Rep. Josh Harder

Cures 2.0 Act This bill addresses pandemic preparedness and public health issues, caregiver and patient engagement, drug development, insurance coverage, and biomedical research. The Department of Health and Human Services (HHS) must undertake research and other activities concerning COVID-19 and develop a strategy for future pandemics and declared emergencies. Additionally, the bill specifies actions to combat antimicrobial resistance. HHS may award grants for caregiver training. The bill also addresses diversity in clinical trials, collecting patient experience data during clinical trials, and coverage for care related to participation in specified clinical trials. The bill modifies the timeframe and requires additional guidance relating to expedited approval of certain breakthrough drugs, devices, or products. It also establishes two intercenter institutes within the Food and Drug Administration (FDA) focused on particular diseases that meet specified criteria. The bill also addresses (1) coverage in Medicare, Medicaid, and the Children's Health Insurance Program for telehealth, genetic and genomic testing, and other services; (2) electronic prescribing standards for Medicare drug benefits; and (3) access to Medicare and Medicaid claims data by certain registries. Furthermore, the bill prohibits the use of geographic tracking or biometrics in Medicaid electronic visit verification systems. The bill establishes the Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health to accelerate biomedical research and innovation through grants, contracts, cash prizes, and other means. The FDA may work with ARPA-H to expedite the development of medical products through specified activities.

This bill authorizes the National Medal of Honor Museum Foundation to establish a commemorative work on federal land in the District of Columbia in honor of the extraordinary acts of valor, selfless service, and sacrifice displayed by Medal of Honor recipients. The foundation shall be solely responsible for the acceptance of contributions for, and the payment of expenses of, the establishment of the commemorative work. Federal funds may not be used to pay any expenses for the establishment of the commemorative work. The establishment of the commemorative work shall be in accordance with the Commemorative Works Act.

Accelerating Access to Critical Therapies for ALS Act This bill establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), and contains other related provisions. The Department of Health and Human Services (HHS) shall award grants to eligible entities for scientific research utilizing data from expanded access to investigational ALS treatments for individuals who are not otherwise eligible for clinical trials.  The Food and Drug Administration (FDA) shall award grants to public and private entities to cover the costs of research and development of drugs that diagnose or treat ALS and other rare neurodegenerative diseases. HHS shall also establish the Public-Private Partnership for Neurodegenerative Diseases between the National Institutes of Health, the FDA, and at least one eligible entity (generally, an institution of higher education or a nonprofit organization). The partnership shall support the development and regulatory review of drugs that address ALS and other rare neurodegenerative diseases. The FDA shall publish on its website a five-year action plan for fostering the development of drugs that improve or extend the lives of people living with rare neurodegenerative diseases. The Government Accountability Office must report to Congress about the grants provided under this bill, including an analysis of the impact of such grants on research and development of treatments for ALS.

Responsible Education Mitigating Options and Technical Extensions Act or the REMOTE Act This act addresses the administration of certain Department of Veterans Affairs (VA) educational assistance benefits. First, the act extends through June 1, 2022, certain adjustments for veterans' education benefits that were put in place due to COVID-19. The act allows the VA to waive the requirement that an educational institution verify the enrollment of a student utilizing VA educational assistance if the VA determines the institution uses a flat rate tuition and fee structure that would make the use of a second verification unnecessary. The act provides an exception from the imposition of specified disciplinary actions (e.g., suspending course and program approval) in situations where an educational institution provides a commission, bonus, or other incentive payment to entities engaged in student recruiting or admission activities related to recruiting foreign students who reside in foreign countries and are ineligible for federal student assistance. Additionally, the act generally exempts from certain requirements and restrictions imposed by the VA or a state approving agency educational institutions (1) located in foreign countries, or (2) that provide information regarding the costs of a program of education using a form or template developed by the Department of Education. The act also exempts educational institutions located in foreign countries from (1) having records and accounts that pertain to an individual who is not receiving VA educational assistance examined by government representatives, and (2) furnishing certain information related to tests that require payment. The act authorizes the VA, in certain circumstances, to provide educational assistance (including a housing stipend) to veterans or eligible persons who are in their last academic period (e.g., semester) of a program of education and are pursuing the program on less than a half-time basis. Specifically, such assistance may be provided if the number of credits the person needs to complete the program of education is less than the number of credits that would constitute enrollment on more than a half-time basis for that last academic period and the person (1) is enrolled in or has completed every course offered by the program of education during that academic period, and (2) enrolls in an additional course that is not required for the program of education to reach enrollment on a more than a half-time basis. The act extends certain loan fee rates through January 14, 2031, under the VA's home loan program. Finally, the act removes the cap on the number of full-time VA employees who provide equal employment opportunity counseling.

Protecting the Health of America's Older Adults Act This bill requires the Centers for Disease Control and Prevention (CDC) to establish a program to promote the health and well-being of older adults. To carry out the program, the CDC must, among other activities, regularly assess the health-related needs of older adults, identify disparities in outcomes of older adults based on demographic and other factors, and coordinate the efforts of federal agencies and nonfederal stakeholders with respect to the health of older adults. Additionally, the CDC must award grants or enter into cooperative agreements with health departments and nonprofit community-based organizations to improve the availability of data on older adult populations, link health care and social services sectors, and undertake related efforts.

This bill posthumously provides for the award of a Congressional Gold Medal in commemoration of the 13 service members who died on August 26, 2021, while stationed at Hamid Karzai International Airport in Afghanistan.

Homeless Children and Youth Act of 2021 This bill modifies definitions relating to homeless individuals and homeless children or youth as used by the Department of Housing and Urban Development (HUD) to verify eligibility for HUD homeless assistance programs, including the Continuum of Care program. Specifically, the bill aligns these terms with the definitions of homeless used to verify eligibility for other federal assistance programs. The definitions are also amended to increase access to federal homeless programs by homeless children, youth, and families. Additionally, the community-wide homeless management information system shall be made available to the public on HUD's website.

Designates the facility of the United States Postal Service located at 3045 Sacramento Street in Placerville, California, as the "Deputy Sheriff Brian Ishmael Post Office."

Humane Cosmetics Act of 2021 This bill generally prohibits animal testing in the evaluation of cosmetic products, and it prohibits the sale or transport of cosmetics developed using animal testing, subject to civil penalties. These prohibitions begin one year after enactment. The bill specifies exceptions to these prohibitions, including if such animal testing (1) is conducted outside the United States to comply with a foreign regulatory authority; (2) is pursuant to a specified finding that there are no nonanimal alternatives to test the safety of a potentially dangerous cosmetic product or ingredient; (3) is of a product or ingredient for a drug or device subject to regulation by the Food and Drug Administration (FDA); or (4) is required for a noncosmetic purpose pursuant to a state, federal, or foreign regulatory authority. Further, no animal-testing evidence may be used to establish the safety of a cosmetic product or ingredient that is regulated by the FDA after the effective date of this bill, subject to limited exceptions.

Mental Health in International Development and Humanitarian Settings Act or the MINDS Act This bill directs the U.S. Agency for International Development (USAID) and the Department of State to integrate mental health and psychosocial support activities across all U.S. foreign assistance programs, with a particular focus on children and other vulnerable populations. To facilitate this integration, the bill makes organizational changes at the USAID. It authorizes the USAID to appoint a coordinator to oversee and direct mental health and psychosocial support activities. The coordinator must ensure that these activities focus on children, adult caretakers and families, displaced populations, and other vulnerable groups. In addition, the bill establishes a working group comprised of representatives from every USAID bureau and the Department of State to coordinate interagency efforts related to, promote best practices for, and ensure sustainability and continuity of mental health and psychosocial support activities. The USAID and the State Department must brief Congress about the amount of foreign assistance spending on mental health and psychosocial support activities and related matters.