Sponsor Promote and Compensation Act This bill establishes additional disclosure requirements for a blank check company (e.g., a special purpose acquisition company) during an initial public offering or prior to a merger. A blank check company is a development stage company that issues a penny stock and (1) has no specific business plan or purpose, or (2) has indicated that its business plan is to merge with a company or companies. Specifically, the bill requires such a company to disclose the amount of cash per share expected to be held by the blank check company immediately prior to the merger under various redemption scenarios; side payments or agreements to pay sponsors, blank check company investors, or private investors in public equity for their participation in the merger; and fees or other payments to the sponsor, underwriter, and any other party.
Military Justice Improvement and Increasing Prevention Act of 2021 This bill modifies the process and policy related to the disposition of charges and convening of courts-martial for certain sexual assault cases and other specified offenses under the Uniform Code of Military Justice (UCMJ). Among other elements, the bill provides that the determinations on the preferral, disposition, and referral of charges for specified offenses under the UCMJ must be made by a commissioned officer of the Armed Forces who is designated as a court-martial convening authority (in grade O-6 or higher) and who is available for detail as trial counsel, has significant trial experience, and is outside the chain of command of the member subject to the charges.
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.
Modernizing Therapeutic Equivalence Rating Determination Act This bill requires the Food and Drug Administration (FDA) to provide a therapeutic equivalence rating for certain new drug applications if the applicant requests such a rating. Upon request in the application, the FDA must provide such a rating for a new drug application that relies on information from studies not conducted by the applicant and that the applicant does not have a right to reference or use (commonly referred to as a 505(b)(2) application). The FDA must provide the rating no later than 30 days after the application's approval. (A drug is a therapeutic equivalent of another if they produce the same clinical effect and have the same safety profile. Typically, for certain generic drugs, the FDA rates the therapeutic equivalence of that generic drug to another drug, such as the brand name version. Currently, an applicant seeking approval of a drug through a 505(b)(2) application typically only receives an equivalence rating by requesting one from the FDA in a separate petition.)
Gabriella Miller Kids First Research Act 2.0 This bill modifies funding for a pediatric disease research initiative within the National Institutes of Health (NIH). Currently, this initiative receives funding through FY2023 from the 10-Year Pediatric Research Initiative Fund. This bill directs certain penalties assessed by the Securities and Exchange Commission against pharmaceutical companies for specified violations to that fund. In making allocations from the fund, the NIH must prioritize pediatric research that does not duplicate existing research activities.
USTR Inspector General Act of 2021 This bill requires the President to appoint an Inspector General of the Office of the U.S. Trade Representative (USTR). Among other responsibilities, the Inspector General shall (1) conduct and supervise audits and investigations relating to the programs and operations of the USTR, (2) recommend policies for preventing and detecting fraud and abuse in those programs, and (3) provide a means for keeping the USTR and Congress informed about problems and deficiencies in those programs and operations.
Constitutional Concealed Carry Reciprocity Act of 2021 This bill allows a qualified individual to carry a concealed handgun into or possess a concealed handgun in another state that allows its residents to carry concealed firearms. A qualified individual must (1) be eligible to possess, transport, or receive a firearm under federal law; (2) carry a valid photo identification document; and (3) carry a valid state-issued concealed carry permit, or be eligible to carry a concealed firearm in his or her state of residence.
Simplifying the Generic Drug Application Process Act This bill removes a requirement for a generic drug maker to, in some instances, petition the Food and Drug Administration (FDA) before seeking market approval for a generic drug. Currently, if an applicant wishes to submit an abbreviated application (i.e., the type of application typically used to get market approval for a generic drug) for a drug that has a different dosage form or strength from an already-approved drug, the applicant must first petition the FDA for permission to submit the application. Under this bill, an applicant is no longer required to petition the FDA for permission in these instances.
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.
