly 2 million at-risk college 
students who were potentially eligible for Supplemental Nutrition 
Assistance Program, SNAP, benefits did not report receiving them. 
Millions of eligible college students across the Nation face steep 
barriers to accessing these critical benefits due to a complex 
application process and a lack of information-sharing from their own 
colleges and universities.
  In California alone, 127,000 college students received CalFresh 
before the pandemic, despite upwards of 690,000 students being 
potentially eligible. Through my conversations with California college 
students, many have said that they wished their campuses told them they 
were eligible for SNAP and how to access benefits.
  That is why I am introducing this bill--to increase awareness of SNAP 
for potentially eligible college students and to continue the fight to 
tackle student hunger.
  If enacted, this bill would require colleges and universities to 
notify students participating in State or federally financed work-study 
programs of their potential eligibility for SNAP benefits. Institutions 
would also need to provide students with details about how they can 
obtain more information about SNAP, confirm their eligibility for the 
program, and access benefits.
  This notification would be developed by the U.S. Department of 
Education, in consultation with the U.S. Department of Agriculture, and 
would be specific to the student's State of residence and provide 
contact information for the local office where the student can apply 
for SNAP.
  The notification would also include an official document confirming 
that the student participates in a work-study program and meets one of 
the SNAP eligibility requirements for college students. This 
documentation would help students overcome a common paperwork hurdle 
they face when applying for SNAP benefits.
  Finally, this bill would require the Department of Education and USDA 
to provide guidance to States and institutions on how to better engage 
with potentially eligible students.
  While I support eliminating the restrictive work requirements that 
limit access to critical nutrition benefits for millions of low-income 
college students, this bill works to tackle barriers students face with 
the eligibility requirements currently in place.
  I want to thank Representative Suzanne Bonamici for introducing this 
bill in the House and for her continued work to combat student hunger. 
I urge my colleagues to support this commonsense legislation to help 
improve student food security, health, and learning.
                                 ______
                                 
      By Mr. PADILLA:
  S. 2898. A bill to amend the Food, Conservation, and Energy Act of 
2008 to authorize the Secretary of Agriculture to authorize the use of 
certain grants to deliver peer-to-peer mental health support to 
individuals who are engaged in farming, ranching, farm work, and other 
occupations relating to agriculture; to the Committee on Agriculture, 
Nutrition, and Forestry.
  Mr. PADILLA. Madam President, I rise to introduce the Supporting Farm 
Workers' Mental Health Act of 2023. This bill would ensure that the 
Farm and Ranch Assistance Network serves the behavioral health needs of 
farm workers.
  The Farm and Ranch Stress Assistance Network is a transformative 
program that addresses the mental health needs of farmers, ranchers, 
and those engaged in agricultural occupations. While grants can be used 
to serve farmworkers, farmworkers are not explicitly identified as 
population of interest, despite their unique health needs.
  Farmworkers face significant barriers to care, including a shortage 
of culturally competent providers and low health literacy in addition 
to the challenges associated with accessing healthcare in rural areas. 
Nineteen percent of farmworkers reported symptoms of anxiety, and 14 
percent reported feeling depressed, according to a recent University of 
California, Merced study.
  The Supporting Farm Workers' Mental Health Act of 2023 would amend 
the Farm and Ranch Stress Act of 2023 would amend the Farm and Ranch 
Stress Assistance Network to explicitly include farmworkers as an 
eligible population and ensure peer-to-peer mental health services are 
an allowable grant activity. Both changes will update the program to 
reflect our agricultural workforce's behavioral health needs.
  Farmworkers feed our Nation. It is our responsibility to ensure they 
have access to behavioral health care they need.
  I look forward to working with my colleagues to enact this important 
initiative as quickly as possible.
                                 ______
                                 
      By Mr. PADILLA:
  S. 2899. A bill to amend the Public Health Service Act to include 
Middle Easterners and North Africans in the statutory definition of a 
``racial and ethnic minority group'', and for other purposes; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. PADILLA. Madam President, I rise to introduce the Health Equity 
and Middle Eastern and North African Community Inclusion Act of 2023. 
This bill would ensure that Middle Eastern and North African 
communities in the United States receive the Federal recognition they 
need to receive targeted public health resources.
  Too often, Federal data collection overlooks people in MENA 
communities. This is true even at the Office of Minority Health, which 
is tasked with the important work of improving health outcomes for 
racial and ethnic minority populations. The office's definition of 
``racial and ethnic minorities'' does not currently include a Middle 
Eastern or North African category, meaning that people in this 
community are often misidentified as White. As a result, the unique 
health concerns that Middle Easterners and North Africans face remain 
underreported and unaddressed.
  This bureaucratic oversight has a tangible impact on individuals' 
abilities to live full and healthy lives.

[[Page S4658]]

  The Health Equity and Middle Eastern and North African Community 
Inclusion Act of 2023 would add a Middle Eastern and North African 
category to the definition of ``racial and ethnic minorities'' used by 
the Office of Minority Health. Additionally, it would direct the 
Department of Health and Human Services to use this data to conduct a 
comprehensive study of the unique patterns and health outcomes in MENA 
populations.
  I want to thank Representative Tlaib for joining me in introducing 
this bill. I look forward to working with my colleagues to take this 
important step to reduce health disparities.
                                 ______
                                 
      By Mr. DURBIN:
  S. 2907. A bill to improve medical device recall notifications by 
amending the Federal Food, Drug, and Cosmetic Act to establish an 
electronic format for device recall notifications, and for other 
purposes; to the Committee on Health, Education, Labor, and Pensions.
  Mr. DURBIN. Madam President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 2907

       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 ``Medical Device Recall 
     Improvement Act''.

     SEC. 2. REGULATION OF MEDICAL DEVICE RECALLS.

       Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 351 et seq.), is amended by inserting after section 
     518A of such Act the following:

     ``SEC. 518B. ELECTRONIC NOTIFICATION FORMAT FOR DEVICE 
                   RECALLS.

       ``(a) Electronic Notification Format for Device Recalls.--
       ``(1) In general.--Not later than 2 years after the date of 
     enactment of the Medical Device Recall Improvement Act, the 
     Secretary shall publish a form and manner for notifications 
     of a recall.
       ``(2) Content.--The form and manner prescribed by the 
     Secretary under paragraph (1) shall--
       ``(A) be electronic;
       ``(B) include mandatory data elements, including--
       ``(i) the name of the manufacturer or importer;
       ``(ii) the contact information and address of the 
     manufacturer or importer;
       ``(iii) the specific reason for the correction or removal 
     from the market of the device;
       ``(iv) the specific device of the manufacturer or importer 
     subject to such recall;
       ``(v) the unique device identifier of the device, 
     including, as applicable, the device identifier and any 
     production identifier;
       ``(vi) information for device user facilities and health 
     professionals with regard to the device and such recall; and
       ``(vii) information for patients with regard to the device 
     and such recall, including--

       ``(I) the risk presented by the device; and
       ``(II) any action that may be taken by, or on behalf of, 
     such patients to eliminate or reduce such risk; and

       ``(C) include optional data elements as the Secretary 
     determines to be appropriate.
       ``(b) Notifications.--
       ``(1) Notifications to the secretary.--
       ``(A) In general.--Beginning 180 days after the Secretary 
     establishes the form and manner for recall notifications 
     under subsection (a), a manufacturer or importer of a device 
     shall submit notifications required under section 519(g) to 
     the Secretary through the electronic notification format 
     established under subsection (a).
       ``(B) Review requirement.--
       ``(i) Initial review.--Not later than 2 business days after 
     receipt of a notification described in subparagraph (A), the 
     Secretary shall conduct an initial review of such 
     notification.
       ``(ii) Response of the secretary.--Not later than 3 
     business days after the completion of such review, the 
     Secretary shall inform the manufacturer or importer of the 
     information the Secretary determines, through the initial 
     review under clause (i), should be shared with device user 
     facilities and health professionals.
       ``(2) Notifications to device user facilities and health 
     professionals.--
       ``(A) Initial notifications.--A manufacturer or importer 
     shall submit notifications to device user facilities and 
     health professionals through the electronic notification 
     format established under subsection (a) after an initial 
     review by the Secretary is completed under paragraph 
     (1)(B)(i).
       ``(B) Subsequent notifications.--A manufacturer or importer 
     shall provide notifications in addition to those described in 
     subparagraph (A), as necessary, to device user facilities or 
     health professionals through the electronic notification 
     format established under subsection (a).
       ``(c) Electronic Database.--The Secretary shall maintain an 
     electronic database that is publicly accessible, 
     downloadable, and populated with information regarding device 
     notifications made under this section.
       ``(d) Definitions.--In this section and in section 518C--
       ``(1) the term `device user facility' has the meaning given 
     such term in section 519(b)(6); and
       ``(2) the term `recall' has the meaning given such term in 
     section 518A.
       ``(e) Authorization of Appropriations.--For purposes of 
     conducting activities under this section and hiring personnel 
     to conduct such activities, there is authorized to be 
     appropriated $6,700,000 for fiscal year 2024, $1,700,000 for 
     fiscal year 2025, and $1,000,000 for each of fiscal years 
     2026 through 2028, to remain available until expended, 
     without fiscal year limitation.

     ``SEC. 518C. PATIENT NOTIFICATION.

       ``(a) In General.--The Secretary shall require that any 
     recall strategy under section 519(g) provides for notice to 
     patients whom device user facilities and health professionals 
     treated with the device.
       ``(b) Compliance.--In accordance with subsection (a), the 
     Secretary shall require recall notifications sent from the 
     manufacturer or importer of the device to--
       ``(1) include information for device user facilities and 
     health professionals about the risks presented by the device 
     to patients whom device user facilities and health 
     professionals treated with the device; and
       ``(2) instruct such device user facilities and health 
     professionals to share information under paragraph (1) with 
     patients whom device user facilities and health professionals 
     treated with the device.
       ``(c) Affected Devices.--Subsection (a) shall apply with 
     respect to any class I or class II recall for a class II or 
     class III device that is used outside of device user 
     facilities and--
       ``(1) implanted in the human body;
       ``(2) life-sustaining;
       ``(3) life-supporting; or
       ``(4) used significantly in pediatric populations.
       ``(d) Rule of Construction.--Nothing in this section shall 
     be construed to require device user facilities or health 
     professionals to provide patient information to the 
     manufacturer or importer of the device.''.

     SEC. 3. 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
       ``(jjj) The refusal or failure to submit notifications in 
     accordance with paragraphs (1) and (2) of section 518B(b).
       ``(kkk) The refusal or failure to provide notice in 
     accordance with section 518C.''.

                          ____________________