This bill establishes that certain data and determinations from a request for emergency use authorization for a drug, biological product, or medical device may apply to later regulatory procedures for that product. Specifically, data generated to support a request for emergency use authorization may constitute valid scientific evidence to be considered for various later submissions to the Food and Drug Administration (FDA), including a request for market approval. Also, when granting emergency use authorization for a medical device, if the FDA determines that the device performs certain simple low-risk examinations, that determination shall apply to certain other regulatory submissions unless additional information contradicts that determination.
Vessel Response Plan Improvement Act This bill directs the U.S. Coast Guard to require the vessel response plans of Coast Guard-approved commercial vessels to include certain notification requirements with regard to search and rescue missions. Such requirements include developing a procedure for the immediate notification of next of kin in the event that search and rescue teams save or recover crew members during the missions.
Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021 or the CONNECT for Health Act of 2021 This bill expands coverage of telehealth services under Medicare. Among other provisions, the bill allows the Centers for Medicare & Medicaid Services (CMS) to waive certain restrictions, such as restrictions on the types of technology that may be used; permanently removes geographic restrictions on originating sites (i.e., the location of the beneficiary) and allows the home of the beneficiary to serve as the originating site for all services; permanently allows federally qualified health centers and rural health clinics to serve as the distant site (i.e., the location of the health care practitioner); and allows the CMS to generally waive coverage restrictions during any public health emergency. Additionally, the CMS must report on the effects of expanded telehealth services during the COVID-19 public health emergency, including with respect to the utilization, quality, and outcomes of services. The Center for Medicare and Medicaid Innovation may also test alternative payment models relating to expanded telehealth services.
This bill provides for the award of Congressional Gold Medals posthumously to Glen Doherty, Tyrone Woods, J. Christopher Stevens, and Sean Smith (four Americans who were killed in the September 11, 2012, attack on the U.S. consulate in Benghazi, Libya) in recognition of their contributions to the nation.
Veterans Burn Pits Exposure Recognition Act of 2021 This bill requires the Department of Veterans Affairs (VA) to concede, for the purposes of health care benefits and wartime disability compensation, that a veteran was exposed to certain toxic substances, chemicals, and hazards from burn pits if such veteran served on active duty in a covered location during a specified time frame (unless there is affirmative evidence to establish that the veteran was not exposed during such service). A burn pit is an area used for burning solid waste in open air without equipment. Specifically, the bill covers the following locations and corresponding time periods: Iraq between August 2, 1990, and February 28, 1991, as well as from March 19, 2003, until burn pits are no longer used in this location; Southwest Asia (including Kuwait, Saudi Arabia, Oman, and Qatar) from August 2, 1990, until burn pits are no longer used in these locations; and Afghanistan, Syria, Jordan, Egypt, Lebanon, Yemen, and Djibouti from September 11, 2001, until burn pits are no longer used in these locations. Under the bill, if an exposed veteran submits insufficient evidence to establish a service-connection for purposes of disability compensation, the VA shall provide a medical examination and request a medical opinion regarding a causal link between the disability and a toxin, chemical, or hazard.
Universal Child Care and Early Learning Act This bill provides funds to the Department of Health and Human Services (HHS) for an affordable child care and early learning program. Children who are at least six weeks of age but not yet required to attend school may participate in the program regardless of family income, disability status, citizenship status, or employment of a family member. Under the program, HHS must support sponsors (e.g., states, local governments, tribal organizations, and nonprofit community organizations) that provide child care and early learning services for families. Families must pay a subsidized fee, based on their income, for the services. The fees are waived for children from families with incomes below 200% of the poverty line. The fees are capped at 7% of a family's income regardless of the family's income level.
Mental Health Justice Act of 2021 This bill creates a grant program for states and local governments to train and dispatch mental health professionals to respond, instead of law enforcement officers, to emergencies that involve people with behavioral health needs. The Substance Abuse and Mental Health Services Administration (SAMHSA) must manage the program in consultation with the Department of Justice (DOJ). SAMHSA may cancel grants that increase incarceration or institutionalization. Grantees must use funds for purposes including de-escalation and anti-racism training. The Department of Health and Human Services and the DOJ must evaluate this program.
Informed Consent Act This bill establishes new federal criminal offenses related to the performance of abortions and sterilization procedures. First, the bill prohibits knowingly performing an abortion or sterilization procedure without obtaining informed consent. It provides exceptions, including for an abortion or sterilization procedure that is necessary to save a mother whose life is endangered by a physical (but not psychological or emotional) disorder, illness, or condition. An individual who performs a prohibited abortion or sterilization procedure is subject to criminal penalties—a fine, a prison term of up to 10 years, or both. Second, the bill requires federal employees and contractors, as well as employees and contractors of certain federally funded entities, who know about a prohibited abortion or sterilization procedure to report it as soon as possible. An individual who knows about a prohibited abortion or sterilization procedure but fails to report it is subject to a fine, a prison term of up to three years, or both.
Mainstreaming Addiction Treatment Act of 2021 This bill removes the requirement that a health care practitioner apply for a separate waiver through the Drug Enforcement Administration (DEA) to dispense certain narcotic drugs (e.g., buprenorphine) for maintenance or detoxification treatment (i.e., substance use disorder treatment). Further, a community health aide or community health practitioner may dispense certain narcotic drugs for maintenance or detoxification treatment without registering with the DEA if the drug is prescribed by a health care practitioner through telemedicine. It preempts state laws related to licensure for this activity. The bill also directs the Substance Abuse and Mental Health Services Administration to conduct a national campaign to educate health care practitioners and encourage them to integrate substance use disorder treatment into their practices.
Countering Chinese Propaganda Act This bill directs the President to impose asset- and visa-blocking sanctions on foreign individuals and entities engaged in certain acts of malign disinformation. Specifically, the President shall impose sanctions on an individual or entity that knowingly commits a significant act of malign disinformation on behalf of a foreign government or political party to influence certain activities in the United States for the purpose of harming (1) U.S. national security, or (2) the safety and security of a U.S. citizen or legal permanent resident. The Department of State shall report to Congress a determination of whether the Chinese Communist Party's United Front Work Department, which engages in disinformation campaigns and other activities, or any of its officials, falls within the sanctions provided under this bill.
LEOSA Reform Act This bill broadens the authority for certain law enforcement officers to carry concealed firearms across state lines. Specifically, the bill allows qualified active and retired law enforcement officers to carry concealed firearms and ammunition (including magazines) in school zones; in national parks; on state, local, or private property that is open to the public; and in certain federal facilities that are open to the public. Further, the bill permits states to reduce the frequency with which retired law enforcement officers must meet certain qualification standards.
Return Excessive Migrants and Asylees to International Neighbors in Mexico Act of 2021 or the REMAIN in Mexico Act of 2021 This bill requires the Department of Homeland Security (DHS) to implement the Migrant Protection Protocols as outlined in the January 25, 2019, memo titled Policy Guidance for Implementation of the Migrant Protection Protocols . (The protocols generally required aliens who are not clearly admissible, including those seeking asylum, arriving by land along the U.S.-Mexico border to be returned to Mexico while their immigration proceedings are pending, rather than remain in the United States. On January 21, 2021, DHS stopped applying the protocols to newly-arrived individuals.)
