116 HR 1154 IH: Public Safety Employer-Employee Cooperation Act
U.S. House of Representatives
2019-02-13
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I116th CONGRESS1st SessionH. R. 1154IN THE HOUSE OF REPRESENTATIVESFebruary 13, 2019Mr. Kildee (for himself and Mr. Fitzpatrick) introduced the following bill; which was referred to the Committee on Education and LaborA BILLTo provide collective bargaining rights for public safety officers employed by States or their
			 political subdivisions, and for other purposes.

 1.Short titleThis Act may be cited as the Public Safety Employer-Employee Cooperation Act. 2.Purpose and policyCongress declares that the following is the policy of the United States:
 (1)Labor-management relationships and partnerships are based on trust, mutual respect, open communication, bilateral consensual problem solving, and shared accountability. Labor-management cooperation fully utilizes the strengths of both parties to best serve the interests of the public, operating as a team, to carry out the public safety mission in a quality work environment. In many public safety agencies, it is the union that provides the institutional stability as elected leaders and appointees come and go.
 (2)State and local public safety officers play an essential role in the efforts of the United States to detect, prevent, and respond to terrorist attacks, and to respond to natural disasters, hazardous materials, and other mass casualty incidents. State and local public safety officers, as first responders, are a component of the National Incident Management System, developed by the Department of Homeland Security to coordinate response to and recovery from terrorism, major natural disasters, and other major emergencies. Public safety employer-employee cooperation is essential in meeting these needs and is, therefore, in the National interest.
 (3)The Federal Government needs to encourage conciliation, mediation, and arbitration to aid and encourage employers and the representatives of their employees to reach and maintain agreements concerning rates of pay, hours, and working conditions, and to make all reasonable efforts through negotiations to settle their differences by mutual agreement reached through collective bargaining or by such methods as may be provided for in any applicable agreement for the settlement of disputes.
 (4)The absence of adequate cooperation between public safety employers and employees has implications for the security of employees and can affect interstate and intrastate commerce. The lack of such labor-management cooperation can detrimentally impact the upgrading of law enforcement, fire, and emergency medical services of local communities, the health and well-being of public safety officers, and the morale of law enforcement, fire, and EMS departments. Additionally, these factors could have significant commercial repercussions. Moreover, providing minimal standards for collective bargaining negotiations in the public safety sector can prevent industrial strife between labor and management that interferes with the normal flow of commerce.
 (5)Many States and localities already provide public safety officers with collective bargaining rights comparable to or greater than the rights and responsibilities set forth in this Act, and such State and local laws should be respected.
 3.DefinitionsIn this Act: (1)AuthorityThe term Authority means the Federal Labor Relations Authority.
 (2)Confidential employeeThe term confidential employee has the meaning given such term under applicable State law on the date of enactment of this Act. If no such State law is in effect, the term means an individual, employed by a public safety employer, who—
 (A)is designated as confidential; and (B)is an individual who routinely assists, in a confidential capacity, supervisory employees and management employees.
 (3)Emergency medical services personnelThe term emergency medical services personnel means an individual who provides out-of-hospital emergency medical care, including an emergency medical technician, paramedic, or first responder.
 (4)Employer; public safety agency; public safety employerThe terms employer,public safety agency, and public safety employer mean any State, or political subdivision of a State, that employs public safety officers. (5)FirefighterThe term firefighter has the meaning given the term employee engaged in fire protection activities in section 3(y) of the Fair Labor Standards Act of 1938 (29 U.S.C. 203(y)).
 (6)Labor organizationThe term labor organization means an organization of any kind, in which employees participate and which exists for the purpose, in whole or in part, of dealing with employers concerning grievances, conditions of employment, and related matters.
 (7)Law enforcement officerThe term law enforcement officer has the meaning given such term in section 1204 of the Omnibus Crime Control and Safe Streets Act of 1968 (34 U.S.C. 10284(6)).
 (8)Management employeeThe term management employee has the meaning given such term under applicable State law in effect on the date of enactment of this Act. If no such State law is in effect, the term means an individual employed by a public safety employer in a position that requires or authorizes the individual to formulate, determine, or influence the policies of the employer.
 (9)PersonThe term person means an individual or a labor organization. (10)Public safety officerThe term public safety officer—
 (A)means an employee of a public safety agency who is a law enforcement officer, a firefighter, or an emergency medical services personnel;
 (B)includes an individual who is temporarily transferred to a supervisory or management position; and (C)does not include a permanent supervisory, management, or confidential employee.
 (11)StateThe term State means each of the several States of the United States, the District of Columbia, and any territory or possession of the United States.
 (12)Substantially providesThe term substantially provides, when used with respect to the rights and responsibilities described in section 4(b), means comparable to or greater than each right and responsibility described in such section.
 (13)Supervisory employeeThe term supervisory employee has the meaning given such term under applicable State law in effect on the date of enactment of this Act. If no such State law is in effect, the term means an individual, employed by a public safety employer, who—
 (A)has the authority in the interest of the employer to hire, direct, assign, promote, reward, transfer, furlough, lay off, recall, suspend, discipline, or remove public safety officers, to adjust their grievances, or to effectively recommend such action, if the exercise of the authority is not merely routine or clerical in nature but requires the consistent exercise of independent judgment; and
 (B)devotes a majority of time at work to exercising such authority. 4.Determination of rights and responsibilities (a)Determination (1)In generalNot later than 180 days after the date of enactment of this Act, the Authority shall make a determination as to whether a State substantially provides for the rights and responsibilities described in subsection (b).
 (2)Consideration of additional opinionsIn making the determination described in paragraph (1), the Authority shall consider the opinions of affected employers and labor organizations. In the case where the Authority is notified by an affected employer and labor organization that both parties agree that the law applicable to such employer and labor organization substantially provides for the rights and responsibilities described in subsection (b), the Authority shall give such agreement weight to the maximum extent practicable in making the Authority’s determination under this subsection.
 (3)Limited criteriaIn making the determination described in paragraph (1), the Authority shall be limited to the application of the criteria described in subsection (b) and shall not require any additional criteria.
				(4)Subsequent determinations
 (A)In generalA determination made pursuant to paragraph (1) shall remain in effect unless and until the Authority issues a subsequent determination, in accordance with the procedures set forth in subparagraph (B) of this section.
 (B)Procedures for subsequent determinationsUpon establishing that a material change in State law or its interpretation has occurred, an employer or a labor organization may submit a written request for a subsequent determination. If satisfied that a material change in State law or its interpretation has occurred, the Authority shall issue a subsequent determination not later than 30 days after receipt of such request.
 (5)Judicial reviewAny person or employer aggrieved by a determination of the Authority under this section may, during the 60-day period beginning on the date on which the determination was made, petition any United States Court of Appeals in the circuit in which the person or employer resides or transacts business or in the District of Columbia Circuit, for judicial review.
 (b)Rights and responsibilitiesIn making a determination described in subsection (a), the Authority shall consider a State’s law to substantially provide the required rights and responsibilities unless such law fails to provide rights and responsibilities comparable to or greater than the following:
 (1)Granting public safety officers the right to form and join a labor organization, which may exclude management employees, supervisory employees, and confidential employees, that is, or seeks to be, recognized as the exclusive bargaining representative of such employees.
 (2)Requiring public safety employers to recognize the employees’ labor organization (freely chosen by a majority of the employees), to agree to bargain with the labor organization, and to commit any agreements to writing in a contract or memorandum of understanding.
 (3)Providing for the right to bargain over hours, wages, and terms and conditions of employment. (4)Providing for binding interest arbitration as a mechanism to resolve an impasse in collective bargaining negotiations.
 (5)Requiring enforcement of all rights, responsibilities, and protections enumerated in this section, and of any written contract or memorandum of understanding between a labor organization and a public safety employer, through—
 (A)a State administrative agency, if the State so chooses; and/or (B)any court of competent jurisdiction.
 (c)Compliance with requirementsIf the Authority determines, acting pursuant to its authority under subsection (a), that a State substantially provides rights and responsibilities described in subsection (b), then this Act shall not preempt State law.
			(d)Failure To meet requirements
 (1)In generalIf the Authority determines, acting pursuant to its authority under subsection (a), that a State does not substantially provide for the rights and responsibilities described in subsection (b), then such State shall be subject to the regulations and procedures described in section 5 beginning on the later of—
 (A)the date that is 2 years after the date of enactment of this Act; (B)the date that is the last day of the first regular session of the legislature of the State that begins after the date the Authority makes a determination under subsection (a)(1); or
 (C)in the case of a State receiving a subsequent determination under subsection (a)(4), the date that is the last day of the first regular session of the legislature of the State that begins after the date the Authority made the determination.
 (2)Partial failureIf the Authority makes a determination that a State does not substantially provide for the rights and responsibilities described in subsection (b) solely because the State law substantially provides for such rights and responsibilities for certain categories of public safety officers covered by the Act but not others, the Authority shall identify those categories of public safety officers that shall be subject to the regulations and procedures described in section 5, pursuant to section 8(b)(3) and beginning on the appropriate date described in paragraph (1), and those categories of public safety officers that shall remain solely subject to State law with respect to the rights and responsibilities described in subsection (b).
				5.Role of Federal Labor Relations Authority
 (a)In generalNot later than 1 year after the date of enactment of this Act, the Authority shall issue regulations, in accordance with the rights and responsibilities described in section 4(b), establishing collective bargaining procedures for employers and public safety officers in States where the Authority has determined, acting pursuant to section 4(a), do not substantially provide for such rights and responsibilities.
 (b)Role of the Federal Labor Relations AuthorityThe Authority, to the extent provided in this Act and in accordance with regulations prescribed by the Authority, shall—
 (1)determine the appropriateness of units for labor organization representation; (2)supervise or conduct elections to determine whether a labor organization has been selected as an exclusive representative by a voting majority of the employees in an appropriate unit;
 (3)resolve issues relating to the duty to bargain in good faith; (4)conduct hearings and resolve complaints of unfair labor practices;
 (5)resolve exceptions to the awards of arbitrators; (6)protect the right of each employee to form, join, or assist any labor organization, or to refrain from any such activity, freely and without fear of penalty or reprisal, and protect each employee in the exercise of such right; and
 (7)take such other actions as are necessary and appropriate to effectively administer this Act, including issuing subpoenas requiring the attendance and testimony of witnesses and the production of documentary or other evidence from any place in the United States, and administering oaths, taking or ordering the taking of depositions, ordering responses to written interrogatories, and receiving and examining witnesses.
				(c)Enforcement
 (1)Authority to petition courtThe Authority may petition any United States Court of Appeals with jurisdiction over the parties, or the United States Court of Appeals for the District of Columbia Circuit, to enforce any final orders under this section, and for appropriate temporary relief or a restraining order.
 (2)Private right of actionUnless the Authority has filed a petition for enforcement as provided in paragraph (1), any party has the right to file suit in any appropriate district court of the United States to enforce compliance with the regulations issued by the Authority pursuant to this section, or to enforce compliance with any order issued by the Authority pursuant to this section. The right provided by this subsection to bring a suit to enforce compliance with any order issued by the Authority pursuant to this section shall terminate upon the filing of a petition seeking the same relief by the Authority. Enforcement against a State shall be pursuant to section 8(b)(4).
				6.Strikes and lockouts prohibited
 (a)In generalSubject to subsection (b), an employer, public safety officer, or labor organization may not engage in a lockout, sickout, work slowdown, strike, or any other organized job action that will measurably disrupt the delivery of emergency services and is designed to compel an employer, public safety officer, or labor organization to agree to the terms of a proposed contract.
 (b)No preemptionNothing in this section shall be construed to preempt any law of any State or political subdivision of any State with respect to strikes by public safety officers.
 7.Existing collective bargaining units and agreementsA certification, recognition, election-held, collective bargaining agreement, or memorandum of understanding that has been issued, approved, or ratified by any public employee relations board or commission or by any State or political subdivision or its agents and is in effect on the day before the date of enactment of this Act shall not be invalidated by the enactment of this Act.
		8.Construction and compliance
 (a)ConstructionNothing in this Act shall be construed— (1)to preempt or limit the remedies, rights, and procedures of any law of any State or political subdivision of any State that provides comparable or greater rights and responsibilities than the rights and responsibilities described in section 4(b);
 (2)to prevent a State from enforcing a right-to-work law that prohibits employers and labor organizations from negotiating provisions in a labor agreement that require union membership or payment of union fees as a condition of employment;
 (3)to preempt or limit any State law in effect on the date of enactment of this Act that provides for the rights and responsibilities described in section 4(b) solely because such State law permits an employee to appear on the employee’s own behalf with respect to the employee’s employment relations with the public safety agency involved;
 (4)to prohibit a State from exempting from coverage under this Act a political subdivision of the State that has a population of less than 5,000 or that employs less than 25 full-time employees, including each individual employed by the political subdivision, except any individual elected by popular vote or appointed to serve on a board or commission; or
 (5)to preempt or limit the laws or ordinances of any State or political subdivision of a State that provide for the rights and responsibilities described in section 4(b) solely because such law or ordinance does not require bargaining with respect to pension, retirement, or health benefits.
				(b)Compliance
 (1)Actions of statesNothing in this Act or the regulations promulgated under this Act shall be construed to require a State to rescind or preempt the laws or ordinances of any of the State’s political subdivisions if such laws provide rights and responsibilities for public safety officers that are comparable to or greater than the rights and responsibilities described in section 4(b).
 (2)Actions of the authorityNothing in this Act or the regulations promulgated under this Act shall be construed to preempt— (A)the laws or ordinances of any State or political subdivision of a State, if such laws provide collective bargaining rights for public safety officers that are comparable to or greater than the rights enumerated in section 4(b);
 (B)the laws or ordinances of any State or political subdivision of a State that provide for the rights and responsibilities described in section 4(b) with respect to certain categories of public safety officers covered by this Act solely because such rights and responsibilities have not been extended to other categories of public safety officers covered by this Act; or
 (C)the laws or ordinances of any State or political subdivision of a State that provide for the rights and responsibilities described in section 4(b), solely because such laws or ordinances provide that a contract or memorandum of understanding between a public safety employer and a labor organization must be presented to a legislative body as part of the process for approving such contract or memorandum of understanding.
 (3)Limited enforcement powerIn the case of a law described in paragraph (2)(B), the Authority shall only exercise the powers provided in section 5 with respect to those categories of public safety officers who have not been afforded the rights and responsibilities described in section 4(b).
 (4)Exclusive enforcement provisionNotwithstanding any other provision of the Act, and in the absence of a waiver of a State’s sovereign immunity, the Authority shall have the exclusive power to enforce the provisions of this Act with respect to employees of a State.
 9.Authorization of appropriationsThere are authorized to be appropriated such sums as may be necessary to carry out the provisions of this Act.


117 S2116 IS: Senior Financial Empowerment Act of 2021
U.S. Senate
2021-06-17
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II
117th CONGRESS1st Session
S. 2116
IN THE SENATE OF THE UNITED STATES

June 17, 2021
Mrs. Gillibrand (for herself and Ms. Collins) introduced the following bill; which was read twice and referred to the Committee on Commerce, Science, and Transportation

A BILL
To prevent mail, telemarketing, and internet fraud targeting seniors in the United States, to promote efforts to increase public awareness of the enormous impact that mail, telemarketing, and internet fraud have on seniors, to educate the public, seniors, their families, and their caregivers about how to identify and combat fraudulent activity, and for other purposes.

1.Short titleThis Act may be cited as the Senior Financial Empowerment Act of 2021. 2.FindingsCongress makes the following findings:
(1)The proportion of the population of the United States that is 60 years of age or older will drastically increase in the next 30 years as more than 76,000,000 baby boomers approach retirement and old age. (2)Each year, anywhere between 500,000 and 5,000,000 seniors in the United States are abused, neglected, or exploited.
(3)Senior abuse, neglect, and exploitation have no boundaries and cross all racial, social class, gender, and geographic lines. (4)Millions of individuals in the United States are victims of financial exploitation, including mail, telemarketing, and internet fraud, each year, and many of the individuals who fall prey to these crimes are seniors.
(5)It is difficult to estimate the prevalence of fraud targeting seniors because cases are severely underreported and national statistics on senior fraud do not exist. (6)The Federal Bureau of Investigation notes that a senior may be less likely to report fraud because the senior—
(A)does not know to whom to report the fraud; (B)is ashamed to have been a victim of fraud;
(C)does not know that the senior has been a victim of fraud; or (D)in some cases, is concerned that relatives may come to the conclusion that the senior no longer has the mental capacity to take care of the financial affairs of the senior.
(7)According to a 2011 report by the MetLife Mature Market Institute, the annual financial loss by victims of senior financial abuse is estimated to be at least $2,900,000,000. (8)As victims of senior financial abuse, many seniors have been robbed of their hard-earned life savings, and even their homes, and can suffer severe emotional and health-related consequences.
(9)Perpetrators of fraud targeting seniors often operate outside the United States, reaching their victims through the mail, telephone lines, and the internet. (10)The Deceptive Mail Prevention and Enforcement Act (Public Law 106–168; 113 Stat. 1806) increased the power of the United States Postal Service to protect consumers against persons who use deceptive mailings, such as those featuring games of chance, sweepstakes, skill contests, and facsimile checks.
(11)During fiscal year 2007, analysts prepared more than 27,000 letters and informative postcards in response to mail fraud complaints. During that same fiscal year, postal inspectors investigated 2,909 mail fraud cases in the United States and arrested 1,236 mail fraud suspects, of whom 1,118 were convicted. Postal inspectors also reported 162 telemarketing fraud investigations with 83 arrests and 61 convictions resulting from the investigations. (12)In 2000, the Special Committee on Aging of the Senate reported that, each year, consumers lose approximately $40,000,000,000 to telemarketing fraud and estimated that approximately 10 percent of the 14,000 telemarketing firms in the United States were fraudulent.
(13)Some researchers estimate that only 1 in 10,000 fraud victims reports the crime to the authorities. (14)A 2003 report by AARP, Inc., found that the crime of telemarketing fraud is grossly underreported among senior victims, but that individuals who are properly counseled by trained peer volunteers are less likely to fall victim to fraudulent practices.
(15)The Federal Bureau of Investigation reports that the threat of fraud to seniors is growing and changing. Many younger baby boomers have considerable computer skills and criminals are modifying their targeting techniques by using not only traditional telephone calls and mass mailings, but also online scams like phishing and e-mail spamming. (16)The Internet Crime Complaint Center is a partnership between the National White Collar Crime Center and the Federal Bureau of Investigation that serves as a vehicle to receive, develop, and refer criminal complaints regarding cybercrime. The Internet Crime Complaint Center processed more than 219,553 complaints of internet crime in 2007 and, from these submissions, the center referred 90,008 complaints of internet crime, representing a total dollar loss of $239,090,000, to Federal, State, and local law enforcement agencies in the United States for further consideration.
(17)Consumer awareness is the best protection from fraud. 3.DefinitionsIn this Act:
(1)CommissionThe term Commission means the Federal Trade Commission. (2)Senior citizenThe term senior citizen means an individual who is not younger than 65 years of age.
4.Information and consumer education on mail, telemarketing, and internet fraud targeting senior citizens
(a)Centralized service
(1)Dissemination of informationThe Commission, after consultation with the Attorney General, the Secretary of Health and Human Services, the Postmaster General, the Chief Postal Inspector for the United States Postal Inspection Service, and the Internet Crime Complaint Center, shall— (A)disseminate to senior citizens and the families and caregivers of the senior citizens information—
(i)regarding mail, telemarketing, and internet fraud that targets senior citizens, including descriptions of the most common fraud schemes; and (ii)which shall be—
(I)disseminated in a way that is easily accessible and user-friendly to senior citizens; and (II)proactive so as to teach senior citizens about scam and fraud prevention through safe and smart financial practices; and
(B)with respect to the information described in subparagraph (A)(ii)(II)— (i)update the information regularly to keep pace with the changing nature of criminal activity; and
(ii)include— (I)instructions on how to refer a complaint to the appropriate law enforcement agency; and
(II)a national toll-free telephone number, to be established by the Commission, which shall— (aa)have a live individual, rather than an automated service, available to answer calls from senior citizens who are calling—
(AA)to seek advice on where and how to report instances of fraud; or (BB)to ask questions about issues relating to scams or fraud of senior citizens; and
(bb)be similar to the Fraud Hotline established by the Special Committee on Aging of the Senate. (2)Sharing of informationThe Commission shall—
(A)maintain an internet website that serves as a source of information for senior citizens and the families and caregivers of senior citizens regarding the types of fraud described in paragraph (1)(A)(i); (B)work with State law enforcement agencies to create a national database that tracks instances of fraud committed against senior citizens; and
(C)in response to a specific request about a particular person, provide publically available information on any record of a civil or criminal law enforcement action taken against the person for fraud that targeted senior citizens. (b)ImplementationNot later than 1 year after the date of the enactment of this Act, the Commission shall establish and implement procedures to carry out the requirements of this section.
5.Education to certain entities regarding financial exploitation of senior citizens
(a)In generalThe Commission shall, in consultation with the appropriate Federal financial institutions (as defined in section 8(e)(7)(D) of the Federal Deposit Insurance Act (12 U.S.C. 1818(e)(7)(D))), regulatory agencies, State agencies, and local agencies, convene and provide education to the entities described in subsection (b) regarding the legal obligations of those entities and industry best practices for those entities with respect to financial exploitation and neglect of senior citizens. (b)Covered entitiesAn entity described in this subsection is—
(1)a depository institution (as defined in section 3(c) of the Federal Deposit Insurance Act (12 U.S.C. 1813(c))); (2)a credit office;
(3)a remittance transfer provider (as defined in section 920(g) of the Electronic Fund Transfer Act (15 U.S.C. 1693o–1(g))); (4)a person who distributes general-use prepaid cards (as defined in section 915(a)(2) of the Electronic Fund Transfer Act (15 U.S.C. 1693l–1(a)(2))); and
(5)any individual who— (A)is employed by a financial institution;
(B)has access to the financial records of senior citizens; and (C)may be able to identify instances of elder financial abuse because of discrepancies in those financial records.
(c)Required trainingA State agency may not receive Federal funds under this Act unless the agency ensures that the entities described in subsection (b) in that State receive appropriate training that improves— (1)the ability of the entities to recognize evidence of financial exploitation and neglect of senior citizens; and
(2)the understanding of the entities of the reporting requirements in that State with respect to financial exploitation and neglect of senior citizens. (d)ImplementationNot later than 1 year after the date of the enactment of this Act, the Commission shall establish and implement procedures to carry out the requirements of this section.
6.Grant program to prevent mail, telemarketing, and internet fraud and for scientific research on senior citizens’ increased vulnerability to scams
(a)Grant program
(1)AuthorizationThe Attorney General may award grants, on a competitive basis, to eligible entities to carry out fraud prevention activities designed to protect senior citizens. (2)Eligible entitiesFor purposes of the grant program, an eligible entity is any State attorney general, State or local law enforcement agency, senior center, or other State or local nonprofit organization that provides assistance to senior citizens.
(3)PriorityIn awarding grants under this subsection, the Attorney General shall give priority to an eligible entity that has established a public-private partnership with a computer or software company that is focused on developing tools to enhance internet scam prevention. (4)Authorization of appropriationsThere are authorized to be appropriated to the Attorney General to carry out this subsection $5,000,000 for each of fiscal years 2022 through 2026.
(b)Research
(1)In generalThe Director of the National Institutes of Health shall conduct scientific research related to the increased vulnerability of senior citizens to scams and fraud due to age-related health and neurological conditions. (2)Availability of fundsNo additional amounts are authorized to be appropriated to carry out this subsection. Amounts to carry out this subsection shall be derived from amounts not specifically appropriated to carry out this subsection.
7.Sense of Congress on National Senior Fraud Awareness WeekIt is the sense of Congress that— (1)there is a need to increase awareness of fraud targeting senior citizens;
(2)a week in March of each year should be designated as National Senior Fraud Awareness Week to coincide with the end of winter, which— (A)is commonly a period of increased isolation; and
(B)precedes tax season; (3)the people of the United States should observe National Senior Fraud Awareness Week with relevant educational activities; and
(4)the President should issue a proclamation supporting increased awareness of senior fraud.


		I
		111th CONGRESS
		1st Session
		H. R. 1427
		IN THE HOUSE OF REPRESENTATIVES

			March 11, 2009
			Mr. Waxman (for
			 himself, Mr. Pallone,
			 Mr. Deal of Georgia, and
			 Mrs. Emerson) introduced the following
			 bill; which was referred to the Committee
			 on Energy and Commerce, and in addition to the Committee on
			 the Judiciary, for a
			 period to be subsequently determined by the Speaker, in each case for
			 consideration of such provisions as fall within the jurisdiction of the
			 committee concerned

		A BILL
		To amend the Public Health Service Act to provide for the
		  licensing of biosimilar and biogeneric biological products, and for other
		  purposes.

		1.Short titleThis Act may be cited as the
			 Promoting Innovation and Access to
			 Life-Saving Medicine Act.
		2.Definitions
			(a)LicensureSection 351(i) of the Public Health Service
			 Act (42 U.S.C. 262(i)) is amended—
				(1)by striking
			 In this section, the term biological product means
			 and inserting the following:

						In this
			 section:(1)The term
				biological product means
						;
				and
				(2)by adding at the
			 end the following:

						(2)The term abbreviated biological
				product application means an abbreviated application for a license of a
				biological product that relies in part on data or information in an application
				for another biological product licensed under this section or approved under
				section 505 of the Federal Food, Drug, and Cosmetic Act.
						(3)The term
				reference product means the single licensed biological product,
				approved under subsection (a) or (k), against which a biological product is
				evaluated for demonstration of safety, potency, or purity.
						(4)The term final action means,
				with respect to an abbreviated biological product application, the Secretary’s
				issuance of a final action letter to the sponsor of an abbreviated biological
				product application which—
							(A)approves the
				application; or
							(B)disapproves the
				application and sets forth in detail an enumeration of the specific
				deficiencies in the particular application and of the specific, enumerated
				actions the sponsor would be required to take in order for the sponsor to
				receive a final action letter that approves such application.
							(5)The term final action date
				means, with respect to an abbreviated biological product application, the date
				by which the Secretary must take a final action on the application pursuant to
				subsection (k)(13).
						(6)The term
				reviewing division means the division responsible for the review
				of an application for approval of a biological product (including all
				scientific and medical matters, chemistry, manufacturing, and
				controls).
						.
				(b)Fees
				(1)Rule of
			 constructionThe definition of a human drug application in
			 section 735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1))
			 shall be construed to include applications under section 351(k) of the Public
			 Health Service Act, as added by section 3, in addition to applications under
			 section 351(a) of such Act.
				(2)SupplementSection
			 735(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(2)) is
			 amended by adding at the end the following: Notwithstanding the
			 preceding sentence, any request for an interchangeability determination under
			 section 351(k) of the Public Health Service Act shall be treated as a
			 supplement for purposes of this part, irrespective of whether such request is
			 included in an application for licensure of a biological product or a
			 subsequent submission..
				3.Regulation of
			 biosimilar and biogeneric biological products
			(a)In
			 generalSection 351 of the Public Health Service Act (42 U.S.C.
			 262), as amended by section 2, is further amended—
				(1)in subsection
			 (a)(1)(A), by inserting under this subsection or subsection (k)
			 after biologics license; and
				(2)by adding at the
			 end the following subsection:

						(k)Regulation of
				biosimilar and interchangeable biological products
							(1)BiosimilarIn
				this subsection, the term biosimilar or
				biosimilarity, in reference to a biological product, means no
				clinically meaningful differences between the biological product and the
				reference product would be expected in terms of the safety, purity, and potency
				if treatment were to be initiated with the biological product instead of the
				reference product.
							(2)InterchangeabilityIn
				this subsection, the term interchangeable or
				interchangeability means, with respect to a given condition of
				use, that—
								(A)the biological
				product is biosimilar to the reference product; and
								(B)if the biological
				product is intended to be administered more than once to a given patient, the
				patient can be switched one or more times between the reference product and the
				biological product without an expected increase in the risk of adverse effects,
				including a clinically significant change in immunogenicity, or diminished
				effectiveness, compared to the expected risks from continuing to use the
				reference product without such switching.
								(3)Submission of an
				abbreviated biological product applicationAny person may file
				with the Secretary an abbreviated biological product application. Any such
				application shall include the following:
								(A)Information
				demonstrating that the biological product and reference product contain highly
				similar molecular structural features, notwithstanding minor differences in
				heterogeneity profile, impurities, or degradation patterns.
								(B)Information
				demonstrating that the biological product is biosimilar to (as defined in
				paragraph (1)) or interchangeable with (as defined in paragraph (2)) the
				reference product for the condition or conditions of use prescribed,
				recommended, or suggested in the proposed labeling based upon, in the
				discretion of the Secretary—
									(i)information
				derived from chemical, physical, and biological assays, and other non-clinical
				laboratory studies; and
									(ii)information from
				any necessary clinical study or studies sufficient to confirm safety, purity,
				and potency.
									Any
				studies under clause (ii) shall be designed to avoid duplicative and unethical
				clinical testing.(C)Information
				demonstrating that the biological product and reference product utilize the
				same mechanism or mechanisms of action for the condition or conditions of use
				prescribed, recommended, or suggested in the proposed labeling, but only to the
				extent the mechanism or mechanisms of action are known for the reference
				product or can reasonably be determined. If the applicant seeks to rely on a
				demonstration of biosimilarity or interchangeability for a single condition of
				use to support approval of additional conditions of use that share the same
				mechanism or mechanisms of action, information demonstrating that such reliance
				is scientifically appropriate.
								(D)Information to
				show that the condition or conditions of use prescribed, recommended, or
				suggested in the proposed labeling for the biological product have been
				previously approved for the reference product.
								(E)Information to
				show that the route of administration, the dosage form, and the strength of the
				biological product are the same as those of the reference product.
								(F)Information
				demonstrating that the facility in which the biological product is
				manufactured, processed, packed, or held meets standards designed to ensure
				that the biological product continues to be safe, pure, and potent.
								(4)Other
				applicationsAny person, including a person who has not conducted
				and does not have a right of reference to the studies in the application for a
				reference product, may submit an abbreviated biological product application
				under this paragraph for a biological product that differs from, or
				incorporates a change to, the reference product with respect to one or more
				characteristics described in subparagraphs (A) through (E) of paragraph (3),
				including a difference in safety, purity, or potency, so long as the
				application contains sufficient information to establish the safety, purity,
				and potency of the biological product for its proposed condition or conditions
				of use.
							(5)Approval of
				biosimilar or interchangeable biological products
								(A)Determination of
				biosimilarityUpon review of an application submitted under
				paragraph (3) for a biological product and any other information available to
				the Secretary, including information in the application for the reference
				product, the Secretary shall issue a biosimilar biological product license for
				the conditions of use prescribed, recommended, or suggested in the proposed
				labeling for the product, unless the Secretary finds and informs the applicant
				(including provision of a detailed explanation) that—
									(i)information
				submitted in the application and any other information available to the
				Secretary is insufficient to show that the biological product and the reference
				product contain highly similar molecular structural features, notwithstanding
				minor differences in heterogeneity profile, impurities, or degradation
				patterns;
									(ii)information
				submitted in the application and any other information available to the
				Secretary is insufficient to show that the biological product is biosimilar to
				the reference product for the condition or conditions of use prescribed,
				recommended, or suggested in the labeling proposed in the application;
									(iii)information
				submitted in the application and any other information available to the
				Secretary is insufficient to show that the biological product and reference
				product utilize the same mechanism or mechanisms of action for the conditions
				of use prescribed, recommended, or suggested in the proposed labeling for the
				biological product, unless the mechanism or mechanisms of action are not known
				and cannot reasonably be determined for the reference product for such
				condition or conditions;
									(iv)if the applicant
				has demonstrated biosimilarity for a single condition of use sharing the same
				mechanism of action as other conditions of use of the reference product, and
				has sought approval of one or more such other conditions of use on the basis of
				such demonstration, information submitted in the application and any other
				information available to the Secretary is insufficient to show the safety,
				purity, and potency of one or more such other conditions of use;
									(v)information
				submitted in the application and any other information available to the
				Secretary is insufficient to show that the route of administration, the dosage
				form, and the strength of the biological product are the same as those of the
				reference product;
									(vi)information
				submitted in the application and any other information available to the
				Secretary is insufficient to show that the condition or conditions of use
				prescribed, recommended, or suggested in the proposed labeling for the
				biological product are limited to one or more of the same use or uses as have
				been previously approved for the reference product;
									(vii)information
				submitted in the application and any other information available to the
				Secretary shows (I) the inactive ingredients of the biological product are
				unsafe for use under the conditions prescribed, recommended, or suggested in
				the proposed labeling for the biological product, or (II) the composition of
				the biological product is unsafe under such conditions because of the type or
				quantity of inactive ingredients included or the manner in which the inactive
				ingredients are included;
									(viii)information
				submitted in the application and any other information available to the
				Secretary fails to demonstrate that the facility in which the biological
				product is manufactured, processed, packed, or held meets standards designed to
				ensure that the biological product continues to be safe, pure, and
				potent;
									(ix)the Secretary
				has, for reasons of safety, purity, or potency, other than reasons that are
				unique to the reference product—
										(I)withdrawn or
				suspended the license of the reference product;
										(II)published a
				notice of opportunity for hearing to withdraw such license; or
										(III)determined that
				the reference product has been withdrawn from sale; or
										(x)the application
				contains an untrue statement of material fact.
									(B)Determinations
				on interchangeabilitySubject to subparagraph (C) and paragraph
				(11), upon issuing a product license for a biological product under
				subparagraph (A), the Secretary shall make and publish one of the following
				determinations:
									(i)Such product is
				interchangeable with the reference product for one or more specified conditions
				of use prescribed, recommended, or suggested in the labeling of the biological
				product.
									(ii)Interchangeability
				has not been established, but the approved product is as safe and effective for
				its approved uses as the reference product.
									(C)Determination of
				interchangeability of subsequent biological productIf the
				Secretary determines that an application meets the approval requirements of
				subparagraph (A), and, prior to the issuance of a product license, the
				Secretary has made a determination of interchangeability of another biological
				product and the reference product for which the exclusivity period under
				paragraph (11) has not expired, the Secretary shall—
									(i)issue the product
				license for the subsequent biological product; and
									(ii)defer issuing any
				determination of interchangeability as to the subsequent biological product and
				the reference product until the exclusivity period under paragraph (11) has
				expired.
									(6)Designation of
				official name
								(A)In
				generalIf, pursuant to section 508 of the Federal Food, Drug,
				and Cosmetic Act, the Secretary determines that designation of an official name
				for a biosimilar biological product is necessary or desirable in the interests
				of usefulness or simplicity, the Secretary shall designate the same official
				name for the biosimilar biological product as the Secretary designated for the
				reference product.
								(B)LimitationThis
				paragraph shall not apply to products approved under paragraph (7).
								(C)Report to
				CongressNot later than 5
				years after the date of the enactment of this subsection, the Comptroller
				General of the United States shall submit a report to the Congress on public
				health and economic impacts associated with practices for designating the
				official names of biosimilar biological products in the United States and in
				other countries that approve biosimilar biological products.
								(7)Other approval
				provisionsThe Secretary shall approve an application for a
				license submitted under paragraph (4) if the application and any other
				information available to the Secretary, including information in the
				application for the reference product, are sufficient to establish the safety,
				purity, and potency of the biosimilar biological product for the proposed
				condition or conditions of use for such product.
							(8)Establishing
				interchangeability for biosimilar biological products
								(A)In
				generalIn an original application or a supplement to an
				application under this subsection, an applicant may submit information to the
				Secretary to demonstrate the interchangeability of a biosimilar biological
				product and the reference product. An applicant may withdraw a request for an
				interchangeability determination at any time. A request for an
				interchangeability determination submitted after the filing of an application
				shall be considered a major amendment to the application. Except as provided in
				paragraph (11), nothing in this subsection shall be construed to prohibit the
				Secretary from making a determination of interchangeability at any time after
				approval.
								(B)GuidanceWithin
				2 years after enactment of this subsection, the Secretary shall issue guidance
				regarding standards and requirements for interchangeability. The Secretary is
				authorized to make determinations of interchangeability under paragraph (5)(B)
				prior to issuing guidance under this subparagraph.
								(9)Interchangeability
				labeling for interchangeable biological productsExcept as
				provided in paragraph (11), upon a determination of interchangeability, the
				Secretary shall, at the request of the applicant, provide for the label of the
				interchangeable biological product to include a statement that the biological
				product is interchangeable with the reference product for the conditions of use
				prescribed, recommended, or suggested in the labeling for which
				interchangeability has been established.
							(10)Delay of
				approval
								(A)Applicable delay
				period
									(i)5-year
				periodIf an application under this subsection refers to a
				biological product described in clause (i) of subparagraph (B), the Secretary
				may not approve such application before the expiration of—
										(I)the 5-year period
				beginning on such product’s approval date; or
										(II)such period, as
				extended under subparagraph (D).
										(ii)3-year
				periodIf an application under this subsection refers to a
				biological product described in subparagraph (C), the Secretary may not approve
				such application for the conditions of approval of such product before the
				expiration of—
										(I)the 3-year period
				beginning on such product’s approval date; or
										(II)such period, as
				extended under subparagraph (D)
										(B)No major
				substance previously approved
									(i)In
				generalA biological product is described in this clause
				if—
										(I)an application is
				submitted for such product under subsection (a);
										(II)no major
				substance of the product, nor any highly similar major substance, has been
				approved in any other application under subsection (a);
										(III)the application
				submitted for such product is approved after the date of the enactment of this
				subsection; and
										(IV)the application
				submitted for such product could not and did not rely on any clinical safety,
				purity, or potency study in any other application approved under this section
				or any clinical safety or effectiveness study in any application approved under
				section 505 of the Federal Food, Drug, and Cosmetic Act.
										(ii)ExclusionsBiological
				products not described in clause (i) include the following:
										(I)Protein biological
				products that differ in structure solely due to post-translational events,
				infidelity of translation or transcription, or minor differences in amino acid
				sequence.
										(II)Polysaccharide
				biological products with similar saccharide repeating units, even if the number
				of units differ and even if there are differences in post-polymerization
				modifications.
										(III)Glycosylated
				protein products that differ in structure solely due to post-translational
				events, infidelity of translation or transcription, or minor differences in
				amino acid sequence, and if they had similar saccharide repeating units, even
				if the number of units differ and even if there were differences in
				post-polymerization modifications.
										(IV)Polynucleotide
				biological products with identical sequence of purine and pyrimidine bases (or
				their derivatives) bound to an identical sugar backbone (ribose, deoxyribose,
				or modifications of these sugars).
										(V)Closely related,
				complex partly definable biological products with similar therapeutic intent,
				such as live viral products for the same indication.
										The Secretary
				may by regulation identify additional biological products not described in
				clause (i).(C)Major substance
				previously approvedA biological product is described in this
				subparagraph if—
									(i)an
				application is submitted for such product under subsection (a);
									(ii)such product
				includes a major substance that has been approved in another application under
				subsection (a), or any highly similar major substance;
									(iii)the application
				submitted for such product is approved after the date of the enactment of this
				subsection;
									(iv)the application
				submitted for such product contains reports of new clinical investigations
				(other than pharmacokinetic or pharmacodynamic studies) essential to the
				approval of the application and conducted or sponsored by the applicant;
				and
									(v)the product
				represents a significant therapeutic advance, which may include demonstration
				of safety, purity, and potency for a significant new indication or
				subpopulation, other than a pediatric subpopulation.
									(D)(i)SupplementIf
				a supplement to an application approved under subsection (a) is approved no
				later than 1 year before the expiration of a period to which the applicant is
				entitled under subparagraph (A), the period described in subparagraph (A)
				shall, except as provided in clause (ii), be extended by 6 months if—
										(I)the supplement contains reports of new
				clinical investigations (other than pharmacokinetic or pharmacodynamic studies)
				essential to the approval of the supplement and conducted or sponsored by the
				person submitting the supplement; and
										(II)the change provides a significant
				therapeutic advance, which may include demonstration of safety, purity, and
				potency for a significant new indication or subpopulation, other than a
				pediatric subpopulation.
										(ii)AdjustmentAny
				period of market exclusivity extended under subclause (I) or (II) of clause (i)
				for a biological product shall be reduced by 3 months if the organization
				designated under subparagraph (E) notifies the Secretary that, with respect to
				any major substance contained in the biological product, the combined annual
				gross sales in the United States for all biological products—
										(I)containing the major substance;
				and
										(II)owned or marketed by the applicant or
				its affiliates;
										exceeded
				$1,000,000,000 in the calendar year preceding approval of the supplement
				involved.(iii)LimitationOnly
				one extension under this subparagraph may be granted for any biological
				product.
									(E)(i)DesignationThe Secretary shall designate an
				organization other than the Food and Drug Administration to make the
				determination of combined annual gross sales described in clause (ii). Prior to
				designating such organization, the Secretary shall determine that such
				organization is independent and is qualified to evaluate the sales of
				pharmaceutical products. The Secretary shall re-evaluate the designation of
				such organization once every 3 years.
									(ii)NotificationThe
				organization designated under clause (i) shall—
										(I)determine, with respect to each major
				substance contained in each biological product that is the subject of a pending
				supplement under subparagraph (D)(i), the amount of the combined annual gross
				sales in the United States in the preceding calendar year for all biological
				products—
											(aa)containing the major substance;
				and
											(bb)owned or marketed by the applicant or
				its affiliates; and
											(II)notify the Secretary of such
				determination.
										(F)DefinitionIn
				this paragraph, the term approval date means the date of approval
				of an application for the biological product under subsection (a).
								(11)Exclusivity
								(A)In
				generalUpon review of an abbreviated biological product
				application relying on the same reference product for which a prior biological
				product has received a determination of interchangeability for any condition of
				use, the Secretary shall not make a determination under paragraph (5)(B) that
				the second or subsequent biological product is interchangeable for any
				condition of use, and no holder of a biological product license approved under
				subsection (a) shall manufacture, market, sell, or distribute a rebranded
				interchangeable biological product, directly or indirectly, or authorize any
				other person to manufacture, market, sell, or distribute a rebranded
				interchangeable biological product, for any condition of use, until the earlier
				of—
									(i)180 days after the
				first commercial marketing of the first interchangeable biological product to
				be approved as interchangeable for that reference product;
									(ii)one year
				after—
										(I)a final court
				decision in favor of the applicant on all patents in suit in an action
				instituted under paragraph (18)(C) against the applicant that submitted the
				application for the first approved interchangeable biological product;
				or
										(II)the dismissal
				with or without prejudice of an action instituted under paragraph (18)(C)
				against the applicant that submitted the application for the first approved
				interchangeable biological product; or
										(iii)(I)36 months after approval
				of the first interchangeable biological product if the applicant has been sued
				under paragraph (18)(C) and such litigation is still ongoing within such
				36-month period; or
										(II)one year after approval in the event
				that the first approved interchangeable biological product applicant has not
				been sued under paragraph (18)(C).
										For purposes
				of this subparagraph, the term ‘final court decision’ means a final decision of
				a court from which no appeal (other than a petition to the United States
				Supreme Court for a writ of certiorari) has been or can be taken.(B)Rebranded
				interchangeable biological productFor purposes of this
				subsection, the term rebranded interchangeable biological
				product—
									(i)means any
				rebranded interchangeable version of the reference product involved that the
				holder of the biological product license approved under subsection (a) for that
				reference product seeks to commence marketing, selling, or distributing,
				directly or indirectly; and
									(ii)does not include
				any product to be marketed, sold, or distributed—
										(I)by an entity
				eligible for exclusivity with respect to such product under this paragraph;
				or
										(II)after expiration
				of any exclusivity with respect to such product under this paragraph.
										(12)HearingIf
				the Secretary decides to disapprove an abbreviated biological product
				application, the Secretary shall give the applicant notice of an opportunity
				for a hearing before the Secretary on the question of whether such application
				is approvable. If the applicant elects to accept the opportunity for hearing by
				written request within 30 days after such notice, such hearing shall commence
				not more than 90 days after the expiration of such 30 days unless the Secretary
				and the applicant otherwise agree. Any such hearing shall thereafter be
				conducted on an expedited basis, and the Secretary’s order thereon shall be
				issued within 90 days after the date fixed by the Secretary for filing final
				briefs.
							(13)Final action
				date
								(A)In
				generalThe Secretary shall take a final action on an abbreviated
				biological product application by the date that is 10 calendar months following
				the sponsor’s submission of such application, or 180 days following the
				Secretary’s notification to the applicant that its application has been
				accepted for filing, whichever is earlier.
								(B)ExtensionThe
				final action date provided by subparagraph (A) with respect to an application
				may be extended for such period of time as is agreed to by the Secretary and
				the applicant in a jointly executed written agreement that is counter-signed by
				the Secretary and the applicant no later than 30 days prior to—
									(i)such final action
				date; or
									(ii)the date on which
				any prior extension under this subparagraph expires.
									(14)Request for
				delay of final actionSubject to paragraph (19)(A)(i) and
				notwithstanding any other provision of law, the Secretary shall not fail or
				refuse to take a final action on an abbreviated biological product application
				by the final action date on the basis that a person, other than the biosimilar
				biological product applicant, has requested (in a petition or otherwise) that
				the Secretary refuse to take or otherwise defer such final action, and no court
				shall enjoin the Secretary from taking final action or stay the effect of final
				action previously taken by the Secretary, except by issuance of a permanent
				injunction based upon an express finding of clear and convincing evidence that
				the person seeking to have the Secretary refuse to take or otherwise to defer
				final action by the final action date—
								(A)has prevailed on
				the merits of the person’s complaint against the Secretary;
								(B)will suffer
				imminent and actual irreparable injury, constituting more than irrecoverable
				economic loss, and that also will threaten imminent destruction of such
				person’s business; and
								(C)has an interest
				that outweighs the overwhelming interest that the public has in obtaining
				prompt access to a biosimilar biological product.
								(15)Report on
				extensions of final action dateThe Secretary shall prepare and
				submit to the President, the Committee on Energy and Commerce of the House of
				Representatives, and the Committee on Health, Education, Labor, and Pensions of
				the Senate a report regarding any jointly executed written agreement to extend
				the final action date under this Act within 15 calendar days after the joint
				execution of any such written agreement.
							(16)Report on
				failure to take final actionThe Secretary shall prepare and
				submit annually to the President, the Committee on Energy and Commerce of the
				House of Representatives, and the Committee on Health, Education, Labor, and
				Pensions of the Senate a report detailing the specific and particularized
				reasons enumerated by the reviewing division for each instance of the
				Secretary’s failure to take final action by the final action date in the
				previous year.
							(17)RegulationsThe
				Secretary shall establish, by regulation within 2 years after the date of the
				enactment of this subsection, requirements for the efficient review, approval,
				suspension, and revocation of abbreviated biological product applications under
				this subsection. The Secretary may not use the absence of final regulations as
				a basis for the Secretary to fail to act on an application submitted under this
				subsection.
							(18)Patents
								(A)Request for
				patent information
									(i)In
				generalAt any time, including at the initial stages of
				development, an applicant or a prospective applicant under this subsection may
				send a written request for patent information to the holder of the approved
				application for the reference product. The holder of the approved application
				for the reference product shall, not later than 60 days after the date on which
				the holder receives the request, provide to the applicant or prospective
				applicant a list of all those patents owned by, licensed to, or otherwise under
				the control of, the holder of the approved application that the holder believes
				in good faith relate to the reference product, including patents that claim the
				approved biological product, any formulation of such product, any method of
				using such product, any component of such product, or any method or process
				that can be used to manufacture such product or component, regardless of
				whether that method or process is used to manufacture the reference
				product.
									(ii)UpdatesFor
				a period of 2 years beginning on the date on which the holder of the approved
				application for the reference product receives the request for information, the
				holder shall send to the applicant or prospective applicant updates of its
				response to the request for information by identifying all relevant patents
				issued or licensed to the holder after the initial response under clause (i).
				Any such update must be provided, in the case of a new patent, not later than
				30 days after the date on which the patent is issued and, in the case of a
				license, not later than 30 days after the date on which the holder obtains the
				license.
									(iii)Additional
				requestsThe applicant may submit additional requests under
				clause (i) for patent information, and each such request shall be subject to
				the requirements of this paragraph.
									(iv)Notification to
				patent holderWithin 30 days of receiving a request under this
				subparagraph, the holder of the approved application for the reference product
				shall give notice of such request to the owner of any patent licensed to, or
				otherwise under the control of, the holder that is identified by the holder
				pursuant to clause (i).
									(B)Patent
				notificationsAt any time after submitting an application under
				this subsection, the applicant may provide a notice of the application with
				respect to any one or more patents identified by the holder of the reference
				product pursuant to subparagraph (A) or with respect to any one or more patents
				owned by, licensed to, or otherwise under the control of the holder of the
				approved application, but not identified pursuant to subparagraph (A). An
				applicant may submit additional notices at any time, and each notice shall be
				subject to the provisions of this subparagraph. Each notice shall—
									(i)be
				sent to the holder of the approved application for the reference product and to
				the owner of any patent identified by the holder pursuant to subparagraph
				(A);
									(ii)include a
				detailed statement of the factual and legal bases for the applicant’s belief
				that the patents included in the notice are invalid, are unenforceable, or will
				not be infringed by the commercial sale of the product for which approval is
				being sought under this subsection; and
									(iii)be submitted to
				the Federal Trade Commission, which shall treat such notice as
				confidential.
									(C)Action for
				infringementWithin 45 days after the date on which the holder of
				the approved application for the reference product, or the owner of a patent,
				receives a notice under subparagraph (B), the holder or patent owner may bring
				an action for infringement only with respect to the patent or patents included
				in the notice.
								(D)Limitation on
				declaratory judgment actionsWith respect to any patent relating
				to a product that is the subject of an application under this subsection, the
				recipient of a notice under subparagraph (B) with respect to that application
				may not, prior to the commercial marketing of the product, bring any action
				under section 2201 of title 28, United States Code, for a declaration of
				infringement, validity, or enforceability of any such patent that was not
				identified in the notice.
								(E)Declaratory
				judgment action
									(i)In
				generalWith respect to any patent identified in a notification
				under subparagraph (A) or (B) for which the holder, or the owner of the
				patent—
										(I)has not brought an
				action for infringement under subparagraph (C); or
										(II)has brought an
				action for infringement under subparagraph (C), but subsequently dismissed that
				action without prejudice;
										the applicant
				may bring an action for a declaratory judgment under section 2201 of title 28,
				United States Code, that such patent is invalid or not infringed by the
				biological product at issue.(ii)Case or
				controversyThe courts of the United States shall have, and shall
				exercise, subject matter jurisdiction to hear such an action to the full extent
				permitted by Article III of the Constitution.
									(F)Discretion of
				applicantsAn applicant or prospective applicant for a biosimilar
				biological product under this subsection may not be compelled, by court order
				or otherwise, to initiate the procedures set forth in this paragraph. Nothing
				in this paragraph requires an applicant or a prospective applicant to invoke
				the procedures set forth in this paragraph.
								(19)Petitions and
				civil actions regarding approval of certain applications
								(A)In
				generalWith respect to a pending application submitted under
				paragraph (3) or (4), if a petition is submitted to the Secretary that seeks to
				have the Secretary take, or refrain from taking, any form of action relating to
				the approval of the application, including a delay in the effective date of the
				application, the following applies, subject to subparagraph (E):
									(i)(I)The Secretary may not,
				on the basis of the petition, delay approval of the application unless the
				Secretary determines, within 30 days after receiving the petition, that a delay
				is necessary to protect the public health. Consideration of a petition shall be
				separate and apart from the review and approval of the application.
										(II)With respect to a determination by the
				Secretary under subclause (I) that a delay is necessary to protect the public
				health:
											(aa)The Secretary shall publish on the
				Internet site of the Food and Drug Administration a statement providing the
				reasons underlying the determination.
											(bb)Not later than 10 days after making
				the determination, the Secretary shall provide notice to the sponsor of the
				application and an opportunity for a meeting with the Commissioner to discuss
				the determination.
											(ii)The Secretary
				shall take final agency action on the petition not later than 180 days after
				the date on which the petition is submitted. The Secretary shall not extend
				such period, even with the consent of the petitioner, for any reason, including
				based upon the submission of comments relating to the petition or supplemental
				information supplied by the petitioner.
									(iii)The Secretary
				may not consider the petition for review unless it is signed and contains the
				following verification: I certify that, to my best knowledge and belief:
				(a) this petition includes all information and views upon which the petition
				relies; (b) this petition includes representative data and/or information known
				to the petitioner which are unfavorable to the petition; and (c) I have taken
				reasonable steps to ensure that any representative data and/or information
				which are unfavorable to the petition were disclosed to me. I further certify
				that the information upon which I have based the action requested herein first
				became known to the party on whose behalf this petition is submitted on or
				about the following date: [___]. I received or expect to receive payments,
				including cash and other forms of consideration, from the following persons or
				organizations to file this petition: [___]. I verify under penalty of perjury
				that the foregoing is true and correct..
									(B)Denial based on
				intent to delayIf the Secretary determines that a petition or
				supplement to the petition was submitted with the primary purpose of delaying
				the licensure or the approval of a condition of use for a biological product,
				the Secretary may deny the petition at any point based on such determination.
				The Secretary may issue guidance to describe the factors that will be used to
				determine under this subparagraph whether a petition is submitted with the
				primary purpose of delaying the approval of an application.
								(C)Exhaustion of
				administrative remedies
									(i)Final agency
				action within 180 daysThe Secretary shall be considered to have
				taken final agency action on a petition referred to in subparagraph (A)
				if—
										(I)during the 180-day
				period referred to in clause (ii) of such subparagraph, the Secretary makes a
				final decision within the meaning of section 10.45(d) of title 21, Code of
				Federal Regulations (or any successor regulations); or
										(II)such period
				expires without the Secretary having made such a final decision, in which case
				the petition shall be deemed to have been denied.
										(ii)Dismissal of
				certain civil actionsIf a civil action is filed with respect to
				a petition referred to in subparagraph (A) before final agency action within
				the meaning of clause (i) has occurred, the court shall dismiss the action for
				failure to exhaust administrative remedies.
									(D)Applicability of
				certain regulationsThe provisions of this section are in
				addition to the requirements for the submission of a petition to the Secretary
				that apply under section 10.30 or 10.35 of title 21, Code of Federal
				Regulations (or any successor regulations).
								(E)Annual report on
				delays in approvals per petitionsThe Secretary shall annually
				submit to the Congress a report that specifies—
									(i)the number of
				applications under this subsection that were approved during the preceding
				12-month period;
									(ii)the number of
				such applications whose effective dates were delayed by petitions referred to
				in subparagraph (A) during such period; and
									(iii)the number of
				days by which the applications were so delayed.
									(F)ExceptionThis
				paragraph does not apply to a petition that is made by the sponsor of an
				application under this subsection and that seeks only to have the Secretary
				take or refrain from taking any form of action with respect to that
				application.
								(G)DefinitionFor
				purposes of this paragraph, the term petition includes any request
				to the Secretary, without regard to whether the request is characterized as a
				petition.
								(20)Authorization
				of appropriationsTo carry out this subsection, there are
				authorized to be appropriated such sums as may be necessary for fiscal years
				2010 and
				2011.
							.
				(b)Additional
			 amendments
				(1)VenueSection
			 1404 of title 28, United States Code, is amended by adding at the end the
			 following:

						(e)Venue in certain
				patent infringement disputes
							(1)In
				generalIn any action for patent infringement brought by the
				holder or owner of the patent pursuant to section 351(k)(18)(C) of the Public
				Health Service Act, the defendant may move to transfer the action to any other
				district in which jurisdiction is proper.
							(2)TimingThe
				schedule applicable to a motion under paragraph (1) is as follows:
								(A)A motion under
				paragraph (1) shall be filed by the defendant no later than 45 days after
				service of the complaint.
								(B)A response to such
				a motion, if any, shall be filed no later than 20 days after service of the
				motion.
								(C)A reply to such
				response, if any, shall be filed no later than 10 days after service of the
				response.
								(D)The schedule set
				forth in this paragraph may be modified only by agreement of all
				parties.
								(3)ResolutionWhen
				ruling on any motion filed under paragraph (2), the greatest weight shall be
				given to the following factors:
								(A)The interest in
				identifying a district court in which the case will be adjudicated
				expeditiously.
								(B)The strong public
				interest in obtaining prompt judicial resolution of patent disputes so that the
				biological product which is the subject of the patent dispute may be brought to
				market as expeditiously as possible, consistent with fair and prompt resolution
				of patent disputes.
								(4)No
				delayAn action described in paragraph (1) shall proceed as
				expeditiously as possible while the court considers a motion under this
				subsection, and the court may not stay the proceedings because a motion under
				this subsection has been
				filed.
							.
				(2)PatentsSection
			 271(e) of title 35, United States Code, is amended—
					(A)in paragraph
			 (2)—
						(i)by
			 striking or at the end of subparagraph (A);
						(ii)by
			 adding or at the end of subparagraph (B);
						(iii)by
			 inserting after subparagraph (B) the following:

								(C)a notice described
				in section 351(k)(18)(B) of the Public Health Service Act, but only with
				respect to a patent identified in such
				notice,
								;
				and
						(iv)in
			 the matter following subparagraph (C) (as inserted by clause (iii) of this
			 subparagraph), by inserting before the period the following: , or if the
			 notice described in subparagraph (C) is provided in connection with an
			 application to obtain a license to engage in the commercial manufacture, use,
			 or sale of a biological product claimed in a patent or the use of which is
			 claimed in a patent before the expiration of such patent;
						(B)by adding at the
			 end the following paragraph:

							(6)(A)This paragraph applies
				in the case of a patent—
									(i)which is disclosed in a response to
				a request for patent information pursuant to subparagraph (A) of section
				351(k)(18) of the Public Health Service Act;
									(ii)with respect to which a notice was
				provided pursuant to subparagraph (B) of such section; and
									(iii)for which an action for
				infringement of the patent—
										(I)was brought after the expiration of the
				45-day period described in subparagraph (C) of such section; or
										(II)was brought before the expiration of the
				45-day period described in subclause (I), but which was dismissed without
				prejudice or was not prosecuted to judgment in good faith.
										(B)In an action for infringement of a
				patent described in subparagraph (A), the sole and exclusive remedy that may be
				granted by a court, upon a finding that the person who submitted the notice
				described in subparagraph (A)(ii) infringed the patent, or that any person
				induced or contributed to infringement of the patent, shall be a reasonable
				royalty.
								(C)The owner or licensee of a patent that
				should have been disclosed in response to a request for patent information made
				by an applicant pursuant to subparagraph (A) of section 351(k)(18) of the
				Public Health Service Act, but that was not timely disclosed under that
				subparagraph, may not bring an action under this title for infringement of that
				patent.
								;
					(C)in paragraph
			 (5)—
						(i)by
			 adding (A) in front of Where; and
						(ii)by
			 adding the following subparagraph:

								(B)Where a person has
				provided a notice described in subparagraph (B) of section 351(k)(18) of the
				Public Health Service Act, and neither the holder for the approved biological
				product or the owner of a patent identified in the notice brought an action for
				infringement of such patent before the expiration of 45 days after the date on
				which the notice was received, the courts of the United States shall, to the
				extent consistent with the Constitution, have and exercise subject matter
				jurisdiction in any action brought by such person under section 2201 of title
				28 for a declaratory judgement that such patent is invalid or not
				infringed.
								;
				and
						(D)in paragraph (4),
			 by striking in paragraph (2) in both places it appears and
			 inserting in subparagraphs (2)(A) or (2)(B).
					(3)Conforming
			 amendments
					(A)Title
			 28Section 2201(b) of title 28, United States Code, is amended by
			 inserting before the period the following: , or section 351 of the
			 Public Health Service Act.
					(B)Public health
			 service actSubjection (j) of section 351 of the Public Health
			 Service Act (42 U.S.C. 262) is amended by inserting or subsection
			 (k) after subsection (a).
					(c)Review of
			 applications submitted during exclusivity periods
				(1)User fee
			 goals
					(A)RevisionWithin
			 180 days after the date of the enactment of this Act, the Secretary of Health
			 and Human Services, in consultation with the relevant stakeholders, shall
			 revise the PDUFA reauthorization performance goals and procedures with respect
			 to the user fee goals for abbreviated biological product applications under
			 section 351(k) of the Public Health Service Act, as added by subsection (a) of
			 this section, that are submitted more than 2 years in advance of the expiration
			 of any period of exclusive marketing to which the reference drug is entitled
			 under subsection (k)(10) or subsection (l) of section 351 of the Public Health
			 Service Act, as added by subsection (a) of this section and section 4
			 respectively.
					(B)ConsiderationsIn
			 revising the user fee goals for applications described in subparagraph (A), the
			 Secretary shall consider—
						(i)the
			 need to provide sufficient time so that a decision on whether to approve the
			 application can be made in advance of the expiration of any exclusivity, and
			 considering the possibility that amendments will be necessary after the initial
			 decision and prior to approval; and
						(ii)the
			 importance of conserving agency resources.
						(2)Review
			 prioritiesIn setting priorities with respect to the review of
			 applications described in paragraph (1)(A), the Secretary shall take into
			 account the number of years in advance of the expiration of any exclusivity
			 granted to the reference drug that an application was submitted.
				(3)Submission of
			 revised performance goals to congressThe Secretary shall, within
			 30 days after revising the PDUFA reauthorization performance goals and
			 procedures under this subsection, submit to the Committee on Energy and
			 Commerce of the House of Representatives and the Committee on Health,
			 Education, Labor, and Pensions of the Senate a letter describing the revised
			 goals and the basis for such revisions.
				(4)DefinitionsIn
			 this subsection:
					(A)The terms
			 abbreviated biological product application and reference
			 product have the meanings given to those terms in section 351(i) of the
			 Public Health Service Act, as amended by section 2(a).
					(B)The term
			 PDUFA reauthorization performance goals and procedures means the
			 performance goals and procedures of the Food and Drug Administration, agreed to
			 for purposes of the reauthorization of part 2 of subchapter C of chapter VII of
			 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 279g et seq.; relating to
			 the prescription drug user fee program) for fiscal year 2008 and succeeding
			 fiscal years.
					4.Pediatric studies
			 of biological productsSection
			 351 of the Public Health Service Act (42 U.S.C. 262), as amended by section 3,
			 is further amended by adding at the end the following:

				(l)Pediatric
				studies
					(1)Application of
				certain provisionsThe provisions of section 505A of the Federal
				Food, Drug, and Cosmetic Act shall, except as inconsistent with this section,
				apply to biological products approved under subsection (a) or (k) of this
				section to the same extent and in the same manner as such provisions apply to
				drugs approved under subsection (c) or (j), respectively, of section 505 of the
				Federal Food, Drug, and Cosmetic Act.
					(2)Market
				exclusively for new biological productsIf, prior to approval of an application
				that is submitted under subsection (a) of this section, the Secretary
				determines that information relating to the use of a new biological product in
				the pediatric population may produce health benefits in that population, the
				Secretary makes a written request for pediatric studies (which shall include a
				timeframe for completing such studies), the applicant agrees to the request,
				such studies are completed using appropriate formulations for each age group
				for which the study is requested within any such timeframe, and the reports
				thereof are submitted and accepted in accordance with section 505A(d)(3) of the
				Federal Food, Drug, and Cosmetic Act—
						(A)the period for such
				biological product referred to in subparagraph (A) of subsection (k)(10),
				including any extension under subparagraph (D) of such subsection, is extended
				by 6 months; and
						(B)if the biological
				product is designated under section 526 for a rare disease or condition, the
				period for such biological product referred to in section 527(a) is deemed to
				be 7 years and 6 months rather than 7 years.
						(3)Market
				exclusivity for already-marketed biological productsIf the Secretary determines that
				information relating to the use of a licensed biological product in the
				pediatric population may produce health benefits in that population and makes a
				written request to the holder of an approved application under subsection (a)
				of this section for pediatric studies (which shall include a timeframe for
				completing such studies), the holder agrees to the request, such studies are
				completed using appropriate formulations for each age group for which the study
				is requested within any such timeframe, and the reports thereof are submitted
				and accepted in accordance with section 505A(d)(3) of the Federal Food, Drug,
				and Cosmetic Act—
						(A)the period for such biological product
				referred to in subparagraph (A) of subsection (k)(10), including any extension
				under subparagraph (D) of such subsection, is extended by 6 months; and
						(B)if the biological
				product is designated under section 526 for a rare disease or condition, the
				period for such biological product referred to in section 527(a) is deemed to
				be 7 years and 6 months rather than 7 years.
						(4)ExceptionThe
				Secretary shall not extend the period referred to in paragraph (2)(A), (2)(B),
				(3)(A), or (3)(B) if the determination under section 505A(d)(3) is made later
				than 9 months prior to the expiration of such
				period.
					.


117 SRES 75 ATS: Celebrating Black History Month.
U.S. Senate
2021-02-24
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

III117th CONGRESS1st SessionS. RES. 75IN THE SENATE OF THE UNITED STATESFebruary 24, 2021Mr. Booker (for himself, Mr. Scott of South Carolina, Mr. Durbin, Mr. Blunt, Ms. Hassan, Mr. Tillis, Ms. Cortez Masto, Mr. Crapo, Mr. Merkley, Mr. Grassley, Mr. Wyden, Mr. Risch, Ms. Smith, Mr. Cramer, Mr. Markey, Mr. Wicker, Ms. Hirono, Mr. Sullivan, Mr. Brown, Mr. Shelby, Mr. Van Hollen, Mr. Rubio, Mr. Menendez, Mr. Scott of Florida, Ms. Duckworth, Mr. Portman, Mr. Blumenthal, Mr. Hagerty, Mr. Coons, Mr. Lankford, Ms. Baldwin, Mr. Braun, Mrs. Murray, Mr. Graham, Mr. Warner, Ms. Ernst, Mr. Kaine, Mr. Burr, Mrs. Feinstein, Mr. Young, Ms. Rosen, Mr. Murphy, Ms. Sinema, Mrs. Shaheen, Mr. Whitehouse, Mr. Schatz, Mrs. Gillibrand, Ms. Klobuchar, Mr. King, Mr. Bennet, Ms. Warren, Mr. Ossoff, Mr. Heinrich, Mr. Sanders, Mr. Carper, Mr. Casey, Mr. Reed, Mr. Cardin, Ms. Cantwell, Mr. Luján, Mrs. Hyde-Smith, Mrs. Blackburn, and Mr. Hoeven) submitted the following resolution; which was considered and agreed toRESOLUTIONCelebrating Black History Month.Whereas, in 1776, people envisioned the United States as a new nation dedicated to the proposition stated in the Declaration of Independence that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness;Whereas Africans were first brought involuntarily to the shores of the United States as early as the 17th century;Whereas African Americans suffered enslavement and subsequently faced the injustices of lynch mobs, segregation, and denial of the basic and fundamental rights of citizenship;Whereas, in 2021, the vestiges of those injustices and inequalities remain evident in the society of the United States;Whereas, in the face of injustices, people of good will and of all races in the United States have distinguished themselves with a commitment to the noble ideals on which the United States was founded and have fought courageously for the rights and freedom of African Americans and others;Whereas African Americans, such as Lieutenant Colonel Allen Allensworth, Maya Angelou, Arthur Ashe, Jr., James Baldwin, James Beckwourth, Clara Brown, Blanche Bruce, Ralph Bunche, Shirley Chisholm, Holt Collier, Miles Davis, Louis Armstrong, Larry Doby, Frederick Douglass, W. E. B. Du Bois, Ralph Ellison, Medgar Evers, Aretha Franklin, Alex Haley, Dorothy Height, Jon Hendricks, Olivia Hooker, Lena Horne, Charles Hamilton Houston, Mahalia Jackson, Stephanie Tubbs Jones, B.B. King, Martin Luther King, Jr., Coretta Scott King, Thurgood Marshall, Constance Baker Motley, Rosa Parks, Walter Payton, Bill Pickett, Homer Plessy, Bass Reeves, Hiram Revels, Amelia Platts Boynton Robinson, Jackie Robinson, Aaron Shirley, Sojourner Truth, Harriet Tubman, Booker T. Washington, the Greensboro Four, the Tuskegee Airmen, Prince Rogers Nelson, Recy Taylor, Fred Shuttlesworth, Duke Ellington, Langston Hughes, Muhammad Ali, Elijah Cummings Ella Fitzgerald, Mamie Till, Toni Morrison, Gwen Ifill, Diahann Carroll, Chadwick Boseman, John Lewis, Katherine Johnson, Rev. C.T. Vivian, Hank Aaron, Edith Savage-Jennings, Septima Clark, Mary Mcleod Bethune, Cicely Tyson, Mary Wilson, John Thompson, John Hope Franklin, and Chief Justice of South Carolina Ernest Finney, along with many others, worked against racism to achieve success and to make significant contributions to the economic, educational, political, artistic, athletic, literary, scientific, and technological advancement of the United States; Whereas the contributions of African Americans from all walks of life throughout the history of the United States reflect the greatness of the United States;Whereas many African Americans lived, toiled, and died in obscurity, never achieving the recognition those individuals deserved, and yet paved the way for future generations to succeed;Whereas African Americans continue to serve the United States at the highest levels of business, government, and the military;Whereas the birthdays of Abraham Lincoln and Frederick Douglass inspired the creation of Negro History Week, the precursor to Black History Month;Whereas Negro History Week represented the culmination of the efforts of Dr. Carter G. Woodson, the Father of Black History, to enhance knowledge of Black history through The Journal of Negro History, published by the Association for the Study of African American Life and History, which was founded by Dr. Carter G. Woodson and Jesse E. Moorland;Whereas Black History Month, celebrated during the month of February, originated in 1926 when Dr. Carter G. Woodson set aside a special period in February to recognize the heritage and achievements of Black people in the United States;Whereas Dr. Carter G. Woodson stated, We have a wonderful history behind us. . . . If you are unable to demonstrate to the world that you have this record, the world will say to you, You are not worthy to enjoy the blessings of democracy or anything else.;Whereas, since its founding, the United States has imperfectly progressed toward noble goals;Whereas the history of the United States is the story of people regularly affirming high ideals, striving to reach those ideals but often failing, and then struggling to come to terms with the disappointment of that failure, before committing to try again;Whereas, on November 4, 2008, the people of the United States elected Barack Obama, an African-American man, as President of the United States; andWhereas, on February 22, 2012, people across the United States celebrated the groundbreaking of the National Museum of African American History and Culture, which opened to the public on September 24, 2016, on the National Mall in Washington, District of Columbia: Now, therefore, be itThat the Senate—(1)acknowledges that all people of the United States are the recipients of the wealth of history provided by Black culture;(2)recognizes the importance of Black History Month as an opportunity to reflect on the complex history of the United States, while remaining hopeful and confident about the path ahead;(3)acknowledges the significance of Black History Month as an important opportunity to commemorate the tremendous contributions of African Americans to the history of the United States;(4)encourages the celebration of Black History Month to provide a continuing opportunity for all people in the United States to learn from the past and understand the experiences that have shaped the United States; and(5)agrees that, while the United States began as a divided country, the United States must—(A)honor the contribution of all pioneers in the United States who have helped to ensure the legacy of the great United States; and(B)move forward with purpose, united tirelessly as a nation indivisible, with liberty and justice for all..