SECTION 1. SHORT TITLE. This Act may be cited as the ``Veteran Employment Transition Act of 2010''. SEC. 2. WORK OPPORTUNITY CREDIT FOR CERTAIN RECENTLY DISCHARGED VETERANS. (a) In General.--Subparagraph (A) of section 51(d)(3) of the Internal Revenue Code of 1986 is amended by striking ``means any veteran'' and all that follows and inserting ``means any recently discharged veteran and any disadvantaged veteran.'' (b) Recently Discharged Veteran; Disadvantaged Veteran.--Paragraph (3) of section 51(d) of the Internal Revenue Code of 1986 is amended-- (1) by redesignating subparagraphs (B) and (C) as subparagraphs (D) and (E), respectively, and (2) by inserting after subparagraph (A) the following new subparagraphs: ``(B) Recently discharged veteran.--For purposes of subparagraph (A), the term `recently discharged veteran' means-- ``(i) any individual who has served on active duty (other than active duty for training) in the Armed Forces of the United States for more than 180 total days (whether consecutive or not), ``(ii) any individual who has been discharged or released from active duty in the Armed Forces of the United States for a service-connected disability, and ``(iii) any member of the National Guard who has served for more than 180 total days (whether consecutive or not) of-- ``(I) active duty (within the meaning of title 32, United States Code) other than for training, ``(II) full-time National Guard duty (within the meaning of such title 32) other than for training, ``(III) duty, other than inactive duty or duty for training, in State status (within the meaning of such title 32), or ``(IV) any combination of duty described in subclause (I), (II), or (III), who has been discharged or released from such duty at any time during the 5-year period ending on the hiring date. Such term shall not include any unemployed veteran who begins work for the employer before the date of the enactment of the Veteran Employment Transition Act of 2010. ``(C) Disadvantaged veteran.--For purposes of subparagraph (A), the term `disadvantaged veteran' means any veteran who is certified by the designated local agency as-- ``(i) being a member of a family receiving assistance under a supplemental nutrition assistance program under the Food and Nutrition Act of 2008 for at least a 3-month period ending during the 12-month period ending on the hiring date, or ``(ii) entitled to compensation for a service-connected disability, and-- ``(I) having a hiring date which is not more than 1 year after having been discharged or released from active duty in the Armed Forces of the United States, or ``(II) having aggregate periods of unemployment during the 1-year period ending on the hiring date which equal or exceed 6 months.''. (c) Conforming Amendments.--Section 51 of the Internal Revenue Code of 1986 is amended-- (1) by striking ``(d)(3)(A)(ii)'' in paragraph (3) of subsection (b) and inserting ``(d)(3)(C)(ii)'', (2) by striking ``For purposes of subparagraph (A)'' each place it appears in subparagraphs (D) and (E) of subsection (d)(3), as redesignated by subsection (b), and inserting ``For purposes of subparagraph (C)'', (3) by adding at the end of paragraph (13) of subsection (d) the following new subparagraph: ``(D) Pre-screening of recently discharged veterans.-- ``(i) In general.--For purposes of subparagraph (A), the term `pre-screening notice' shall include any documentation provided to an individual by the Department of Defense or the National Guard upon release or discharge from the Armed Forces or from service in the National Guard which includes information sufficient to establish that such individual is a recently discharged veteran. ``(ii) Additional certification not required.--Subparagraph (A) shall be applied without regard to clause (ii)(II) thereof in the case of a recently discharged veteran who provides to the employer documentation described in clause (i).'', (4) by inserting ``who begins work for the employer after December 31, 2008, and before the date of the enactment of the Veteran Employment Transition Act of 2010,'' after ``Any unemployed veteran'' in subparagraph (A) of subsection (d)(14), and (5) by inserting a comma after ``during 2009 or 2010'' in subparagraph (A) of subsection (d)(14). (d) Effective Date.--The amendments made by subsections (a), (b), and (c) shall apply to individuals whose hiring date (as defined in section 51(d)(11) of the Internal Revenue Code of 1986) is on or after the date of the enactment of this Act. (e) Department of Defense Documentation.-- (1) In general.--The Department of Defense and the National Guard, as applicable, shall provide-- (A) to each individual who is discharged or released from active duty in the Armed Forces of the United States on or after the date of the enactment of this Act; and (B) to each member of the National Guard who is released from duty described in section 51(d)(3)(B)(iii) of the Internal Revenue Code of 1986 (as added by this Act) on or after the date of the enactment of this Act; in addition to the documentation which, without regard to this subsection, is provided at the time of such discharge or release, documentation described in paragraph (4). If the documentation which is provided without regard to this subsection at the time of the discharge or release described in the preceding sentence does not include information sufficient to satisfy the requirements of section 51(d)(13)(D)(i) of the Internal Revenue Code of 1986 (as added by this Act), the Department of Defense or the National Guard, whichever is applicable, shall provide additional documentation which includes such information. (2) Informational briefing.--In the case of an individual who is discharged or released from duty described in subparagraph (A) or (B) of paragraph (1) after the date of the enactment of this Act, the Department of Defense or the National Guard, whichever is applicable, shall provide a briefing to such individual before or at the time of such discharge or release to inform such individual of the credit for employment of recently discharged veterans under section 51 of the Internal Revenue Code of 1986. (3) Request for documentation.--The Department of Defense or the National Guard, whichever is applicable, shall provide upon request the documentation described in paragraph (1) to any individual who is discharged or released from duty described in subparagraph (A) or (B) of paragraph (1) during the 5-year period preceding and including the date of the enactment of this Act. (4) Instructions for use of work opportunity credit.--The documentation described in this paragraph is a document which includes-- (A) instructions for an individual to ensure treatment as a recently discharged veteran for purposes of section 51(d)(3)(B) of the Internal Revenue Code of 1986 (as added by this Act), (B) instructions for employers detailing the use of the credit under such section 51 with respect to such individual, and (C) the dates during which the credit under such section 51 is available. Such instructions shall be developed in collaboration with the Internal Revenue Service.

Summary: Veteran Employment Transition Act of 2010 - Amends the Internal Revenue Code to revise the definition of "qualified veteran" for purposes of the work opportunity tax credit to mean recently discharged veterans and disadvantaged veterans. Defines "recently discharged veteran" to mean: (1) any individual who has served on active duty (other than active duty for training) in the Armed Forces for more than 180 total days (whether consecutive or not); (2) any individual who has been discharged or released from active duty for a service-connected disability; and (3) any member of the National Guard who has served for more than 180 total days (whether consecutive or not) in active duty, full-time National Guard duty, or duty in state status. Defines "disadvantaged veteran" as any veteran who is certified as being a member of a family receiving assistance under a supplemental nutrition assistance program and is entitled to compensation for a service-connected disability. Requires the Department of Defense (DOD) and the National Guard to inform military personnel who are discharged or released from active duty of the work opportunity tax credit and provide them with documentation relating to eligibility for and use of such credit.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Clean Energy Technology Manufacturing and Export Assistance Act of 2011''. SEC. 2. CLEAN ENERGY TECHNOLOGY MANUFACTURING AND EXPORT ASSISTANCE PROGRAM. (a) Definitions.--In this section: (1) Clean energy technology.--The term ``clean energy technology'' means a technology related to the production, use, transmission, storage, control, or conservation of energy that is designed to-- (A) reduce the need for additional energy supplies-- (i) by using existing energy supplies with greater efficiency; or (ii) by transmitting, distributing, or transporting energy with greater effectiveness through the infrastructure of the United States; (B) diversify the sources of the energy supply of the United States to strengthen energy security and to increase supplies of energy with a favorable balance of environmental effects if the entire technology system is considered; or (C) contribute to a stabilization of atmospheric greenhouse gas concentrations through reduction, avoidance, or long-term sequestration of energy-related emissions. (2) Small- and medium-sized businesses.--The term ``small- and medium-sized businesses'' means businesses with not more than 500 employees. (3) Under secretary.--The term ``Under Secretary'' means the Under Secretary for International Trade of the Department of Commerce. (b) Establishment.--The Secretary of Commerce shall establish a Clean Energy Technology Manufacturing and Export Assistance Program, to be carried out by the Under Secretary, for the purposes of-- (1) promoting policies to reduce production costs and encourage innovation, investment, and productivity among businesses in the United States that produce or export clean energy technologies or related services; (2) implementing a national strategy with respect to the exportation of clean energy technologies and related services from the United States; and (3) ensuring that businesses in the United States that produce or export clean energy technologies or related services, including suppliers of parts for the production of clean energy technologies and engineering and design firms, have the information and assistance necessary-- (A) to be competitive; and (B) to create and maintain clean energy technology jobs in the United States. (c) Assistance.-- (1) In general.--The Under Secretary shall, consistent with the National Export Initiative (established by Executive Order 13534 (75 Fed. Reg. 12433)), provide information and other assistance under the program established under subsection (b) to businesses in the United States, particularly small- and medium-sized businesses, to promote the production and exportation of clean energy technologies and related services. (2) Types of assistance.--The assistance provided under paragraph (1) shall include-- (A) analyzing and making recommendations with respect to policies to reduce production costs and encourage innovation, investment, and productivity among businesses in the United States that produce or export clean energy technologies or related services; (B) providing information to businesses in the United States with respect to-- (i) the process of exporting clean energy technologies and related services to foreign countries; (ii) opportunities for the exportation of such technologies and services to foreign countries; (iii) tailoring their products and activities to the needs of specific markets in foreign countries; and (iv) conducting business in foreign countries, including with respect to the financing, marketing, and assembly of exported products and other logistics with respect to those products; and (C) assisting businesses in the United States in expressing their views and providing input with respect to any policy developments relating to the production or exportation of clean energy technologies or related services. (d) Reports to Congress.-- (1) Report on implementation of program.--Not later than 180 days after the date of the enactment of this Act, the Under Secretary shall submit to Congress a report describing how the program established under subsection (b) will be used to-- (A) encourage the production and exportation of clean energy technologies and related services in the United States; (B) encourage the creation and maintenance of clean energy technology jobs in the United States; and (C) benefit small- and medium-sized businesses in the United States. (2) Report on effectiveness of program.--Not later than January 1, 2015, the Under Secretary shall submit to Congress a report on the program established under subsection (b) that includes-- (A) an assessment of the extent to which the program has been successful-- (i) in analyzing and making recommendations with respect to policies to reduce production costs and encourage innovation, investment, and productivity among businesses in the United States that produce or export clean energy technologies or related services; (ii) in increasing the competitiveness of businesses in the United States that export clean energy technologies or related services to foreign countries; (iii) in assisting businesses in the United States, particularly small- and medium-sized businesses, in exporting clean energy technologies and related services; (iv) in creating and maintaining clean energy technology jobs in the United States; and (v) in assisting businesses in the United States in expressing their views and providing input with respect to any policy developments relating to the production or exportation of clean energy technologies or related services; (B) detailed information with respect to the nature, location, and duration of any jobs created or maintained as a result of the program established under subsection (b) and a description of the methodology used by the Under Secretary to compile that information; and (C) any recommendations with respect to continuing or improving the program.

Summary: Clean Energy Technology Manufacturing and Export Assistance Act of 2011 - Requires the Secretary of Commerce to establish a Clean Energy Technology Manufacturing and Export Assistance Program, to be carried out by the Under Secretary for International Trade, to: (1) promote policies to reduce production costs and encourage innovation, investment, and productivity among businesses in the United States that produce or export clean energy technologies or related services; (2) implement a national strategy with respect to the exportation of such technologies and related services; and (3) ensure that such businesses, including suppliers of parts for the production of such technologies and engineering and design firms, have the information and assistance necessary to be competitive and to create and maintain clean energy technology jobs. Defines "clean energy technology" to means a technology related to the production, use, transmission, storage, control, or conservation of energy that is designed to: (1) reduce the need for additional energy supplies by using existing energy supplies with greater efficiency or by transmitting, distributing, or transporting energy with greater effectiveness; (2) diversify the sources of the energy supply of the United States to strengthen energy security and to increase supplies of energy with a favorable balance of environmental effects if the entire technology system is considered; or (3) contribute to a stabilization of atmospheric greenhouse gas concentrations through reduction, avoidance, or long-term sequestration of energy-related emissions. Requires the Under Secretary, consistent with the National Export Initiative, to provide information and other assistance under the Program to businesses, particularly businesses with no more than 500 employees, to promote the production and exportation of such technologies and related services.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Fair And Immediate Release of Generic Drugs Act'' or the ``FAIR Generics Act''. SEC. 2. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS REGARDING FIRST APPLICANT STATUS. (a) Amendments to Federal Food, Drug, and Cosmetic Act.-- (1) In general.--Section 505(j)(5)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)) is amended-- (A) in clause (iv)(II)-- (i) by striking item (bb); and (ii) by redesignating items (cc) and (dd) as items (bb) and (cc), respectively; and (B) by adding at the end the following: ``(v) First Applicant Defined.--As used in this subsection, the term `first applicant' means an applicant-- ``(I)(aa) that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug; and ``(bb) that has not entered into a disqualifying agreement described under clause (vii)(II); or ``(II)(aa) for the drug that is not described in subclause (I) and that, with respect to the applicant and drug, each requirement described in clause (vi) is satisfied; and ``(bb) that has not entered into a disqualifying agreement described under clause (vii)(II). ``(vi) Requirement.--The requirements described in this clause are the following: ``(I) The applicant described in clause (v)(II) submitted and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) or a statement described in paragraph (2)(A)(viii) for each unexpired patent for which a first applicant described in clause (v)(I) had submitted a certification described in paragraph (2)(A)(vii)(IV) on the first day on which a substantially complete application containing such a certification was submitted. ``(II) With regard to each such unexpired patent for which the applicant described in clause (v)(II) submitted a certification described in paragraph (2)(A)(vii)(IV), no action for patent infringement was brought against such applicant within the 45 day period specified in paragraph (5)(B)(iii); or if an action was brought within such time period, such an action was withdrawn or dismissed by a court (including a district court) without a decision that the patent was valid and infringed; or if an action was brought within such time period and was not withdrawn or so dismissed, such applicant has obtained the decision of a court (including a district court) that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity, and including a settlement order or consent decree signed and entered by the court stating that the patent is invalid or not infringed). ``(III) If an applicant described in clause (v)(I) has begun commercial marketing of such drug, the applicant described in clause (v)(II) does not begin commercial marketing of such drug until the date that is 30 days after the date on which the applicant described in clause (v)(I) began such commercial marketing.''. (2) Conforming amendment.--Section 505(j)(5)(D)(i)(IV) of such Act (21 U.S.C. 355(j)(5)(D)(i)(IV)) is amended by striking ``The first applicant'' and inserting ``The first applicant, as defined in subparagraph (B)(v)(I),''. (b) Applicability.--The amendments made by subsection (a) shall apply only with respect to an application filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) to which the amendments made by section 1102(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173) apply. SEC. 3. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS REGARDING AGREEMENTS TO DEFER COMMERCIAL MARKETING. (a) Amendments to Federal Food, Drug, and Cosmetic Act.-- (1) Limitations on agreements to defer commercial marketing date.--Section 505(j)(5)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)), as amended by section 2, is further amended by adding at the end the following: ``(vii) Agreement by first applicant to defer commercial marketing; limitation on acceleration of deferred commercial marketing date.-- ``(I) Agreement to defer approval or commercial marketing date.--An agreement described in this subclause is an agreement between a first applicant and the holder of the application for the listed drug or an owner of one or more of the patents as to which any applicant submitted a certification qualifying such applicant for the 180-day exclusivity period whereby that applicant agrees, directly or indirectly, (aa) not to seek an approval of its application that is made effective on the earliest possible date under this subparagraph, subparagraph (F) of this paragraph, section 505A, or section 527, (bb) not to begin the commercial marketing of its drug on the earliest possible date after receiving an approval of its application that is made effective under this subparagraph, subparagraph (F) of this paragraph, section 505A, or section 527, or (cc) to both items (aa) and (bb). ``(II) Agreement that disqualifies applicant from first applicant status.--An agreement described in this subclause is an agreement between an applicant and the holder of the application for the listed drug or an owner of one or more of the patents as to which any applicant submitted a certification qualifying such applicant for the 180-day exclusivity period whereby that applicant agrees, directly or indirectly, not to seek an approval of its application or not to begin the commercial marketing of its drug until a date that is after the expiration of the 180-day exclusivity period awarded to another applicant with respect to such drug (without regard to whether such 180-day exclusivity period is awarded before or after the date of the agreement). ``(viii) Limitation on acceleration.--If an agreement described in clause (vii)(I) includes more than 1 possible date when an applicant may seek an approval of its application or begin the commercial marketing of its drug-- ``(I) the applicant may seek an approval of its application or begin such commercial marketing on the date that is the earlier of-- ``(aa) the latest date set forth in the agreement on which that applicant can receive an approval that is made effective under this subparagraph, subparagraph (F) of this paragraph, section 505A, or section 527, or begin the commercial marketing of such drug, without regard to any other provision of such agreement pursuant to which the commercial marketing could begin on an earlier date; or ``(bb) 180 days after another first applicant begins commercial marketing of such drug; and ``(II) the latest date set forth in the agreement on which that applicant can receive an approval that is made effective under this subparagraph, subparagraph (F) of this paragraph, section 505A, or section 527, or begin the commercial marketing of such drug, without regard to any other provision of such agreement pursuant to which commercial marketing could begin on an earlier date, shall be the date used to determine whether an applicant is disqualified from first applicant status pursuant to clause (vii)(II).''. (2) Notification of fda.--Section 505(j) of such Act (21 U.S.C. 355(j)) is amended by adding at the end the following: ``(11)(A) The holder of an abbreviated application under this subsection shall submit to the Secretary a notification that includes-- ``(i)(I) the text of any agreement entered into by such holder described under paragraph (5)(B)(vii)(I); or ``(II) if such an agreement has not been reduced to text, a written detailed description of such agreement that is sufficient to disclose all the terms and conditions of the agreement; and ``(ii) the text, or a written detailed description in the event of an agreement that has not been reduced to text, of any other agreements that are contingent upon, provide a contingent condition for, or are otherwise related to an agreement described in clause (i). ``(B) The notification described under subparagraph (A) shall be submitted not later than 10 business days after execution of the agreement described in subparagraph (A)(i). Such notification is in addition to any notification required under section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. ``(C) Any information or documentary material filed with the Secretary pursuant to this paragraph shall be exempt from disclosure under section 552 of title 5, United States Code, and no such information or documentary material may be made public, except as may be relevant to any administrative or judicial action or proceeding. Nothing in this paragraph is intended to prevent disclosure to either body of the Congress or to any duly authorized committee or subcommittee of the Congress.''. (3) Prohibited acts.--Section 301(e) of such Act (21 U.S.C. 331(e)) is amended by striking ``505 (i) or (k)'' and inserting ``505 (i), (j)(11), or (k)''. (b) Infringement of Patent.--Section 271(e) of title 35, United States Code, is amended by adding at the end the following: ``(7) The exclusive remedy under this section for an infringement of a patent for which the Secretary of Health and Human Services has published information pursuant to subsection (b)(1) or (c)(2) of section 505 of the Federal Food, Drug, and Cosmetic Act shall be an action brought under this subsection within the 45-day period described in subsection (j)(5)(B)(iii) or (c)(3)(C) of section 505 of the Federal Food, Drug, and Cosmetic Act.''. (c) Applicability.-- (1) Limitations on acceleration of deferred commercial marketing date.--The amendment made by subsection (a)(1) shall apply only with respect to-- (A) an application filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) to which the amendments made by section 1102(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173) apply; and (B) an agreement described under section 505(j)(5)(B)(vii)(I) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)(1)) executed after the date of enactment of this Act. (2) Notification of fda.--The amendments made by paragraphs (2) and (3) of subsection (a) shall apply only with respect to an agreement described under section 505(j)(5)(B)(vii)(I) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)(1)) executed after the date of enactment of this Act.

Summary: Fair And Immediate Release of Generic Drugs Act or the FAIR Generics Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the definition of “first applicant” for purposes of the 180-day exclusivity period given to first applicants to file an abbreviated new drug application (generic drug). Makes applicants for a generic drug eligible for the exclusivity period only if they have not entered into a disqualifying agreement (an agreement between a generic drug applicant and the holder of the application for the listed drug [brand name drug] or the patentholder for the brand name drug whereby the generic drug applicant agrees not to seek approval of its generic drug or not to begin the commercial marketing of its generic drug until the expiration of the exclusivity period awarded to another generic applicant). Expands the definition of “first applicant” to include an applicant that meets the following criteria: (1) the applicant is not the first generic applicant; (2) either no action for patent infringement was brought, such action was withdrawn or dismissed by a court without a decision that the patent was valid and infringed, or the court decided that the patent was invalid or not infringed; and (3) the applicant does not begin commercial marketing of such drug until 30 days after the first applicant began such commercial marketing. Prohibits a party that enters an agreement to delay seeking approval of its generic drug application or to delay the commercial marketing of a generic drug from seeking approval of its application or beginning commercial marketing before the earlier of: (1) the latest date set forth in the agreement to seek approval or market the drug without regard to any earlier date under the agreement when commercial marketing could begin, or (2) 180 days after another first applicant begins commercial marketing of such drug. Requires notice to the Secretary of the Health and Human Services (HHS) of the details of any agreement under this Act not later than ten business days after execution of the agreement. Declares that the exclusive remedy for an infringement of a patent included within a new drug application shall be an action brought under the FFDCA within the 45-day period prescribed.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Public Health Equity Act''. SEC. 2. FINDINGS. Congress finds that-- (1) all communities and individuals are entitled to protection from occupational and other exposure to substances that are hazardous to the public health; (2) hazardous substances have had a disproportionate impact on the public health of poor and ethnic minority communities and individuals, resulting in exclusion from participation in, denial of benefits under, and discrimination under, programs and activities receiving Federal financial assistance; and (3) each Federal agency has an obligation to ensure that all federally assisted programs and activities that affect human health do not directly or through contractual arrangements use criteria, methods, or practices that cause discrimination on the ground of race, color, or national origin. SEC. 3. PUBLIC HEALTH EQUITY. The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by adding at the end thereof the following new title: ``TITLE XXVII--PUBLIC HEALTH EQUITY ``SEC. 2701. DEFINITIONS. ``As used in this title: ``(1) Activity; program.--The term `program or activity' means any operation of-- ``(A)(i) a department, agency, special purpose district, or other instrumentality of a State or of a local government; or ``(ii) the entity of such State or local government that distributes such assistance and each such department or agency (and each other State or local government entity) to which the assistance is extended, in the case of assistance to a State or local government; ``(B)(i) a college, university, or other postsecondary institution, or a public system of higher education; or ``(ii) a local educational agency (as defined in section 198(a)(10) of the Elementary and Secondary Education Act of 1965), system of vocational education, or other school system; ``(C)(i) an entire corporation, partnership, or other private organization, or an entire sole proprietorship-- ``(I) if assistance is extended to such corporation, partnership, private organization, or sole proprietorship as a whole; or ``(II) which is principally engaged in the business of providing education, health care, housing, social services, or parks and recreation; or ``(ii) the entire plant or other comparable, geographically separate facility to which Federal financial assistance is extended, in the case of any other corporation, partnership, private organization, or sole proprietorship; or ``(D) any other entity which is established by two or more of the entities described in subparagraph (A), (B), or (C); any part of which is extended Federal financial assistance relating to a covered substance. ``(2) Administrator.--The term `Administrator' has the meaning given the term in section 511(7) of the Education for Economic Security Act (20 U.S.C. 4020(7)). ``(3) Covered substance.--The term `covered substance' means-- ``(A) any material subject to the requirements concerning material safety data sheets for chemicals under the Occupational and Safety and Health Act of 1970 (29 U.S.C. 651 et seq.); ``(B) any contaminant identified in title XIV; ``(C) any substance described in section 201(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(q)), and any material registered pursuant to the Act referred to in such section; ``(D) any chemical listed by the National Toxicology Program of the Department of Health and Human Services as a known or probable human carcinogen; and ``(E) any substance defined in section 101(14) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (42 U.S.C. 9601(14)) and any chemical subject to section 313 of the Emergency Planning and Community Right-To-Know Act of 1986 (42 U.S.C. 11023). ``SEC. 2702. NONDISCRIMINATION. ``(a) Prohibition of Discrimination.--The President shall ensure that no person shall be excluded from participation in, be denied the benefits of, or be subject to discrimination under, any program or activity, on the ground of race, color, or national origin. ``(b) Promulgation of Regulations.-- ``(1) Subject.--Subject to paragraph (2), the Secretary of Labor, the Secretary of Health and Human Services, the Administrator, and any other head of a Federal agency with responsibility for providing Federal financial assistance to a program or activity shall issue regulations implementing the nondiscrimination requirements described in subsection (a) in accordance with any applicable law. The regulations shall bar acts with discriminatory effects as well as intentionally discriminatory acts. The regulations shall address actions of programs or activities that result in disproportionate exposure to a covered substance on the basis of race, color, or national origin. ``(2) Timetable.--In issuing regulations under paragraph (1)-- ``(A) not later than 180 days after the date of enactment of this Act, each individual described in paragraph (1) shall publish a notice of proposed rulemaking in the Federal Register; ``(B) each individual described in paragraph (1) shall provide a public comment period, subject to section 553 of title 5, United States Code, of 60 days after the publication of the notice of proposed rulemaking required under subparagraph (A); and ``(C) not later than 45 days after the close of the public comment period required under subparagraph (B), each individual described in paragraph (1) shall publish final regulations.''.

Summary: Public Health Equity Act - Amends the Public Health Service Act to add a new title, title XXVII: Public Health Equity. Prohibits, under such title, acts with discriminatory effect as well as intentionally discriminatory acts that result in disproportionate exposure to a covered substance on the basis of race, color, or national origin. Defines a covered substance to include certain hazardous materials, substances, contaminants, or chemicals listed, identified, or defined in specified laws.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Brownfield Cleanup and Redevelopment Revolving Loan Fund Pilot Project Act of 1996''. SEC. 2. FINDINGS AND PURPOSES. (a) Findings.--The Congress finds the following: (1) Contaminated and underused or abandoned industrial sites in distressed communities are, economically, at a competitive disadvantage relative to greenfield sites, as capital for their cleanup and redevelopment may not be available. (2) Contaminated and underused and abandoned industrial properties located in distressed areas, owned by private, public, or nonprofit entities, often with significant economic development potential once cleaned up, are unable to secure initial financing for site remediation. (3) Considerable public benefits can accrue from such sites once cleaned up and brought back to productive reuse, especially those devoted to industrial purposes that employ environmentally sound practices. (4) Voluntary cleanup programs spur private sector cleanups when the property value is sufficient and its location favorable enough to make the additional costs of cleanup economically feasible, but this approach does not resolve the problems facing properties with little or no value, common among sites located in economically distressed areas. (5) Because of their experience in administering targeted loan assistance programs, States are in a good position to use Federal funds to capitalize revolving loan funds to support local cleanup and redevelopment projects. (b) Purpose.--The purpose of this Act is to establish a pilot project to revitalize distressed communities by providing loans for cleanup of certain industrial properties that have the potential to attract private investment, foster clean manufacturing, and create jobs for local residents. SEC. 3. PILOT PROJECT PROVIDING REVOLVING LOAN FUND FOR CLEANUPS UNDER STATE VOLUNTARY CLEANUP PROGRAMS. (a) Establishment of Loan Program.--The Administrator of the Environmental Protection Agency (hereinafter in this Act referred to as the ``Administrator'') shall establish a pilot project to provide a capitalization loan to one or more States that submit applications to the Administrator to establish or expand a State revolving loan fund for purposes of providing loans for voluntary environmental cleanups of eligible facilities. (b) Application for Loan.--An application for a capitalization loan under this section shall be in such form as the Administrator considers appropriate. At a minimum, the application shall include each of the following: (1) Evidence that the State is carrying out a voluntary cleanup program for eligible facilities. The Administrator shall ensure that the State voluntary program provides, at a minium, adequate opportunities for public participation, sufficient technical assistance, and oversight to ensure that cleanups comply with Federal and State laws, and certification to the owner and prospective purchaser that the cleanup is complete. (2) Evidence that the State will provide a matching share of at least 20 percent of the costs of such cleanup from either new or existing sources of State funding. (3) A description of the State's proposed revolving loan program and of the State's capability to manage the program. States may use interest income or loan repayments (in an amount equal to not more than 10 percent of their revolving loan fund amount) for program administrative purposes. At a minimum, the State's revolving loan program shall-- (A) provide loans to both public and private parties conducting voluntary cleanups under the State's voluntary cleanup program who are unable to secure loans from private lending institutions or other means of financing; (B) require that borrowers demonstrate credit worthiness and the ability to carry out the cleanup; and (C) give priority to loans for the purpose of cleaning up-- (i) facilities that are planned to be reused for industrial purposes that employ environmentally sound practices; and (ii) facilities that will generate jobs for contractors whose principal place of business is the political subdivision in which the facility is located or for laborers who reside in such political subdivisions. (4) A statement that the State will begin repayment of the loan within 5 years after receipt of the loan, and evidence of the State's ability to repay the loan. (5) A statement that a loan from the revolving loan fund will not be used to pay for any of the following: (A) New construction. (B) Environmental fines or penalties. (C) Speculative assessments or speculative rehabilitation at facilities with little or no potential for economic development. (6) Such other elements as the Administrator considers appropriate. (c) Amount of Loan.--The Administrator shall determine the distribution of funds among the eligible States. The amount of a capitalization loan made by the Administrator under this Act to a State may not exceed 15 percent of the amount available each year to all the eligible States. (d) Authorization.--There are authorized to be appropriated to the Administrator for purposes of making capitalization loans to States under the pilot project established by this section the sum of $5,000,000 for fiscal year 1996 and $7,500,000 for each of the fiscal years 1997 and 1998. SEC. 4. DEFINITIONS. For purposes of this Act the term ``eligible facility'' means a facility or property in a State that is determined by the State to have environmental contamination that-- (1) could prevent the timely use, development, or reuse of the facility or property; and (2) is limited in scope and can be comprehensively and readily evaluated. Such term shall not include any of the following: (A) A facility that is eligible for abatement action under section 106 of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980. (B) A facility that, as of the date of the enactment of this Act, is subject to Federal enforcement action under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (42 U.S.C. 9601 et seq.). (C) A facility included, or proposed for inclusion, on the National Priorities List or on the comprehensive environmental response, compensation, and liability inventory system (``CERCLIS'') that has been evaluated as high priority under the hazard ranking system. (D) A facility required to have a permit under section 3005 of the Solid Waste Disposal Act that does not have a permit under that section and does not qualify for authorization to operate in interim status under subsection (e) of that section. (E) A land disposal unit with respect to which a closure notification under subtitle C of the Solid Waste Disposal Act (42 U.S.C. 6921 et seq.) is submitted and closure requirements are specified in a closure plan or permit. (F) A facility subject to corrective action under section 3004(u) or 3008(h) of the Solid Waste Disposal Act (42 U.S.C. 5924(u) or 6928(h)) that is evaluated as high priority under the Environmental Protection Agency's National Corrective Action Priority System as set forth in regulations under subtitle C of the Solid Waste Disposal Act. (G) A facility at which assistance for response activities may be obtained pursuant to subtitle I of the Solid Waste Disposal Act (42 U.S.C. 6991 et seq.) from the Leaking Underground Storage Tank Trust Fund established under section 9508 of the Internal Revenue Code of 1986. (H) A facility owned or operated by a department, agency, or instrumentality of the United States.

Summary: Brownfield Cleanup and Redevelopment Revolving Loan Fund Pilot Project Act of 1996 - Directs the Administrator of the Environmental Protection Agency to establish a pilot project to provide capitalization loans to States to establish or expand revolving loan funds that provide loans for voluntary environmental cleanups of eligible facilities (those determined by the State to have limited environmental contamination that can be readily and comprehensively evaluated and that could prevent the timely use, development, or reuse of the facility or property). Authorizes appropriations. Makes ineligible for such assistance facilities that are: (1) eligible for abatement actions, or subject to Federal enforcement action, under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980; (2) on or proposed for inclusion on the National Priorities List or evaluated as high priority under the hazard ranking system; (3) subject to certain actions, or unqualified to conduct certain hazardous waste disposal activities, under the Solid Waste Disposal Act; or (4) owned or operated by the United States.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Smith-Mundt Modernization Act of 2012''. SEC. 2. DISSEMINATION ABROAD OF INFORMATION ABOUT THE UNITED STATES. (a) United States Information and Educational Exchange Act of 1948.--Section 501 of the United States Information and Educational Exchange Act of 1948 (22 U.S.C. 1461) is amended to read as follows: ``general authorization ``Sec. 501. (a) The Secretary and the Broadcasting Board of Governors are authorized to use funds appropriated or otherwise made available for public diplomacy information programs to provide for the preparation, dissemination, and use of information intended for foreign audiences abroad about the United States, its people, and its policies, through press, publications, radio, motion pictures, the Internet, and other information media, including social media, and through information centers, instructors, and other direct or indirect means of communication. ``(b)(1) Except as provided in paragraph (2), the Secretary and the Broadcasting Board of Governors may, upon request and reimbursement of the reasonable costs incurred in fulfilling such a request, make available, in the United States, motion pictures, films, video, audio, and other materials prepared for dissemination abroad or disseminated abroad pursuant to this Act, the United States International Broadcasting Act of 1994 (22 U.S.C. 6201 et seq.), the Radio Broadcasting to Cuba Act (22 U.S.C. 1465 et seq.), or the Television Broadcasting to Cuba Act (22 U.S.C. 1465aa et seq.). The Secretary and the Broadcasting Board of Governors shall issue necessary regulations-- ``(A) to establish procedures to maintain such material; ``(B) for reimbursement of the reasonable costs incurred in fulfilling requests for such material; and ``(C) to ensure that the persons seeking release of such material have secured and paid for necessary United States rights and licenses. ``(2) With respect to material prepared for dissemination abroad or disseminated abroad before the effective date of the Smith-Mundt Modernization Act of 2012-- ``(A) the Secretary and the Broadcasting Board of Governors shall make available to the Archivist of the United States, for domestic distribution, motion pictures, films, videotapes, and other material 12 years after the initial dissemination of the material abroad; and ``(B) the Archivist shall be the official custodian of the material and shall issue necessary regulations to ensure that persons seeking its release in the United States have secured and paid for necessary United States rights and licenses and that all costs associated with the provision of the material by the Archivist shall be paid by the persons seeking its release, in accordance with paragraph (3). ``(3) The Archivist may charge fees to recover the costs described in paragraph (2), in accordance with section 2116(c) of title 44. Such fees shall be paid into, administered, and expended as part of the National Archives Trust Fund. ``(c) Nothing in this section may be construed to require the Secretary or the Broadcasting Board of Governors to make material disseminated abroad available in any format other than in the format disseminated abroad.''. (b) Rule of Construction.--Nothing in this section may be construed to affect the allocation of funds appropriated or otherwise made specifically available for public diplomacy. (c) Foreign Relations Authorization Act, Fiscal Years 1986 and 1987.--Section 208 of the Foreign Relations Authorization Act, Fiscal Years 1986 and 1987 (22 U.S.C. 1461-1a) is amended to read as follows: ``SEC. 208. CLARIFICATION ON DOMESTIC DISTRIBUTION OF PROGRAM MATERIAL. ``(a) In General.--No funds authorized to be appropriated to the Department of State or the Broadcasting Board of Governors shall be used to influence public opinion in the United States. This section shall apply only to programs carried out pursuant to the United States Information and Educational Exchange Act of 1948 (22 U.S.C. 1431 et seq.), the United States International Broadcasting Act of 1994 (22 U.S.C. 6201 et seq.), the Radio Broadcasting to Cuba Act (22 U.S.C. 1465 et seq.), and the Television Broadcasting to Cuba Act (22 U.S.C. 1465aa et seq.). This section shall not prohibit or delay the Department of State or the Broadcasting Board of Governors from providing information about its operations, policies, programs, or program material, or making such available, to the media, public, or Congress, in accordance with other applicable law. ``(b) Rule of Construction.--Nothing in this section shall be construed to prohibit the Department of State or the Broadcasting Board of Governors from engaging in any medium or form of communication, either directly or indirectly, because a United States domestic audience is or may be thereby exposed to program material, or based on a presumption of such exposure. Such material may be made available within the United States and disseminated, when appropriate, pursuant to sections 502 and 1005 of the United States Information and Educational Exchange Act of 1948 (22 U.S.C. 1462 and 1437), except that nothing in this section may be construed to authorize the Department of State or the Broadcasting Board of Governors to disseminate within the United States any program material prepared for dissemination abroad on or before the effective date of the Smith-Mundt Modernization Act of 2012. ``(c) Application.--The provisions of this section shall apply only to the Department of State and the Broadcasting Board of Governors and to no other department or agency of the Federal Government.''. (d) Conforming Amendments.--The United States Information and Educational Exchange Act of 1948 is amended-- (1) in section 502 (22 U.S.C. 1462)-- (A) by inserting ``and the Broadcasting Board of Governors'' after ``Secretary''; and (B) by inserting ``or the Broadcasting Board of Governors'' after ``Department''; and (2) in section 1005 (22 U.S.C. 1437), by inserting ``and the Broadcasting Board of Governors'' after ``Secretary'' each place it appears. (e) Effective Date.--This Act shall take effect and apply on the date that is 180 days after the date of the enactment of this Act.

Summary: Smith-Mundt Modernization Act of 2012 - Amends the United States Information and Educational Exchange Act of 1948 to authorize the Secretary of State and the Broadcasting Board of Governors to provide for the preparation and dissemination of information intended for foreign audiences abroad about the United States, including about its people, its history, and the federal government's policies, through press, publications, radio, motion pictures, the Internet, and other information media, including social media, and through information centers and instructors. (Under current law such authority is restricted to information disseminated abroad, with a limited domestic exception.) Authorizes the Secretary and the Board to make available in the United States motion pictures, films, video, audio, and other materials prepared for dissemination abroad or disseminated abroad pursuant to such Act, the United States International Broadcasting Act of 1994, the Radio Broadcasting to Cuba Act, or the Television Broadcasting to Cuba Act. Amends the Foreign Relations Authorization Act, Fiscal Years 1986 and 1987 to prohibit funds for the Department of State or the Board from being used to influence public opinion or propagandizing in the United States. (Under current law such provision applies to the United States Information Agency [USIA].) Applies such prohibition only to programs carried out pursuant to the United States Information and Educational Exchange Act of 1948, the United States International Broadcasting Act of 1994, the Radio Broadcasting to Cuba Act, and the Television Broadcasting to Cuba Act. States that such provision shall: (1) not prohibit the Department or the Board from providing information about its operations, policies, programs, or program material, or making such information available to members of the media, public, or Congress; (2) not be construed to prohibit the Department from engaging in any medium of information on a presumption that a U.S. domestic audience may be exposed to program material; and (3) apply only to the Department and the Board and to no other federal department or agency.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Access to Obstetric Care Act of 1993''. SEC. 2. MEDICAID DEMONSTRATION PROJECTS TO IMPROVE ACCESS IN UNDERSERVED AREAS TO OBSTETRIC SERVICES. (a) In General.--The Secretary of Health and Human Services shall provide under this section for demonstration projects by States that seek to reduce infant mortality by improving access in urban and rural underserved areas to obstetric services for eligible pregnant women under title XIX of the Social Security Act. (b) Nature of Projects.--Demonstration projects under this section shall incorporate innovative approaches for increasing the participation of obstetric providers under title XIX of the Social Security Act, such as-- (1) expediting reimbursement and using innovative payment mechanisms, including global fees for obstetric services with guaranteed periodic payments; (2) special or enhanced reimbursement for early prenatal care, risk-assessment, and high-risk services; (3) patient distribution or referral systems; (4) subsidizing medical liability insurance premiums, in whole or in part, for selected obstetric providers; (5) paying for all or a portion of payments made in settlement of malpractice claims by patients of obstetric providers who meet certain criteria; and (6) providing professional liability coverage under the State tort claims act for certain obstetric providers while treating a specified category of patients. Demonstration projects addressing reimbursement must provide for integrated prenatal, delivery and postpartum services. (c) Supplemental Funding.--(1) With respect to the additional expenditures for medical assistance made under the State plan under title XIX of the Social Security Act to carry out a demonstration project under this section, the Federal medical assistance percentage (otherwise determined under section 1905(b) of such Act) shall be increased by 25 percentage points (but in no case to a percentage greater than 95 percent). (2) The amount of funds that may be expended as medical assistance to carry out the purposes of this section shall be such sums as may be appropriated during the 5-fiscal-year period beginning with fiscal year 1994. (d) Waiver Authority.--(1) Except as provided under paragraphs (2) and (3), the Secretary is authorized to waive the requirements of title XIX of the Social Security Act to the extent necessary to implement demonstration projects under this section. (2) Except as permitted under section 1915(b)(1) of the Social Security Act, the Secretary may not waive under paragraph (1) the requirement of sections 1902(a)(23) and 1916 of such Act. (3) The Secretary may not approve a demonstration project under this section, or a waiver under paragraph (1), that reduces the amount, duration, or scope of medical assistance made available under title XIX of the Social Security Act or that results in a loss of eligibility for individuals otherwise eligible for such assistance. (e) Timely Action on Applications.--A request to the Secretary by a State for approval of a demonstration project under this section (and any accompanying waiver of a requirement of title XIX of the Social Security Act) shall be deemed granted unless the Secretary, within 90 days after the date of its submission to the Secretary, either denies such request in writing or informs the State in writing with respect to any additional information which is needed in order to make a final determination with respect to the request. After the date the Secretary receives such additional information, the request shall be deemed granted unless the Secretary, within 90 days of such date, denies the request. (f) Duration.--A demonstration project under this section may be conducted for any portion of the period beginning after the date of enactment of this Act and ending December 31, 1997. (g) Evaluation.--Such projects must include a plan for evaluating the effects of the demonstration projects on provider participation. (h) Report.--The Secretary shall report to Congress, not later than March 1, 1998, on the demonstration projects carried out under this section and on how the results of such projects may be used to implement programs to lower infant mortality and morbidity through improving the access of pregnant women to obstetric services in urban and rural underserved areas. (i) Obstetric Provider Defined.--In this section, the term ``obstetric provider'' means an obstetrician, obstetrician- gynecologist, family practitioner, certified nurse midwife, or certified family nurse practitioner. SEC. 3. ANNUAL COMPENDIUM ON STATE INITIATIVES. (a) In General.--The Secretary of Health and Human Services, in consultation with the Office of Rural Health Policy, shall develop and make available to the public each year a compendium of the various State initiatives undertaken to address the obstetric access crisis in urban and rural areas. (b) Nature of Compendium.--The compendium shall include information on State laws, regulations, programs and other initiatives undertaken to increase access to obstetric care in underserved areas. The compendium shall include information on activities addressing liability problems, efforts to retain and place providers of pregnancy-related services in underserved areas, and efforts to recruit and retain providers of obstetric services under the Medicaid program. The compendium shall also include information on the results on any evaluations that have been conducted on such initiatives. SEC. 4. STUDY OF OBSTETRICAL MALPRACTICE CLAIMS. (a) Study.--The Secretary of Health and Human Services shall provide a grant to a public or private nonprofit organization to conduct a study on the rate of medical malpractice actions or claims relating to obstetrical care for patients whose care is paid for by title XIX of the Social Security Act as compared to those whose care is paid for by private insurance. Such study shall include a review of medical records at selected hospitals, including rural hospitals, to determine the rates for each group. (b) Report.--By not later than 2 years after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the study conducted under subsection (a). (c) Medical Malpractice Action or Claim Defined.--In this section, the term ``medical malpractice action or claim'' has the meaning given such term in section 431(7) of the Health Care Quality Improvement Act of 1986 (42 U.S.C. 11151(7)).

Summary: Access to Obstetric Care Act of 1993 - Directs the Secretary of Health and Human Services to: (1) provide for demonstration projects to improve access to obstetric services in underserved urban and rural areas for eligible pregnant women under title XIX (Medicaid) of the Social Security Act; (2) develop and make public each year a compendium of State initiatives to address the obstetric access crisis; and (3) provide a grant for the study of obstetrical malpractice claims.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Student Disciplinary Fairness Act of 2015''. SEC. 2. FINDINGS. Congress finds the following: (1) Too many juveniles are introduced to the formal criminal justice system for minor behavioral infractions at school. (2) Common behavioral infractions at school often result in suspension, expulsion, or incarceration of the juvenile students involved. (3) Zero-tolerance school discipline policies increase the number of incarcerated juveniles. (4) Research shows that juveniles who are incarcerated are significantly less likely to complete secondary school, experience less human capital development and diminished earnings potential, and are more likely to recidivate and be incarcerated as adults. SEC. 3. SCHOOL DISCIPLINE POLICY. The Juvenile Justice and Delinquency Prevention Act of 1974 (42 U.S.C. 5601 et seq.) is amended by inserting after title V the following new title: ``TITLE VI--SCHOOL DISCIPLINE POLICY ``SEC. 601. ESTABLISHMENT OF OFFICE. ``(a) In General.--There is hereby established within the Office of Juvenile Justice and Delinquency Prevention an Office of School and Discipline Policy (referred to in this title as the `Office'), headed by a Director appointed by the Administrator of the Office of Juvenile Justice and Delinquency Prevention. ``(b) Purpose.--The purpose of the Office shall be to reduce the number of juveniles who are incarcerated and develop a criminal record based on activity that occurs while the juvenile is at school. ``SEC. 602. DUTIES. ``The Office shall-- ``(1) collect and publish data, in collaboration with the Office for Civil Rights of the Department of Education, relating to the arrest and incarceration of juvenile students for violations of school rules or policies; ``(2) work with States, units of local government, local educational agencies, and non-governmental organizations in order to expand the use of alternatives to detention and incarceration programming in schools in order to reduce the number of juvenile students who are arrested and incarcerated for violating school rules or policies; and ``(3) collect and publish data, in collaboration with the Office of Justice Programs, relating to the relationship between the presence of a school resource officer at a school and the rate of juvenile students who are arrested and incarcerated for violations of school rules or policies. ``SEC. 603. SCHOOL DISCIPLINE POLICY GRANT PROGRAM. ``(a) Grants Authorized.--The Director may make grants to States, units of local government, and local educational agencies in order to further the purpose described in section 601(b). ``(b) Application.--A State, unit of local government, or local educational agency seeking a grant under this section shall submit an application to the Director at such time, in such manner, and containing such information as the Director may reasonably require. ``(c) Preference.--The Director shall give preference in awarding grants to an applicant that demonstrates that it has, at the time of submitting an application, begun to take steps to further the purpose described in section 601(b). ``(d) Uses of Funds.--A State, unit of local government or local educational agency that receives a grant under this section shall use such funds for programs that reduce the rate of juvenile students who are arrested and incarcerated for violations of school rules or policies, and any other activity that the Director determines will further the purpose described in section 601(b). ``SEC. 604. DEFINITIONS. ``In this title: ``(1) The term `school' means an elementary school or a secondary school as such terms are defined in section 9101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). ``(2) The term `school resource officer' has the meaning given such term in section 1709 of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796dd-8). ``(3) The term `local educational agency' has the meaning given such term in section 9101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). ``(4) The term `juvenile student' means a juvenile who is enrolled in school. ``SEC. 605. AUTHORIZATION OF APPROPRIATIONS. ``There is authorized to be appropriated such sums as may be necessary for fiscal years 2014 and 2015 to carry out this title.''. SEC. 4. CONDITIONS FOR STATES TO RECEIVE ``COPS ON THE BEAT'' GRANTS. Section 1702(c) of the Omnibus Crime Control and Safe Streets Act of 1968 is amended-- (1) in paragraph (10), by striking ``and'' at the end; (2) in paragraph (11), by striking the period at the end and inserting ``; and''; and (3) by inserting after paragraph (11), the following new paragraph: ``(12) in the case of an applicant that is a State or unit of local government, provide assurances that-- ``(A) the administration of juvenile justice in the applicant's jurisdiction is consistent with any requirements of the United States Constitution and the 4th, 5th, and 14th amendments to the Constitution, including assurances that-- ``(i) before a juvenile is arrested, the arresting law enforcement officer must have probable cause specific to that juvenile; and ``(ii) juveniles who are arrested must receive adequate procedural due process, including-- ``(I) adequate and timely notice to the juvenile and the juvenile's guardian regarding any court proceedings related to the incident for which the juvenile was arrested; ``(II) representation by an attorney in any court proceeding as a result of which the juvenile could face incarceration; ``(III) protections against self- incrimination; and ``(IV) an opportunity to cross- examine any witness testifying against the juvenile; and ``(B) any contract governing the terms of probation for a juvenile shall not contain any clauses that-- ``(i) the juvenile cannot understand; and ``(ii) in the case of a juvenile student (as such term is defined in section 604 of the Juvenile Justice and Delinquency Prevention Act of 1974), could result in incarceration for violations of school rules or policies.''. SEC. 5. AUTHORITY FOR THE ATTORNEY GENERAL TO ACCESS CERTAIN RECORDS RELATING TO JUVENILE JUSTICE. Section 210401 of the Violent Crime Control and Law Enforcement Act of 1994 (42 U.S.C. 14141) is amended by adding at the end the following: ``(c) Access to Certain Records Relating to Juvenile Justice.--The Attorney General may issue subpoenas requiring the production of any documents relating to any matter which the Attorney General is authorized to investigate under subsection (a).''. SEC. 6. DEPARTMENT OF EDUCATION GRANT PROGRAM. (a) Program Authorized.--From the amounts appropriated to carry out this section, the Secretary of Education (acting through the Office of Civil Rights of the Department of Education) shall make grants to eligible entities to fund training for school personnel in elementary schools and secondary schools on de-escalation techniques to teach the personnel procedures and tactics to mitigate delinquent student behavior which may avoid a referral to law enforcement officials. (b) Application.--To receive a grant under this section, an eligible entity shall submit an application to the Secretary of Education at such time, in such manner, and containing such information as the Secretary may require, including information that demonstrates that the eligible entity-- (1) is fully compliant with all applicable Federal school discipline data reporting requirements, including, if applicable, the reporting requirements of section 618 of the Individuals with Disabilities Education Act of 1965 (20 U.S.C. 1418(a)); and (2) has provided complete information to all applicable data surveys of Department of Education, including the Office for Civil Rights. (c) Limitation.--An elementary school or secondary school may only receive assistance under this section during a grant period from 1 eligible entity receiving a grant under this section during the grant period. (d) Definitions.--For purposes of this section: (1) Eligible entity.--The term ``eligible entity'' means a State, unit of general local government, or juvenile justice agency. (2) General esea terms.--The terms ``elementary schools'', ``secondary schools'', and ``State'' have the meanings given the terms in section 9101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). (3) School personnel.--The term ``school personnel'' has the meaning given the term in section 4151 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7161). (e) Authorization of Appropriations.--There are authorized to be appropriated such sums as may be necessary for fiscal years 2014 and 2015 to carry out this section.

Summary: Student Disciplinary Fairness Act of 2015 This bill amends the Juvenile Justice and Delinquency Prevention Act of 1974 to establish an Office of School and Discipline Policy within the Department of Justice (DOJ). The Office must collect and publish data on the arrests or incarceration of juvenile students for violations of school rules or policies. It must also collaborate with states and local governments to expand alternatives to juvenile detention and incarceration. The legislation amends the Omnibus Crime Control and Streets Act of 1968 to require state or local governments that apply for public safety and community policing grants to provide assurances that the administration of juvenile justice in their jurisdictions is consistent with constitutional guarantees, including due process and equal protection, and that probation terms for a juvenile meet certain conditions. This bill amends the Violent Crime Control and Law Enforcement Act of 1994 to authorize DOJ to issue subpoenas during investigations of law enforcement agencies for alleged patterns or practices of conduct that violate constitutional rights. The Office of Civil Rights of the Department of Education must make grants to states, local governments, and juvenile justice agencies to train elementary and secondary school teachers and administrators on de-escalation techniques to mitigate delinquent student behavior.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Medicare Certified Registered Nurse First Assistant Direct Reimbursement Act of 2001''. SEC. 2. MEDICARE COVERAGE OF SURGICAL FIRST ASSISTING SERVICES OF CERTIFIED REGISTERED NURSE FIRST ASSISTANTS. (a) Services Covered.--Section 1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)), as amended by sections 102(a) and 105(a) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, as enacted into law by section 1(a)(6) of Public Law 106-554, is amended-- (1) by striking ``and'' at the end of subparagraph (U); (2) by inserting ``and'' at the end of subparagraph (V); and (3) by adding at the end the following new subparagraph: ``(W) surgical first assisting services (as defined in subsection (ww)(1)) furnished by a certified registered nurse first assistant (as defined in subsection (ww)(2));''. (b) Services Described.--Section 1861 of the Social Security Act (42 U.S.C. 1395x) , as amended by sections 102(b) and 105(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, as enacted into law by section 1(a)(6) of Public Law 106-554, is amended by adding at the end the following new subsection: ``Surgical First Assisting Services; Certified Registered Nurse First Assistant ``(ww)(1) The term `surgical first assisting services' means services consisting of first assisting a physician with surgery and related preoperative, intraoperative, and postoperative care (as determined by the Secretary) furnished by a certified registered nurse first assistant (as defined in paragraph (2)) which the certified registered nurse first assistant is legally authorized to perform by the State in which the services are performed. ``(2) The term `certified registered nurse first assistant' means an individual who-- ``(A) is a registered nurse and is licensed to practice nursing in the State in which the surgical first assisting services are performed; ``(B) has completed a minimum of 2,000 hours of first assisting a physician with surgery and related preoperative, intraoperative, and postoperative care; and ``(C) is certified as a registered nurse first assistant by an organization recognized by the Secretary.''. (c) Payment Amount.--Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)), as amended by sections 105(c) and 223(c) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, as enacted into law by section 1(a)(6) of Public Law 106- 554, is amended-- (1) by striking ``and'' before ``(U)''; and (2) by inserting before the semicolon at the end the following: ``, and (V) with respect to surgical first assisting services (as defined in section 1861(ww)(1)) furnished by a certified registered nurse first assistant (as defined in section 1861(ww)(2)), the amount paid shall be 80 percent of the lesser of the actual charge for the services or 85 percent of the amount determined under the fee schedule established under section 1848(b) for the same services if furnished by a physician''. (d) Payments to Employers.-- (1) In general.--Section 1833(r) of the Social Security Act (42 U.S.C. 1395l(r)) is amended-- (A) in paragraph (1), by inserting ``or section 1861(s)(2)(W) (relating to surgical first assisting services)'' after ``clinical nurse specialist services)''; and (B) in paragraph (2), by striking ``1861(s)(2)(K)(ii)'' and inserting ``1861(s)(2)(K)(ii) or 1861(s)(2)(W)''. (2) Application of mandatory assignment rules.--Section 1842(b)(18)(C)(i) of such Act (42 U.S.C. 1395u(b)(18)(C)(i)) is amended by striking ``physician assistant, nurse practitioner, clinical nurse specialist'' and inserting ``physician assistant, nurse practitioner, clinical nurse specialist, or certified registered nurse first assistant''. (3) Exclusion from bundled payments for covered skilled nursing facility services.--Section 1888(e)(2)(A)(ii) of such Act (42 U.S.C. 1395yy(e)(2)(A)(ii)) is amended by inserting ``surgical first assisting services of a certified registered nurse first assistant,'' after ``services of a certified registered nurse anesthetist,''. (e) Reduction in Payments To Avoid Duplicate Payment.-- Notwithstanding any other provision of law, the Secretary of Health and Human Services may reduce the amount of payments otherwise made to hospitals under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) to eliminate estimated duplicate payments for historical or current costs attributable to surgical first assisting services furnished by certified registered nurse first assistants as described in section 1861(ww) of such Act (as added by subsection (a)). (f) Effective Date.--The amendments made by this section shall apply to services furnished on or after the date of the enactment of this Act. SEC. 3. STUDY OF PAYMENT RATES. Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report containing recommendations for adjustments to the payment amounts established under part B of title XVIII of the Social Security Act for surgical first assisting services furnished by certified registered nurse first assistants (as described in section 1861(ww) of such Act (as added by section 1(a)) to ensure that the payment amounts reflect the approximate costs of furnishing such services, taking into account the costs of compensation, overhead, and supervision attributable to certified registered nurse first assistants.

Summary: Medicare Certified Registered Nurse First Assistant Direct Reimbursement Act of 2001 - Amends title XVIII (Medicare) of the Social Security Act to provide for coverage of surgical first assisting services furnished by certified registered nurse first assistants.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Generating Antibiotic Incentives Now Act of 2011''. SEC. 2. TABLE OF CONTENTS. The table of contents of this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Sec. 3. Extension of exclusivity period for drugs. Sec. 4. Additional extension of exclusivity period for qualified infectious disease products for which a companion diagnostic test is cleared or approved. Sec. 5. Priority review. Sec. 6. Fast track product. Sec. 7. Study on incentives for qualified infectious disease biological products. Sec. 8. Clinical trials. SEC. 3. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS. (a) In General.--The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505D (21 U.S.C. 355e) the following: ``SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW QUALIFIED INFECTIOUS DISEASE PRODUCTS. ``(a) Extension.--If, prior to approval of a drug pursuant to an application submitted under section 505(b), the Secretary determines that the drug is a qualified infectious disease product, then the four- and five-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the three-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of section 505, or the seven-year period described in section 527, as applicable, shall be extended by five years. ``(b) Relation to Pediatric Exclusivity.--Any extension under subsection (a) of a period shall be in addition to any extension of the period under section 505A with respect to the drug. ``(c) Limitations.--Subsection (a) does not apply to the approval of-- ``(1) a supplement to an application under section 505(b) for any qualified infectious disease product for which an extension described in subsection (a) is in effect or has expired; or ``(2) a subsequent application filed by the same sponsor or manufacturer of a qualified infectious disease product described in paragraph (1) (or a licensor, predecessor in interest, or other related entity) for-- ``(A) a change (not including a modification to the structure of the qualified infectious disease product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or ``(B) a modification to the structure of the qualified infectious disease product that does not result in a change in safety or effectiveness. ``(d) Determination.--The manufacturer or sponsor of a drug may request the Secretary to designate a drug as a qualified infectious disease product. Such a request for designation shall be made at least 45 days before the submission of an application under section 505(b) for such drug. The Secretary shall, not later than 30 days after the submission of such request, determine whether the drug is a qualified infectious disease product. ``(e) Regulations.--The Secretary shall promulgate regulations for carrying out this section. The Secretary shall promulgate the initial regulations for carrying out this section not later than 12 months after the date of the enactment of this section. ``(f) Definitions.--In this section: ``(1) Qualified infectious disease product.--The term `qualified infectious disease product' means an antibiotic drug for treating, detecting, preventing, or identifying a qualifying pathogen. ``(2) Qualifying pathogen.--The term `qualifying pathogen' means-- ``(A) resistant gram positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Staphylococcus aureus (VRSA), and vancomycin-resistant enterococcus (VRE); ``(B) multi-drug resistant gram negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species; ``(C) multi-drug resistant tuberculosis; or ``(D) any other infectious pathogen identified for purposes of this section by the Secretary.''. (b) Application.--Section 505E of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies only with respect to a drug that is first approved under section 505(c) of such Act (21 U.S.C. 355(c)) on or after the date of the enactment of this Act. SEC. 4. ADDITIONAL EXTENSION OF EXCLUSIVITY PERIOD FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS FOR WHICH A COMPANION DIAGNOSTIC TEST IS CLEARED OR APPROVED. The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), as amended by section 3, is further amended by inserting after section 505E the following: ``SEC. 505E-1. ADDITIONAL EXTENSION OF EXCLUSIVITY FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS FOR WHICH A COMPANION DIAGNOSTIC TEST IS CLEARED OR APPROVED. ``(a) In General.--If the sponsor or manufacturer of a qualified infectious disease product identifies in accordance with subsection (b) a companion diagnostic test described in subsection (c), any period extended under section 505E(a) with respect to such product shall be further extended by 6 months. ``(b) Identification Requirements.--For purposes of subsection (a), the identification of a companion diagnostic test shall-- ``(1) be made in such manner as the Secretary may require; and ``(2) occur before the expiration of the period to be extended under subsection (a), not counting any extension to such period under section 505E(a) or 505A. ``(c) Companion Diagnostic Test.--For purposes of subsection (a), a device is a companion diagnostic test with respect to a qualified infectious disease product if each of the following is met: ``(1) The device is determined by the Secretary under subsection (f) to be a test for diagnosis of a qualifying pathogen. ``(2) The qualified infectious disease product has been determined under section 505E(d) to be for treating, detecting, preventing, or identifying such qualifying pathogen. ``(3) The device is cleared under section 510(k) or approved under section 515. ``(4) The sponsor or manufacturer, as applicable, of the qualified infectious disease product has the exclusive rights to submit an identification under subsection (a) with respect to the device. ``(d) Relation to Pediatric Exclusivity.--Any extension under subsection (a) of a period with respect to a qualified infectious disease product shall be in addition to any extension of the period under section 505A of this Act with respect to the product. ``(e) Limitations.--After the extension of any period under subsection (a) with respect to a qualified infectious disease product pursuant to the identification of a device as a companion diagnostic test, subsection (a) does not authorize-- ``(1) any subsequent extension with respect to such product; or ``(2) any extension with respect to any other product pursuant to identification of such device. ``(f) Determination.--The sponsor or manufacturer of a drug may request the Secretary to determine that a device is a test for diagnosis of a qualifying pathogen. Such a request shall be made at least 45 days before the submission of a notification under section 510(k) or an application under section 515 for such device. The Secretary shall, not later than 30 days after the submission of such request, determine whether the device is a test for diagnosis of a qualifying pathogen. ``(g) Definitions.--In this section: ``(1) The term `qualified infectious disease product' means a drug that is determined to be a qualified infectious disease product under section 505E. ``(2) The term `qualifying pathogen' has the meaning given to such term in section 505E.''. SEC. 5. PRIORITY REVIEW. (a) Amendment.--Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 524 (21 U.S.C. 360n) the following: ``SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS. ``(a) In General.--If the Secretary makes a determination under section 505E(c) that a drug is a qualified infectious disease product, then the Secretary shall give priority review to any application submitted for approval for such drug under section 505(b). ``(b) Definition.--In this section, the term `priority review', with respect to an application described in subsection (a), means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application.''. (b) Application.--Section 524A of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies only with respect to an application that is submitted under section 505(b) (21 U.S.C. 355(b)) on or after the date of the enactment of this Act. SEC. 6. FAST TRACK PRODUCT. Paragraph (1) of section 506(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)) is amended by inserting after ``if it is intended for the treatment of a serious or life-threatening condition and it demonstrates the potential to address unmet medical needs for such a condition'' the following: ``or if the Secretary determines under section 505E that the drug is a qualified infectious disease product''. SEC. 7. STUDY ON INCENTIVES FOR QUALIFIED INFECTIOUS DISEASE BIOLOGICAL PRODUCTS. (a) In General.--The Comptroller General of the United States shall-- (1) conduct a study on the need for incentives to encourage the research, development, and marketing of qualified infectious disease biological products; and (2) not later than 1 year after the date of the enactment of this Act, submit a report to the Congress on the results of such study, including any recommendations of the Comptroller General on appropriate incentives for addressing such need. (b) Definitions.--In this section: (1) The term ``biological product'' has the meaning given to such term in section 351 of the Public Health Service Act (42 U.S.C. 262). (2) The term ``qualified infectious disease biological product'' means a biological product for treating, detecting, preventing, or identifying a qualifying pathogen. (3) The term ``qualifying pathogen'' has the meaning given to such term in section 505E of the Federal Food, Drug, and Cosmetic Act, as added by section 3 of this Act. SEC. 8. CLINICAL TRIALS. (a) Review and Revision of Guidelines.-- (1) In general.--Not later than 1 year after the date of the enactment of this Act, and not later than 4 years thereafter, the Secretary shall-- (A) review the guidelines of the Food and Drug Administration for the conduct of clinical trials with respect to antibiotic drugs; and (B) as appropriate, revise such guidelines to reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval of an antibiotic drug under chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.). (2) Issues for review.--At a minimum, the review under paragraph (1) shall address the appropriate animal models of infection, in vitro techniques, valid micro-biological surrogate markers, the use of non-inferiority versus superiority trials, and appropriate delta values for non- inferiority trials. (3) Rule of construction.--Except to the extent to which the Secretary of Health and Human Services makes revisions under paragraph (1)(B), nothing in this section shall be construed to repeal or otherwise affect the guidelines of the Food and Drug Administration. (b) Recommendations for Investigations.-- (1) Request.--The sponsor of a drug intended to be used to treat, detect, prevent, or identify a qualifying pathogen may request that the Secretary provide written recommendations for nonclinical and clinical investigations which may be conducted with the drug before it may be approved for such use under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355). (2) Recommendations.--If the Secretary has reason to believe that a drug for which a request is made under this subsection is a qualified infections disease product, the Secretary shall provide the person making the request written recommendations for the nonclinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request, would be necessary for approval under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) of such drug for the use described in paragraph (1). (c) Definitions.--In this section: (1) The term ``drug'' has the meaning given to such term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). (2) The term ``qualifying pathogen'' has the meaning given to such term in section 505E of the Federal Food, Drug, and Cosmetic Act, as added by section 3 of this Act. (3) The term ``Secretary'' means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.

Summary: Generating Antibiotic Incentives Now Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to extend the exclusivity period for a new prescription drug by five years for a drug that the Secretary of Health and Human Services (HHS) determines to be a qualified infectious disease product. Defines "qualified infectious disease product" to mean an antibiotic drug for treating, detecting, preventing, or identifying a qualifying pathogen (certain pathogens that are resistant to antibiotics). Excludes drugs that are: (1) a supplement to a new drug application for which an extension is in effect or has expired; or (2) a subsequent application for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or a modification to the structure of the product that does not result in a change in safety or effectiveness. Extends such period of exclusivity an additional six months for a sponsor or manufacturer of a qualified infectious disease product that identifies a companion diagnostic test. Requires the Secretary to give priority review to any drug determined to be a qualified infectious disease product. Includes qualified infectious disease products as fast track products for which the Secretary shall facilitate development and expedite review. Directs the Comptroller General to study the need for incentives to encourage the research, development, and marketing of qualified infectious disease biological products. Requires the Secretary to: (1) review Food and Drug Administration (FDA) guidelines for clinical trials of antibiotic drugs; and (2) revise such guidelines, as appropriate, to reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval of an antibiotic drug.


SECTION 1. EXTENSION OF MEDICARE PRESCRIPTION DRUG INITIAL ENROLLMENT PERIODS FOR 2006 AND 2007; SUSPENSION OF LATE ENROLLMENT PENALTY THROUGH DECEMBER 31, 2007. (a) Extension of Medicare Prescription Drug Initial Enrollment Periods for 2006 and 2007.--Section 1860D-1(b)(1) of the Social Security Act (42 U.S.C. 1395w-101(b)(1)) is amended-- (1) in subparagraph (B)(iii), by inserting ``subparagraph (D) and'' after ``Subject to''; and (2) by adding at the end the following new subparagraph: ``(D) Extension of initial enrollment periods.--For purposes of subparagraph (B)(iii), in applying section 1851(e)(1), with respect to the annual, coordinated election period-- ``(i) for 2006, such period shall begin on November 15, 2005, and end on November 14, 2006; and ``(ii) for 2007, such period shall begin on November 15, 2006, and end on November 14, 2007.''. (b) Suspension of Late Enrollment Penalty Through December 31, 2007.--Section 1860D-13(b)(3)(B) of such Act (42 U.S.C. 1395w- 113(b)(3)(B)) is amended by inserting ``(after December 2007)'' after ``any month''. SEC. 2. OPEN ENROLLMENT AND DISENROLLMENT IN PRESCRIPTION DRUG PLANS ALLOWED DURING FIRST 12 MONTHS OF ENROLLMENT. Section 1860D-1(b)(1) of the Social Security Act (42 U.S.C. 1395w- 101(b)(1)) is amended by adding at the end the following new subparagraph: ``(D) Open enrollment and disenrollment period for first 12 months of enrollment.--In establishing the process under subparagraph (A), in the case of a part D eligible individual who initially enrolls under section 1860D-1(a) in a prescription drug plan on or after the date of enactment of this paragraph, the Secretary shall permit such individual to change such enrollment into another prescription drug plan once at any time during the first 12 months of such initial enrollment (other than during an annual, coordinated election period referred to in section 1860D- 1(b)(1)(B)(iii)).''. SEC. 3. LIMITATIONS ON CHANGING PRESCRIPTION DRUG PLAN FORMULARIES; NOTICE OF CHANGE IN FORMULARY. (a) Limitation on Removal or Change of Covered Part D Drugs From the Prescription Drug Plan Formulary.--Section 1860D-4(b)(3)(E) of the Social Security Act (42 U.S.C. 1395w-104(b)(3)(E)) is amended to read as follows: ``(E) Removing a drug from formulary or imposing a restriction or limitation on coverage.-- ``(i) Limitation on removal, limitation, or restriction.-- ``(I) In general.--Subject to subclause (II) and clause (ii), beginning with 2006, the PDP sponsor of a prescription drug plan may not remove a covered part D drug from the plan formulary or impose a restriction or limitation on the coverage of such a drug (such as through the application of a preferred status, usage restriction, step therapy, prior authorization, or quantity limitation) other than at the beginning of each plan year except as the Secretary may permit to take into account new therapeutic uses and newly covered part D drugs. ``(II) Special rule for newly enrolled individuals.--Subject to clause (ii), in the case of an individual who enrolls in a prescription drug plan on or after the date of enactment of this subparagraph, the PDP sponsor of such plan may not remove a covered part D drug from the plan formulary or impose a restriction or limitation on the coverage of such a drug (such as through the application of a preferred status, usage restriction, step therapy, prior authorization, or quantity limitation) during the period beginning on the date of such enrollment and ending on December 31 of the immediately succeeding plan year except as the Secretary may permit to take into account new therapeutic uses and newly covered part D drugs. ``(ii) Exceptions to limitation on removal.--Clause (i) shall not apply with respect to a covered part D drug that-- ``(I) is a brand name drug for which there is a generic drug approved under section 505(j) of the Food and Drug Cosmetic Act (21 U.S.C. 355(j)) that is placed on the market during the period in which there are limitations on removal or change in the formulary under subclause (I) or (II) of clause (i); ``(II) is a brand name drug that goes off-patent during such period; ``(III) is a drug for which the Commissioner of Food and Drugs issues a clinical warning that imposes a restriction or limitation on the drug during such period; or ``(IV) has been determined to be ineffective during such period. ``(iii) Notice of removal under application of exception to limitation.--The PDP sponsor of a prescription drug plan shall provide appropriate notice (such as under subsection (a)(3)) of any removal or change under clause (ii) to the Secretary, affected enrollees, physicians, pharmacies, and pharmacists.''. (b) Notice of Change in Formulary and Other Restrictions or Limitations on Coverage.-- (1) In general.--Section 1860D-4(a) of such Act (42 U.S.C. 1395w-104(a)) is amended by adding at the end the following new paragraph: ``(5) Annual notice of changes in formulary and other restrictions or limitations on coverage.--Each PDP sponsor offering a prescription drug plan shall furnish to each enrollee at the time of each annual coordinated election period (referred to in section 1860D-1(b)(1)(B)(iii)) for a plan year a notice of any changes in the formulary or other restrictions or limitations on coverage of a covered part D drug under the plan that will take effect for the plan year.''. (2) Effective date.--The amendment made by paragraph (1) shall apply to annual coordinated election periods beginning after the date of the enactment of this Act.

Summary: Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to: (1) extend the 2006 and 2007 initial enrollment periods for the Medicare prescription drug benefit; (2) suspend the late enrollment penalty through December 31, 2007; and (3) permit Medicare beneficiaries to change enrollment in a prescription drug plan during the first 12 months of enrollment. Prohibits a PDP sponsor, beginning with 2006, from removing a covered part D drug from the plan formulary, or imposing a restriction or limitation on the coverage of such a drug, other than at the beginning of each plan year, except as the Secretary may permit to take into account new therapeutic uses and newly covered part D drugs. Requires each PDP sponsor to furnish to each plan enrollee, at the time of each annual coordinated election period, a notice of any changes in the formulary or other part D drug coverage restrictions or limitations that will take effect for the upcoming plan year.