cheaptrix/billsum-US_congress_and_house huggingface dataset:
Simplifying the Generic Drug Application Process Act

To amend the Federal Food, Drug, and Cosmetic Act to simplify the generic drug application process. 1. Short title This Act may be cited as the Simplifying the Generic Drug Application Process Act 2. Submission for suitability Subparagraph (C) of section 505(j)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(2) (C) Submission for suitability determinations (i) In general A person may submit an abbreviated application for a new drug that has a different dosage form or strength from that of a listed drug. (ii) Secretary's determination on submission The Secretary shall approve or disapprove the submission of such an abbreviated application during the course of its determination whether to receive the application pursuant to section 314.101 of title 21, Code of Federal Regulations (or any successor regulations). (iii) Approval of submission The Secretary shall approve the submission of such an abbreviated application, provided the application is otherwise determined to be eligible to be received, unless the Secretary finds that— (I) clinical investigations are required to be conducted to show the safety and effectiveness of the drug or of any of its dosage forms or strengths which differ from the listed drug; or (II) any of the proposed changes from the listed drug would jeopardize the safe or effective use of the product so as to necessitate significant labeling changes to address the newly introduced safety or effectiveness problem. (iv) Disapproval of submission If the Secretary disapproves the submission of an abbreviated application under this subparagraph, the application shall be considered not to have been received within the meaning of paragraph (5)(A). .

Summary: 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.
Modernizing Therapeutic Equivalence Rating Determination Act

To amend the Federal Food, Drug, and Cosmetic Act to modernize therapeutic equivalence rating determinations. 1. Short title This Act may be cited as the Modernizing Therapeutic Equivalence Rating Determination Act 2. Therapeutic equivalence determinations Section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(7)(A) (v) (I) The Secretary shall make a determination under clause (i)(III)— (aa) with respect to an application submitted under this subsection, at the time of approval of such application or not later than 30 days after the date of such approval; or (bb) with respect to an application submitted under subsection (b)(2), at the time of approval of such application or not later than 30 days after the date of such approval, provided that the sponsor requests such a determination in the original application, in a form prescribed by the Secretary. (II) When the Secretary makes a determination under clause (i)(III), the Secretary shall, in revisions made to the list pursuant to clause (ii), include such information for such drug. (III) When the Secretary makes a determination under clause (i)(III) with respect to a drug, the Secretary shall, at the same time, make such a determination with respect to any other drug— (aa) whose application under subsection (b)(2) was approved; (bb) which references the same listed drug as the application for the first drug for which such determination is made; and (cc) for which there is a citizen petition pending requesting that the Secretary make a determination under clause (i)(III). .

Summary: 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.)
Respect for Workers Act

To reaffirm the importance of workers. 1. Short title This Act may be cited as the Respect for Workers Act 2. Board of Governors of the Federal Reserve System The Federal Reserve Act ( 12 U.S.C. 221 (1) in section 2B(b) ( 12 U.S.C. 225b(b) and distributional effect conduct (2) in section 10 ( 12 U.S.C. 241 and at least 1 member with demonstrated primary experience in supporting or protecting the rights of workers, who shall be the lead member of the Board in charge of promoting effectively and developing policy recommendations for the Board to meet the goal of maximum employment described in section 2A 3. Applicability The amendment made by section 1(2) shall apply to any appointment to the Board of Governors of the Federal Reserve System made on or after the date of enactment of this Act.

Summary: Respect for Workers Act This bill requires at least one member of the Board of Governors of the Federal Reserve System to have experience supporting or protecting the rights of workers. This member is in charge of developing policy recommendations regarding the board's goal of maximum employment. (The board is made up of seven members that are nominated by the President and confirmed by the Senate. Members serve 14-year terms, with one term beginning every two years.) The bill also requires the board to discuss in their semiannual report the distributional effect of monetary policy.
Livestock Regulatory Protection Act of 2021

To amend the Clean Air Act to prohibit the issuance of permits under title V of that Act for certain emissions from agricultural production. 1. Short title This Act may be cited as the Livestock Regulatory Protection Act of 2021 2. Prohibition on permitting certain emissions from agricultural production Section 502(f) of the Clean Air Act ( 42 U.S.C. 7661a(f) (1) by redesignating paragraphs (1) through (3) as clauses (i) through (iii), respectively, and indenting appropriately; (2) in the undesignated matter following clause (iii) (as so redesignated), by striking Approval of (B) No relief of obligation Approval of ; (3) by striking the subsection designation and heading and all that follows through No partial (f) Prohibitions (1) Partial permit programs (A) In general No partial ; and (4) by adding at the end the following: (2) Certain emissions from agricultural production No permit shall be issued under a permit program under this title for any carbon dioxide, nitrogen oxide, water vapor, or methane emissions resulting from biological processes associated with livestock production. .

Summary: Livestock Regulatory Protection Act of 2021 This bill prohibits the Environmental Protection Agency from issuing permits under the Clean Air Act for any carbon dioxide, nitrogen oxide, water vapor, or methane emissions resulting from biological processes associated with livestock production.
SENIOR CARE Act

To amend title XIX of the Social Security Act to enable greater participation by seniors and Medicare beneficiaries in State Medicaid programs for working people with disabilities. 1. Short title This Act may be cited as the Supporting and Empowering the Nation to Improve Outcomes that Reaffirm Careers, Activities, and Recreation for the Elderly Act SENIOR CARE Act 2. Allowing seniors and Medicare beneficiaries to participate in State Medicaid programs for working people with disabilities Title XIX of the Social Security Act ( 42 U.S.C. 1396 , but less than 65,

Summary: Supporting and Empowering the Nation to Improve Outcomes that Reaffirm Careers, Activities, and Recreation for the Elderly Act or the SENIOR CARE Act This bill expands eligibility for the Medicaid Ticket to Work Program to include individuals who are 65 years of age or older. (Under the current program, states may establish a Medicaid buy-in option for working individuals with disabilities whose income exceeds the customary limits and who are between the ages of 16 and 64.)
Recognizing Military Service in PSLF Act

To direct the Secretary of Education to deem each month for which certain Federal student loans are in deferment during a period of active duty service as months counted toward public service loan forgiveness. 1. Short title This Act may be cited as the Recognizing Military Service in PSLF Act 2. Active duty deferment periods counted toward public service loan forgiveness Section 455(m) of the Higher Education Act of 1965 ( 20 U.S.C. 1087e(m) (1) by redesignating paragraphs (2) through (4) as paragraphs (3) through (5), respectively; (2) in paragraph (1), in the matter preceding subparagraph (A), by striking paragraph (2) paragraph (3) (3) by inserting after paragraph (1) the following: (2) Active duty deferment periods Notwithstanding any other provision of this subsection, the Secretary shall deem each month for which a loan payment was in deferment under subsection (f)(2) of this section or for which a loan payment was in forbearance under section 685.205(a)(7) of title 34, Code of Federal Regulations, (or similar successor regulations), for a borrower described in subsection (f)(2)(C) as if the borrower of the loan had made a payment for the purpose of public service loan forgiveness under this subsection. .

Summary: Recognizing Military Service in PSLF Act This bill requires the Department of Education to count each month for which a borrower's federal student loan payment was in deferment or forbearance during a period of active duty, including certain National Guard duty, as a qualifying payment for the purpose of the Public Service Loan Forgiveness (PSLF) program. Under current law, a borrower who is a service member is eligible to receive student loan forgiveness under the PSLF program; however, if the borrower places their loan into deferment or forbearance while they are on active duty, that period of time does not count as a qualifying payment for the PSLF program.
ALERT Act

To ensure that certain incidents involving a covered employee that are reported to the title IX coordinator at an eligible institution of higher education have been reviewed by the president of the institution and not less than 1 additional member of the institution's board of trustees, and for other purposes. 1. Short title This Act may be cited as the Accountability of Leaders in Education to Report Title IX Investigations Act ALERT Act 2. Review of title IX investigations Section 487 of the Higher Education Act of 1965 ( 20 U.S.C. 1094 (30) (A) The institution will submit an annual certification to the Secretary affirming that— (i) the president of the institution (or the equivalent officer) and not less than 1 additional member of the institution’s board of trustees (or a designee of the board) have completed a comprehensive review of any incident involving a covered employee that was reported to the title IX coordinator at that institution in the previous 12 months involving an offense described in section 485(f)(8)(A)(i); and (ii) the individuals described in clause (i) who completed the comprehensive review did not interfere with or influence any investigation or disposition relating to the reported incident. (B) In this paragraph— (i) the term comprehensive review (I) material findings of fact relating to the incident that was reported to the title IX coordinator; (II) the basis for any conclusions about whether a covered employee violated a policy of the institution; and (III) the disposition of any complaints arising from the reported incident, including any sanctions imposed on a covered employee; (ii) the term covered employee (I) means— (aa) a full-time employee of the institution; or (bb) an individual who was acting as an employee of the institution, or who was paid by an entity contracting with the institution and acting on behalf of the institution, at the time of the incident that was reported to the title IX coordinator; and (II) does not include an undergraduate student; and (iii) the term title IX coordinator 20 U.S.C. 1681 .

Summary: Accountability of Leaders in Education to Report Title IX Investigations Act or the ALERT Act This bill requires institutions of higher education (IHEs) that participate in federal student-aid programs to certify annually with the Department of Education that they have reviewed reports of misconduct by their employees involving domestic violence, dating violence, sexual assault, or stalking. The certification must include a confirmation that the IHE's president and board members involved in the review did not interfere with or influence investigations or dispositions.
USTR Inspector General Act of 2021

To amend the Inspector General Act of 1978 to establish an Inspector General of the Office of the United States Trade Representative, and for other purposes. 1. Short title This Act may be cited as the USTR Inspector General Act of 2021 2. Findings Congress makes the following findings: (1) Section 8 of article I of the Constitution of the United States provides that Congress has the sole power to regulate international trade. (2) Congress established the Office of the United States Trade Representative in the Executive Office of the President under section 141 of the Trade Act of 1974 ( 19 U.S.C. 2171 (3) The United States Trade Representative has primary responsibility for administering a variety of trade statutes and for monitoring the implementation and enforcement of trade agreements. (4) Section 141(c)(1)(F) of the Trade Act of 1974 ( 19 U.S.C. 2171(c)(1)(F) report directly to the President and the Congress regarding, and be responsible to the President and the Congress for the administration of, trade agreements programs 3. Establishment of Inspector General of the Office of the United States Trade Representative (a) Definitions Section 12 of the Inspector General Act of 1978 (5 U.S.C. App.) is amended— (1) in paragraph (1), by striking or the Director of the National Reconnaissance Office; the Director of the National Reconnaissance Office; or the United States Trade Representative; (2) in paragraph (2), by striking or the National Reconnaissance Office, the National Reconnaissance Office, or the Office of the United States Trade Representative, (b) Appointment of Inspector General Not later than 120 days after the date of the enactment of this Act, the President shall appoint an individual to serve as the Inspector General of the Office for the United States Trade Representative in accordance with section 3(a)

Summary: 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.
A bill to amend title XI of the Social Security Act to provide Secretarial authority to temporarily waive or modify application of certain Medicare requirements with respect to ambulance services furnished during certain emergency periods.

To amend title XI of the Social Security Act to provide Secretarial authority to temporarily waive or modify application of certain Medicare requirements with respect to ambulance services furnished during certain emergency periods. 1. Secretarial authority to temporarily waive or modify application of certain Medicare requirements with respect to ambulance services furnished during certain emergency periods (a) Waiver authority Section 1135(b) of the Social Security Act ( 42 U.S.C. 1320b–5(b) (1) in the first sentence— (A) in paragraph (7), by striking and (B) in paragraph (8), by striking the period at the end and inserting ; and (C) by inserting after paragraph (8) the following new paragraph: (9) any requirement under section 1861(s)(7) or section 1834(l) that an ambulance service include the transport of an individual to the extent necessary to allow payment for ground ambulance services furnished in response to a 911 call (or the equivalent in areas without a 911 call system) in cases in which an individual would have been transported to a destination permitted under Medicare regulations (as described in section 410.40 to title 42, Code of Federal Regulations (or successor regulations)) but such transport did not occur as a result of community-wide emergency medical service (EMS) protocols due to the public health emergency described in subsection (g)(1)(B). ; and (2) in the flush matter at the end, by adding at the end the following: Ground ambulance services for which payment is made pursuant to paragraph (9) shall be paid at the base rate that would have been paid under the fee schedule established under 1834(l) (excluding any mileage payment) if the individual had been so transported and, with respect to ambulance services furnished by a critical access hospital or an entity described in paragraph (8) of such section, at the amount that otherwise would be paid under such paragraph. (b) Emergency period exception Section 1135(g)(1)(B) of the Social Security Act ( 42 U.S.C. 1320b–5(g)(1)(B) subsection (b)(8) paragraphs (8) and (9) of subsection (b)

Summary: This bill allows for Medicare payment of ground ambulance services that did not result in the actual transport of an individual to a permitted facility, if the lack of transport was due to community-wide COVID-19 (i.e., coronavirus disease 2019) protocols for emergency medical services during the public health emergency.
Housing Financial Literacy Act of 2021

To require the Secretary of Housing and Urban Development to discount FHA single-family mortgage insurance premium payments for first-time homebuyers who complete a financial literacy housing counseling program. 1. Short title This Act may be cited as the Housing Financial Literacy Act of 2021 2. Discount on mortgage insurance premium payments for first-time homebuyers who complete financial literacy housing counseling programs The second sentence of subparagraph (A) of section 203(c)(2) of the National Housing Act ( 12 U.S.C. 1709(c)(2)(A) (1) by inserting before the comma the following: and such program is completed before the mortgagor has signed an application for a mortgage to be insured under this title or a sales agreement (2) by striking not exceed 2.75 percent of the amount of the original insured principal obligation of the mortgage be 25 basis points lower than the premium payment amount established by the Secretary under the first sentence of this subparagraph

Summary: Housing Financial Literacy Act of 2021 This bill modifies the discount given by the Federal Housing Administration (FHA) on single-family mortgage-insurance premium payments for first-time homebuyers who complete a financial-management counseling program. Under current law, the maximum premium amount for such homebuyers is 2.75% of the original insured principal obligation of the mortgage (compared to 3% for other homebuyers). The bill instead requires that the premium amount for such homebuyers be 25 basis points (0.25% of the original insured principal obligation of mortgage) lower than the amount otherwise established by the FHA. The bill also specifies that first-time homebuyers must complete the financial-management counseling program prior to applying for a mortgage or entering into a sales agreement.
Remote Recreational Small Business Interruption Program Act

To direct the Administrator of the Small Business Administration to establish a forgivable loan program for remote recreational businesses, and for other purposes. 1. Short title This Act may be cited as the Remote Recreational Small Business Interruption Program Act 2. Definitions In this Act: (1) Administrator The term Administrator (2) Remote recreational business The term remote recreational business (A) a small business concern (as defined in section 3 of the Small Business Act ( 15 U.S.C. 632 (B) located within 75 miles of the United States and Canadian border; and (C) only accessible by land via Canada. 3. Forgivable loan program for remote recreational businesses (a) In general The Administrator shall establish a program to make forgivable loans available to remote recreational businesses that experienced a loss in revenue that is greater than 50 percent during the period beginning on March 1, 2020 and ending on July 1, 2020 as compared with the same period during 2019. (b) Eligibility To be eligible for a forgivable loan under subsection (a), a remote recreational business shall— (1) have been in operation on March 1, 2020; and (2) show that the closure of the United States and Canadian border restricted the ability of American customers to access the location of the remote recreational business. (c) Loan amount The maximum loan amount under subsection (a) shall be equal to 75 percent of the gross annual receipts for the remote recreational business for fiscal year 2019. (d) Forgiveness Not later than 1 year after the date of enactment of this Act, the Administrator shall forgive 100 percent of the value of a loan made to a remote recreational business under subsection (a) less the amount the remote recreational business received from— (1) any other loan forgiveness program, including any program established under the CARES Act ( Public Law 116–136 (2) an advance under section 1110 of the CARES Act ( 15 U.S.C. 9009

Summary: Remote Recreational Small Business Interruption Program Act This bill requires the Small Business Administration (SBA) to establish a program to make forgivable loans to certain remote recreational businesses that are impacted by border closures due to COVID-19 (i.e., coronavirus disease 2019). Eligible remote recreational businesses must (1) have experienced a loss in revenue that is greater than 50% between March 1, 2020, and July 1, 2020, as compared with the same period in the previous year; and (2) show that the closure of the U.S.-Canada border restricted the ability of American customers to access the location of such businesses. The maximum loan amount shall be equal to 75% of the business's FY2019 revenue, and the SBA shall forgive 100% of the value of such loan, less the amount the borrower received from (1) any other loan forgiveness program, or (2) any emergency advance under the economic impact disaster loan program.