SECTION 1. SHORT TITLE. This Act may be cited as the ``Ensuring Full Use of Federal Health Care Funding Act of 2014''. SEC. 2. RECOUPMENT AND REALLOCATION OF FEDERAL SECTION 1311 ACA GRANT FUNDS. Section 1311(a) of the Patient Protection and Affordable Care Act (42 U.S.C. 18031(a)) is amended-- (1) in paragraph (1), by inserting before the period at the end the following: ``and to make grants under paragraph (7) to qualified entities in a State from funds recouped under paragraph (6) from that State''; (2) in paragraph (2), by adding at the end the following: ``Not later than May 1, 2014, the Secretary shall determine the recoupment amount under paragraph (6) for each State and the amounts that will be made so available for grants under paragraph (7) for qualified entities in each State.''; (3) in paragraph (3), by adding at the end the following: ``A qualified entity awarded a grant under paragraph (7) shall use such grant for activities consistent with subparagraph (C) of such paragraph.''; and (4) by adding at the end the following new paragraphs: ``(6) Recoupment of unexpended funds.-- ``(A) In general.--Subject to subparagraph (B), the Secretary shall recoup any funds awarded to a State under this subsection to the extent that such funds are not obligated by the State for expenditure before April 1, 2014. ``(B) Exception.--The Secretary may, in the Secretary's discretion, decide not to recoup the funds of a State under subparagraph (A) if the State has submitted to the Secretary and the Secretary has approved, before March 31, 2014, a plan for spending such funds in accordance with this subsection in a timely manner. ``(7) Application of recouped funds for grants to other entities within a state.-- ``(A) In general.--Insofar as the Secretary recoups funds under paragraph (6) from a State, the Secretary shall use all such funds to make grants, before the beginning of the open enrollment period for 2015, to qualified entities under subparagraph (B) to carry out activities in the State consistent with subparagraph (C). ``(B) Eligibility.-- ``(i) In general.--To be eligible to receive a grant under this paragraph with respect to a State, an entity shall demonstrate to the Secretary that the entity-- ``(I) has (or can readily and on a timely basis establish) relationships with employers and employees, consumers (including uninsured and underinsured consumers), or self-employed individuals in the State that are likely to be qualified to enroll in coverage options made available through an Exchange in the State; ``(II) is capable of carrying out the activities described in subparagraph (C) for which a grant is being granted; ``(III) meets the standards described in clause (iii); and ``(IV) provides information consistent with standards developed under clause (iv). ``(ii) Types of qualified entities.--Such an entity may be a trade, industry, and professional association, commercial fishing industry organization, ranching and farming organization, community and consumer-focused nonprofit group, chamber of commerce, union, resource partner of the Small Business Administration, and other licensed insurance agent or broker, and another entity, so long as it meets the requirements of clause (i). ``(iii) Entity standards.--The Secretary shall establish standards for qualified entities under this subparagraph relating to their qualification to engage in the outreach, education, and enrollment activities described in subparagraph (C) and to avoid conflicts of interest. Under such standards, a qualified entity shall not-- ``(I) be a health insurance issuer; or ``(II) receive any consideration directly or indirectly from any health insurance issuer in connection with the enrollment of any qualified individuals or employees of a qualified employer in a qualified health plan. ``(iv) Fair and impartial information and services.--The Secretary shall develop standards to ensure that information made available by qualified entities under a grant under this paragraph is fair, accurate, and impartial. ``(C) Use of grants.--Grants under this paragraph may be used for any of the purposes or activities for which a grant to a State under this subsection may be used, including the following: ``(i) Non-navigator assistance personnel.-- To build and fund operations of an in-person assistance personnel (IPA) program (also known as `non-Navigator assistance personnel'). ``(ii) Outreach.--To coordinate with other health and human services organizations in the State to broaden outreach (such as Marketplace information on applications for other programs, websites, emails or through IPA call centers) to individuals eligible to enroll in qualified health plans through the Exchange operating in the State. ``(iii) Marketing.--To produce and disseminate marketing and campaign materials, including brochures, direct mail, print ads, social media and digital and online ads, and TV and radio buys, such materials subject to approval by the Secretary.''.

Summary: Ensuring Full Use of Federal Health Care Funding Act of 2014 - Amends the Patient Protection and Affordable Care Act to direct the Secretary of Health and Human Services (HHS) to recoup any funds awarded to a state to establish health care exchanges to the extent the state has not obligated them for expenditure before April 1, 2014. Allows the Secretary, however, not to recoup such funds from a state if the state has approved, before March 31, 2014, a plan to spend them for such exchanges in a timely manner. Requires the Secretary to use any recouped funds to make grants to qualified entities to: (1) build and fund operations of an in-person assistance personnel (IPA) program (also known as "non-Navigator assistance personnel"); (2) coordinate with other health and human services organizations in the state to broaden outreach to individuals eligible to enroll in qualified health plans through the exchange operating in the state; and (3) produce and disseminate marketing and campaign materials, subject to the Secretary's approval. Requires a qualified entity to: (1) have (or readily and on a timely basis be able to establish) relationships with employers and employees, consumers (both uninsured and underinsured), or self-employed individuals in the state that are likely to be qualified to enroll in coverage options made available through a health care exchange in the state; (2) be capable of carrying out grant activities; and (3) meet specified standards. Lists as types of qualified entities: (1) a trade, industry, and professional association; (2) a commercial fishing industry organization; (3) a ranching and farming organization; (4) a community and consumer-focused nonprofit group; (5) a chamber of commerce; (6) a union; (7) a resource partner of the Small Business Administration (SBA); (8) a licensed insurance agent or broker; and (9) any other entity that meets the qualification standards.


SECTION 1. SHORT TITLE. This Act may be cited as the ``New War on Cancer Act''. SEC. 2. NONPATENT MARKET EXCLUSIVITY FOR CANCER DRUGS. Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end the following subchapter: ``Subchapter G--Cancer Drugs ``SEC. 575. RECOMMENDATIONS FOR INVESTIGATIONS OF CANCER DRUGS. ``(a) Request for Recommendations.--The sponsor of a drug intended for use for cancer (referred to in this subchapter as a `cancer drug') may request the Secretary to provide written recommendations for the nonclinical and clinical investigations which must be conducted with the drug before-- ``(1) it may be approved for use for cancer under section 505; or ``(2) if the drug is a biological product, it may be licensed for use for cancer under section 351 of the Public Health Service Act. ``(b) Recommendations.--If the Secretary has reason to believe that a drug for which a request is made under subsection (a) is a cancer drug, 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-- ``(1) approval of such drug for use for cancer under section 505; or ``(2) licensing of such drug for use for cancer under section 351 of the Public Health Service Act. ``(c) Regulations.--The Secretary shall by regulation promulgate procedures for the implementation of subsections (a) and (b). ``SEC. 576. DESIGNATION OF CANCER DRUGS. ``(a) Request for Designation.--The sponsor of a drug may request the Secretary to designate the drug as a cancer drug. A request for designation of a drug shall be made before the submission of an application under section 505(b) for the drug, or the submission of an application for licensing of the drug under section 351 of the Public Health Service Act. Such a request shall contain the consent of the applicant to notice being given by the Secretary under subsection (c) respecting the designation of the drug. ``(b) Designation.--In the case of a drug for which a request is submitted under subsection (a), the Secretary shall designate the drug as a cancer drug if the Secretary finds that the drug is being or will be investigated for use for cancer. ``(c) Conditions.--A designation of a drug under subsection (b) shall be subject to the condition that-- ``(1) after an application is approved for the drug under section 505(b) or a license is issued for the drug under section 351 of the Public Health Service Act, the manufacturer of the drug will notify the Secretary of any discontinuance of the production of the drug at least one year before discontinuance; and ``(2) before an application is approved for the drug under section 505(b) or a license is issued for the drug under section 351 of the Public Health Service Act, the sponsor of the drug will notify the Secretary of any decision to discontinue active pursuit of approval of an application under section 505(b) or approval of a license under section 351 of the Public Health Service Act. ``(d) Public Availability of Notice.--Notice respecting the designation of a drug under subsection (b) shall be made available to the public. ``(e) Regulations.--The Secretary shall by regulation promulgate procedures for the implementation of subsections (a) and (b). ``SEC. 577. MARKET PROTECTION FOR CANCER DRUGS. ``(a) In General.--Except as provided in subsection (b), if the Secretary approves an application filed pursuant to section 505 for a drug designated under section 576 as a cancer drug, or if the Secretary issues a license under section 351 of the Public Health Service Act for such a drug, the Secretary may not approve another application under section 505 or issue another license under section 351 of the Public Health Service Act for such drug for a person who is not the holder of such approved application or of such license until the expiration of seven years from the date of the approval of the approved application or the issuance of the license. Section 505(c)(2) does not apply to the refusal to approve an application under the preceding sentence. ``(b) Exception.--If an application filed pursuant to section 505 is approved for a drug designated under section 576 as a cancer drug or if a license is issued under section 351 of the Public Health Service Act for such a drug, the Secretary may, during the seven-year period beginning on the date of the application approval or of the issuance of the license, approve another application under section 505 or issue a license under section 351 of the Public Health Service Act for such drug for cancer for a person who is not the holder of such approved application or of such license if-- ``(1) the Secretary finds, after providing the holder notice and opportunity for the submission of views, that in such period the holder of the approved application or of the license cannot assure the availability of sufficient quantities of the drug to meet the needs of persons with the cancer involved; or ``(2) such holder provides the Secretary in writing the consent of such holder for the approval of other applications or the issuance of other licenses before the expiration of such seven-year period. ``SEC. 578. OPEN PROTOCOLS FOR INVESTIGATIONS OF CANCER DRUGS. ``If a drug is designated under section 576 as a cancer drug and if notice of a claimed exemption under section 505(i) or regulations issued thereunder is filed for such drug, the Secretary shall encourage the sponsor of such drug to design protocols for the drug which include persons with the cancer involved who need the drug to treat the cancer and who cannot be satisfactorily treated by available alternative drugs.''. SEC. 3. ABBREVIATED APPLICATIONS FOR NEW DRUGS; NONPATENT MARKET EXCLUSIVITY FOR CANCER DRUGS. Section 505(j)(5)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(F)(ii)) is amended-- (1) by striking ``(ii)'' and inserting ``(ii)(I)''; and (2) by adding at the end the following subclause: ``(II) With respect to an application under subsection (b) for a drug referred to in subclause (I), in any case in which the drug is for use for cancer, the reference in such subclause to five years is deemed to be ten years, the reference to four years is deemed to be eight years, the reference to forty-eight months is deemed to be ninety-six months, and the reference to seven and one-half years is deemed to be twelve and one-half years.''. SEC. 4. EXTENSION OF PATENT TERM ON CANCER DRUGS. Section 156(c) of title 35, United States Code, is amended by adding at the end the following flush sentence: ``Paragraphs (2) and (3) shall not apply in the case of a drug approved for use for cancer.''.

Summary: New War on Cancer Act - Allows the sponsor of a drug intended for use for cancer to request the Secretary of Health and Human Services to: (1) provide written recommendations for investigations which must be conducted before approval of a drug or before licensure of a biological product for use for cancer; and (2) designate such drug as a cancer drug before the submission of a request for approval or licensing. Requires the Secretary to designate such drug as a cancer drug if the drug is being or will be investigated for use for cancer. Prohibits the Secretary from approving another application or issuing another license for a designated cancer drug for a person who is not the holder of the approved application or license until the expiration of seven years, with certain exceptions. Requires the Secretary to encourage the sponsor of a designated cancer drug approved for investigational use to design protocols for the drug that include persons with the cancer involved who cannot be satisfactorily treated by alternative drugs. Extends the time during which an application for approval of drug with the same active ingredient as an approved cancer drug may not be approved. Excludes approved cancer drugs from time limits imposed on the maximum length of a patent.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Department of Homeland Security Component Privacy Officer Act of 2008''. SEC. 2. ESTABLISHMENT OF PRIVACY OFFICIAL WITHIN EACH COMPONENT OF DEPARTMENT OF HOMELAND SECURITY. (a) In General.--Subtitle C of title II of the Homeland Security Act of 2002 (6 U.S.C. 141 et seq.) is amended by inserting after section 222 the following new section: ``SEC. 222A. PRIVACY OFFICIALS. ``(a) Designation.-- ``(1) In general.--For each component of the Department under paragraph (2), the Secretary shall, in consultation with the head of the component, designate a full-time privacy official, who shall report directly to the senior official appointed under section 222. Each such component privacy official shall have primary responsibility for its component in implementing the privacy policy for the Department established by the senior official appointed under section 222. ``(2) Components.--The components of the Department referred to in this subparagraph are as follows: ``(A) The Transportation Security Administration. ``(B) The Bureau of Citizenship and Immigration Services. ``(C) Customs and Border Protection. ``(D) Immigration and Customs Enforcement. ``(E) The Federal Emergency Management Agency. ``(F) The Coast Guard. ``(G) The Directorate of Science and Technology. ``(H) The Office of Intelligence and Analysis. ``(I) The Directorate for National Protection and Programs. ``(b) Responsibilities.--Each privacy official designated under subsection (a) shall report directly to both the head of the official's component and the senior official appointed under section 222, and shall have the following responsibilities with respect to the component: ``(1) Serve as such senior official's main point of contact at the component to implement the polices and directives of such senior official in carrying out section 222. ``(2) Advise the head of that component on privacy considerations when any law, regulation, program, policy, procedure, or guideline is proposed, developed, or implemented. ``(3) Assure that the use of technologies by the component sustain or enhance privacy protections relating to the use, collection, and disclosure of personal information within the component. ``(4) Identify privacy issues related to component programs and apply appropriate privacy policies in accordance with Federal privacy law and Departmental policies developed to ensure that the component protects the privacy of individuals affected by its activities. ``(5) Monitor the component's compliance with all applicable Federal privacy laws and regulations, implement corrective, remedial, and preventive actions and notify the senior official appointed under section 222 of privacy issues or non-compliance, whenever necessary. ``(6) Ensure that personal information contained in Privacy Act systems of records is handled in full compliance with section 552a of title 5, United States Code. ``(7) Assist in drafting and reviewing privacy impact assessments, privacy threshold assessments, and system of records notices, in conjunction with and under the direction of the senior official appointed under section 222, for any new or substantially changed program or technology that collects, maintains, or disseminates personally identifiable information within the official's component. ``(8) Assist in drafting and reviewing privacy impact assessments, privacy threshold assessments, and system of records notices in conjunction with and under the direction of the senior official appointed under section 222, for proposed rulemakings and regulations within the component. ``(9) Conduct supervision of programs, regulations, policies, procedures, or guidelines to ensure the component's protection of privacy and, as necessary, promulgate guidelines and conduct oversight to ensure the protection of privacy. ``(10) Implement and monitor privacy training for component employees and contractors in coordination with the senior official appointed under section 222. ``(11) Provide the senior official appointed under section 222 with written materials and information regarding the relevant activities of the component, including privacy violations and abuse, that are needed by the senior official to successfully prepare the reports the senior official submits to Congress and prepares on behalf of the Department. ``(12) Any other responsibilities assigned by the Secretary or the senior official appointed under section 222. ``(c) Role of Component Heads.--The head of a component identified in subsection (a)(2) shall ensure that the privacy official designated under subsection (a) for that component-- ``(1) has the information, material, and resources necessary to fulfill the responsibilities of such official under this section; ``(2) is advised of proposed policy changes and the development of new programs, rules, regulations, procedures, or guidelines during the planning stage and is included in the decision-making process; and ``(3) is given access to material and personnel the privacy official deems necessary to carry out the official's responsibilities. ``(d) Limitation.--Nothing in this section shall be considered to abrogate the role and responsibilities of the senior official appointed under section 222.''. (b) Clerical Amendment.--The table of contents in section 1(b) of such Act is amended by inserting after the item related to section 222 the following new item: ``Sec. 222A. Privacy officials.''. Passed the House of Representatives July 30, 2008. Attest: LORRAINE C. MILLER, Clerk.

Summary: Department of Homeland Security Component Privacy Officer Act of 2008 - Amends the Homeland Security Act of 2002 to direct the Secretary of Homeland Security to designate a full-time privacy official for each of the following Department of Homeland Security (DHS) components: (1) the Transportation Security Administration (TSA); (2) the Bureau of Citizenship and Immigration Services (CIS); (3) Customs and Border Protection (CBP); (4) Immigration and Customs Enforcement (ICE); (5) the Federal Emergency Management Agency (FEMA); (6) the Coast Guard; (7) the Directorate of Science and Technology; (8) the Office of Intelligence and Analysis; and (9) the Directorate for National Protection and Programs. Grants each component's privacy official primary responsibility for implementing the privacy policy for DHS established by DHS's privacy officer. Requires each designated privacy official to report directly to both the component head and DHS's privacy officer. Lists the responsibilities of each component privacy official, including: (1) serving as DHS's privacy officer's main point of contact at the component to implement that officer's policies and directives; (2) advising the component head on privacy considerations when any law, regulation, or guideline is proposed, developed, or implemented; (3) assuring that the use of technologies sustains or enhances privacy protections; (4) identifying privacy issues related to component programs; (5) monitoring the component's compliance with all applicable federal privacy laws and regulations; (6) assisting in drafting and reviewing privacy impact assessments, privacy threshold assessments, and system of records notices; (7) implementing and monitoring privacy training for component employees and contractors in coordination with DHS's privacy officer; and (8) providing DHS's privacy officer with written materials and information regarding the relevant activities of the component, including privacy violations and abuse, that are needed to successfully prepare reports for Congress and on behalf of DHS. Directs each component head to ensure that the component's privacy official: (1) has the information, resources, and access to material and personnel necessary to fulfill his or her responsibilities; (2) is advised of proposed policy changes and the development of new programs, regulations, procedures, or guidelines during the planning stages; and (3) is included in decision-making.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018'' or the ``SOUND Disposal and Packaging Act''. SEC. 2. IMPROVED TECHNOLOGIES, CONTROLS, OR MEASURES WITH RESPECT TO THE PACKAGING OR DISPOSAL OF CERTAIN DRUGS. (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505-1 (21 U.S.C. 355-1) the following new section: ``SEC. 505-2. SAFETY-ENHANCING PACKAGING AND DISPOSAL FEATURES. ``(a) Orders.-- ``(1) In general.--The Secretary may issue an order requiring the holder of a covered application to implement or modify one or more technologies, controls, or measures with respect to the packaging or disposal of one or more drugs identified in the covered application, if the Secretary determines such technologies, controls, or measures to be appropriate to help mitigate the risk of abuse or misuse of such drug or drugs, which may include by reducing the availability of unused drugs. ``(2) Prior consultation.--The Secretary may not issue an order under paragraph (1) unless the Secretary has consulted with relevant stakeholders, through a public meeting, workshop, or otherwise, about matters that are relevant to the subject of the order. ``(3) Assuring access and minimizing burden.--Technologies, controls, or measures required under paragraph (1) shall-- ``(A) be commensurate with the specific risk of abuse or misuse of the drug listed in the covered application; ``(B) considering such risk, not be unduly burdensome on patient access to the drug, considering in particular any available evidence regarding the expected or demonstrated public health impact of such technologies, controls, or measures; and ``(C) reduce the risk of abuse or misuse of such drug. ``(4) Order contents.--An order issued under paragraph (1) may-- ``(A) provide for a range of options for implementing or modifying the technologies, controls, or measures required to be implemented by such order; and ``(B) incorporate by reference standards regarding packaging or disposal set forth in an official compendium, established by a nationally or internationally recognized standard development organization, or described on the public website of the Food and Drug Administration, so long as the order includes the rationale for incorporation of such standard. ``(5) Orders applicable to drug class.--When a concern about the risk of abuse or misuse of a drug relates to a pharmacological class, the Secretary may, after consultation with relevant stakeholders, issue an order under paragraph (1) which applies to the pharmacological class. ``(b) Compliance.--The holder of a covered application shall-- ``(1) submit a supplement containing proposed changes to the covered application to comply with an order issued under subsection (a) not later than-- ``(A) 180 calendar days after the date on which the order is issued; or ``(B)(i) such longer time period as specified by the Secretary in such order; or ``(ii) if a request for an alternative date is submitted by the holder of such application not later than 60 calendar days after the date on which such order is issued-- ``(I) such requested alternative date if agreed to by the Secretary; or ``(II) another date as specified by the Secretary; and ``(2) implement the changes approved pursuant to such supplement not later than the later of-- ``(A) 90 calendar days after the date on which the supplement is approved; or ``(B) the end of such longer period as is-- ``(i) determined to be appropriate by the Secretary; or ``(ii) approved by the Secretary pursuant to a request by the holder of the covered application that explains why such longer period is needed, including to satisfy any other applicable Federal statutory or regulatory requirements. ``(c) Alternative Measures.--The holder of the covered application may propose, and the Secretary shall approve, technologies, controls, or measures regarding packaging, storage, or disposal other than those specified in the applicable order issued under subsection (a), if such technologies, controls, or measures are supported by data and information demonstrating that such alternative technologies, controls, or measures can be expected to mitigate the risk of abuse or misuse of the drug or drugs involved, including by reducing the availability of unused drugs, to at least the same extent as the technologies, controls, or measures specified in such order. ``(d) Dispute Resolution.--If a dispute arises in connection with a supplement submitted under subsection (b), the holder of the covered application may appeal a determination made with respect to such supplement using applicable dispute resolution procedures specified by the Secretary in regulations or guidance. ``(e) Definitions.--In this section-- ``(1) the term `covered application' means an application submitted under subsection (b) or (j) of section 505 for approval under such section or an application submitted under section 351 of Public Health Service Act for approval under such section, with respect to a drug that is or contains an opioid for which a listing in schedule II or III (on a temporary or permanent basis) is in effect under section 202 of the Controlled Substances Act; and ``(2) the term `relevant stakeholders' may include scientific experts within the drug manufacturing industry; brand and generic drug manufacturers; standard development organizations; wholesalers and distributors; payers; health care providers; pharmacists; pharmacies; manufacturers; poison centers; and representatives of the National Institute on Drug Abuse, the National Institutes of Health, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the Drug Enforcement Agency, the Consumer Product Safety Commission, individuals who specialize in treating addiction, and patient and caregiver groups.''. (b) Prohibited Acts.--Section 501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph (j) the following: ``(k) If it is a drug approved under a covered application (as defined in section 505-2(e)), the holder of which does not meet the requirements of paragraphs (1) and (2) of subsection (b) of such section.''. (c) Required Content of an Abbreviated New Drug Application.-- Section 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(A)) is amended-- (1) in clause (vii)(IV), by striking ``and'' at the end; (2) in clause (viii), by striking the period at the end and inserting ``; and''; and (3) by adding at the end the following: ``(ix) if the drug is or contains an opioid for which a listing in schedule II or III (on a temporary or permanent basis) is in effect under section 202 of the Controlled Substances Act, information to show that the applicant has proposed technologies, controls, or measures related to the packaging or disposal of the drug that provide protections comparable to those provided by the technologies, controls, or measures required for the applicable listed drug under section 505-2, if applicable.''. (d) Grounds for Refusing to Approve an Abbreviated New Drug Application.--Section 505(j)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(4)), is amended-- (1) in subparagraph (J), by striking ``or'' at the end; (2) in subparagraph (K), by striking the period at the end and inserting ``; or''; and (3) by adding at the end the following: ``(L) if the drug is a drug described in paragraph (2)(A)(ix) and the applicant has not proposed technologies, controls, or measures related to the packaging or disposal of such drug that the Secretary determines provide protections comparable to those provided by the technologies, controls, or measures required for the applicable listed drug under section 505-2.''. (e) Rules of Construction.-- (1) Any labeling describing technologies, controls, or measures related to packaging or disposal intended to mitigate the risk of abuse or misuse of a drug product that is subject to an abbreviated new drug application, including labeling describing differences from the reference listed drug resulting from the application of section 505-2 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall not be construed-- (A) as changes to labeling not permissible under clause (v) of section 505(j)(2)(A) of such Act (21 U.S.C. 355(j)(2)(A)), or a change in the conditions of use prescribed, recommended, or suggested in the labeling proposed for the new drug under clause (i) of such section; or (B) to preclude approval of an abbreviated new drug application under subparagraph (B) or (G) of section 505(j)(4) of such Act (21 U.S.C. 355(j)(4)). (2) For a covered application that is an application submitted under subsection (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), subsection (j)(2)(A) of such section 505 shall not be construed to limit the type of data or information the Secretary of Health and Human Services may request or consider in connection with making any determination under section 505-2. (f) GAO Report.--Not later than 12 months after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit to the Congress a report containing-- (1) a description of available evidence, if any, on the effectiveness of site-of-use, in-home controlled substance disposal products and packaging technologies; (2) identification of ways in which such disposal products intended for use by patients, consumers, and other end users that are not registrants under the Controlled Substances Act, are made available to the public and barriers to the use of such disposal products; (3) identification of ways in which packaging technologies are made available to the public and barriers to the use of such technologies; (4) a description of Federal oversight, if any, of site-of- use, in-home controlled substance disposal products, including-- (A) identification of the Federal agencies that oversee such products; (B) identification of the methods of disposal of controlled substances recommended by these agencies for site-of-use, in-home disposal; and (C) a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; (5) a description of Federal oversight, if any, of controlled substance packaging technologies, including-- (A) identification of the Federal agencies that oversee such technologies; (B) identification of the technologies recommended by these agencies, including unit dose packaging, packaging that provides a set duration, or other packaging systems that may mitigate abuse or misuse; and (C) a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; and (6) recommendations on-- (A) whether site-of-use, in-home controlled substance disposal products and packaging technologies require Federal oversight and, if so, which agencies should be responsible for such oversight and, as applicable, approval of such products or technologies; and (B) the potential role of the Federal Government in evaluating such products to ensure product efficacy. Passed the House of Representatives June 19, 2018. Attest: KAREN L. HAAS, Clerk.

Summary: Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 or the SOUND Disposal and Packaging Act This bill amends the Federal Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration to require certain packaging and disposal technologies, controls, or measures to mitigate the risk of abuse or misuse of a drug or a class of drugs.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Federal Surface Transportation Policy and Planning Act of 2009''. SEC. 2. ESTABLISHMENT OF A NATIONAL SURFACE TRANSPORTATION POLICY AND PLAN. (a) In General.--Chapter 3 of title 49, United States Code, is amended-- (1) by redesignating sections 304 through 309 as sections 307 through 312; (2) by redesignating sections 303 and 303a as sections 305 and 306, respectively; and (3) by inserting after section 302, the following: ``Sec. 303. National surface transportation policy ``(a) Policy.--It is the policy of the United States to develop a comprehensive national surface transportation system that advances the national interest and defense, interstate and foreign commerce, the efficient and safe interstate mobility of people and goods, and the protection of the environment. The system shall be built, maintained, managed, and operated as a partnership between the Federal, State, and local governments and the private sector and shall be coordinated with the overall transportation system of the United States, including the Nation's air, rail, pipeline, and water transportation systems. The Secretary of Transportation shall be responsible for carrying out this policy and for defining the Federal Government's role in the system. ``(b) Objectives.--The objectives of the policy shall be to facilitate and advance-- ``(1) the efficient connectivity of persons and goods within and between nations, regions, States, and metropolitan areas; ``(2) the safety and health of the public; ``(3) the security of the Nation and the public; ``(4) environmental protection and enhancement, including the reduction of carbon-related emissions; ``(5) energy conservation and security, including reducing transportation-related energy use; ``(6) international and interstate freight movement, trade enhancement, job creation, and economic development; ``(7) responsible land use and sustainable development; ``(8) the preservation and adequate performance of system- critical transportation assets, as defined by the Secretary; ``(9) reasonable access to the national surface transportation system for all system users, including rural communities; ``(10) sustainable, balanced, and adequate financing of the national surface transportation system; and ``(11) innovation in transportation services, infrastructure, and technology. ``(c) Goals.-- ``(1) In general.--The goals of the policy shall be-- ``(A) to reduce national per capita motor vehicle miles traveled on an annual basis; ``(B) to reduce national motor vehicle-related fatalities by 50 percent by 2030; ``(C) to reduce national surface transportation- generated carbon dioxide levels by 40 percent by 2030; ``(D) to reduce national surface transportation delays per capita on an annual basis; ``(E) to increase the percentage of system-critical surface transportation assets, as defined by the Secretary, that are in a state of good repair by 20 percent by 2030; ``(F) to increase the total usage of public transportation, intercity passenger rail services, and non-motorized transportation on an annual basis; ``(G) to increase the proportion of national freight transportation provided by non-highway or multimodal services by 10 percent by 2020; ``(H) to reduce passenger and freight transportation delays and congestion at international points of entry on an annual basis; ``(I) to ensure adequate transportation of domestic energy supplies; and ``(J) to maintain or the reduce the percentage of gross domestic product consumed by transportation costs. ``(2) Baselines.--Within 1 year after the date of enactment of the National Surface Transportation Policy and Planning Act of 2009, the Secretary shall develop baselines for the goals and shall determine appropriate methods of data collection to measure the attainment of the goals. ``(d) Requirements.--The Secretary, consistent with the plan developed under section 304 and notwithstanding any other provision of law in effect as of the date of enactment of the National Surface Transportation Policy and Planning Act of 2009, shall-- ``(1) develop appropriate performance criteria and data collections systems for each Federal surface transportation program in order to evaluate: ``(A) whether such programs are consistent with the policy, objectives, and goals established by this section; and ``(B) how effective such programs are in contributing to the achievement of the policy, objectives, and goals established by this section; ``(2) using the criteria developed under paragraph (1), annually evaluate each such program and provide the results to the public; ``(3) based on the evaluation performed under paragraph (2), make any necessary changes or improvements to such programs to ensure such consistency and effectiveness; ``(4) align the availability and award of Federal surface transportation funding to meet the policy, objectives, goals, and performance criteria established by this section, consistent with the evaluation performed under paragraph (2); ``(5) carry out this section in a manner that is consistent with sections 302, 5503, 10101, and 13101 of this title and section 101 of title 23 to the extent that such sections do not conflict with the policy, objectives, and goals established by this section; ``(6) review, update, and reissue all relevant surface transportation planning requirements to ensure that such requirements require that regional, State, and local surface transportation planning efforts funded with Federal funds are consistent with the policy, objectives, and goals established by this section; and ``(7) require recipients of Federal surface transportation funds to annually report on the use of such funds, including a description of-- ``(A) which projects and priorities were funded with such funds; ``(B) the rationale and method employed for apportioning such funds to the projects and priorities; and ``(C) how the obligation of such funds is consistent with or advances the policy, objectives, and goals established by this section. ``(e) Authority.-- ``(1) In general.--Notwithstanding any other provision of law in effect as of the date of enactment of the National Surface Transportation Policy and Planning Act of 2009, the Secretary may, through a process of public notice and comment and with reasonable prior notice to the Senate Committee on Commerce, Science, and Transportation and the House of Representatives Committee on Transportation and Infrastructure preceding any significant change, consistent with the public interest, amend the goals under subsection (c) or develop additional goals to effectively meet the policy and objectives set forth in this section. ``(2) The Secretary may also make recommendations to those Committees for reorganizing the Department of Transportation, as necessary and consistent with the requirements of section 304(b)(6), in order to achieve the policy, objectives, and goals established by this section. ``Sec. 304. National surface transportation performance plan ``(a) Development.--Within 2 years after the date of enactment of the National Surface Transportation Policy and Planning Act of 2009, the Secretary of Transportation shall develop and implement a National Surface Transportation Performance Plan to achieve the policy, objectives, and goals set forth in section 303. ``(b) Contents.--The plan shall include-- ``(1) an assessment of the current performance of the national surface transportation system and an analysis of the system's ability to achieve the policy, objectives, and goals set forth in section 303; ``(2) an analysis of emerging and long-term projected trends that will impact the performance, needs, and uses of the national surface transportation system; ``(3) a description of the major impediments to effectively meeting the policy, objectives, and goals set forth in section 303 and recommended actions to address such impediments; ``(4) a comprehensive strategy and investment plan to meet the policy, objectives, and goals set forth in section 303; ``(5) initiatives to improve transportation modeling, research, data collection, and analysis; and ``(6) a plan for any reorganization of the Department of Transportation or its agencies necessary to meet the policy, objectives, and goals set forth in section 303. ``(c) Consultation.--In developing the plan required by subsection (a), the Secretary shall-- ``(1) consult with local, State, and tribal governments, public and private transportation providers and carriers, non- profit organizations representing transportation employees, appropriate foreign governments, and other interested parties; and ``(2) provide public notice and hearings and solicit public comments on the plan. ``(d) Submittal.--The Secretary shall submit the completed plan to the Senate Committee on Commerce, Science, and Transportation and the House of Representatives Committee on Transportation and Infrastructure. ``(e) Progress Reports.--The Secretary shall submit biennial progress reports on the implementation of the plan beginning 2 years after the date of submittal of the plan under subsection (d) to the Committees. The progress report shall-- ``(1) describe progress made toward fully implementing the plan and achieving the policies, objectives, and goals established under section 303; ``(2) describe challenges and obstacles to full implementation; ``(3) describe updates to the plan necessary to reflect changed circumstances or new developments; and ``(4) make policy and legislative recommendations the Secretary believes are necessary and appropriate to fully implement the plan. ``(f) Data.--The Secretary shall have the authority to conduct studies, gather information, and require the production of data necessary to develop or update this plan, consistent with Federal privacy standards. ``(g) Funding.--The Secretary may use such sums as may be necessary from any funds provided to the Department of Transportation for surface transportation programs for the purpose of completing and updating the plan and developing and issuing the progress reports pursuant to this section.''. (b) Conforming Amendments.-- (1) Section 302(a) of title 49, United States Code, is amended by striking ``10101 and 13101'' and inserting ``303, 10101, and 13101''. (2) Section 308, as redesignated, of title 49, United States Code, is amended by striking ``sections 301-304'' and inserting ``sections 301 through 307''. (3) The table of contents for chapter 3 of title 49, United States Code, is amended-- (A) by redesignating the items relating to sections 303 through 309 as relating to sections 305 through 312; and (B) by inserting after the item relating to section 302 the following: ``303. National surface transportation policy. ``304. National surface transportation performance plan.''.

Summary: Federal Surface Transportation Policy and Planning Act of 2009 - Declares it is U.S. policy to develop a national surface transportation system that advances the national interest and defense, interstate and foreign commerce, the efficient and safe interstate mobility of people and goods, and the protection of the environment. Sets forth certain U.S. policy objectives and goals, including to: (1) reduce national per capita motor vehicle miles traveled annually; (2) reduce national surface transportation-generated carbon dioxide levels by 40% by 2030; (3) reduce national surface transportation (including passenger and freight) delays and congestion at U.S. points of entry; (4) increase the total usage of public transportation, intercity passenger rail services, and non-motorized transportation; and (5) ensure adequate transportation of domestic energy supplies. Directs the Secretary of Transportation to: (1) develop performance criteria and data collections systems to evaluate the effectiveness of federal surface transportation programs; (2) implement such programs to meet the policy, objectives, goals, and performance criteria established by this Act; and (3) develop and implement a National Surface Transportation Performance Plan. Authorizes the Secretary to amend the goals established under this Act.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Enhancing Renewable Energy Investment Act''. SEC. 2. INCREASE OF ENERGY CREDIT FOR EQUIPMENT USED TO GENERATE ELECTRICITY BY GEOTHERMAL POWER. (a) In General.--Clause (i) of section 48(a)(2)(A) of the Internal Revenue Code of 1986 is amended-- (1) in subclause (III), by striking ``and''; and (2) by adding at the end the following: ``(V) energy property described in paragraph (3)(A)(iii), but only with respect to periods ending before January 1, 2017, and''. (b) Effective Date.--The amendments made by this section shall apply to property placed in service after the date of the enactment of this Act. SEC. 3. EXTENSION OF SPECIFIED ENERGY PROPERTY GRANTS IN LIEU OF CREDIT. (a) In General.--Subsection (a) of section 1603 of the American Recovery and Reinvestment Tax Act of 2009 is amended by striking ``unless such property--'' and all that follows through the period at the end and inserting the following: ``unless such property is placed in service before the credit termination date with respect to such property.''. (b) Effective Date.--The amendment made by this section shall apply to grants made after the date of the enactment of this Act. SEC. 4. NONQUALIFIED DEFERRED COMPENSATION FROM CERTAIN TAX INDIFFERENT PARTIES. (a) In General.--Subpart B of part II of subchapter E of chapter 1 of the Internal Revenue Code of 1986 is amended by inserting after section 457 the following new section: ``SEC. 457A. NONQUALIFIED DEFERRED COMPENSATION FROM CERTAIN TAX INDIFFERENT PARTIES. ``(a) In General.--Any compensation which is deferred under a nonqualified deferred compensation plan of a nonqualified entity shall be includible in gross income when there is no substantial risk of forfeiture of the rights to such compensation. ``(b) Nonqualified Entity.--For purposes of this section, the term `nonqualified entity' means-- ``(1) any foreign corporation unless substantially all of its income is-- ``(A) effectively connected with the conduct of a trade or business in the United States, or ``(B) subject to a comprehensive foreign income tax, and ``(2) any partnership unless substantially all of its income is allocated to persons other than-- ``(A) foreign persons with respect to whom such income is not subject to a comprehensive foreign income tax, and ``(B) organizations which are exempt from tax under this title. ``(c) Determinability of Amounts of Compensation.-- ``(1) In general.--If the amount of any compensation is not determinable at the time that such compensation is otherwise includible in gross income under subsection (a)-- ``(A) such amount shall be so includible in gross income when determinable, and ``(B) the tax imposed under this chapter for the taxable year in which such compensation is includible in gross income shall be increased by the sum of-- ``(i) the amount of interest determined under paragraph (2), and ``(ii) an amount equal to 20 percent of the amount of such compensation. ``(2) Interest.--For purposes of paragraph (1)(B)(i), the interest determined under this paragraph for any taxable year is the amount of interest at the underpayment rate under section 6621 plus 1 percentage point on the underpayments that would have occurred had the deferred compensation been includible in gross income for the taxable year in which first deferred or, if later, the first taxable year in which such deferred compensation is not subject to a substantial risk of forfeiture. ``(d) Other Definitions and Special Rules.--For purposes of this section-- ``(1) Substantial risk of forfeiture.-- ``(A) In general.--The rights of a person to compensation shall be treated as subject to a substantial risk of forfeiture only if such person's rights to such compensation are conditioned upon the future performance of substantial services by any individual. ``(B) Exception for compensation based on gain recognized on an investment asset.-- ``(i) In general.--To the extent provided in regulations prescribed by the Secretary, if compensation is determined solely by reference to the amount of gain recognized on the disposition of an investment asset, such compensation shall be treated as subject to a substantial risk of forfeiture until the date of such disposition. ``(ii) Investment asset.--For purposes of clause (i), the term `investment asset' means any single asset (other than an investment fund or similar entity)-- ``(I) acquired directly by an investment fund or similar entity, ``(II) with respect to which such entity does not (nor does any person related to such entity) participate in the active management of such asset (or if such asset is an interest in an entity, in the active management of the activities of such entity), and ``(III) substantially all of any gain on the disposition of which (other than such deferred compensation) is allocated to investors in such entity. ``(iii) Coordination with special rule.-- Paragraph (3)(B) shall not apply to any compensation to which clause (i) applies. ``(2) Comprehensive foreign income tax.--The term `comprehensive foreign income tax' means, with respect to any foreign person, the income tax of a foreign country if-- ``(A) such person is eligible for the benefits of a comprehensive income tax treaty between such foreign country and the United States, or ``(B) such person demonstrates to the satisfaction of the Secretary that such foreign country has a comprehensive income tax. ``(3) Nonqualified deferred compensation plan.-- ``(A) In general.--The term `nonqualified deferred compensation plan' has the meaning given such term under section 409A(d), except that such term shall include any plan that provides a right to compensation based on the appreciation in value of a specified number of equity units of the service recipient. ``(B) Exception.--Compensation shall not be treated as deferred for purposes of this section if the service provider receives payment of such compensation not later than 12 months after the end of the taxable year of the service recipient during which the right to the payment of such compensation is no longer subject to a substantial risk of forfeiture. ``(4) Exception for certain compensation with respect to effectively connected income.--In the case of a foreign corporation with income which is taxable under section 882, this section shall not apply to compensation which, had such compensation had been paid in cash on the date that such compensation ceased to be subject to a substantial risk of forfeiture, would have been deductible by such foreign corporation against such income. ``(5) Application of rules.--Rules similar to the rules of paragraphs (5) and (6) of section 409A(d) shall apply. ``(e) Regulations.--The Secretary shall prescribe such regulations as may be necessary or appropriate to carry out the purposes of this section, including regulations disregarding a substantial risk of forfeiture in cases where necessary to carry out the purposes of this section.''. (b) Conforming Amendment.--Section 26(b)(2) of such Code is amended by striking ``and'' at the end of subparagraph (V), by striking the period at the end of subparagraph (W) and inserting ``, and'', and by adding at the end the following new subparagraph: ``(X) section 457A(c)(1)(B) (relating to determinability of amounts of compensation).''. (c) Clerical Amendment.--The table of sections of subpart B of part II of subchapter E of chapter 1 of such Code is amended by inserting after the item relating to section 457 the following new item: ``Sec. 457A. Nonqualified deferred compensation from certain tax indifferent parties.''. (d) Effective Date.-- (1) In general.--Except as otherwise provided in this subsection, the amendments made by this section shall apply to amounts deferred which are attributable to services performed after December 31, 2008. (2) Application to existing deferrals.--In the case of any amount deferred to which the amendments made by this section do not apply solely by reason of the fact that the amount is attributable to services performed before January 1, 2009, to the extent such amount is not includible in gross income in a taxable year beginning before 2018, such amounts shall be includible in gross income in the later of-- (A) the last taxable year beginning before 2018, or (B) the taxable year in which there is no substantial risk of forfeiture of the rights to such compensation (determined in the same manner as determined for purposes of section 457A of the Internal Revenue Code of 1986, as added by this section). (3) Accelerated payments.--No later than 120 days after the date of the enactment of this Act, the Secretary shall issue guidance providing a limited period of time during which a nonqualified deferred compensation arrangement attributable to services performed on or before December 31, 2008, may, without violating the requirements of section 409A(a) of the Internal Revenue Code of 1986, be amended to conform the date of distribution to the date the amounts are required to be included in income. (4) Certain back-to-back arrangements.--If the taxpayer is also a service recipient and maintains one or more nonqualified deferred compensation arrangements for its service providers under which any amount is attributable to services performed on or before December 31, 2008, the guidance issued under paragraph (4) shall permit such arrangements to be amended to conform the dates of distribution under such arrangement to the date amounts are required to be included in the income of such taxpayer under this subsection. (5) Accelerated payment not treated as material modification.--Any amendment to a nonqualified deferred compensation arrangement made pursuant to paragraph (4) or (5) shall not be treated as a material modification of the arrangement for purposes of section 409A of the Internal Revenue Code of 1986.

Summary: Enhancing Renewable Energy Investment Act - Amends the Internal Revenue Code to: (1) allow a 30% energy tax credit through 2016 for equipment used to produce electricity by geothermal power; and (2) require the inclusion in gross income for income tax purposes of employee compensation deferred under a nonqualified deferred compensation plan of certain foreign entities when there is no substantial risk of forfeiture of the rights to such compensation. Amends the American Recovery and Reinvestment Tax Act of 2009 to allow an extension of the grant period for specified energy property in lieu of applicable tax credits.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Coastal Barrier Resources Reauthorization Act of 1999''. SEC. 2. ADDITIONS TO COASTAL BARRIER RESOURCES SYSTEM. (a) Voluntary Additions.--Section 4 of the Coastal Barrier Resources Act (16 U.S.C. 3503) is amended by adding at the end the following: ``(d) Voluntary Additions to System.--The Secretary may add any parcel of real property to the System, if-- ``(1) the owner of the parcel requests that the Secretary add the parcel to the System; and ``(2) the parcel is a depositional geologic feature described in section 3(1)(A).''. (b) Technical Amendments Relating to Additions of Excess Property.-- (1) In general.--Section 4(d) of the Coastal Barrier Improvement Act of 1990 (16 U.S.C. 3503 note)-- (A) is redesignated and moved so as to appear as subsection (e) of section 4 of the Coastal Barrier Resources Act (16 U.S.C. 3503); and (B) is amended-- (i) in paragraph (1) by striking ``one hundred and eighty'' and inserting ``180''; (ii) in paragraph (2) by striking ``subsection (d)(1)'' and inserting ``paragraph (1)''; and (iii) by striking paragraph (3). (2) Conforming amendment.--Section 4(f) of the Coastal Barrier Improvement Act of 1990 (16 U.S.C. 3503 note) is repealed. (c) Notice Regarding Additions to System.--Section 4 of the Coastal Barrier Resources Act (16 U.S.C. 3503) is further amended by adding at the end the following: ``(f) Notice Regarding Additions to System.--The Secretary shall-- ``(1) publish in the Federal Register a notice of any addition of property to the System under this section, including notice of the availability of a map showing the location of the property; ``(2) provide a copy of that map to the State and local government in which the property is located and the Committee on Resources of the House of Representatives; and ``(3) revise the maps referred to in subsection (a) to reflect the addition of the property to the System.''. (d) Conforming Amendment.--Subsection (a) of section 4 of the Coastal Barrier Resources Act (16 U.S.C. 3503(a)) is amended by striking ``, which shall consist of'' and all that follows through the end of that subsection and inserting the following: ``, that-- ``(1) shall consist of those undeveloped coastal barriers and other areas located on the coasts of the United States that are identified and generally depicted on the set of maps on file with the Secretary entitled `Coastal Barrier Resources System', dated October 24, 1990, as such maps may be modified, revised, corrected, or replaced under subsection (c), (d), or (e) of this section, or any other provision of law enacted on or after November 16, 1990, that specifically authorizes the modification, revision, correction, or replacement; and ``(2) includes areas added to the System in accordance with subsection (d) or (e).''. SEC. 3. CLERICAL AMENDMENTS. (a) Coastal Barrier Resources Act.--The Coastal Barrier Resources Act (16 U.S.C. 3501 et seq.) is amended-- (1) in section 3(3) (16 U.S.C. 3502(3)), in the matter following subparagraph (D), by striking ``Effective October 1, 1983, such'' and inserting ``Such''; and (2) by repealing section 10 (16 U.S.C. 3509). (b) Coastal Barrier Improvement Act of 1990.--Section 8 of the Coastal Barrier Improvement Act of 1990 (16 U.S.C. 3503 note) is repealed. SEC. 4. AUTHORIZATION OF APPROPRIATIONS. Section 12 of the Coastal Barrier Resources Act (16 U.S.C. 3510) is redesignated as section 10 and amended to read as follows: ``SEC. 10. AUTHORIZATION OF APPROPRIATIONS. ``There are authorized to be appropriated to the Secretary to carry out this Act $2,000,000 for each of fiscal years 2000, 2001, 2002, 2003, and 2004.''. SEC. 5. DIGITAL MAPPING PILOT PROJECT. (a) Requirement to Undertake Project.-- (1) In general.--The Secretary of the Interior, in consultation with the Director of the Federal Emergency Management Agency, shall undertake a pilot project to determine the feasibility and cost of creating digital versions of the Coastal Barrier Resources System maps referred to in section 4(a)(1) of the Coastal Barrier Resources Act, as amended by this Act. The pilot project shall include the creation of digital maps for at least 5 units of the System. (2) Use of existing data.--(A) To the extent practicable, in completing the pilot project under this subsection, the Secretary shall use existing digital spatial data including digital orthophotos; shoreline, elevation, and bathymetric data; and electronic navigational charts in the possession of other Federal agencies, including the United States Geological Survey and the National Oceanic and Atmospheric Administration. (B) The head of any Federal agency that possesses digital spatial data referred to in subparagraph (A) shall promptly provide that data to the Secretary at no cost upon request by the Secretary. (3) Obtaining additional data.--If the Secretary determines that data necessary to complete the pilot project under this subsection does not exist, the Secretary shall enter into an agreement with the Director of the United States Geological Survey under which the Director shall obtain, in cooperation with other Federal agencies, as appropriate, and provide to the Secretary any digital spatial data required to carry out this subsection. (4) Data standards.--All digital spatial data used or created to carry out this subsection shall comply with the National Spatial Data Infrastructure established by Executive Order 12906 and any other standards established by the Federal Geographic Data Committee established by the Office of Management and Budget Circular A-16. (5) Digital maps not controlling.--Any determination of whether a location is inside or outside of the System shall be made without regard to the digital maps prepared under this subsection. (6) Report.--(A) Not later than 2 years after the date of the enactment of this Act, the Secretary shall submit a report to the Committee on Resources of the House of Representatives that describes the results of the pilot project and the feasibility, data needs, and costs of completing digital maps for the entire System. (B) The report shall include a description of-- (i) the cooperative agreements entered into by the Secretary with other Federal agencies to complete the pilot project and cooperative agreements needed to complete digital mapping of the entire System; (ii) the availability of existing data to complete digital mapping of the entire System; (iii) the need for additional data to complete digital mapping of the entire System; and (iv) the funding needed to complete digital mapping of the entire System. (b) Authorization of Appropriations.--There are authorized to be appropriated to the Secretary of the Interior $500,000 for each of fiscal years 2000, 2001, and 2002 to carry out the pilot project required under this section. SEC. 6. CORRECTIONS TO MAPS RELATING TO UNIT P19-P. (a) In General.--The Secretary of the Interior shall, before the end of the 30-day period beginning on the date of the enactment of this Act, make such corrections to the map described in subsection (b) as are necessary to ensure that depictions of areas on that map are consistent with the depictions of areas appearing on the map relating to unit P19-P entitled ``Amendment to the Coastal Barrier Resources System'' and dated September 16, 1998. (b) Map Described.--The map described in this subsection is the map that-- (1) is included in a set of maps entitled ``Coastal Barrier Resources System'', dated November 2, 1994; and (2) relates to unit P19-P of the Coastal Barrier Resources System. SEC. 7. REPLACEMENT OF MAPS RELATING TO UNITS NC-03P AND L03. (a) In General.--The 7 maps included in the set of maps entitled ``Coastal Barrier Resources System'' and referred to in section 4(a)(1) of the Coastal Barrier Resources Act, as amended by this Act, relating to the portions of Coastal Barrier Resources System units NC-03P and L03 located in Dare County, North Carolina, are hereby replaced by other maps relating to that unit that are entitled ``DARE COUNTY, NORTH CAROLINA, Coastal Barrier Resources System, Cape Hatteras Unit NC-03P'' or ``DARE COUNTY, NORTH CAROLINA, Coastal Barrier Resources System, Cape Hatteras Unit NC-03P, Hatteras Island Unit L03'' and dated July 1, 1999. (b) Availability.--The Secretary of the Interior shall keep the maps referred to in subsection (a) on file and available for inspection in accordance with the provisions of section 4(b) of the Coastal Barrier Resources Act (16 U.S.C. 3503(b)). SEC. 8. CORRECTIONS TO MAP RELATING TO UNIT DE-03P. (a) In General.--Not later than 30 days after the date of enactment of this Act, the Secretary of the Interior shall make such corrections to the map described in subsection (b) as are necessary to move on that map the boundary of the otherwise protected area (as defined in section 12 of the Coastal Barrier Improvement Act of 1990 (16 U.S.C. 3503 note; Public Law 101-591)) to the Cape Henlopen State Park boundary to the extent necessary-- (1) to exclude from the otherwise protected area the adjacent property leased, as of the date of enactment of this Act, by the Barcroft Company and Cape Shores Associates (which are privately held corporations under the law of the State of Delaware); and (2) to include in the otherwise protected area the northwestern corner of Cape Henlopen State Park seaward of the Lewes and Rehoboth Canal. (b) Map Described.--The map described in this subsection is the map that is included in a set of maps entitled ``Coastal Barrier Resources System'', dated October 24, 1990, as revised October 15, 1992, and that relates to the unit of the Coastal Barrier Resources System entitled ``Cape Henlopen Unit DE-03P''. Passed the House of Representatives September 21, 1999. Attest: JEFF TRANDAHL, Clerk.

Summary: Coastal Barrier Resources Reauthorization Act of 1999 - Amends the Coastal Barrier Resources Act to authorize the Secretary of the Interior to add any parcel of real property to the Coastal Barrier Resources System if the parcel's owner so requests and the parcel is a depositional geologic feature described in specified provisions. Moves from the Coastal Barrier Improvement Act of 1990 to the Coastal Barrier Resources Act provisions relating to additions to the System of excess government property and amends the Coastal Barrier Improvement Act of 1990 to repeal notice provisions relating to the moved provisions. Amends the Coastal Barrier Resources Act to impose notice requirements regarding any System addition. (Sec. 4) Authorizes appropriations to carry out the Coastal Barrier Resources Act. (Sec. 5) Mandates a pilot project and report to a specified House of Representatives committee on the feasibility and cost of creating digital versions of System maps. Authorizes appropriations. (Sec. 6) Mandates corrections to the System map for unit P19-P (North Captiva Island, Florida) to make that map consistent with a specified map. (Sec. 7) Replaces seven System maps relating to units NC-03P and L03 in Dare County, North Carolina, with other specified maps. (Sec. 8) Directs the Secretary of the Interior to make corrections to a specified Coastal Barrier Resources map as necessary to move the boundary of the otherwise-protected area to the Cape Henlopen Sate Park boundary to the extent necessary to exclude from the otherwise- protected area the adjacent property leased by the Barcroft Company and Cape Shores Associates, privately held corporations under the law of the State of Delaware, and to include in the otherwise-protected area the northeastern corner of Cape Henlopen State Park seaward of the Lewes and Rehoboth Canal.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Good Neighbor Social Security Office and Community Protection Act of 2012''. SEC. 2. FINDINGS. Congress finds that: (1) As of March 2012, more than 61,000,000 Americans received benefits from the Social Security Administration. (2) Americans depend upon convenient access to Social Security Administration field offices. (3) The Social Security Administration faces growing financial constraints consistent with the fiscal emergency faced by the Nation. (4) Americans rightly expect the Social Security Administration to meet its financial objectives through methods that preserve service standards to the highest degree possible. (5) The Social Security Administration is in the process of closing large numbers of field offices in an effort that is expected to last several years. (6) The Social Security Administration is closing field offices without adequate community input and process transparency. (7) The shortcomings in the Social Security Administration's process for closing field offices are due in part to an absence of a statutorily defined field office closure procedures that protect the interests of all interested parties. (8) Social Security beneficiaries and the communities surrounding Social Security field offices deserve notice of office closures, an opportunity to offer comment and have those comments given due consideration, and a clear plan to minimize service disruption from an office closure. SEC. 3. DEFINITIONS. In this Act: (1) Administration.--The term ``Administration'' means the Social Security Administration. (2) Closure.--The term ``closure'' includes any realignment, consolidation, or merger of an Administration field office. (3) Commissioner.--The term ``Commissioner'' means the Commissioner of Social Security. (4) State.--The term ``State'' means each of the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northen Mariana Islands. SEC. 4. GUIDELINES AND STANDARDIZED PROCEDURES FOR CLOSURE OF SOCIAL SECURITY ADMINISTRATION FIELD OFFICES. (a) Guidelines for Identification of Offices for Possible Closure.--Not later than 180 days after the date of enactment of this Act, the Commissioner shall develop and publish-- (1) financial guidelines that may be used to identify Administration field offices for possible closure; and (2) standardized closure procedures that meet the requirements of section 5. (b) Non-Binding.--The financial guidelines and standardized closure procedures developed under subsection (a) shall provide that identification of an Administration field office for possible closure shall not require the Commissioner to begin closure procedures for any field office identified as a result of the application of such guidelines or the initiation of such procedures. SEC. 5. REQUIREMENTS FOR CLOSURE OF SOCIAL SECURITY ADMINISTRATION FIELD OFFICES. (a) Office Closure and Service Continuity Proposal.--In any case where the Commissioner has identified an Administration field office for possible closure as a result of the application of the financial guidelines developed under section 4 and decides to initiate procedures to close that field office, the Commissioner shall develop an office closure and service continuity proposal for the office that contains the following information: (1) The financial justification for the proposed office closure, with estimated savings in costs relating to real estate, labor, and miscellaneous expenses. (2) The estimated cost of the office closure. (3) Data for monthly customer traffic at the office. (4) The location of the two nearest Administration field offices that would remain open after the office closure. (5) The estimated travel time, by private vehicle and public transit, from the Administration field office proposed for closure and the two nearest Administration field offices that would remain open after the office closure. (6) The steps the Administration plans to take to mitigate any hardship created by the office closure. (7) The names and addresses of governmental agencies and community organizations to be notified in accordance with subsection (b). (8) The postal and electronic addresses for which public comments may be sent in accordance with subsection (c). (b) Notices Required Prior to Final Closure Decision.-- (1) In general.--Not less than 90 days prior to the proposed closure date for an Administration field office, the Commissioner shall-- (A) provide copies of the office closure and service continuity proposal developed for the Administration field office to-- (i) the chief executive office of the State in which field office proposed for closure is located; (ii) the chief executive officers for the county and city government jurisdictions in which the field office proposed for closure is located; and (iii) the head of the social services agencies that receive Federal funds that are located within a 10-mile radius of the field office proposed for closure; (B) publish the proposal in newspapers whose circulation area includes areas served by the field office proposed for closure; and (C) broadcast the proposal over Federally licensed radio stations whose broadcast area includes areas served by the field office proposed for closure. (2) Records.--The Commissioner shall maintain records of the dates on which the notices, publications, and broadcasts required under paragraph (1) are made. (c) Public Comment Required Prior to Final Closure Decision.-- (1) In general.--The Commissioner shall hold at least 1 hearing at which public comments may be made prior making any final decision to close an Administration field office. The Commissioner also shall provide postal and electronic addresses for which written comments regarding the proposed closure may be submitted. (2) Notice.--The date and time for the public comment hearing on the proposed closure of an Administration field office shall be included in the notices, publications, and broadcasts required under subsection (b). (3) Timing.--The public comment hearing shall be held at least 21 days after notice of the date and time for the hearing is made in accordance with paragraph (2) and at least 60 days prior to the proposed closure date for the Administration field office. (4) Attendance.--The Regional Commissioner for the region in which the Administration field office proposed for closure is located shall attend the public comment hearing. Only in cases where Regional Commissioner is, in good faith, unable to attend the hearing, may a designated representative attend the public comment hearing in lieu of the Regional Commissioner. (5) Format.--The public comment hearing shall be conducted as follows: (A) The hearing shall begin with a presentation by the Commissioner of the case for closure of the field office. (B) The hearing shall then provide at least 1 hour following the conclusion of the presentation of the case for closure for comments from elected officials. (C) Following the conclusion of the period for comment from elected officials, the hearing shall then provide at least 1 hour for comments from the public. (6) Records.--The Commissioner shall maintain a record of the comments provided at the hearing and shall include in the record any written comments received regarding the proposed closure of the field office. The Commissioner shall publish the record on the Administration Web site within 5 days after the conclusion of the public comment hearing. (d) Final Closure Decision.-- (1) In general.--The Commissioner shall issue a final closure decision regarding an Administration field office only after review of the comments received regarding the closure and evaluation of any alternatives to closing the office that are made at the public comment hearing or through written submission. (2) Notice.--Notice of the Commissioner's final closure decision with respect to an Administration field office shall be published on the Administration Web site and shall be distributed, published, and broadcast in the same manner as notice of the office closure and service continuity proposal is made under subsection (b). (3) Decision to close.--If the Commissioner's final closure decision is to close a field office, the Commissioner shall amend the office closure and service continuity proposal for the field office to incorporate additional information obtained during the public comment period. (4) Timing.--Notice of the Commissioner's final closing decision shall be provided at least 45 days prior to a closing date for a field office. (e) Additional Requirements.--The Commissioner shall continue to operate an Administration field office proposed for closure in good faith and with the assumption of continued service, until notice of the Commissioner's final closure decision is made. The Commissioner shall not take any action to close an Administration field office prior to providing notice of the Commissioner's final closure decision, including-- (1) terminating or providing notice to terminate any real estate lease, rental, or similar arrangement; (2) concluding agreements with collective bargaining units related to the office closure; (3) making expenditures related to the proposed office closure, except those necessary to fulfill the requirements of this Act; and (4) entering into contracts related to the proposed office closure, except those necessary to fulfill the process requirements of this Act. (f) Extensions of Time for Closure.--The Commissioner may-- (1) toll any time periods for action established by this Act, provided that an equivalent delay in the proposed closing date is made; and (2) delay the proposed closing date for an Administration field office at any time in the closing process, including, if the final closure decision is to close the office, after making that decision. SEC. 6. NON-APPLICABILITY TO DISPOSAL OF REAL PROPERTY RELATED TO CLOSED OFFICES. Nothing in this Act shall be construed to prevent or delay the speedy disposal of surplus Government real property, including any Administration field offices closed in accordance with the requirements of this Act.

Summary: Good Neighbor Social Security Office and Community Protection Act of 2012 - Directs the Commissioner of Social Security to develop and publish: (1) financial guidelines that may be used to identify Social Security Administration field offices for possible closure, and (2) standardized closure procedures that meet certain requirements. Requires such guidelines and procedures to provide that identification of an Administration field office for possible closure shall not require the Commissioner to begin closure procedures for it. Requires the Commissioner to: (1) develop an office closure and service continuity proposal for any office so identified which the Commissioner decides to close that contains, among other specified items, the estimated cost of the closure; (2) notify state and local chief executive offices and the public before closure; (3) require the Commissioner to hold at least one hearing to take public comments before making a final decision to close a field office; (5) issue a final closure decision only after review of such comments and evaluation of any alternatives to closing the office; and (6) continue to operate an office proposed for closure in good faith and with the assumption of continued service until the notice of the Commisioner's final closure decision is made.


SECTION 1. FINDINGS. The Congress finds that-- (1) the Russian Federation has adopted constitutional protections and statutory and administrative procedures that accord its citizens the right and opportunity to emigrate, free of anything more than a nominal tax on emigration or on the visas or other documents required for emigration and free of any tax, levy, fine, fee, or other charge on any citizens as a consequence of the desire of such citizens to emigrate to the country of their choice or to return to the Russian Federation; (2) the Russian Federation has been found to be in full compliance with the freedom of emigration requirements under title IV of the Trade Act of 1974 since 1994; (3) the Russian Federation has taken important steps toward the creation of democratic institutions and a free-market economy and, as a participating state of the Organization for Security and Cooperation in Europe (in this Act referred to as the ``OSCE''), is committed to developing a system of governance in accordance with the principles regarding human rights and humanitarian affairs that are set forth in the Final Act of the Conference on Security and Cooperation in Europe (also known as the ``Helsinki Final Act'') and successive documents; (4) the Russian Federation is committed to addressing issues relating to its national and religious minorities as a participating state of the OSCE, to adopting measures to ensure that persons belonging to national minorities have full equality both individually and communally, and to respecting the independence of minority religious communities, although problems still exist regarding the registration of religious groups, visa, and immigration requirements, and other laws, regulations, and practices that interfere with the activities or internal affairs of minority religious communities; (5) the Russian Federation has enacted legislation providing protection against discrimination or incitement to violence against persons or groups based on national, racial, ethnic, or religious discrimination, including anti-Semitism; (6) the Russian Federation has committed itself, including through exchanges of letters, to ensuring freedom of religion, equal treatment of all religious groups, and combating racial, ethnic, and religious intolerance and hatred, including anti- Semitism; (7) the Russian Federation has engaged in efforts to combat ethnic and religious intolerance by cooperating with various United States nongovernmental organizations; (8) the Russian Federation is continuing the restitution of religious properties, including religious and communal properties confiscated from national and religious minorities during the Soviet era, facilitating the reemergence of these minority groups in the national life of the Russian Federation, and has committed itself, including through exchanges of letters, to continue the restitution of such properties; (9) the Russian Federation has received normal trade relations treatment since concluding a bilateral trade agreement with the United States that entered into force on June 17, 1992; (10) the Russian Federation is making progress toward accession to the World Trade Organization, recognizing that many central issues remain to be resolved, including removal of unjustified restrictions on agricultural products of the United States, commitments relating to tariff reductions for goods, trade in services, protection of intellectual property rights, reform of the industrial energy sector, elimination of export incentives for industrial goods, reform of customs procedures and technical, sanitary, and phytosanitary measures, and inclusion of trade remedy provisions; (11) the Russian Federation has enacted some protections reflecting internationally recognized labor rights, but serious gaps remain both in the country's legal regime and its enforcement record; (12) the Russian Federation has provided constitutional guarantees of freedom of the press, although infringements of this freedom continue to occur; and (13) the Russian Federation has demonstrated a strong desire to build a friendly and cooperative relationship with the United States. SEC. 2. TERMINATION OF APPLICATION OF TITLE IV OF THE TRADE ACT OF 1974 TO THE RUSSIAN FEDERATION. (a) Presidential Determinations and Extensions of Nondiscriminatory Treatment.--Notwithstanding any provision of title IV of the Trade Act of 1974 (19 U.S.C. 2431 et seq.), the President may-- (1) determine that such title should no longer apply to the Russian Federation; and (2) after making a determination under paragraph (1) with respect to the Russian Federation, proclaim the extension of nondiscriminatory treatment (normal trade relations treatment) to the products of that country. (b) Termination of Application of Title IV.--On and after the effective date of the extension under subsection (a)(2) of nondiscriminatory treatment to the products of the Russian Federation, chapter 1 of title IV of the Trade Act of 1974 shall cease to apply to that country. SEC. 3. POLICY OF THE UNITED STATES. It is the policy of the United States to remain fully committed to a multifaceted engagement with the Russian Federation, including by-- (1) urging the Russian Federation to ensure that its national, regional, and local laws, regulations, practices, and policies fully, and in conformity with the standards of the OSCE-- (A) provide for the free emigration of its citizens; (B) safeguard religious liberty throughout the Russian Federation, including by ensuring that the registration of religious groups, visa and immigration requirements, and other laws, regulations, and practices are not used to interfere with the activities or internal affairs of minority religious communities; (C) enforce and enhance existing Russian laws at the national and local levels to combat ethnic, religious, and racial discrimination and related violence; (D) expand the restitution of religious and communal properties, including by establishing a legal framework for the timely completion of such restitution; and (E) respect fully freedom of the press; (2) working with the Russian Federation, including through the Secretary of Labor and other appropriate executive branch officials, to address the issues described in section 1(11); and (3) continuing rigorous monitoring by the United States of human rights issues in the Russian Federation, including the issues described in paragraphs (1) and (2), providing assistance to nongovernmental organizations and human rights groups involved in human rights activities in the Russian Federation, and promoting annual discussions and ongoing dialog with the Russian Federation regarding those issues, including the participation of United States and Russian nongovernmental organizations in such discussions. SEC. 4. REPORTING REQUIREMENT. The reports required by sections 102(b) and 203 of the International Religious Freedom Act of 1998 (22 U.S.C. 6412(b) and 6433) shall include an assessment of the status of the issues described in subparagraphs (A) through (D) of section 3(1). SEC. 5. CONTINUED ENJOYMENT OF RIGHTS UNDER THE JUNE 17, 1992, BILATERAL TRADE AGREEMENT. (a) Finding.--The Congress finds that the trade agreement between the United States and the Russian Federation that entered into force on June 17, 1992, remains in force between the 2 countries and provides the United States with important rights, including the right to use specific safeguard rules to respond to import surges from the Russian Federation. (b) Applicability of Safeguard.--Section 421 of the Trade Act of 1974 (19 U.S.C. 2451) shall apply to the Russian Federation to the same extent as such section applies to the People's Republic of China. SEC. 6. EXERCISE OF CONGRESSIONAL OVERSIGHT OVER WTO ACCESSION NEGOTIATIONS. (a) Notice of Agreement on Accession to WTO by Russian Federation.--Not later than 5 days after the date on which the United States has entered into a bilateral agreement with the Russian Federation on the terms of accession by the Russian Federation to the World Trade Organization, the President shall so notify the Congress, and the President shall transmit to the Congress, not later than 15 days after that agreement is entered into, a report that sets forth the provisions of that agreement. (b) Resolution of Disapproval.-- (1) Introduction.--If a resolution of disapproval is introduced in the House of Representatives or the Senate during the 30-day period (not counting any day which is excluded under section 154(b) of the Trade Act of 1974 (19 U.S.C. 2194(b)), beginning on the date on which the President first notifies the Congress under subsection (a) of the agreement referred to in that subsection, that resolution of disapproval shall be considered in accordance with this subsection. (2) Resolution of disapproval.--In this subsection, the term ``resolution of disapproval'' means only a joint resolution of the two Houses of the Congress, the matter after the resolving clause of which is as follows: ``That the Congress does not approve the agreement between the United States and the Russian Federation on the terms of accession by the Russian Federation to the World Trade Organization, of which Congress was notified on ____.'', with the blank space being filled with the appropriate date. (3) Procedures for considering resolutions.-- (A) Introduction and referral.--Resolutions of disapproval-- (i) in the House of Representatives-- (I) may be introduced by any Member of the House; (II) shall be referred to the Committee on Ways and Means and, in addition, to the Committee on Rules; and (III) may not be amended by either Committee; and (ii) in the Senate-- (I) may be introduced by any Member of the Senate; (II) shall be referred to the Committee on Finance; and (III) may not be amended. (B) Committee discharge and floor consideration.-- The provisions of subsections (c) through (f) of section 152 of the Trade Act of 1974 (19 U.S.C. 2192(c) through (f)) (relating to committee discharge and floor consideration of certain resolutions in the House and Senate) apply to a resolution of disapproval to the same extent as such subsections apply to resolutions under such section. (c) Rules of House of Representatives and Senate.--Subsection (b) is enacted by the Congress-- (1) as an exercise of the rulemaking power of the House of Representatives and the Senate, respectively, and as such are deemed a part of the rules of each House, respectively, and such procedures supersede other rules only to the extent that they are inconsistent with such other rules; and (2) with the full recognition of the constitutional right of either House to change the rules (so far as relating to the procedures of that House) at any time, in the same manner, and to the same extent as any other rule of that House.

Summary: Authorizes the President to extend nondiscriminatory treatment (normal trade relations treatment) to the products of the Russian Federation.Declares that it is the policy of the United States to remain fully committed to a multifaceted engagement with the Russian Federation, including by urging the Russian Federation to ensure that its laws and policies in conformity with Organization for Security and Cooperation in Europe (OSCE) standards provide for the free emigration of its citizens and recognize human rights.Declares that the trade agreement between the United States and the Russian Federation that entered into force on June 17, 1992, remains in force and provides the United States with important rights, including the right to use specific safeguard rules to respond to import surges from the Russian Federation.Requires the President to notify Congress not later than five days after the United States has entered into a bilateral agreement with the Russian Federation on the terms of its accession to the World Trade Organization (WTO).Provides for congressional approval of such agreement.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Medicare Prescription Drug Lifeline Act of 2006''. SEC. 2. TEMPORARY PROCESS FOR INDIVIDUALS ENTERING THE MEDICARE COVERAGE GAP TO SWITCH TO A PLAN THAT PROVIDES COVERAGE IN THE GAP. (a) Process.--Notwithstanding any other provision of law, by not later than 30 days after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the ``Secretary'') shall establish a process under which an applicable individual may terminate enrollment in the prescription drug plan or the MA-PD plan in which they are enrolled and enroll in any prescription drug plan or MA-PD plan-- (1) that provides some coverage of covered part D drugs (as defined in subsection (e) of section 1860D-2 of the Social Security Act (42 U.S.C. 1395w-102)) after the individual has reached the initial coverage limit under the plan but has not reached the annual out-of-pocket threshold under subsection (b)(4)(B) of such section; and (2) subject to subsection (b), that serves the area in which the individual resides. (b) Special Rule Permitting Applicable Individuals to Enroll in a Prescription Drug Plan Outside of the Region in Which the Individual Resides.--In the case of an applicable individual that resides in a PDP region under section 1860D-11(a)(2) of the Social Security Act (42 U.S.C. 1395w-111(a)(2)) in which there is no prescription drug plan available that provides some coverage of brand name covered part D drugs (as so defined) after the individual has reached the initial coverage limit under the plan but before the individual has reached such annual out-of-pocket threshold, the Secretary shall ensure that the process established under subsection (a) permits the individual to enroll in a prescription drug plan that provides such coverage but is in another PDP region. The Secretary shall determine the PDP region in which the individual may enroll in such a prescription drug plan. (c) Notification of Applicable Individuals.--Under the process established under subsection (a), the Secretary shall notify, or require sponsors of prescription drug plans and organizations offering MA-PD plans to notify, applicable individuals of the option to change plans under such process. Such notice shall be provided to an applicable individual within 30 days of meeting the definition of such an individual. (d) Process in Effect for Remaining Portion of 2006.--The process established under subsection (a) shall remain in effect through December 31, 2006. (e) Definitions.--In this section: (1) Applicable individual.--The term ``applicable individual'' means a part D eligible individual (as defined in section 1860D-1(a)(3)(A) of the Social Security Act (42 U.S.C. 1395w-101(a)(3)(A)) who, with respect to a year-- (A) is enrolled in a prescription drug plan or an MA-PD plan that does not provide any coverage of covered part D drugs (as so defined) after the individual has reached the initial coverage limit under the plan but has not reached such annual out-of-pocket threshold; and (B) has reached such initial coverage limit or is within $750 of reaching such limit. (2) Prescription drug plan; ma-pd plan.--The terms ``prescription drug plan'' and ``MA-PD plan'' have the meanings given those terms in section 1860D-41(a)(14) of the Social Security Act (42 U.S.C. 1395w-151(a)(14)) and section 1860D- 1(a)(3)(C) of such Act (42 U.S.C. 1395w-101(a)(3)(C)), respectively. SEC. 3. GAO STUDY AND REPORT ON THE ELIMINATION OF THE MEDICARE PART D COVERAGE GAP. (a) Study.--The Comptroller General of the United States shall conduct a study on-- (1) the costs to the Medicare program of eliminating the initial coverage limit under paragraph (3) of section 1860D- 2(b) of the Social Security Act (42 U.S.C. 1395w-102(b)) (and providing that standard prescription drug coverage included the coverage described in paragraph (2) of such section until the individual reached the annual out-of-pocket threshold under subsection (b)(4)(B) of such section); and (2) the adjustment to the coinsurance under paragraph (2) of such section that would be necessary to eliminate the initial coverage limit (and provide that standard prescription drug coverage included such adjusted coinsurance amount until the individual reached such annual out-of-pocket threshold) without increasing the costs to the Medicare program. (b) Report.--Not later than May 1, 2007, the Comptroller General of the United States shall submit a report to Congress on the study conducted under subsection (a) together with such recommendations as the Comptroller General determines to be appropriate.

Summary: Medicare Prescription Drug Lifeline Act of 2006 - Directs the Secretary of Health and Human Services to establish a process under which an individual may terminate enrollment in the prescription drug plan or the Medicare Advantage Prescription Drug (MA-PD) Plan in which he or she is enrolled and enroll in any prescription drug plan or MA-PD Plan serving the area where the individual resides that provides some coverage of covered part D (Voluntary Prescription Drug Benefit Program) drugs after the individual has reached the initial coverage limit but not yet the annual out-of-pocket threshold. Sets forth a special rule permitting applicable individuals to enroll in a prescription drug plan outside the region in which they reside. Directs the Comptroller General to study and report to Congress on: (1) the costs to the Medicare program of eliminating the initial coverage limit and providing specified standard prescription drug coverage until the individual reaches the annual out-of-pocket threshold; and (2) the adjustment to the applicable coinsurance that would be necessary to eliminate the initial coverage limit under such conditions without increasing the costs to the Medicare program.