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Bill· HRH.R. 6530 (117th)referred
United States · United States Congress · 28 January 2022
Safeguarding Elderly Needs for Infrastructure and Occupational Resources Act of 2022 or the SENIOR Act of 2022 This bill requires the Department of Health and Human Services (HHS) to award grants to assisted living facilities for health care expenses and lost revenue attributable to COVID-19 and other purposes. It also addresses matters related to the senior caregiver workforce. To receive a grant, an assisted living facility must demonstrate that it had uncompensated losses due to COVID-19 and consistently maintained operations from March 13, 2020, to December 31, 2020. A facility must also certify that the grant is necessary for its ongoing operations. HHS must also award grants to assisted living facilities for broadband connectivity and telehealth support and other operation and maintenance costs. The Government Accountability Office must report on the efficacy of these grants. With respect to the senior caregiver workforce, the bill authorizes grants for assisted living facilities to establish or expand workforce training and recruitment programs. The National Health Care Workforce Commission must also designate the workforce needs of assisted living and other senior care populations as a high priority area and report on those needs.
Bill· HRH.R. 6520 (117th)referred
United States · United States Congress · 28 January 2022
Medical and Health Stockpile Accountability Act of 2022 This bill requires the Department of Health and Human Services (HHS) to develop an automated application to track the amount of supplies in the Strategic National Stockpile and in similar inventories maintained by states, tribes, territories, and private entities (e.g., hospitals). Additionally, HHS must (1) provide for an annual exercise to test the effectiveness of the application, and (2) establish a program to assist health care entities in obtaining automated vendor management systems.
Bill· HRH.R. 6515 (117th)referred
United States · United States Congress · 28 January 2022
Responsible Path to Full Obamacare Repeal Act This bill repeals the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, effective at the beginning of FY2023. Provisions of law amended by those acts are restored.
Bill· HRH.R. 6514 (117th)referred
United States · United States Congress · 28 January 2022
This bill allows an individual taxpayer a deduction from gross income for insurance premiums paid for the health care coverage of the taxpayer and the taxpayer's spouse and dependents. The bill makes the deduction available whether or not the taxpayer itemizes other deductions.
Bill· HRH.R. 6508 (117th)referred
United States · United States Congress · 25 January 2022
Family Plus Health Care Act of 2022 This bill extends coverage under private health insurance to enrollees' parents who are not eligible for separate coverage under Medicare or Medicaid. Specifically, private health insurers that offer dependent coverage of enrollees' children must also offer coverage of enrollees' parents, at an enrollee's option, if such parents are not eligible for Medicare or Medicaid. The bill also provides for the treatment of such parents as dependents for related tax purposes.
Bill· HRH.R. 6483 (117th)referred
United States · United States Congress · 25 January 2022
Improved Transparency of Foreign Drug Manufacturing Act of 2022 This bill modifies requirements for certain foreign establishments that manufacture drugs (including active pharmaceutical ingredients) to register with the Food and Drug Administration (FDA). Under this bill, if an establishment outside of the United States manufactures (or otherwise processes or prepares) a drug to be imported (or offered for import) into the United States, the establishment must comply with the registration requirements even if the drug undergoes further manufacturing at another non-U.S. establishment prior to importation into the United States. A non-U.S. manufacturing establishment must also file with the FDA a list of drugs manufactured by the establishment. For each drug on the list, the establishment must (1) identify every other known establishment where additional manufacturing is performed, and (2) notify each foreign establishment involved of the listing of the drug and the obligation to register with the FDA. The bill also requires each registered non-U.S. manufacturing establishment to report every three months to the FDA a list of each drug it manufactures for commercial distribution, where currently this report is required once a year.
Resolution· HRESH.Res. 886 (117th)referred
United States · United States Congress · 25 January 2022
This resolution recognizes the service of Certified Registered Nurse Anesthetists (CRNAs), including during the COVID-19 pandemic, and encourages participation in National CRNA Week.
Bill· HRH.R. 6502 (117th)referred
United States · United States Congress · 25 January 2022
Religious Freedom Over Mandates Act This bill prohibits the use of federal funds for a record system that captures religious accommodations (e.g., exemptions) related to COVID-19 vaccination requirements requested by or granted to an employee, contractor, volunteer, or any other person.
Bill· HRH.R. 6468 (117th)referred
United States · United States Congress · 21 January 2022
Domestic Security Using Production Partnerships and Lessons from Yesterday Act of 2022 or the Domestic SUPPLY Act of 2022 This bill establishes a program and sets out other requirements to promote domestic manufacturing of personal protective equipment (PPE) for infectious diseases and other public health emergencies. The Department of Health and Human Services (HHS) must establish a program to enter into purchasing agreements for PPE produced domestically by manufacturers that are majority-owned and -operated by U.S. citizens. HHS must coordinate with the Department of Defense and the Department of Homeland Security on this program. In addition, the federal government must only procure, subject to limited exceptions, PPE that is produced domestically to prevent the transmission of an infectious disease. If using federal funds, states or localities must also procure PPE domestically. Further, the bill requires HHS to consult with the Occupational Safety and Health Administration on a report about changes to federal requirements for PPE during the COVID-19 pandemic and the impact of those changes on health care workers who cared for patients in 2020 and 2021.
Bill· HRH.R. 6464 (117th)referred
United States · United States Congress · 20 January 2022
Hear our Heroes Act of 2022 This bill provides a presumption of service-connection for hearing-related issues in certain veterans for purposes of wartime disability compensation. Under a presumption of service-connection, specific conditions diagnosed in certain veterans are presumed to have been caused by the circumstances of their military service. Health care benefits and disability compensation may then be awarded. Per the bill, certain veterans with diagnosed hearing loss, tinnitus, or both shall be presumed to have incurred or aggravated such conditions during active military, naval, or air service. This bill applies to veterans who (1) served in combat, or (2) were assigned to a military occupational specialty that likely exposed them to a sufficiently high level of acoustic trauma. The bill also requires the Department of Veterans Affairs to adjust the schedule of rating disabilities to establish a minimum disability rating for a veteran who requires a hearing aid because of a service-connected disability.
Bill· HRH.R. 6463 (117th)referred
United States · United States Congress · 20 January 2022
Medical Equality and Discrimination Stoppage Act or the MEDS Act This bill prohibits the Department of Health and Human Services (HHS) from discriminating against or providing preferential treatment to any person or group on the basis of race, color, ethnicity, or national origin. The prohibitions also apply to the administration of HHS programs, including HHS-funded programs administered by states, territories, and private entities. An individual aggrieved by conduct prohibited under the bill may commence a civil action in the appropriate U.S. district court to obtain relief.
Bill· HRH.R. 6421 (117th)referred
United States · United States Congress · 19 January 2022
VA Same-Day Scheduling Act of 2022 This bill requires the Department of Veterans Affairs (VA) to ensure that when a veteran enrolled in the VA health care system contacts the VA by telephone to schedule an appointment for care or services at a VA facility, the scheduling for the appointment occurs during that telephone call.
Resolution· HRESH.Res. 876 (117th)referred
United States · United States Congress · 19 January 2022
This resolution states that the Food and Drug Administration (FDA) should, to the extent scientifically and legally possible, integrate the process behind Operation Warp Speed into FDA operations. (Operation Warp Speed was a partnership between the Department of Health and Human Services and the Department of Defense to coordinate federal efforts to accelerate the development of COVID-19 medical countermeasures, including vaccines.) The resolution also states that the FDA should issue guidance identifying ways to accelerate drug and biological product development through clinical trials and the approval and licensure processes.
Bill· HRH.R. 6431 (117th)referred
United States · United States Congress · 19 January 2022
Data Transparency and Drug Safety Act of 2022 This bill makes it a prohibited act under the Federal Food, Drug, and Cosmetic Act to destroy or falsify certain records pertaining to drugs regulated by the Food and Drug Administration (FDA). Specifically, the bill prohibits falsifying, destroying, omitting. or removing records or information that (1) must be produced during the development or manufacture of a drug, (2) must be produced in an application for FDA approval for a drug or maintained after a drug is approved, or (3) is subject to FDA inspection. A person (entity or individual) that violates this provision shall be subject to civil monetary penalties. The bill also provides for additional monetary penalties in instances where the violation is not sufficiently remedied after the responsible person has received written notice from the FDA of the violation.
Resolution· HRESH.Res. 880 (117th)referred
United States · United States Congress · 19 January 2022
This resolution expresses support for the goals and ideals of Endometriosis Awareness Month. Endometriosis is a painful condition in which the tissue that normally lines the inside of the uterus grows outside the uterus.
Resolution· HRESH.Res. 879 (117th)referred
United States · United States Congress · 19 January 2022
This resolution expresses support for the goals and ideals of Uterine Fibroids Awareness Month. Uterine fibroids are muscular tumors that grow in the wall of the uterus and may cause pain, heavy menstrual bleeding, and reproductive issues.
Resolution· HRESH.Res. 878 (117th)referred
United States · United States Congress · 19 January 2022
This resolution expresses support for the goals and ideals of PCOS Awareness Month. Polycystic ovary syndrome (PCOS) is caused by a hormone imbalance. Symptoms can include infertility, weight gain, excess hair growth, and acne.
Bill· HRH.R. 6429 (117th)referred
United States · United States Congress · 19 January 2022
This bill addresses the COVID-19 vaccine for members of the Armed Forces and basic pay for members of the uniformed services. Specifically, the bill prohibits the use of federal funds to require a member of the Armed Forces to receive a COVID-19 vaccination. The bill also prohibits adverse action (e.g., punishment) being taken against a member of the Armed Forces because the member refuses to receive a COVID-19 vaccination. The bill also increases the rate of monthly basic pay for members of the uniformed services by 2.7% starting on January 1, 2023. Uniformed services means members of the Armed Forces, the commissioned corps of the National Oceanic and Atmospheric Administration, and the commissioned corps of the Public Health Service.
Resolution· SRESS.Res. 492 (117th)referred
United States · United States Congress · 19 January 2022
This resolution designates January 23, 2022, as Maternal Health Awareness Day.
Bill· HRH.R. 6411 (117th)referred
United States · United States Congress · 18 January 2022
Support The Resiliency of Our Nation's Great Veterans Act of 2022 or the STRONG Veterans Act of 2022 This bill addresses mental health care provided by the Department of Veterans Affairs (VA), including by requiring the VA to update training for the VA workforce and Veterans Crisis Line staff, implement pilot programs, expand access to mental health care, conduct studies and research, and provide outreach to veterans regarding mental health resources. Among other requirements, the VA must ensure its medical centers have at least one full-time minority veteran coordinator and that such coordinators receive training on culturally appropriate mental health and suicide prevention services for American Indian and Alaska Native veterans; increase the number of full-time equivalent employees at Vet Centers and paid mental health trainees in the VA's workforce; expand specified scholarships and loan repayment programs for mental health providers and students; review and update the training for Veterans Crisis Line responders and social service assistants; designate a Buddy Check Week to organize outreach events and educate veterans on conducting peer wellness checks; update the Veterans Justice Outreach Program, including by conducting program outreach to justice-involved veterans; make permanent and expand the Peer Specialist Support program; expand eligibility for Vet Center services; offer mental health consultations to certain veterans; improve the assessment and treatment of veterans with sleep disorders; and perform various studies and research related to mental health issues and care. Additionally, the bill permanently authorizes and expands the Solid Start program.
Bill· HRH.R. 6414 (117th)referred
United States · United States Congress · 18 January 2022
No Mandates for Healthcare Workers Act This bill prohibits the Centers for Medicare & Medicaid Services (CMS) from requiring any drug or vaccine or other biological product to be administered to employees of health care providers as a condition of Medicare and Medicaid participation. On November 5, 2021, the CMS issued a rule titled Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination . The rule requires health care providers, as a condition of Medicare and Medicaid participation, to ensure that staff are fully vaccinated against COVID-19.
Bill· SS. 3516 (117th)referred
United States · United States Congress · 18 January 2022
Increase Access to COVID Testing Act This bill directs the Food and Drug Administration (FDA) to provide upon request emergency use authorization for COVID-19 rapid antigen tests approved for use in the European Union. During the declared COVID-19 public health emergency, the FDA shall grant emergency use authorization to a COVID-19 rapid antigen test upon a proper request by the test's manufacturer if (1) the test is on the European Commission Directorate-General for Health and Food Safety's common list for approved COVID-19 tests, and (2) the request is for the non-laboratory use of the test without a prescription. The bill waives certain requirements for a request for emergency use authorization under this bill, such as a finding from the FDA that the test may be effective in diagnosing COVID-19. If a test authorized under this bill is removed from the EU common list, the FDA must determine within 30 days of such removal whether the emergency use authorization for the test should continue.
Bill· HRH.R. 6400 (117th)referred
United States · United States Congress · 13 January 2022
Save America's Rural Hospitals Act This bill establishes and otherwise modifies payment requirements for rural health care providers under Medicare and Medicaid, including by (1) exempting Medicare payments to rural hospitals from sequestration, (2) making permanent certain payment increases for services in rural areas (e.g., Medicaid primary care services), and (3) permanently removing the 96-hour physician certification requirement for inpatient critical access hospital services under Medicare.
Bill· HRH.R. 6401 (117th)referred
United States · United States Congress · 13 January 2022
Title X Age of Consent Notification Act This bill requires providers of federally funded family planning services to inform a minor who receives services of the age of consent for sexual activity that applies in the minor's state.
Bill· HRH.R. 6397 (117th)referred
United States · United States Congress · 13 January 2022
Medical Student Education Authorization Act of 2022 This bill establishes matching grants awarded by the Health Resources and Services Administration (HRSA) to expand and support medical education with a particular focus on training students to serve as primary care physicians in tribal, rural, or medically underserved communities. HRSA must award the grants to public institutions of higher education located in states that rank in the top quartile of states based on projected unmet demand for primary care providers. In awarding the grants, HRSA must give priority to recipients that (1) are located in states with two or more federally recognized Indian tribes, and (2) demonstrate a public-private partnership. Recipients must use grant funds for specified activities that include developing curricula, expanding partnerships with health care providers and community-based organizations, and providing scholarships.
Bill· HRH.R. 6395 (117th)referred
United States · United States Congress · 13 January 2022
No Mandates Act This bill prohibits federal agencies and certain entities that receive federal funding from requiring COVID-19 vaccinations. Specifically, federal agencies may not issue rules, regulations, or guidance that require an individual to receive a COVID-19 vaccination. The bill also prohibits requiring a COVID-19 vaccination to access federal property and services or congressional grounds and services. Additionally, an entity that received federal COVID-19 relief funds or receives other federal funds after this bill's enactment may not require a COVID-19 vaccination as a condition of providing any service to an individual.
Bill· SS. 3506 (117th)referred
United States · United States Congress · 13 January 2022
Strengthening the Public Health Workforce Act This bill reauthorizes through FY2025 and makes changes to the Public Health Workforce Loan Repayment Program (a program that awards student loan repayment to individuals with qualifying degrees who commit to work full-time for a federal, state, tribal, or local public health agency for a period of obligated service). Changes to the program include increasing the maximum repayment amount; eliminating the option for individuals to complete the service obligation in a federal public health agency; and expanding the scope of qualifying degrees to cover, for example, those in statistics, computer science, and programs related to information technology. In addition, the Department of Health and Human Services may take actions to equitably distribute awards across geographic regions, among jurisdictional levels, and between urban and rural areas. The bill also requires the Government Accountability Office to conduct an evaluation of the public health workforce.
Bill· SS. 3498 (117th)referred
United States · United States Congress · 13 January 2022
Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2022 or the FORWARD Act of 2022 This bill establishes programs to support research on endemic fungal diseases and the development of antifungal drugs, with a particular focus on Valley Fever. Endemic fungal diseases are fungal infections that tend to occur in specific geographic areas and affect older adults and other at-risk populations. Specifically, the bill establishes the Endemic Fungal Disease Working Group to review, coordinate, and make recommendations about the Department of Health and Human Services' efforts to address endemic fungal diseases. The working group is comprised of experts from both relevant federal agencies and the private sector. In addition, the National Institutes of Health must continue its support for research on endemic fungal diseases. Furthermore, the Food and Drug Administration must issue guidance for entities seeking approval for therapies, diagnostics, and vaccines to prevent and treat Valley Fever. Additionally, the bill provides for the use of priority reviews and other fast-track procedures to incentivize and expedite development and approval of these medical products. The bill also requires the Biomedical Advanced Research and Development Authority to implement the Combating Antimicrobial Resistance Biopharmaceutical Accelerator Program to reduce and prevent antimicrobial resistance.
Bill· SS. 3496 (117th)referred
United States · United States Congress · 13 January 2022
Promoting Access to Critical Countermeasures by Ensuring Specimen Samples to Diagnostics Act or the Promoting ACCESS to Diagnostics Act This bill directs the Department of Health and Human Services (HHS) to support the development of medical products and diagnostic tests for emerging infectious diseases. Specifically, HHS must develop policies and procedures governing access by public and private entities to samples of pathogens (or suitable surrogates). The samples may be used for preparedness and response activities, developing medical products for emerging infectious diseases, and similar purposes. Additionally, HHS may contract with public and private entities to increase the capacity to rapidly develop, validate, and disseminate diagnostic tests to health departments and other entities to respond to emerging infectious diseases with significant potential to cause a public health emergency.
Bill· SS. 3509 (117th)referred
United States · United States Congress · 13 January 2022
Creating Efficiency in Foreign Facility Inspections Act This bill prohibits, with some exceptions, the Food and Drug Administration (FDA) from providing notification in advance of a planned inspection of an establishment located outside of the United States that is engaged in drug manufacturing, processing, packing, or holding. Specifically, the FDA may not provide such an establishment advance notification of a planned inspection unless (1) advance notification is required by the laws of the country where the establishment is located; (2) providing advance notification is needed to protect the public health; or (3) the inspection in question is a preapproval, prelicensure, or for-cause inspection. If the FDA must provide advance notification, it must minimize the time between the notification and the inspection. If an establishment is located in a country that, on or after the date this bill is enacted, enacts a law requiring advance notification of inspections, the drug manufacturer must agree to waive the right to enforce the requirement, to the extent expressly permitted by the law.
Bill· SS. 3500 (117th)referred
United States · United States Congress · 13 January 2022
Ensuring Accurate and Complete Abortion Data Reporting Act of 2022 This bill requires states, as a condition of federal payment under Medicaid for family planning services, to report certain abortion data to the Centers for Disease Control and Prevention (CDC). (Currently, reporting is voluntary.) The CDC must develop standardized questions for states with respect to specified variables (e.g., maternal demographics and methods of abortion).
Bill· SS. 3497 (117th)referred
United States · United States Congress · 13 January 2022
Medical Student Education Authorization Act of 2022 This bill provides statutory authority for the Medical Student Education Program, through which the Health Resources and Services Administration (HRSA) awards matching grants for expanding and supporting medical education with a particular focus on training students to serve as primary care physicians in tribal, rural, or medically underserved communities. HRSA must award the grants to public institutions of higher education located in states that rank in the top quartile of states based on projected unmet demand for primary care providers. In awarding the grants, HRSA must give priority to recipients that (1) are located in states with two or more federally recognized Indian tribes, and (2) demonstrate a public-private partnership. Recipients must use grant funds for specified activities that include developing curricula, expanding partnerships with health care providers and community-based organizations, and providing scholarships.
Bill· HRH.R. 6384 (117th)referred
United States · United States Congress · 12 January 2022
Improving Awareness of Health Coverage Options Act of 2022 This bill modifies the notification requirements with respect to eligibility for certain health coverage options due to a qualifying event (e.g., loss of coverage due to termination of employment). For example, a health insurance plan must provide a clear explanation that an individual who is eligible for COBRA (Consolidated Omnibus Budget Reconciliation Act) continuation coverage may be eligible to enroll instead, with financial assistance, in a qualified health plan offered through a health insurance exchange.
Bill· HRH.R. 6385 (117th)referred
United States · United States Congress · 12 January 2022
Masks for All Act of 2022 This bill directs the Federal Emergency Management Agency (FEMA) to manufacture and distribute N-95 respirator masks to every individual in the United States and to provide N-95 masks to all individuals working in health care settings in the United States that are experiencing a shortage of such masks. FEMA must provide the masks at no cost to individuals and deliver them, to the greatest extent possible, using the U.S. Postal Service. Additionally, FEMA shall designate mask pickup sites in each community and shall provide masks to each site, allocated according to population; consider new designs for masks to improve comfort, fit, and size options; and submit to Congress a strategic plan that includes monthly, measurable targets to eliminate shortages and increase domestic production of N-95 masks and to fulfill all other requirements of this bill. The President shall make use of any and all available authorities (including emergency authorities) at the disposal of the federal government to procure and domestically manufacture N-95 masks and support the domestic manufacturing of N-95 masks.
Bill· HRH.R. 6377 (117th)referred
United States · United States Congress · 12 January 2022
Free At-Home Tests for All Act This bill requires the Department of Health and Human Services (HHS) to provide free antigen diagnostic tests for COVID-19 (i.e., rapid tests) to U.S. residents. The bill also automatically grants emergency use authorization for rapid tests approved by certain foreign regulators. Specifically, HHS must purchase a sufficient quantity of rapid tests to provide two tests per week at no cost to each resident for the 12 months following the bill's enactment. The President may use authorities available under the Defense Production Act of 1950 to obtain the tests. That act confers upon the President a broad set of authorities to influence domestic industry in order to provide essential materials and goods needed for the national defense. In addition, HHS must conduct outreach about the availability of free rapid tests to Medicare and Medicaid participants and make the tests available through those programs. The bill also automatically grants emergency use authorization during the public health emergency for rapid tests that are listed for emergency use by (1) the World Health Organization (WHO), or (2) a foreign regulator that is a stringent regulatory authority as defined by the WHO for purposes of medicine procurement. The Food and Drug Administration (FDA) may rescind authority for, or otherwise regulate, a rapid test that was automatically authorized. Additionally, the FDA must establish a permanent advisory committee focused on diagnostic and serological testing for public health needs.
Bill· SS. 3486 (117th)referred
United States · United States Congress · 12 January 2022
Masks for All Act of 2022 This bill directs the Federal Emergency Management Agency (FEMA) to manufacture and distribute N-95 respirator masks to every individual in the United States and to provide N-95 masks to all individuals working in health care settings in the United States that are experiencing a shortage of such masks. FEMA must provide the masks at no cost to individuals and deliver them, to the greatest extent possible, using the U.S. Postal Service. Additionally, FEMA shall designate mask pickup sites in each community and shall provide masks to each site, allocated according to population; consider new designs for masks to improve comfort, fit, and size options; and submit to Congress a strategic plan that includes monthly, measurable targets to eliminate shortages and increase domestic production of N-95 masks and to fulfill all other requirements of this bill. The President shall make use of any and all available authorities (including emergency authorities) at the disposal of the federal government to procure and domestically manufacture N-95 masks and support the domestic manufacturing of N-95 masks.
Bill· SS. 3489 (117th)referred
United States · United States Congress · 12 January 2022
This bill directs the National Institutes of Health (NIH) to support research on medical products for virus families and viral pathogens with pandemic potential. Specifically, the NIH must establish or continue a multidisciplinary program for supporting research centers to advance the discovery and development of medical products to prevent, treat, and diagnose such viruses.
Bill· SS. 3493 (117th)referred
United States · United States Congress · 12 January 2022
Drug Shortages Shelf Life Extension Act This bill requires the Food and Drug Administration (FDA) to issue or revise guidance to address issues relating to extending drug expiration dates. Specifically, the guidance must address recommendations to drug companies relating to (1) submitting stability testing data in applications for market approval for drugs or biological products; and (2) establishing on drug labels the longest feasible expiration date supported by such data, taking into consideration how extended expiration dates may help prevent or mitigate drug shortages. The FDA must also periodically report to Congress certain information about requests to change the expiration date on a drug label, including the number of such requests from the FDA to the manufacturer and the rationale for each request.
Bill· HRH.R. 6372 (117th)referred
United States · United States Congress · 11 January 2022
Tribal Medical Supplies Stockpile Access Act of 2022 This bill requires the Department of Health and Human Services (HHS) to deploy drugs, vaccines, biological products, medical devices, and other supplies from the Strategic National Stockpile directly to health programs or facilities operated by the Indian Health Service (IHS), tribes, or tribal organizations. Such supplies from the stockpile are used to respond to public health emergencies. Specifically, if HHS distributes pandemic or epidemic products (e.g., drugs or medical devices) to states or other entities, HHS must also deploy such products directly to health programs or facilities operated by IHS or other tribal entities. HHS must coordinate with states, programs, and facilities to ensure supplies and products are distributed to such tribal entities.
Bill· SS. 3478 (117th)referred
United States · United States Congress · 11 January 2022
Generating Antibiotic Incentives Now Through Opening Opportunities to Leverage Science Act of 2022 or the GAIN TOOLS Act of 2022 This bill expands the definition of a qualified infectious disease product (QIDP) to include eligible biological products. Under current law, the first application (or supplement) for a specific product and indication to be designated a QIDP shall receive priority review for market approval by the Food and Drug Administration. Generally, a biological product designated as a QIDP is one that acts on bacteria or fungi and is intended to treat a serious or life-threatening infection. However, a biological product with a QIDP designation shall not receive the market exclusivity extension currently available to drugs that receive the designation.
Bill· SS. 3477 (117th)referred
United States · United States Congress · 11 January 2022
Planning, Reporting, and Enabling Voluntary Expansion of Notifications Targeting Medical Device Shortages Act of 2022 or the PREVENT Medical Device Shortages Act of 2022 This bill expands existing requirements for manufacturers of certain medical devices to alert the Food and Drug Administration (FDA) of supply disruptions and addresses related issues. Under this bill, a manufacturer of a medical device that is critical to public health during a declared public health emergency must notify the FDA as soon as practicable of any circumstance that is likely to lead to a meaningful disruption to the supply of the device in the United States. Currently, the manufacturer is only required to notify the FDA of supply disruptions stemming from manufacturing issues. The bill also authorizes the FDA to receive notifications from manufacturers of medical devices that are critical to public health about manufacturing issues that are likely to lead to a meaningful disruption to the U.S. supply of the device. Each manufacturer of a medical device that is critical to the public health must develop and implement a redundancy risk management plan in each manufacturing facility for the device. Such a plan shall be subject to FDA inspection.
Bill· SS. 3479 (117th)referred
United States · United States Congress · 11 January 2022
Building a Sustainable Workforce for Healthy Communities Act This bill reauthorizes through FY2027 and revises a program carried out by the Centers for Disease Control and Prevention that supports the use of community health workers to improve health outcomes in medically underserved communities. The bill also requires the Government Accountability Office to report on the effectiveness of and other matters concerning the program.
Bill· SS. 3476 (117th)referred
United States · United States Congress · 11 January 2022
Securing Uninterrupted Pandemic Preparation Of Resources and Therapies Act or the SUPPORT Act This bill expressly incorporates the provision of mental health and substance use disorder services during public health emergencies into the authorities and other activities of the Substance Abuse and Mental Health Services Administration (SAMHSA). Additionally, SAMHSA must report to Congress about recommendations to improve the provision of such services during public health emergencies. The Government Accountability Office must also report on SAMHSA's programs and activities for supporting the provision of such services during the COVID-19 pandemic.
Bill· HRH.R. 6363 (117th)referred
United States · United States Congress · 10 January 2022
Genetic Sequencing Accountability Act This bill requires the Government Accountability Office to report on national security and related risks of human genomic sequencing services or genetic services that are funded by the Department of Health and Human Services and carried out by certain foreign entities. In particular, the report must focus on entities that receive such funding and are organized under the laws of a country or countries of concern, as determined by the Office of the Director of National Intelligence or other federal departments.
Bill· SS. 3449 (117th)referred
United States · United States Congress · 10 January 2022
Registration of Certain Foreign Establishments Act This bill expands statutory provisions that require foreign manufacturers of drugs or medical devices for the U.S. market to register with the Food and Drug Administration. Specifically, if an establishment outside of the United States manufactures (or otherwise processes or prepares) a drug or medical device to be imported (or offered for import) into the United States, the establishment must comply with the registration requirements even if the drug or medical device in question undergoes further manufacturing at another non-U.S. establishment prior to importation into the United States.
Bill· HRH.R. 6356 (117th)referred
United States · United States Congress · 6 January 2022
More Opportunities for Veterans to Exercise Act or the MOVE Act This bill requires the General Services Administration to delegate authority to the Department of Veterans Affairs (VA) for leasing space for preventive health fitness programs and counseling. The bill also expands the definition of preventive health services (in relation to VA health care programs) to include (1) physical activity counseling, and (2) weight management services and physical activity programs.
Bill· SS. 3444 (117th)referred
United States · United States Congress · 5 January 2022
Tribal Medical Supplies Stockpile Access Act of 2022 This bill requires the Department of Health and Human Services (HHS) to deploy drugs, vaccines, biological products, medical devices, and other supplies from the Strategic National Stockpile directly to health programs or facilities operated by the Indian Health Service (IHS), tribes, or tribal organizations. Such supplies from the stockpile are used to respond to public health emergencies. Specifically, if HHS distributes pandemic or epidemic products (e.g., drugs or medical devices) to states or other entities, HHS must also deploy such products directly to health programs or facilities operated by IHS or other tribal entities. HHS must coordinate with states, programs, and facilities to ensure supplies and products are distributed to such tribal entities.
Bill· SS. 3440 (117th)referred
United States · United States Congress · 4 January 2022
This bill restricts various presidential and federal authorities related to the acquisition of supplies to combat COVID-19. Specifically, the bill prohibits the President from exercising certain authorities under the Defense Production Act of 1950 to prioritize the performance of federal contracts or orders for COVID-19 supplies over the performance of state or territorial contracts or orders. In addition, states or territories may use federal COVID-19 relief funds for COVID-19 supplies that they had been unable to purchase because of prioritized performance of federal contracts or orders. (The Defense Production Act of 1950 confers upon the President a broad set of authorities to influence domestic industry in order to provide essential materials and goods needed for the national defense.) Additionally, the Food and Drug Administration may not ration, limit, restrict access to, or otherwise control the quantity of a medical product authorized for use during an emergency, including by requiring products to be distributed through a state- or territorial-based system.