[Congressional Record (Bound Edition), Volume 158 (2012), Part 6]
[Senate]
[Pages 7629-7657]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 2127. Mr. DURBIN (for himself and Mr. Blumenthal) submitted an 
amendment intended to be proposed by him to the bill S. 3187, to amend 
the Federal Food, Drug, and Cosmetic Act to revise and extend the user-
fee programs for prescription drugs and medical devices, to establish 
user-fee programs for generic drugs and biosimilars, and for other 
purposes; which was ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. REGISTRATION OF FACILITIES WITH RESPECT TO DIETARY 
                   SUPPLEMENTS.

       (a) In General.--Section 415(a) (21 U.S.C. 350d(a)) is 
     amended by adding at the end the following:
       ``(6) Requirements with respect to dietary supplements.--
       ``(A) In general.--A facility engaged in the manufacturing 
     processing, packing, or holding of dietary supplements that 
     is required to register under this section shall comply with 
     the requirements of this paragraph, in addition to the other 
     requirements of this section.
       ``(B) Additional information.--A facility described in 
     subparagraph (A) shall submit a registration under paragraph 
     (1) that includes, in addition to the information required 
     under paragraph (2)--
       ``(i) a description of each dietary supplement product 
     manufactured by such facility;
       ``(ii) a list of all ingredients in each such dietary 
     supplement product; and
       ``(iii) a copy of the label and labeling for each such 
     product.
       ``(C) Registration with respect to new, reformulated, and 
     discontinued dietary supplement products.--
       ``(i) In general.--Not later than the date described in 
     clause (ii), if a facility described in subparagraph (A)--

       ``(I) manufactures a dietary supplement product that the 
     facility previously did not manufacture and for which the 
     facility did not submit the information required under 
     clauses (i) through (iii) of subparagraph (B);
       ``(II) reformulates a dietary supplement product for which 
     the facility previously submitted the information required 
     under clauses (i) through (iii) of subparagraph (B); or
       ``(III) no longer manufactures a dietary supplement for 
     which the facility previously submitted the information 
     required under clauses (i) through (iii) of subparagraph (B),

     such facility shall submit to the Secretary an updated 
     registration describing the change described in subclause 
     (I), (II), or (III) and, in the case of a facility described 
     in subclause (I) or (II), containing the information required 
     under clauses (i) through (iii) of subparagraph (B).
       ``(ii) Date described.--The date described in this clause 
     is--

       ``(I) in the case of a facility described in subclause (I) 
     of clause (i), 30 days after the date on which such facility 
     first markets the dietary supplement product described in 
     such subclause;
       ``(II) in the case of a facility described in subclause 
     (II) of clause (i), 30 days after the date on which such 
     facility first markets the reformulated dietary supplement 
     product described in such subclause; or
       ``(III) in the case of a facility described in subclause 
     (III) of clause (i), 30 days after the date on which such 
     facility removes the dietary supplement product described in 
     such subclause from the market.''.

       (b) Enforcement.--Section 403 (21 U.S.C. 343) is amended by 
     adding at the end the following:
       ``(z) If it is a dietary supplement for which a facility is 
     required to submit the registration information required 
     under section 415(a)(6) and such facility has not complied 
     with the requirements of such section 415(a)(6) with respect 
     to such dietary supplement.''.
                                 ______
                                 
  SA 2128. Mrs. GILLIBRAND (for herself and Mr. Blumenthal) submitted 
an amendment intended to be proposed by her to the bill S. 3187, to 
amend the Federal Food, Drug, and Cosmetic Act to revise and extend the 
user-fee programs for prescription drugs and medical devices, to 
establish user-fee programs for generic drugs and biosimilars, and for 
other purposes; which was ordered to lie on the table; as follows:

       At the end of title IX, add the following:

     SEC. 9__. PATIENT MEDICATION INFORMATION FOR PRESCRIPTION 
                   DRUGS.

       (a) Short Title.--This section may be cited as the ``Cody 
     Miller Initiative for Safer Prescriptions Act''.
       (b) Patient Medication Information for Prescription 
     Drugs.--Chapter V (21 U.S.C. 351 et seq.) is amended by 
     inserting after section 505E, as added by this Act, the 
     following:

     ``SEC. 505F. PATIENT MEDICATION INFORMATION FOR PRESCRIPTION 
                   DRUGS.

       ``(a) In General.--Not later than 2 years after the date of 
     enactment of this section, the Secretary shall issue 
     regulations regarding the authorship, content, format, and 
     dissemination requirements for patient medication information 
     (referred to in this section as `PMI') for drugs subject to 
     section 503(b)(1).
       ``(b) Content.--The regulations promulgated under 
     subsection (a) shall require that the PMI with respect to a 
     drug--
       ``(1) be scientifically accurate and based on the 
     professional labeling approved by the Secretary and 
     authoritative, peer-reviewed literature; and
       ``(2) includes nontechnical, understandable, plain language 
     that is not promotional in tone or content, and contains at 
     least--
       ``(A) the established name of drug, including the 
     established name of such drug as a listed drug (as described 
     in section 505(j)(2)(A)) and as a drug that is the subject

[[Page 7630]]

     of an approved abbreviated new drug application under section 
     505(j) or of an approved license for a biological product 
     submitted under section 351(k) of the Public Health Service 
     Act, if applicable;
       ``(B) drug uses and clinical benefits;
       ``(C) general directions for proper use;
       ``(D) contraindications, common side effects, and most 
     serious risks of the drug, especially with respect to certain 
     groups such as children, pregnant women, and the elderly;
       ``(E) measures patients may be able to take, if any, to 
     reduce the side effects and risks of the drug;
       ``(F) when a patient should contact his or her health care 
     professional;
       ``(G) instructions not to share medications, and, if any 
     exist, key storage requirements, and recommendations relating 
     to proper disposal of any unused portion of the drug; and
       ``(H) known clinically important interactions with other 
     drugs and substances.
       ``(c) Timeliness, Consistency, and Accuracy.--The 
     regulations promulgated under subsection (a) shall include 
     standards related to--
       ``(1) performing timely updates of drug information as new 
     drugs and new information becomes available;
       ``(2) ensuring that common information is applied 
     consistently and simultaneously across similar drug products 
     and for drugs within classes of medications in order to avoid 
     patient confusion and harm; and
       ``(3) developing a process, including consumer testing, to 
     assess the quality and effectiveness of PMI in ensuring that 
     PMI promotes patient understanding and safe and effective 
     medication use.
       ``(d) Electronic Repository.--The regulations promulgated 
     under subsection (a) shall provide for the development of a 
     publicly accessible electronic repository for all PMI 
     documents and content to facilitate the availability of 
     PMI.''.
       (c) Publication on Internet Website.--The Secretary of 
     Health and Human Services shall publish on the Internet 
     website of the Food and Drug Administration a link to the 
     Daily Med website (http://dailymed.nlm.nih.gov/dailymed) (or 
     any successor website).
                                 ______
                                 
  SA 2129. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 3187, to amend the Federal Food, Drug, and 
Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. REGULATIONS ON CLINICAL TRIAL REGISTRATION; GAO 
                   STUDY OF CLINICAL TRIAL REGISTRATION AND 
                   REPORTING REQUIREMENTS.

       (a) Definitions.--In this section--
       (1) the term ``applicable clinical trial'' has the meaning 
     given such term under section 402(j) of the Public Health 
     Service Act (42 U.S.C. 282(j));
       (2) the term ``Director'' means the Director of the 
     National Institutes of Health;
       (3) the term ``responsible party'' has the meaning given 
     such term under such section 402(j); and
       (4) the term ``Secretary'' means the Secretary of Health 
     and Human Services.
       (b) Required Regulations.--
       (1) Proposed rulemaking.--Not later than 180 days after the 
     date of enactment of this Act, the Secretary, acting through 
     the Director, shall issue a notice of proposed rulemaking for 
     a proposed rule on the registration of applicable clinical 
     trials by responsible parties under section 402(j) of the 
     Public Health Service Act (42 U.S.C. 282(j)) (as amended by 
     section 801 of the Food and Drug Administration Amendments 
     Act of 2007).
       (2) Final rule.--Not later than 180 days after the issuance 
     of the notice of proposed rulemaking under paragraph (1), the 
     Secretary, acting through the Director, shall issue the final 
     rule on the registration of applicable clinical trials by 
     responsible parties under such section 402(j).
       (3) Letter to congress.--If the final rule described in 
     paragraph (2) is not issued by the date required under such 
     paragraph, the Secretary shall submit to Congress a letter 
     that describes the reasons why such final rule has not been 
     issued.
       (c) Report by GAO.--
       (1) In general.--Not later than 2 years after the issuance 
     of the final rule under subsection (b), the Comptroller 
     General of the United States shall submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report on the implementation of the 
     registration and reporting requirements for applicable drug 
     and device clinical trials under section 402(j) the Public 
     Health Service Act (42 U.S.C. 282(j)) (as amended by section 
     801 of the Food and Drug Administration Amendments Act of 
     2007).
       (2) Content.--The report under paragraph (1) shall 
     include--
       (A) information on the rate of compliance and non-
     compliance (by category of sponsor, category of trial (phase 
     II, III, or IV), whether the applicable clinical trial is 
     conducted domestically, in foreign sites, or a combination of 
     sites, and such other categories as the Comptroller General 
     determines useful) with the requirements of--
       (i) registering applicable clinical trials under such 
     section 402(j);
       (ii) reporting the results of such trials under such 
     section; and
       (iii) the completeness of the reporting of the required 
     data under such section; and
       (B) information on the promulgation of regulations for the 
     registration of applicable clinical trials by the responsible 
     parties under such section 402(j).
       (3) Recommendations.--If the Comptroller General finds 
     problems with timely compliance or completeness of the data 
     being reported under such section 402(j), or finds that the 
     implementation of registration and reporting requirements 
     under such section 402(j) for applicable drug and device 
     clinical trials could be improved, the Comptroller General 
     shall, after consulting with the Commissioner of Food and 
     Drugs, applicable stakeholders, and experts in the conduct of 
     clinical trials, make recommendations for administrative or 
     legislative actions to increase the compliance with the 
     requirements of such section 402(j).
                                 ______
                                 
  SA 2130. Mr. BURR (for himself and Mr. Coburn) submitted an amendment 
intended to be proposed by him to the bill S. 3187, to amend the 
Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee 
programs for prescription drugs and medical devices, to establish user-
fee programs for generic drugs and biosimilars, and for other purposes; 
which was ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. TRANSPARENCY IN FDA USER FEE AGREEMENT 
                   NEGOTIATIONS.

       (a) PDUFA.--Section 736B(d) (21 U.S.C. 379h 2(d)), as 
     amended by section 104, is further amended by adding at the 
     end the following:
       ``(7) Inclusion of congressional representatives.--
     Notwithstanding any other provision of this section, Members 
     of Congress or their designated staff may be present at any 
     negotiation meeting conducted under this subsection between 
     the Food and Drug Administration and the regulated industry, 
     if a Member of Congress decides to attend, or have his or her 
     designated staff attend on his or her behalf. Any staff 
     designated under the preceding sentence may be required to 
     comply with applicable confidentiality agreements.''.
       (b) MDUFA.--Section 738A(b) (21 U.S.C. 379j 1(b)), as 
     amended by section 204, is further amended by adding at the 
     end the following:
       ``(7) Inclusion of congressional representatives.--
     Notwithstanding any other provision of this section, Members 
     of Congress or their designated staff may be present at any 
     negotiation meeting conducted under this subsection between 
     the Food and Drug Administration and the regulated industry, 
     if a Member of Congress decides to attend, or have his or her 
     designated staff attend on his or her behalf. Any staff 
     designated under the preceding sentence may be required to 
     comply with applicable confidentiality agreements.''.
       (c) GDUFA.--Section 744C(d), as added by section 303 of 
     this Act, is amended by adding at the end the following:
       ``(7) Inclusion of congressional representatives.--
     Notwithstanding any other provision of this section, Members 
     of Congress or their designated staff may be present at any 
     negotiation meeting conducted under this subsection between 
     the Food and Drug Administration and the regulated industry, 
     if a Member of Congress decides to attend, or have his or her 
     designated staff attend on his or her behalf. Any staff 
     designated under the preceding sentence may be required to 
     comply with applicable confidentiality agreements.''.
       (d) BSUFA.--Section 744I(e), as added by section 403 of 
     this Act, is amended by adding at the end the following:
       ``(4) Inclusion of congressional representatives.--
     Notwithstanding any other provision of this section, Members 
     of Congress or their designated staff may be present at any 
     negotiation meeting conducted under this subsection between 
     the Food and Drug Administration and the regulated industry, 
     if a Member of Congress decides to attend, or have his or her 
     designated staff attend on his or her behalf. Any staff 
     designated under the preceding sentence may be required to 
     comply with applicable confidentiality agreements.''.
                                 ______
                                 
  SA 2131. Mr. COBURN (for himself and Mr. Burr) submitted an amendment 
intended to be proposed by him to the bill S. 3187, to amend the 
Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee 
programs for prescription drugs and medical devices, to establish user-
fee programs for generic drugs and biosimilars, and for other purposes;

[[Page 7631]]

which was ordered to lie on the table; as follows:

       At the end of title VII, add the following:

     SEC. 7__. INDEPENDENT ASSESSMENT.

       (a) In General.--The Secretary shall contract with a 
     private, independent consulting firm capable of performing 
     the technical analysis, management assessment, and program 
     evaluation tasks required to conduct a comprehensive 
     assessment of the process for the review of drug applications 
     under subsections (b) and (j) of section 505 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(b), (j)) and 
     subsections (a) and (k) of section 351 of the Public Health 
     Service Act (42 U.S.C. 262(a), (k)). The assessment shall 
     address the premarket review process of drugs by the Food and 
     Drug Administration, using an assessment framework that draws 
     from appropriate quality system standards, including 
     management responsibility, documents controls and records 
     management, and corrective and preventive action.
       (b) Participation.--Representatives of the Food and Drug 
     Administration and manufacturers of drugs subject to user 
     fees under part 2 of subchapter C of chapter VII of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) 
     shall participate in a comprehensive assessment of the 
     process for the review of drug applications under section 505 
     of the Federal Food, Drug, and Cosmetic Act and section 351 
     of the Public Health Service Act. The assessment shall be 
     conducted in phases.
       (c) First Contract.--The Secretary shall award the contract 
     for the first assessment under this section not later than 
     March 31, 2013. Such contractor shall evaluate the 
     implementation of recommendations and publish a written 
     assessment not later than February 1, 2016.
       (d) Findings and Recommendations.--
       (1) In general.--The Secretary shall publish the findings 
     and recommendations under this section that are likely to 
     have a significant impact on review times not later than 6 
     months after the contract is awarded. Final comprehensive 
     findings and recommendations shall be published not later 
     than 1 year after the contract is awarded.
       (2) Implementation plan.--The Food and Drug Administration 
     shall publish an implementation plan not later than 6 months 
     after the date of receipt of each set of recommendation.
       (e) Scope of Assessment.--The assessment under this section 
     shall include the following:
       (1) Identification of process improvements and best 
     practices for conducting predictable, efficient, and 
     consistent premarket reviews that meet regulatory review 
     standards.
       (2) Analysis of elements of the review process that consume 
     or save time to facilitate a more efficient process. Such 
     analysis shall include--
       (A) consideration of root causes for inefficiencies that 
     may affect review performance and total time to decision;
       (B) recommended actions to correct any failures to meet 
     user fee program goals; and
       (C) consideration of the impact of combination products on 
     the review process.
       (3) Assessment of methods and controls of the Food and Drug 
     Administration for collecting and reporting information on 
     premarket review process resource use and performance.
       (4) Assessment of effectiveness of the reviewer training 
     program of the Food and Drug Administration.
       (5) Recommendations for ongoing periodic assessments and 
     any additional, more detailed or focused assessments.
       (f) Requirements.--The Secretary shall--
       (1) analyze the recommendations for improvement 
     opportunities identified in the assessment, develop and 
     implement a corrective action plan, and ensure its 
     effectiveness;
       (2) incorporate the findings and recommendations of the 
     contractors, as appropriate, into the management of the 
     premarket review program of the Food and Drug Administration; 
     and
       (3) incorporate the results of the assessment in a Good 
     Review Management Practices guidance document, which shall 
     include initial and ongoing training of Food and Drug 
     Administration staff, and periodic audits of compliance with 
     the guidance.
                                 ______
                                 
  SA 2132. Mr. COBURN (for himself and Mr. Burr) submitted an amendment 
intended to be proposed by him to the bill S. 3187, to amend the 
Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee 
programs for prescription drugs and medical devices, to establish user-
fee programs for generic drugs and biosimilars, and for other purposes; 
which was ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. PERFORMANCE AWARDS.

       (a) In General.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall establish a system by which a portion of the 
     performance awards of each employee described in subsection 
     (b) shall be connected to the evaluation of the employee's 
     contribution, in the discretion of the Secretary, to the 
     goals under the user fee agreements described in section 
     101(b), 201(b), 301(b), or 401(b), as appropriate.
       (b) Employees Described.--
       (1) In general.--Subsection (a) shall apply only to 
     employees who--
       (A) are employed by the Center for Drug Evaluation and 
     Research, the Center for Devices and Radiological Health, or 
     the Center for Biologics Evaluation and Research; and
       (B) are involved in the review of drugs, devices, or 
     biological products.
       (2) Commissioned corps.--For purposes of this section, the 
     term ``employee'' includes members of the Public Health 
     Service Commissioned Corps.
       (c) Effect on Award.--The degree to which the performance 
     award of an employee is affected by the evaluation of the 
     employee's contribution to the goals under the user fee 
     agreements, as described in subsection (a), shall be 
     proportional to the extent to which the employee is involved 
     in the review of drugs, devices, or biological products.
       (d) Report.--The Secretary shall issue an annual report 
     detailing how many employees were involved in meeting the 
     goals under the user fee agreements described in section 
     101(b), 201(b), 301(b), and 401(b), and the manner of the 
     involvement of such employees.
                                 ______
                                 
  SA 2133. Mr. DeMINT (for himself and Mr. Vitter) submitted an 
amendment intended to be proposed by him to the bill S. 3187, to amend 
the Federal Food, Drug, and Cosmetic Act to revise and extend the user-
fee programs for prescription drugs and medical devices, to establish 
user-fee programs for generic drugs and biosimilars, and for other 
purposes; which was ordered to lie on the table; as follows:

       At the appropriate place, insert the following:

     SEC. 11__. DOCUMENT DISCLOSURE RELATING TO THE PATIENT 
                   PROTECTION AND AFFORDABLE CARE ACT.

       (a) In General.--Not later than 60 days after the date of 
     the enactment of this Act, a representative of the Executive 
     Office of the President shall provide to Congress all 
     documents and correspondences exchanged between employees of 
     the Executive Office of the President and the Pharmaceutical 
     Research and Manufacturers of America since January 20, 2009.
       (b) Publication of Documents and Correspondences.--The 
     Secretary of Health and Human Services shall publish all 
     documents and correspondences described in subsection (a) on 
     the Internet website of the Department of Health and Human 
     Services.
                                 ______
                                 
  SA 2134. Mr. BLUMENTHAL submitted an amendment intended to be 
proposed by him to the bill S. 3187, to amend the Federal Food, Drug, 
and Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title X, insert the following:

     SEC. 10__. MARKET MANIPULATION WITH RESPECT TO DRUGS IN 
                   SHORTAGE.

       (a) Definitions.--In this section:
       (1) Drug.--The term ``drug'' has the meaning given such 
     term in section 201(g)(1) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 321(g)(1)) and is intended for human 
     use.
       (2) Drug shortage.--The term ``drug shortage'' or 
     ``shortage'', with respect to a drug defined in section 
     506C(a) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 
     356c(a)), means a period of time when the demand or projected 
     demand for the drug within the United States exceeds the 
     supply of the drug (as defined in section 506(c) of the 
     Federal Food Drug and Cosmetic Act (21 U.S.C. 356(c)).
       (b) Prohibition on Market Manipulation.--It shall be 
     unlawful for any person to directly or indirectly use any 
     manipulative or deceptive device or contrivance, in 
     connection with the purchase or sale of a drug in shortage, 
     in contravention of rules or regulations the Federal Trade 
     Commission may prescribe as necessary or appropriate in the 
     public interest or for the protection of United States 
     citizens.
       (c) Prohibition on False Information.--It shall be unlawful 
     for any person to report or distribute information related to 
     the purchase or sale of a prescription drug in shortage if 
     the person knew the information to be false or misleading, in 
     order to support activities described in subsection (b).
       (d) Enforcement by Federal Trade Commission.--
       (1) Unfair or deceptive acts or practices.--A violation of 
     subsection (b) shall be treated as an unfair and deceptive 
     act or practice in violation of a regulation under section 
     18(a)(1)(B) of the Federal Trade Commission Act (15 U.S.C. 
     57a(a)(1)(B)) regarding unfair or deceptive acts or 
     practices.
       (2) Powers of commission.--

[[Page 7632]]

       (A) In general.--The Federal Trade Commission shall enforce 
     this section in the same manner, by the same means, and with 
     the same jurisdiction, powers, and duties as though all 
     applicable terms and provisions of the Federal Trade 
     Commission Act (15 U.S.C. 41 et seq.) were incorporated into 
     and made a part of this section.
       (B) Privileges and immunities.--Any person who violates 
     this section shall be subject to the penalties and entitled 
     to the privileges and immunities provided in the Federal 
     Trade Commission Act (15 U.S.C. 41 et seq.).
       (e) Enforcement by States.--
       (1) In general.--In any case in which the attorney general 
     of a State has reason to believe that an interest of the 
     residents of the State has been or is threatened or adversely 
     affected by the engagement of any person in an act that 
     violates subsection (b), the attorney general of the State 
     may, as parens patriae, bring a civil action on behalf of the 
     residents of the State in an appropriate district court of 
     the United States--
       (A) to enjoin further violation of such subsection by such 
     person;
       (B) to compel compliance with such subsection;
       (C) to obtain damages, restitution, or other compensation 
     on behalf of such residents;
       (D) to obtain such other relief as the court considers 
     appropriate; or
       (E) to obtain civil penalties in the amount determined 
     under paragraph (2).
       (2) Civil penalties.--
       (A) In general.--In addition to any penalty applicable 
     under the Federal Trade Commission Act (15 U.S.C. 41 et 
     seq.), any person that violates subsection (b) or (c) shall 
     be subject to a civil penalty of not more than $1,000,000.
       (B) Method.--The civil penalty provided under subparagraph 
     (A) shall be obtained in the same manner as civil penalties 
     imposed under section 5 of the Federal Trade Commission Act 
     (15 U.S.C. 45).
       (C) Multiple offenses; other considerations.--In assessing 
     the civil penalty under this paragraph--
       (i) each day of a continuing violation shall be considered 
     a separate violation; and
       (ii) the seriousness of the violation, and the efforts of 
     the person committing the violation to remedy the harm caused 
     by the violation shall be considered.
       (D) Adjustment for inflation.--Beginning on the date on 
     which the Bureau of Labor Statistics first publishes the 
     Consumer Price Index after the date that is 1 year after the 
     date of the enactment of this Act, and annually thereafter, 
     the maximum amount specified in subparagraph (A) shall be 
     increased by the percentage increase in the Consumer Price 
     Index published on that date from the Consumer Price Index 
     published the previous year.
       (3) Rights of federal trade commission.--
       (A) Notice to federal trade commission.--
       (i) In general.--Except as provided in clause (iii), the 
     attorney general of a State shall notify the Federal Trade 
     Commission in writing that the attorney general intends to 
     bring a civil action under paragraph (1) before initiating 
     the civil action.
       (ii) Contents.--The notification required by clause (i) 
     with respect to a civil action shall include a copy of the 
     complaint to be filed to initiate the civil action.
       (iii) Exception.--If it is not feasible for the attorney 
     general of a State to provide the notification required by 
     clause (i) before initiating a civil action under paragraph 
     (1), the attorney general shall notify the Federal Trade 
     Commission immediately upon instituting the civil action.
       (B) Intervention by federal trade commission.--The Federal 
     Trade Commission may--
       (i) intervene in any civil action brought by the attorney 
     general of a State under paragraph (1); and
       (ii) upon intervening--

       (I) be heard on all matters arising in the civil action; 
     and
       (II) file petitions for appeal of a decision in the civil 
     action.

       (4) Investigatory powers.--Nothing in this subsection may 
     be construed to prevent the attorney general of a State from 
     exercising the powers conferred on the attorney general by 
     the laws of the State to conduct investigations, to 
     administer oaths or affirmations, or to compel the attendance 
     of witnesses or the production of documentary or other 
     evidence.
       (5) Preemptive action by federal trade commission.--If the 
     Federal Trade Commission institutes a civil action or an 
     administrative action with respect to a violation of 
     subsection (b), the attorney general of a State may not, 
     during the pendency of such action, bring a civil action 
     under paragraph (1) against any defendant named in the 
     complaint of the Commission for the violation with respect to 
     which the Commission instituted such action.
       (6) Venue; service of process.--
       (A) Venue.--Any action brought under paragraph (1) may be 
     brought in--
       (i) the district court of the United States that meets 
     applicable requirements relating to venue under section 1391 
     of title 28, United States Code; or
       (ii) another court of competent jurisdiction.
       (B) Service of process.--In an action brought under 
     paragraph (1), process may be served in any district in which 
     the defendant--
       (i) is an inhabitant; or
       (ii) may be found.
       (7) Actions by other state officials.--
       (A) In general.--In addition to civil actions brought by 
     attorneys general under paragraph (1), any other officer of a 
     State who is authorized by the State to do so may bring a 
     civil action under paragraph (1), subject to the same 
     requirements and limitations that apply under this subsection 
     to civil actions brought by attorneys general.
       (B) Savings provision.--Nothing in this subsection may be 
     construed to prohibit an authorized official of a State from 
     initiating or continuing any proceeding in a court of the 
     State for a violation of any civil or criminal law of the 
     State.
       (f) Reporting of Market Manipulation With Respect to Drugs 
     in Shortage, Referrals, and Education and Outreach.--
       (1) Logging and acknowledging complaints of market 
     manipulation.--Not later than 1 year after the date of the 
     enactment of this Act, the Federal Trade Commission shall 
     establish a process by which the Commission shall log and 
     acknowledge the receipt by the Commission of each complaint 
     submitted to the Commission by a person in which the person--
       (A) complains of a violation of subsection (b) about which 
     the person certifies a reasonable belief or knowledge of such 
     violation; or
       (B) claims to be a victim of a violation of such section.
       (2) Referrals.--To the degree practicable, the Commission 
     shall refer each person from whom the Commission receives a 
     complaint under paragraph (1) to an appropriate entity for--
       (A) in the case of a victim of a violation of subsection 
     (b), assistance in mitigating any damages caused by such 
     violation; or
       (B) enforcement of such subsection.
       (3) Program of education and outreach.--The Commission 
     shall carry out a program of education and outreach whereby 
     the Commission informs consumers of the following:
       (A) The prohibition set forth in subsection (b).
       (B) Common ways in which such subsection is violated and 
     how consumers can protect themselves from violations of such 
     subsection.
       (C) The process established under paragraph (1).
       (g) Authorization of Appropriations.--There are authorized 
     to be appropriated such sums as may be necessary to carry out 
     this section.
                                 ______
                                 
  SA 2135. Mr. BLUMENTHAL submitted an amendment intended to be 
proposed by him to the bill S. 3187, to amend the Federal Food, Drug, 
and Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title X, add the following:

     SEC. 10__. CRITICAL DRUG SUPPLY REINFORCEMENT PROGRAM.

       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 G--Drug Shortages

     ``SEC. 575. DEFINITIONS.

       ``For purposes of this subchapter--
       ``(1) the term `critical reinforcement drug' means a drug 
     that--
       ``(A) is the subject of a permanent discontinuance or an 
     interruption in the manufacture of the drug that could lead 
     to a meaningful disruption in the supply of that drug in the 
     United States, as defined in section 506C(f)(3); and
       ``(B) is identified as vulnerable to a drug shortage based 
     on the criteria established under section 575A;
       ``(2) the term `drug'--
       ``(A) means a drug (as defined in section 201(g)) that is 
     intended for human use and is the subject of an approved 
     application under section 505(j); and
       ``(B) does not include biological products (as defined in 
     section 351 of the Public Health Service Act); and
       ``(3) the term `drug shortage' or `shortage', with respect 
     to a drug, means a period of time when the demand or 
     projected demand for the drug within the United States 
     exceeds the supply of the drug.

     ``SEC. 575A. CRITICAL DRUG SUPPLY EVALUATION AND 
                   REINFORCEMENT.

       ``(a) Development of Criteria for Evaluation of Critical 
     Reinforcement Need.--
       ``(1) Evaluation.--Not later than 180 days after the date 
     of enactment of this section, the Secretary, in consultation 
     with Office of Drug Shortages, shall conduct an evaluation to 
     establish evidence-based criteria for identifying drugs that 
     are vulnerable to a drug shortage.
       ``(2) Content.--The evaluation under paragraph (1) shall 
     include a comprehensive trend analysis to forecast drug 
     shortages and target drugs that are vulnerable to a shortage. 
     The Secretary is authorized to contract with a third party to 
     conduct or participate

[[Page 7633]]

     in such evaluation. In conducting such evaluation, the 
     Secretary or any authorized third party shall not use any 
     confidential, trade secret, or proprietary information of any 
     other entity without such entity's consent.
       ``(3) Consultation with stakeholders.--The Secretary, as 
     part of the evaluation under paragraph (1), shall convene a 
     discussion with stakeholders to assess methodology and 
     findings applicable to such evaluation.
       ``(4) Report to congress.--Not later than 2 years after the 
     date of enactment of this section, the Secretary shall submit 
     a report to Congress that describes the methods and processes 
     used to conduct the evaluation under this subsection.
       ``(b) Critical Reinforcement.--To carry out this section, 
     the Secretary may award the incentives under subsection (d) 
     to qualified manufacturers to secure an agreement--
       ``(1) for the rapid production of a critical reinforcement 
     drug;
       ``(2) that the qualified manufacturer will maintain 
     production of a critical reinforcement drug; or
       ``(3) that would allow the Secretary to purchase supply of 
     a critical reinforcement drug from the qualified manufacturer 
     under certain market conditions and on terms and conditions 
     mutually agreed upon.
       ``(c) Qualified Manufacturers.--To be a qualified 
     manufacturer for purposes of this section--
       ``(1) an entity shall be a drug manufacturer; and
       ``(2) the Secretary shall ensure that the manufacturer--
       ``(A) is in compliance with good manufacturing practice 
     regulations of the Food and Drug Administration to produce a 
     critical reinforcement drug or a similar product; and
       ``(B)(i) currently produces a critical reinforcement drug 
     or a similar product and can increase production immediately 
     to address the shortage with no regulatory approvals 
     required;
       ``(ii) does not currently produce a critical reinforcement 
     drug but has the capability, capacity and regulatory 
     authority to do so and could commence supply in time to 
     address need; or
       ``(iii) has capability and capacity to produce a critical 
     reinforcement drug but not the regulatory authority and could 
     commence supply upon regulatory filing and approval.
       ``(d) Incentives.--
       ``(1) In general.--If the Secretary ensures a manufacturer 
     is a qualified manufacturer, the Secretary shall negotiate a 
     manufacturing contingency plan with the manufacturer to meet 
     an identified critical reinforcement in subsection (c). The 
     Secretary may--
       ``(A) expedite the review of any abbreviated new drug 
     application submitted under section 505 by the qualified 
     manufacturer for a drug that is vulnerable to shortage as 
     identified pursuant to the criteria established under 
     subsection (a); and
       ``(B) waive any application fees related to such an 
     abbreviated new drug application.
       ``(2) Limitation.--If the qualified manufacturer fails to 
     meet benchmarks specified by the Secretary in the agreement 
     between the Secretary and the manufacturer, or otherwise 
     violates such agreement, the Secretary may retroactively 
     assess the application fees waived under paragraph (1)(B).
       ``(e) Trademark Protection.--Nothing in this section shall 
     be construed to alter or modify in any way, any applicable 
     patent, copyright, trademark, or other intellectual property 
     rights of any holder of a new drug application, an 
     abbreviated new drug application, or a biologics license 
     application, including any applicable regulatory exclusivity 
     periods or periods during which the Secretary may not accept 
     for filing or approve any new drug application, an 
     abbreviated new drug application, or a biologics license 
     application, and procedures associated therewith, under this 
     Act or the Public Health Service Act.''.
                                 ______
                                 
  SA 2136. Mr. BLUMENTHAL (for himself, Mr. Franken, Mr. Schumer, Mr. 
Cardin, and Ms. Klobuchar) submitted an amendment intended to be 
proposed by him to the bill S. 3187, to amend the Federal Food, Drug, 
and Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title X, add the following:

     SEC. 10__. CIVIL PENALTIES FOR FAILURE TO SUBMIT 
                   NOTIFICATION.

       Section 303 (21 U.S.C. 333) is amended--
       (1) in subsection (f)(5), by inserting ``or subsection 
     (h)'' after ``or (9)'' each place such term appears; and
       (2) by adding at the end the following:
       ``(h)(1) Any manufacturer that knowingly fails to submit a 
     notification in violation of section 506C(a) shall be subject 
     to a civil money penalty not to exceed $10,000 for each day 
     on which the violation continues, and not to exceed 
     $1,800,000 for all such violations adjudicated in a single 
     proceeding.
       ``(2) Not later than 180 days after the date of enactment 
     of the Food and Drug Administration Safety and Innovation 
     Act, the Secretary shall, subject to paragraph (1), 
     promulgate final regulations establishing a schedule of civil 
     monetary penalties for violations of section 506C(a).''.
                                 ______
                                 
  SA 2137. Mr. ROCKEFELLER submitted an amendment intended to be 
proposed by him to the bill S. 3187, to amend the Federal Food, Drug, 
and Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title VII, add the following:

     SEC. 7__. PROHIBITION OF AUTHORIZED GENERICS.

       (a) In General.--Section 505 (21 U.S.C. 355), as amended by 
     section 510(a), is further amended by adding at the end the 
     following:
       ``(x) Prohibition of Authorized Generic Drugs.--
       ``(1) In general.--Notwithstanding any other provision of 
     this Act, no holder of a new drug application approved under 
     subsection (c) shall manufacture, market, sell, or distribute 
     an authorized generic drug, directly or indirectly, or 
     authorize any other person to manufacture, market, sell, or 
     distribute an authorized generic drug.
       ``(2) Authorized generic drug.--For purposes of this 
     subsection, the term `authorized generic drug'--
       ``(A) means any version of a listed drug (as such term is 
     used in subsection (j)) that the holder of the new drug 
     application approved under subsection (c) for that listed 
     drug seeks to commence marketing, selling, or distributing, 
     directly or indirectly, after receipt of a notice sent 
     pursuant to subsection (j)(2)(B) with respect to that listed 
     drug; and
       ``(B) does not include any drug to be marketed, sold, or 
     distributed--
       ``(i) by an entity eligible for 180-day exclusivity with 
     respect to such drug under subsection (j)(5)(B)(iv); or
       ``(ii) after expiration or forfeiture of any 180-day 
     exclusivity with respect to such drug under such subsection 
     (j)(5)(B)(iv).''.
       (b) Conforming Amendment.--Section 505(t)(3) (21 U.S.C. 
     355(t)(3)) is amended by striking ``In this section'' and 
     inserting ``In this subsection''.
                                 ______
                                 
  SA 2138. Mr. VITTER submitted an amendment intended to be proposed by 
him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic 
Act to revise and extend the user-fee programs for prescription drugs 
and medical devices, to establish user-fee programs for generic drugs 
and biosimilars, and for other purposes; which was ordered to lie on 
the table; as follows:

       At the end, add the following:

                      DIVISION B--FLOOD INSURANCE

     SEC. 100. REFERENCES.

       Except as expressly provided otherwise, any reference to 
     ``this Act'' contained in any division of this Act shall be 
     treated as referring only to the provisions of that division.

           TITLE I--FLOOD INSURANCE REFORM AND MODERNIZATION

     SEC. 101. SHORT TITLE.

       This title may be cited as the ``Flood Insurance Reform and 
     Modernization Act of 2012''.

     SEC. 102. FINDINGS.

       Congress finds that--
       (1) the flood insurance claims resulting from the hurricane 
     season of 2005 exceeded all previous claims paid by the 
     National Flood Insurance Program;
       (2) in order to pay the legitimate claims of policyholders 
     from the hurricane season of 2005, the Federal Emergency 
     Management Agency has borrowed $19,000,000,000 from the 
     Treasury;
       (3) the interest alone on this debt has been as high as 
     $800,000,000 annually, and that the Federal Emergency 
     Management Agency has indicated that it will be unable to pay 
     back this debt;
       (4) the flood insurance program must be strengthened to 
     ensure it can pay future claims;
       (5) while flood insurance is mandatory in the 100-year 
     floodplain, substantial flooding occurs outside of existing 
     special flood hazard areas;
       (6) events throughout the country involving areas behind 
     flood control structures, known as ``residual risk'' areas, 
     have produced catastrophic losses;
       (7) although such flood control structures produce an added 
     element of safety and therefore lessen the probability that a 
     disaster will occur, they are nevertheless susceptible to 
     catastrophic loss, even though such areas at one time were 
     not included within the 100-year floodplain; and
       (8) voluntary participation in the National Flood Insurance 
     Program has been minimal and many families residing outside 
     the 100-year floodplain remain unaware of the potential risk 
     to their lives and property.

[[Page 7634]]



     SEC. 103. DEFINITIONS.

       (a) In General.--In this title, the following definitions 
     shall apply:
       (1) 100-year floodplain.--The term ``100-year floodplain'' 
     means that area which is subject to inundation from a flood 
     having a 1-percent chance of being equaled or exceeded in any 
     given year.
       (2) 500-year floodplain.--The term ``500-year floodplain'' 
     means that area which is subject to inundation from a flood 
     having a 0.2-percent chance of being equaled or exceeded in 
     any given year.
       (3) Administrator.--The term ``Administrator'' means the 
     Administrator of the Federal Emergency Management Agency.
       (4) National flood insurance program.--The term ``National 
     Flood Insurance Program'' means the program established under 
     the National Flood Insurance Act of 1968 (42 U.S.C. 4011 et 
     seq.).
       (5) Write your own.--The term ``Write Your Own'' means the 
     cooperative undertaking between the insurance industry and 
     the Federal Insurance Administration which allows 
     participating property and casualty insurance companies to 
     write and service standard flood insurance policies.
       (b) Common Terminology.--Except as otherwise provided in 
     this title, any terms used in this title shall have the 
     meaning given to such terms under section 1370 of the 
     National Flood Insurance Act of 1968 (42 U.S.C. 4121).

     SEC. 104. EXTENSION OF NATIONAL FLOOD INSURANCE PROGRAM.

       (a) Financing.--Section 1309(a) of the National Flood 
     Insurance Act of 1968 (42 U.S.C. 4016(a)) is amended by 
     striking ``the earlier of the date of the enactment into law 
     of an Act that specifically amends the date specified in this 
     section or May 31, 2012'' and inserting ``September 30, 
     2016''.
       (b) Program Expiration.--Section 1319 of the National Flood 
     Insurance Act of 1968 (42 U.S.C. 4026) is amended by striking 
     ``the earlier of the date of the enactment into law of an Act 
     that specifically amends the date specified in this section 
     or May 31, 2012'' and inserting ``September 30, 2016''.

     SEC. 105. AVAILABILITY OF INSURANCE FOR MULTIFAMILY 
                   PROPERTIES.

       Section 1305 of the National Flood Insurance Act of 1968 
     (42 U.S.C. 4012) is amended--
       (1) in subsection (b)(2)(A), by inserting ``not described 
     in subsection (a) or (d)'' after ``properties''; and
       (2) by adding at the end the following:
       ``(d) Availability of Insurance for Multifamily 
     Properties.--
       ``(1) In general.--The Administrator shall make flood 
     insurance available to cover residential properties of more 
     than 4 units. Notwithstanding any other provision of law, the 
     maximum coverage amount that the Administrator may make 
     available under this subsection to such residential 
     properties shall be equal to the coverage amount made 
     available to commercial properties.
       ``(2) Rule of construction.--Nothing in this subsection 
     shall be construed to limit the ability of individuals 
     residing in residential properties of more than 4 units to 
     obtain insurance for the contents and personal articles 
     located in such residences.''.

     SEC. 106. REFORM OF PREMIUM RATE STRUCTURE.

       (a) To Exclude Certain Properties From Receiving Subsidized 
     Premium Rates.--
       (1) In general.--Section 1307 of the National Flood 
     Insurance Act of 1968 (42 U.S.C. 4014) is amended--
       (A) in subsection (a)(2), by striking ``; and'' and 
     inserting the following: ``, except that the Administrator 
     shall not estimate rates under this paragraph for--
       ``(A) any property which is not the primary residence of an 
     individual;
       ``(B) any severe repetitive loss property;
       ``(C) any property that has incurred flood-related damage 
     in which the cumulative amounts of payments under this title 
     equaled or exceeded the fair market value of such property;
       ``(D) any business property; or
       ``(E) any property which on or after the date of the 
     enactment of the Flood Insurance Reform and Modernization Act 
     of 2012 has experienced or sustained--
       ``(i) substantial damage exceeding 50 percent of the fair 
     market value of such property; or
       ``(ii) substantial improvement exceeding 30 percent of the 
     fair market value of such property; and''; and
       (B) by adding at the end the following:
       ``(g) No Extension of Subsidy to New Policies or Lapsed 
     Policies.--The Administrator shall not provide flood 
     insurance to prospective insureds at rates less than those 
     estimated under subsection (a)(1), as required by paragraph 
     (2) of that subsection, for--
       ``(1) any property not insured by the flood insurance 
     program as of the date of the enactment of the Flood 
     Insurance Reform and Modernization Act of 2012;
       ``(2) any policy under the flood insurance program that has 
     lapsed in coverage, as a result of the deliberate choice of 
     the holder of such policy; or
       ``(3) any prospective insured who refuses to accept any 
     offer for mitigation assistance by the Administrator 
     (including an offer to relocate), including an offer of 
     mitigation assistance--
       ``(A) following a major disaster, as defined in section 102 
     of the Robert T. Stafford Disaster Relief and Emergency 
     Assistance Act (42 U.S.C. 5122); or
       ``(B) in connection with--
       ``(i) a repetitive loss property; or
       ``(ii) a severe repetitive loss property.
       ``(h) Definition.--In this section, the term `severe 
     repetitive loss property' has the following meaning:
       ``(1) Single-family properties.--In the case of a property 
     consisting of 1 to 4 residences, such term means a property 
     that--
       ``(A) is covered under a contract for flood insurance made 
     available under this title; and
       ``(B) has incurred flood-related damage--
       ``(i) for which 4 or more separate claims payments have 
     been made under flood insurance coverage under this chapter, 
     with the amount of each such claim exceeding $5,000, and with 
     the cumulative amount of such claims payments exceeding 
     $20,000; or
       ``(ii) for which at least 2 separate claims payments have 
     been made under such coverage, with the cumulative amount of 
     such claims exceeding the value of the property.
       ``(2) Multifamily properties.--In the case of a property 
     consisting of more than 4 units, such term shall have such 
     meaning as the Director shall by regulation provide.''.
       (2) Effective date.--The amendments made by paragraph (1) 
     shall become effective 90 days after the date of the 
     enactment of this Act.
       (b) Estimates of Premium Rates.--Section 1307(a)(1)(B) of 
     the National Flood Insurance Act of 1968 (42 U.S.C. 
     4014(a)(1)(B)) is amended--
       (1) in clause (ii), by striking ``and'' at the end;
       (2) in clause (iii), by adding ``and'' at the end; and
       (3) by inserting after clause (iii) the following:
       ``(iv) all costs, as prescribed by principles and standards 
     of practice in ratemaking adopted by the American Academy of 
     Actuaries and the Casualty Actuarial Society, including--

       ``(I) an estimate of the expected value of future costs,
       ``(II) all costs associated with the transfer of risk, and
       ``(III) the costs associated with an individual risk 
     transfer with respect to risk classes, as defined by the 
     Administrator,''.

       (c) Increase in Annual Limitation on Premium Increases.--
     Section 1308(e) of the National Flood Insurance Act of 1968 
     (42 U.S.C. 4015(e)) is amended--
       (1) by striking ``under this title for any properties 
     within any single'' and inserting the following: ``under this 
     title for any properties--
       ``(1) within any single'';
       (2) by striking ``10 percent'' and inserting ``15 
     percent''; and
       (3) by striking the period at the end and inserting the 
     following: ``; and
       ``(2) described in subparagraphs (A) through (E) of section 
     1307(a)(2) shall be increased by 25 percent each year, until 
     the average risk premium rate for such properties is equal to 
     the average of the risk premium rates for properties 
     described under paragraph (1).''.
       (d) Premium Payment Flexibility for New and Existing 
     Policyholders.--Section 1308 of the National Flood Insurance 
     Act of 1968 (42 U.S.C. 4015) is amended by adding at the end 
     the following:
       ``(g) Frequency of Premium Collection.--With respect to any 
     chargeable premium rate prescribed under this section, the 
     Administrator shall provide policyholders that are not 
     required to escrow their premiums and fees for flood 
     insurance as set forth under section 102 of the Flood 
     Disaster Protection Act of 1973 (42 U.S.C. 4012a) with the 
     option of paying their premiums either annually or in more 
     frequent installments.''.

     SEC. 107. MANDATORY COVERAGE AREAS.

       (a) Special Flood Hazard Areas.--Not later than 90 days 
     after the date of the enactment of this Act, the 
     Administrator shall issue final regulations establishing a 
     revised definition of areas of special flood hazards for 
     purposes of the National Flood Insurance Program.
       (b) Residual Risk Areas.--The regulations required by 
     subsection (a) shall require the expansion of areas of 
     special flood hazards to include areas of residual risk that 
     are located behind levees or near dams or other flood control 
     structures, as determined by the Administrator.
       (c) Mandatory Participation in National Flood Insurance 
     Program.--
       (1) In general.--Any area described in subsection (b) shall 
     be subject to the mandatory purchase requirements of sections 
     102 and 202 of the Flood Disaster Protection Act of 1973 (42 
     U.S.C. 4012a, 4106).
       (2) Limitation.--The mandatory purchase requirement under 
     paragraph (1) shall have no force or effect until the mapping 
     of all residual risk areas in the United States that the 
     Administrator determines essential in order to administer the 
     National Flood Insurance Program, as required under section 
     118, are in the maintenance phase.
       (3) Accurate pricing.--In carrying out the mandatory 
     purchase requirement under paragraph (1), the Administrator 
     shall ensure that the price of flood insurance policies in 
     areas of residual risk accurately reflects the level of flood 
     protection provided by any levee, dam, or other flood control 
     structure

[[Page 7635]]

     in such area, regardless of the certification status of the 
     flood control structure.
       (d) Decertification.--Upon decertification of any levee, 
     dam, or flood control structure under the jurisdiction of the 
     Army Corps of Engineers, the Corps shall immediately provide 
     notice to the Administrator of the National Flood Insurance 
     Program.

     SEC. 108. PREMIUM ADJUSTMENT.

       Section 1308 of the National Flood Insurance Act of 1968 
     (42 U.S.C. 4015), as amended by section 106(c), is further 
     amended by adding at the end the following:
       ``(h) Premium Adjustment To Reflect Current Risk of 
     Flood.--Notwithstanding subsection (f), upon the effective 
     date of any revised or updated flood insurance rate map under 
     this Act, the Flood Disaster Protection Act of 1973, or the 
     Flood Insurance Reform and Modernization Act of 2012, any 
     property located in an area that is participating in the 
     national flood insurance program shall have the risk premium 
     rate charged for flood insurance on such property adjusted to 
     accurately reflect the current risk of flood to such 
     property, subject to any other provision of this Act. Any 
     increase in the risk premium rate charged for flood insurance 
     on any property that is covered by a flood insurance policy 
     on the effective date of such an update that is a result of 
     such updating shall be phased in over a 4-year period, at the 
     rate of 40 percent for the first year following such 
     effective date and 20 percent for each of the second, third, 
     and fourth years following such effective date. In the case 
     of any area that was not previously designated as an area 
     having special flood hazards and that, pursuant to any 
     issuance, revision, updating, or other change in a flood 
     insurance map, becomes designated as such an area, the 
     chargeable risk premium rate for flood insurance under this 
     title that is purchased on or after the date of enactment of 
     this subsection with respect to any property that is located 
     within such area shall be phased in over a 4-year period, at 
     the rate of 40 percent for the first year following the 
     effective date of such issuance, revision, updating, or 
     change and 20 percent for each of the second, third, and 
     fourth years following such effective date.''.

     SEC. 109. STATE CHARTERED FINANCIAL INSTITUTIONS.

       Section 1305(c) of the National Flood Insurance Act of 1968 
     (42 U.S.C. 4012(c)) is amended--
       (1) in paragraph (1), by striking ``, and'' and inserting a 
     semicolon;
       (2) in paragraph (2), by striking the period at the end and 
     inserting ``; and''; and
       (3) by adding at the end the following:
       ``(3) given satisfactory assurance that by the date that is 
     6 months after the date of enactment of the Flood Insurance 
     Reform and Modernization Act of 2012, lending institutions 
     chartered by a State, and not insured by the Federal Deposit 
     Insurance Corporation or the National Credit Union 
     Administration, shall be subject to regulations by that State 
     that are consistent with the requirements of section 102 of 
     the Flood Disaster Protection Act of 1973 (42 U.S.C. 
     4012a).''.

     SEC. 110. ENFORCEMENT.

       Section 102(f)(5) of the Flood Disaster Protection Act of 
     1973 (42 U.S.C. 4012a(f)(5)) is amended--
       (1) in the first sentence, by striking ``$350'' and 
     inserting ``$2,000''; and
       (2) by striking the second sentence.

     SEC. 111. ESCROW OF FLOOD INSURANCE PAYMENTS.

       (a) In General.--
       (1) Definitions.--Section 3 of the Flood Disaster 
     Protection Act of 1973 (42 U.S.C. 4003) is amended--
       (A) in paragraph (10), by striking ``and'' at the end;
       (B) in paragraph (11), by striking the period at the end 
     and inserting a semicolon; and
       (C) by adding at the end the following:
       ``(12) `State entity for lending regulation' means the 
     State entity or agency with primary responsibility for the 
     supervision or regulation of State lending institutions in a 
     State; and
       ``(13) `State lending institution' means any bank, savings 
     and loan association, credit union, farm credit bank, 
     production credit association, or similar lending institution 
     subject to the supervision or regulation of a State entity 
     for lending regulation.''.
       (2) Escrow requirements.--Paragraph (1) of section 102(d) 
     of the Flood Disaster Protection Act of 1973 (42 U.S.C. 
     4012a(d)) is amended to read as follows:
       ``(1) Regulated lending institutions and state lending 
     institutions.--
       ``(A) Federal entities responsible for lending 
     regulations.--Each Federal entity for lending regulation 
     (after consultation and coordination with the Federal 
     Financial Institutions Examination Council) shall, by 
     regulation, direct that all premiums and fees for flood 
     insurance under the National Flood Insurance Act of 1968, for 
     improved real estate or a mobile home, shall be paid to the 
     regulated lending institution or servicer for any loan 
     secured by the improved real estate or mobile home, with the 
     same frequency as payments on the loan are made, for the 
     duration of the loan. Except as provided in subparagraph (C), 
     upon receipt of any premiums or fees, the regulated lending 
     institution or servicer shall deposit such premiums and fees 
     in an escrow account on behalf of the borrower. Upon receipt 
     of a notice from the Administrator or the provider of the 
     flood insurance that insurance premiums are due, the premiums 
     deposited in the escrow account shall be paid to the provider 
     of the flood insurance.
       ``(B) State entities responsible for lending regulations.--
     In order to continue to participate in the flood insurance 
     program, each State shall direct that its State entity for 
     lending regulation require that premiums and fees for flood 
     insurance under the National Flood Insurance Act of 1968, for 
     improved real estate or a mobile home shall be paid to the 
     State lending institution or servicer for any loan secured by 
     the improved real estate or mobile home, with the same 
     frequency as payments on the loan are made, for the duration 
     of the loan. Except as provided in subparagraph (C), upon 
     receipt of any premiums or fees, the State lending 
     institution or servicer shall deposit such premiums and fees 
     in an escrow account on behalf of the borrower. Upon receipt 
     of a notice from the Administrator or the provider of the 
     flood insurance that insurance premiums are due, the premiums 
     deposited in the escrow account shall be paid to the provider 
     of the flood insurance.
       ``(C) Limitation.--Except as may be required under 
     applicable State law, neither a Federal entity for lending 
     regulation nor a State entity for lending regulation may 
     direct or require a regulated lending institution or State 
     lending institution to deposit premiums or fees for flood 
     insurance under the National Flood Insurance Act of 1968 in 
     an escrow account on behalf of a borrower under subparagraph 
     (A) or (B), if--
       ``(i) the regulated lending institution or State lending 
     institution has total assets of less than $1,000,000,000; and
       ``(ii) on or before the date of enactment of the Flood 
     Insurance Reform and Modernization Act of 2012 the regulated 
     lending institution or State lending institution--

       ``(I) was not required under Federal or State law to 
     deposit taxes, insurance premiums, fees, or any other charges 
     in an escrow account for a loan secured by residential 
     improved real estate or a mobile home; and
       ``(II) did not have a policy of consistently and uniformly 
     requiring the deposit of taxes, insurance premiums, fees, or 
     any other charges in an escrow account for loans secured by 
     residential improved real estate or a mobile home.''.

       (b) Applicability.--The amendment made by subsection (a)(2) 
     shall apply to any mortgage outstanding or entered into on or 
     after the expiration of the 2-year period beginning on the 
     date of the enactment of this Act.

     SEC. 112. MINIMUM DEDUCTIBLES FOR CLAIMS UNDER THE NATIONAL 
                   FLOOD INSURANCE PROGRAM.

       Section 1312 of the National Flood Insurance Act of 1968 
     (42 U.S.C. 4019) is amended--
       (1) by striking ``The Director is'' and inserting the 
     following:
       ``(a) In General.--The Administrator is''; and
       (2) by adding at the end the following:
       ``(b) Minimum Annual Deductible.--
       ``(1) Pre-firm properties.--For any structure which is 
     covered by flood insurance under this title, and on which 
     construction or substantial improvement occurred on or before 
     December 31, 1974, or before the effective date of an initial 
     flood insurance rate map published by the Administrator under 
     section 1360 for the area in which such structure is located, 
     the minimum annual deductible for damage to such structure 
     shall be--
       ``(A) $1,500, if the flood insurance coverage for such 
     structure covers loss of, or physical damage to, such 
     structure in an amount equal to or less than $100,000; and
       ``(B) $2,000, if the flood insurance coverage for such 
     structure covers loss of, or physical damage to, such 
     structure in an amount greater than $100,000.
       ``(2) Post-firm properties.--For any structure which is 
     covered by flood insurance under this title, and on which 
     construction or substantial improvement occurred after 
     December 31, 1974, or after the effective date of an initial 
     flood insurance rate map published by the Administrator under 
     section 1360 for the area in which such structure is located, 
     the minimum annual deductible for damage to such structure 
     shall be--
       ``(A) $1,000, if the flood insurance coverage for such 
     structure covers loss of, or physical damage to, such 
     structure in an amount equal to or less than $100,000; and
       ``(B) $1,250, if the flood insurance coverage for such 
     structure covers loss of, or physical damage to, such 
     structure in an amount greater than $100,000.''.

     SEC. 113. CONSIDERATIONS IN DETERMINING CHARGEABLE PREMIUM 
                   RATES.

       Section 1308 of the National Flood Insurance Act of 1968 
     (42 U.S.C. 4015), as amended by this Act, is amended--
       (1) in subsection (a), by striking ``, after consultation 
     with'' and all that follows through ``by regulation'' and 
     inserting ``prescribe, after providing notice'';
       (2) in subsection (b)--
       (A) in paragraph (1), by striking the period at the end and 
     inserting a semicolon;
       (B) in paragraph (2), by striking the comma at the end and 
     inserting a semicolon;

[[Page 7636]]

       (C) in paragraph (3), by striking ``, and'' and inserting a 
     semicolon;
       (D) in paragraph (4), by striking the period and inserting 
     ``; and''; and
       (E) by adding at the end the following:
       ``(5) adequate, on the basis of accepted actuarial 
     principles, to cover the average historical loss year 
     obligations incurred by the National Flood Insurance Fund.''; 
     and
       (3) by adding at the end the following:
       ``(i) Rule of Construction.--For purposes of this section, 
     the calculation of an `average historical loss year'--
       ``(1) includes catastrophic loss years; and
       ``(2) shall be computed in accordance with generally 
     accepted actuarial principles.''.

     SEC. 114. RESERVE FUND.

       Chapter I of the National Flood Insurance Act of 1968 (42 
     U.S.C. 4011 et seq.) is amended by inserting after section 
     1310 (42 U.S.C. 4017) the following:

     ``SEC. 1310A. RESERVE FUND.

       ``(a) Establishment of Reserve Fund.--In carrying out the 
     flood insurance program authorized by this chapter, the 
     Administrator shall establish in the Treasury of the United 
     States a National Flood Insurance Reserve Fund (in this 
     section referred to as the `Reserve Fund') which shall--
       ``(1) be an account separate from any other accounts or 
     funds available to the Administrator; and
       ``(2) be available for meeting the expected future 
     obligations of the flood insurance program.
       ``(b) Reserve Ratio.--Subject to the phase-in requirements 
     under subsection (d), the Reserve Fund shall maintain a 
     balance equal to--
       ``(1) 1 percent of the sum of the total potential loss 
     exposure of all outstanding flood insurance policies in force 
     in the prior fiscal year; or
       ``(2) such higher percentage as the Administrator 
     determines to be appropriate, taking into consideration any 
     circumstance that may raise a significant risk of substantial 
     future losses to the Reserve Fund.
       ``(c) Maintenance of Reserve Ratio.--
       ``(1) In general.--The Administrator shall have the 
     authority to establish, increase, or decrease the amount of 
     aggregate annual insurance premiums to be collected for any 
     fiscal year necessary--
       ``(A) to maintain the reserve ratio required under 
     subsection (b); and
       ``(B) to achieve such reserve ratio, if the actual balance 
     of such reserve is below the amount required under subsection 
     (b).
       ``(2) Considerations.--In exercising the authority granted 
     under paragraph (1), the Administrator shall consider--
       ``(A) the expected operating expenses of the Reserve Fund;
       ``(B) the insurance loss expenditures under the flood 
     insurance program;
       ``(C) any investment income generated under the flood 
     insurance program; and
       ``(D) any other factor that the Administrator determines 
     appropriate.
       ``(3) Limitations.--In exercising the authority granted 
     under paragraph (1), the Administrator shall be subject to 
     all other provisions of this Act, including any provisions 
     relating to chargeable premium rates or annual increases of 
     such rates.
       ``(d) Phase-in Requirements.--The phase-in requirements 
     under this subsection are as follows:
       ``(1) In general.--Beginning in fiscal year 2012 and not 
     ending until the fiscal year in which the ratio required 
     under subsection (b) is achieved, in each such fiscal year 
     the Administrator shall place in the Reserve Fund an amount 
     equal to not less than 7.5 percent of the reserve ratio 
     required under subsection (b).
       ``(2) Amount satisfied.--As soon as the ratio required 
     under subsection (b) is achieved, and except as provided in 
     paragraph (3), the Administrator shall not be required to set 
     aside any amounts for the Reserve Fund.
       ``(3) Exception.--If at any time after the ratio required 
     under subsection (b) is achieved, the Reserve Fund falls 
     below the required ratio under subsection (b), the 
     Administrator shall place in the Reserve Fund for that fiscal 
     year an amount equal to not less than 7.5 percent of the 
     reserve ratio required under subsection (b).
       ``(e) Limitation on Reserve Ratio.--In any given fiscal 
     year, if the Administrator determines that the reserve ratio 
     required under subsection (b) cannot be achieved, the 
     Administrator shall submit a report to Congress that--
       ``(1) describes and details the specific concerns of the 
     Administrator regarding the consequences of the reserve ratio 
     not being achieved;
       ``(2) demonstrates how such consequences would harm the 
     long-term financial soundness of the flood insurance program; 
     and
       ``(3) indicates the maximum attainable reserve ratio for 
     that particular fiscal year.''.

     SEC. 115. REPAYMENT PLAN FOR BORROWING AUTHORITY.

       Section 1309 of the National Flood Insurance Act of 1968 
     (42 U.S.C. 4016) is amended by adding at the end the 
     following:
       ``(c) Upon the exercise of the authority established under 
     subsection (a), the Administrator shall transmit a schedule 
     for repayment of such amounts to--
       ``(1) the Secretary of the Treasury;
       ``(2) the Committee on Banking, Housing, and Urban Affairs 
     of the Senate; and
       ``(3) the Committee on Financial Services of the House of 
     Representatives.
       ``(d) In connection with any funds borrowed by the 
     Administrator under the authority established in subsection 
     (a), the Administrator, beginning 6 months after the date on 
     which such funds are borrowed, and continuing every 6 months 
     thereafter until such borrowed funds are fully repaid, shall 
     submit a report on the progress of such repayment to--
       ``(1) the Secretary of the Treasury;
       ``(2) the Committee on Banking, Housing, and Urban Affairs 
     of the Senate; and
       ``(3) the Committee on Financial Services of the House of 
     Representatives.''.

     SEC. 116. PAYMENT OF CONDOMINIUM CLAIMS.

       Section 1312 of the National Flood Insurance Act of 1968 
     (42 U.S.C. 4019), as amended by section 112, is amended by 
     adding at the end the following:
       ``(c) Payment of Claims to Condominium Owners.--The 
     Administrator may not deny payment for any damage to or loss 
     of property which is covered by flood insurance to 
     condominium owners who purchased such flood insurance 
     separate and apart from the flood insurance purchased by the 
     condominium association in which such owner is a member, 
     based solely, or in any part, on the flood insurance coverage 
     of the condominium association or others on the overall 
     property owned by the condominium association.''.

     SEC. 117. TECHNICAL MAPPING ADVISORY COUNCIL.

       (a) Establishment.--There is established a council to be 
     known as the Technical Mapping Advisory Council (in this 
     section referred to as the ``Council'').
       (b) Membership.--
       (1) In general.--The Council shall consist of the 
     Administrator, or the designee thereof, and 17 additional 
     members to be appointed by the Administrator or the designee 
     of the Administrator, who shall be--
       (A) the Under Secretary of Commerce for Oceans and 
     Atmosphere (or the designee thereof);
       (B) a member of a recognized professional surveying 
     association or organization;
       (C) a member of a recognized professional mapping 
     association or organization;
       (D) a member of a recognized professional engineering 
     association or organization;
       (E) a member of a recognized professional association or 
     organization representing flood hazard determination firms;
       (F) a representative of the United States Geological 
     Survey;
       (G) a representative of a recognized professional 
     association or organization representing State geographic 
     information;
       (H) a representative of State national flood insurance 
     coordination offices;
       (I) a representative of the Corps of Engineers;
       (J) the Secretary of the Interior (or the designee 
     thereof);
       (K) the Secretary of Agriculture (or the designee thereof);
       (L) a member of a recognized regional flood and storm water 
     management organization;
       (M) a representative of a State agency that has entered 
     into a cooperating technical partnership with the 
     Administrator and has demonstrated the capability to produce 
     flood insurance rate maps;
       (N) a representative of a local government agency that has 
     entered into a cooperating technical partnership with the 
     Administrator and has demonstrated the capability to produce 
     flood insurance rate maps;
       (O) a member of a recognized floodplain management 
     association or organization;
       (P) a member of a recognized risk management association or 
     organization; and
       (Q) a State mitigation officer.
       (2) Qualifications.--Members of the Council shall be 
     appointed based on their demonstrated knowledge and 
     competence regarding surveying, cartography, remote sensing, 
     geographic information systems, or the technical aspects of 
     preparing and using flood insurance rate maps.
       (c) Duties.--The Council shall--
       (1) recommend to the Administrator how to improve in a 
     cost-effective manner the--
       (A) accuracy, general quality, ease of use, and 
     distribution and dissemination of flood insurance rate maps 
     and risk data; and
       (B) performance metrics and milestones required to 
     effectively and efficiently map flood risk areas in the 
     United States;
       (2) recommend to the Administrator mapping standards and 
     guidelines for--
       (A) flood insurance rate maps; and
       (B) data accuracy, data quality, data currency, and data 
     eligibility;
       (3) recommend to the Administrator how to maintain, on an 
     ongoing basis, flood insurance rate maps and flood risk 
     identification;
       (4) recommend procedures for delegating mapping activities 
     to State and local mapping partners;
       (5) recommend to the Administrator and other Federal 
     agencies participating in the Council--
       (A) methods for improving interagency and intergovernmental 
     coordination on flood mapping and flood risk determination; 
     and
       (B) a funding strategy to leverage and coordinate budgets 
     and expenditures across Federal agencies; and

[[Page 7637]]

       (6) submit an annual report to the Administrator that 
     contains--
       (A) a description of the activities of the Council;
       (B) an evaluation of the status and performance of flood 
     insurance rate maps and mapping activities to revise and 
     update flood insurance rate maps, as required under section 
     118; and
       (C) a summary of recommendations made by the Council to the 
     Administrator.
       (d) Future Conditions Risk Assessment and Modeling 
     Report.--
       (1) In general.--The Council shall consult with scientists 
     and technical experts, other Federal agencies, States, and 
     local communities to--
       (A) develop recommendations on how to--
       (i) ensure that flood insurance rate maps incorporate the 
     best available climate science to assess flood risks; and
       (ii) ensure that the Federal Emergency Management Agency 
     uses the best available methodology to consider the impact 
     of--

       (I) the rise in the sea level; and
       (II) future development on flood risk; and

       (B) not later than 1 year after the date of the enactment 
     of this Act, prepare written recommendations in a future 
     conditions risk assessment and modeling report and to submit 
     such recommendations to the Administrator.
       (2) Responsibility of the administrator.--The 
     Administrator, as part of the ongoing program to review and 
     update National Flood Insurance Program rate maps under 
     section 118, shall incorporate any future risk assessment 
     submitted under paragraph (1)(B) in any such revision or 
     update.
       (e) Chairperson.--The members of the Council shall elect 1 
     member to serve as the chairperson of the Council (in this 
     section referred to as the ``Chairperson'').
       (f) Coordination.--To ensure that the Council's 
     recommendations are consistent, to the maximum extent 
     practicable, with national digital spatial data collection 
     and management standards, the Chairperson shall consult with 
     the Chairperson of the Federal Geographic Data Committee 
     (established pursuant to Office of Management and Budget 
     Circular A-16).
       (g) Compensation.--Members of the Council shall receive no 
     additional compensation by reason of their service on the 
     Council.
       (h) Meetings and Actions.--
       (1) In general.--The Council shall meet not less frequently 
     than twice each year at the request of the Chairperson or a 
     majority of its members, and may take action by a vote of the 
     majority of the members.
       (2) Initial meeting.--The Administrator, or a person 
     designated by the Administrator, shall request and coordinate 
     the initial meeting of the Council.
       (i) Officers.--The Chairperson may appoint officers to 
     assist in carrying out the duties of the Council under 
     subsection (c).
       (j) Staff.--
       (1) Staff of fema.--Upon the request of the Chairperson, 
     the Administrator may detail, on a nonreimbursable basis, 
     personnel of the Federal Emergency Management Agency to 
     assist the Council in carrying out its duties.
       (2) Staff of other federal agencies.--Upon request of the 
     Chairperson, any other Federal agency that is a member of the 
     Council may detail, on a nonreimbursable basis, personnel to 
     assist the Council in carrying out its duties.
       (k) Powers.--In carrying out this section, the Council may 
     hold hearings, receive evidence and assistance, provide 
     information, and conduct research, as it considers 
     appropriate.
       (l) Report to Congress.--The Administrator, on an annual 
     basis, shall report to the Committee on Banking, Housing, and 
     Urban Affairs of the Senate, the Committee on Financial 
     Services of the House of Representatives, and the Office of 
     Management and Budget on the--
       (1) recommendations made by the Council;
       (2) actions taken by the Federal Emergency Management 
     Agency to address such recommendations to improve flood 
     insurance rate maps and flood risk data; and
       (3) any recommendations made by the Council that have been 
     deferred or not acted upon, together with an explanatory 
     statement.

     SEC. 118. NATIONAL FLOOD MAPPING PROGRAM.

       (a) Reviewing, Updating, and Maintaining Maps.--The 
     Administrator, in coordination with the Technical Mapping 
     Advisory Council established under section 117, shall 
     establish an ongoing program under which the Administrator 
     shall review, update, and maintain National Flood Insurance 
     Program rate maps in accordance with this section.
       (b) Mapping.--
       (1) In general.--In carrying out the program established 
     under subsection (a), the Administrator shall--
       (A) identify, review, update, maintain, and publish 
     National Flood Insurance Program rate maps with respect to--
       (i) all populated areas and areas of possible population 
     growth located within the 100-year floodplain;
       (ii) all populated areas and areas of possible population 
     growth located within the 500-year floodplain;
       (iii) areas of residual risk, including areas that are 
     protected by levees, dams, and other flood control 
     structures;
       (iv) areas that could be inundated as a result of the 
     failure of a levee, dam, or other flood control structure; 
     and
       (v) the level of protection provided by flood control 
     structures;
       (B) establish or update flood-risk zone data in all such 
     areas, and make estimates with respect to the rates of 
     probable flood caused loss for the various flood risk zones 
     for each such area; and
       (C) use, in identifying, reviewing, updating, maintaining, 
     or publishing any National Flood Insurance Program rate map 
     required under this section or under the National Flood 
     Insurance Act of 1968 (42 U.S.C. 4011 et seq.), the most 
     accurate topography and elevation data available.
       (2) Mapping elements.--Each map updated under this section 
     shall--
       (A) assess the accuracy of current ground elevation data 
     used for hydrologic and hydraulic modeling of flooding 
     sources and mapping of the flood hazard and wherever 
     necessary acquire new ground elevation data utilizing the 
     most up-to-date geospatial technologies in accordance with 
     guidelines and specifications of the Federal Emergency 
     Management Agency; and
       (B) develop National Flood Insurance Program flood data on 
     a watershed basis--
       (i) to provide the most technically effective and efficient 
     studies and hydrologic and hydraulic modeling; and
       (ii) to eliminate, to the maximum extent possible, 
     discrepancies in base flood elevations between adjacent 
     political subdivisions.
       (3) Other inclusions.--In updating maps under this section, 
     the Administrator shall include--
       (A) any relevant information on coastal inundation from--
       (i) an applicable inundation map of the Corps of Engineers; 
     and
       (ii) data of the National Oceanic and Atmospheric 
     Administration relating to storm surge modeling;
       (B) any relevant information of the United States 
     Geological Survey on stream flows, watershed characteristics, 
     and topography that is useful in the identification of flood 
     hazard areas, as determined by the Administrator;
       (C) any relevant information on land subsidence, coastal 
     erosion areas, and other floor-related hazards;
       (D) any relevant information or data of the National 
     Oceanic and Atmospheric Administration and the United States 
     Geological Survey relating to the best available climate 
     science and the potential for future inundation from sea 
     level rise, increased precipitation, and increased intensity 
     of hurricanes due to global warming; and
       (E) any other relevant information as may be recommended by 
     the Technical Mapping Advisory Committee.
       (c) Standards.--In updating and maintaining maps under this 
     section, the Administrator shall--
       (1) establish standards to--
       (A) ensure that maps are adequate for--
       (i) flood risk determinations; and
       (ii) use by State and local governments in managing 
     development to reduce the risk of flooding; and
       (B) facilitate identification and use of consistent methods 
     of data collection and analysis by the Administrator, in 
     conjunction with State and local governments, in developing 
     maps for communities with similar flood risks, as determined 
     by the Administrator; and
       (2) publish maps in a format that is--
       (A) digital geospatial data compliant;
       (B) compliant with the open publishing and data exchange 
     standards established by the Open Geospatial Consortium; and
       (C) aligned with official data defined by the National 
     Geodetic Survey.
       (d) Communication and Outreach.--
       (1) In general.--The Administrator shall--
       (A) work to enhance communication and outreach to States, 
     local communities, and property owners about the effects--
       (i) of any potential changes to National Flood Insurance 
     Program rate maps that may result from the mapping program 
     required under this section; and
       (ii) that any such changes may have on flood insurance 
     purchase requirements; and
       (B) engage with local communities to enhance communication 
     and outreach to the residents of such communities on the 
     matters described under subparagraph (A).
       (2) Required activities.--The communication and outreach 
     activities required under paragraph (1) shall include--
       (A) notifying property owners when their properties become 
     included in, or when they are excluded from, an area covered 
     by the mandatory flood insurance purchase requirement under 
     section 102 of the Flood Disaster Protection Act of 1973 (42 
     U.S.C. 4012a);
       (B) educating property owners regarding the flood risk and 
     reduction of this risk in their community, including the 
     continued flood risks to areas that are no longer subject to 
     the flood insurance mandatory purchase requirement;
       (C) educating property owners regarding the benefits and 
     costs of maintaining or acquiring flood insurance, including, 
     where applicable, lower-cost preferred risk policies under 
     the National Flood Insurance Act of 1968 (42 U.S.C. 4011 et 
     seq.) for such properties and the contents of such 
     properties;

[[Page 7638]]

       (D) educating property owners about flood map revisions and 
     the process available to such owners to appeal proposed 
     changes in flood elevations through their community; and
       (E) encouraging property owners to maintain or acquire 
     flood insurance coverage.
       (e) Authorization of Appropriations.--There is authorized 
     to be appropriated to the Administrator to carry out this 
     section $400,000,000 for each of fiscal years 2012 through 
     2016.

     SEC. 119. SCOPE OF APPEALS.

       Section 1363 of the National Flood Insurance Act of 1968 
     (42 U.S.C. 4104) is amended--
       (1) in subsection (a)--
       (A) in the heading, by inserting ``and Designations of 
     Special Flood Hazard Areas'' after ``Elevation 
     Determinations'';
       (B) by inserting ``and designating special flood hazard 
     areas'' after ``flood elevations''; and
       (C) by striking ``such determinations'' and inserting 
     ``such determinations and designations''; and
       (2) in subsection (b)--
       (A) in the heading, by inserting ``and Designations of 
     Special Flood Hazard Areas'' after ``Elevation 
     Determinations'';
       (B) in the first sentence, by inserting ``and designation 
     of special flood hazard areas'' after ``flood elevation 
     determinations''; and
       (C) by amending the third sentence to read as follows: 
     ``The sole grounds for appeal shall be the possession of 
     knowledge or information indicating that (1) the elevations 
     being proposed by the Administrator with respect to an 
     identified area having special flood hazards are 
     scientifically or technically incorrect, or (2) the 
     designation of an identified special flood hazard area is 
     scientifically or technically incorrect.''

     SEC. 120. SCIENTIFIC RESOLUTION PANEL.

       (a) Establishment.--The National Flood Insurance Act of 
     1968 (42 U.S.C. 4011 et seq.) is amended by inserting after 
     section 1363 (42 U.S.C. 4104) the following:

     ``SEC. 1363A. SCIENTIFIC RESOLUTION PANEL.

       ``(a) Availability.--
       ``(1) In general.--Pursuant to the authority provided under 
     section 1363(e), the Administrator shall make available an 
     independent review panel, to be known as the Scientific 
     Resolution Panel, to any community--
       ``(A) that has--
       ``(i) filed a timely map appeal in accordance with section 
     1363;
       ``(ii) completed 60 days of consultation with the Federal 
     Emergency Management Agency on the appeal; and
       ``(iii) not allowed more than 120 days, or such longer 
     period as may be provided by the Administrator by waiver, to 
     pass since the end of the appeal period; or
       ``(B) that has received an unsatisfactory ruling under the 
     map revision process established pursuant to section 1360(f).
       ``(2) Appeals by owners and lessees.--If a community and an 
     owner or lessee of real property within the community appeal 
     a proposed determination of a flood elevation under section 
     1363(b), upon the request of the community--
       ``(A) the owner or lessee shall submit scientific and 
     technical data relating to the appeals to the Scientific 
     Resolution Panel; and
       ``(B) the Scientific Resolution Panel shall make a 
     determination with respect to the appeals in accordance with 
     subsection (c).
       ``(3) Definition.--For purposes of paragraph (1)(B), an 
     `unsatisfactory ruling' means that a community--
       ``(A) received a revised Flood Insurance Rate Map from the 
     Federal Emergency Management Agency, via a Letter of Final 
     Determination, after September 30, 2008 and prior to the date 
     of enactment of this section;
       ``(B) has subsequently applied for a Letter of Map Revision 
     or Physical Map Revision with the Federal Emergency 
     Management Agency; and
       ``(C) has received an unfavorable ruling on their request 
     for a map revision.
       ``(b) Membership.--The Scientific Resolution Panel made 
     available under subsection (a) shall consist of 5 members 
     with expertise that relate to the creation and study of flood 
     hazard maps and flood insurance. The Scientific Resolution 
     Panel may include representatives from Federal agencies not 
     involved in the mapping study in question and from other 
     impartial experts. Employees of the Federal Emergency 
     Management Agency may not serve on the Scientific Resolution 
     Panel.
       ``(c) Determination.--
       ``(1) In general.--Following deliberations, and not later 
     than 90 days after its formation, the Scientific Resolution 
     Panel shall issue a determination of resolution of the 
     dispute. Such determination shall set forth recommendations 
     for the base flood elevation determination or the 
     determination of an area having special flood hazards that 
     shall be reflected in the Flood Insurance Rate Maps.
       ``(2) Basis.--The determination of the Scientific 
     Resolution Panel shall be based on--
       ``(A) data previously provided to the Administrator by the 
     community, and, in the case of a dispute submitted under 
     subsection (a)(2), an owner or lessee of real property in the 
     community; and
       ``(B) data provided by the Administrator.
       ``(3) No alternative determinations permissible.--The 
     Scientific Resolution Panel--
       ``(A) shall provide a determination of resolution of a 
     dispute that--
       ``(i) is either in favor of the Administrator or in favor 
     of the community on each distinct element of the dispute; or
       ``(ii) in the case of a dispute submitted under subsection 
     (a)(2), is in favor of the Administrator, in favor of the 
     community, or in favor of the owner or lessee of real 
     property in the community on each distinct element of the 
     dispute; and
       ``(B) may not offer as a resolution any other alternative 
     determination.
       ``(4) Effect of determination.--
       ``(A) Binding.--The recommendations of the Scientific 
     Resolution Panel shall be binding on all appellants and not 
     subject to further judicial review unless the Administrator 
     determines that implementing the determination of the panel 
     would--
       ``(i) pose a significant threat due to failure to identify 
     a substantial risk of special flood hazards; or
       ``(ii) violate applicable law.
       ``(B) Written justification not to enforce.--If the 
     Administrator elects not to implement the determination of 
     the Scientific Resolution Panel pursuant to subparagraph (A), 
     then not later than 60 days after the issuance of the 
     determination, the Administrator shall issue a written 
     justification explaining such election.
       ``(C) Appeal of determination not to enforce.--If the 
     Administrator elects not to implement the determination of 
     the Scientific Resolution Panel pursuant to subparagraph (A), 
     the community may appeal the determination of the 
     Administrator as provided for under section 1363(g).
       ``(d) Maps Used for Insurance and Mandatory Purchase 
     Requirements.--With respect to any community that has a 
     dispute that is being considered by the Scientific Resolution 
     Panel formed pursuant to this subsection, the Federal 
     Emergency Management Agency shall ensure that for each such 
     community that--
       ``(1) the Flood Insurance Rate Map described in the most 
     recently issued Letter of Final Determination shall be in 
     force and effect with respect to such community; and
       ``(2) flood insurance shall continue to be made available 
     to the property owners and residents of the participating 
     community.''.
       (b) Conforming Amendments.--
       (1) Administrative review.--Section 1363(e) of the National 
     Flood Insurance Act of 1968 (42 U.S.C. 4104(e)) is amended by 
     striking ``an independent scientific body or appropriate 
     Federal agency for advice'' and inserting ``the Scientific 
     Resolution Panel provided for in section 1363A''.
       (2) Judicial review.--The first sentence of section 1363(g) 
     of the National Flood Insurance Act of 1968 (42 U.S.C. 
     4104(g)) is amended by striking ``Any appellant'' and 
     inserting ``Except as provided in section 1363A, any 
     appellant''.

     SEC. 121. REMOVAL OF LIMITATION ON STATE CONTRIBUTIONS FOR 
                   UPDATING FLOOD MAPS.

       Section 1360(f)(2) of the National Flood Insurance Act of 
     1968 (42 U.S.C. 4101(f)(2)) is amended by striking ``, but 
     which may not exceed 50 percent of the cost of carrying out 
     the requested revision or update''.

     SEC. 122. COORDINATION.

       (a) Interagency Budget Crosscut and Coordination Report.--
       (1) In general.--The Secretary of Homeland Security, the 
     Administrator, the Director of the Office of Management and 
     Budget, and the heads of each Federal department or agency 
     carrying out activities under sections 118 and 119 shall work 
     together to ensure that flood risk determination data and 
     geospatial data are shared among Federal agencies in order to 
     coordinate the efforts of the Nation to reduce its 
     vulnerability to flooding hazards.
       (2) Report.--Not later than 30 days after the submission of 
     the budget of the United States Government by the President 
     to Congress, the Director of the Office of Management and 
     Budget, in coordination with the Federal Emergency Management 
     Agency, the United States Geological Survey, the National 
     Oceanic and Atmospheric Administration, the Army Corps of 
     Engineers, and other Federal agencies, as appropriate, shall 
     submit to the appropriate authorizing and appropriating 
     committees of the Senate and the House of Representatives an 
     interagency budget crosscut and coordination report, 
     certified by the Secretary or head of each such agency, 
     that--
       (A) contains an interagency budget crosscut report that 
     displays relevant sections of the budget proposed for each of 
     the Federal agencies working on flood risk determination data 
     and digital elevation models, including any planned 
     interagency or intra-agency transfers; and
       (B) describes how the efforts aligned with such sections 
     complement one another.
       (b) Duties of the Administrator.--In carrying out sections 
     118 and 119, the Administrator shall--
       (1) participate, pursuant to section 216 of the E-
     Government Act of 2002 (44 U.S.C. 3501 note), in the 
     establishment of such standards and common protocols as are 
     necessary to assure the interoperability of geospatial data 
     for all users of such information;
       (2) coordinate with, seek assistance and cooperation of, 
     and provide a liaison to the

[[Page 7639]]

     Federal Geographic Data Committee pursuant to the Office of 
     Management and Budget Circular A-16 and Executive Order 12906 
     (43 U.S.C. 1457 note; relating to the National Spatial Data 
     Infrastructure) for the implementation of and compliance with 
     such standards;
       (3) integrate with, leverage, and coordinate funding of, to 
     the maximum extent practicable, the current flood mapping 
     activities of each unit of State and local government;
       (4) integrate with, leverage, and coordinate, to the 
     maximum extent practicable, the current geospatial activities 
     of other Federal agencies and units of State and local 
     government; and
       (5) develop a funding strategy to leverage and coordinate 
     budgets and expenditures, and to maintain or establish joint 
     funding and other agreement mechanisms with other Federal 
     agencies and units of State and local government to share in 
     the collection and utilization of geospatial data among all 
     governmental users.

     SEC. 123. INTERAGENCY COORDINATION STUDY.

       (a) In General.--The Administrator shall enter into a 
     contract with the National Academy of Public Administration 
     to conduct a study on how the Federal Emergency Management 
     Agency--
       (1) should improve interagency and intergovernmental 
     coordination on flood mapping, including a funding strategy 
     to leverage and coordinate budgets and expenditures; and
       (2) can establish joint funding mechanisms with other 
     Federal agencies and units of State and local government to 
     share the collection and utilization of data among all 
     governmental users.
       (b) Timing.--Not later than 180 days after the date of the 
     enactment of this title, the National Academy of Public 
     Administration shall report the findings of the study 
     required under subsection (a) to--
       (1) the Committee on Banking, Housing, and Urban Affairs of 
     the Senate;
       (2) the Committee on Financial Services of the House of 
     Representatives;
       (3) the Committee on Appropriations of the Senate; and
       (4) the Committee on Appropriations of the House of 
     Representatives.

     SEC. 124. NONMANDATORY PARTICIPATION.

       (a) Nonmandatory Participation in National Flood Insurance 
     Program for 500-Year Floodplain.--Any area located within the 
     500-year floodplain shall not be subject to the mandatory 
     purchase requirements of sections 102 or 202 of the Flood 
     Disaster Protection Act of 1973 (42 U.S.C. 4012a and 4106).
       (b) Notice.--
       (1) By administrator.--In carrying out the National Flood 
     Insurance Program, the Administrator shall provide notice to 
     any community located in an area within the 500-year 
     floodplain.
       (2) Timing of notice.--The notice required under paragraph 
     (1) shall be made not later than 6 months after the date of 
     completion of the initial mapping of the 500-year floodplain, 
     as required under section 118.
       (3) Lender required notice.--
       (A) Regulated lending institutions.--Each Federal or State 
     entity for lending regulation (after consultation and 
     coordination with the Federal Financial Institutions 
     Examination Council) shall, by regulation, require regulated 
     lending institutions, as a condition of making, increasing, 
     extending, or renewing any loan secured by property located 
     in an area within the 500-year floodplain, to notify the 
     purchaser or lessee (or obtain satisfactory assurances that 
     the seller or lessor has notified the purchaser or lessee) 
     and the servicer of the loan that such property is located in 
     an area within the 500-year floodplain, in a manner that is 
     consistent with, and substantially identical to, the notice 
     required under section 1364(a)(1) of the National Flood 
     Insurance Act of 1968 (42 U.S.C. 4104a(a)(1)).
       (B) Federal or state agency lenders.--Each Federal or State 
     agency lender shall, by regulation, require notification in 
     the same manner as provided under subparagraph (A) with 
     respect to any loan that is made by a Federal or State agency 
     lender and secured by property located in an area within the 
     500-year floodplain.
       (C) Penalty for noncompliance.--Any regulated lending 
     institution or Federal or State agency lender that fails to 
     comply with the notice requirements established by this 
     paragraph shall be subject to the penalties prescribed under 
     section 102(f)(5) of the Flood Disaster Protection Act of 
     1973 (42 U.S.C. 4012a(f)(5)).

     SEC. 125. NOTICE OF FLOOD INSURANCE AVAILABILITY UNDER RESPA.

       Section 5(b) of the Real Estate Settlement Procedures Act 
     of 1974 (12 U.S.C. 2604(b)), as amended by section 1450 of 
     the Dodd-Frank Wall Street Reform and Consumer Protection Act 
     (Public Law 111-203; 124 Stat. 2174), is amended by adding at 
     the end the following:
       ``(14) An explanation of flood insurance and the 
     availability of flood insurance under the National Flood 
     Insurance Program, whether or not the real estate is located 
     in an area having special flood hazards.''.

     SEC. 126. PARTICIPATION IN STATE DISASTER CLAIMS MEDIATION 
                   PROGRAMS.

       Chapter I of the National Flood Insurance Act of 1968 (42 
     U.S.C. 4011 et seq.) is amended by inserting after section 
     1313 (42 U.S.C. 4020) the following:

     ``SEC. 1314. PARTICIPATION IN STATE DISASTER CLAIMS MEDIATION 
                   PROGRAMS.

       ``(a) Requirement To Participate.--In the case of the 
     occurrence of a major disaster, as defined in section 102 of 
     the Robert T. Stafford Disaster Relief and Emergency 
     Assistance Act (42 U.S.C. 5122), that may have resulted in 
     flood damage covered under the flood insurance program 
     established under this chapter and other personal lines 
     residential property insurance coverage offered by a State 
     regulated insurer, upon a request made by the insurance 
     commissioner of a State (or such other official responsible 
     for regulating the business of insurance in the State) for 
     the participation of representatives of the Administrator in 
     a program sponsored by such State for nonbinding mediation of 
     insurance claims resulting from a major disaster, the 
     Administrator shall cause representatives of the flood 
     insurance program to participate in such a State program 
     where claims under the flood insurance program are involved 
     to expedite settlement of flood damage claims resulting from 
     such disaster.
       ``(b) Extent of Participation.--In satisfying the 
     requirements of subsection (a), the Administrator shall 
     require that each representative of the Administrator--
       ``(1) be certified for purposes of the flood insurance 
     program to settle claims against such program resulting from 
     such disaster in amounts up to the limits of policies under 
     such program;
       ``(2) attend State-sponsored mediation meetings regarding 
     flood insurance claims resulting from such disaster at such 
     times and places as may be arranged by the State;
       ``(3) participate in good faith negotiations toward the 
     settlement of such claims with policyholders of coverage made 
     available under the flood insurance program; and
       ``(4) finalize the settlement of such claims on behalf of 
     the flood insurance program with such policyholders.
       ``(c) Coordination.--Representatives of the Administrator 
     shall at all times coordinate their activities with insurance 
     officials of the State and representatives of insurers for 
     the purposes of consolidating and expediting settlement of 
     claims under the national flood insurance program resulting 
     from such disaster.
       ``(d) Qualifications of Mediators.--Each State mediator 
     participating in State-sponsored mediation under this section 
     shall be--
       ``(1)(A) a member in good standing of the State bar in the 
     State in which the mediation is to occur with at least 2 
     years of practical experience; and
       ``(B) an active member of such bar for at least 1 year 
     prior to the year in which such mediator's participation is 
     sought; or
       ``(2) a retired trial judge from any United States 
     jurisdiction who was a member in good standing of the bar in 
     the State in which the judge presided for at least 5 years 
     prior to the year in which such mediator's participation is 
     sought.
       ``(e) Mediation Proceedings and Documents Privileged.--As a 
     condition of participation, all statements made and documents 
     produced pursuant to State-sponsored mediation involving 
     representatives of the Administrator shall be deemed 
     privileged and confidential settlement negotiations made in 
     anticipation of litigation.
       ``(f) Liability, Rights, or Obligations Not Affected.--
     Participation in State-sponsored mediation, as described in 
     this section does not--
       ``(1) affect or expand the liability of any party in 
     contract or in tort; or
       ``(2) affect the rights or obligations of the parties, as 
     established--
       ``(A) in any regulation issued by the Administrator, 
     including any regulation relating to a standard flood 
     insurance policy;
       ``(B) under this Act; and
       ``(C) under any other provision of Federal law.
       ``(g) Exclusive Federal Jurisdiction.--Participation in 
     State-sponsored mediation shall not alter, change, or modify 
     the original exclusive jurisdiction of United States courts, 
     as set forth in this Act.
       ``(h) Cost Limitation.--Nothing in this section shall be 
     construed to require the Administrator or a representative of 
     the Administrator to pay additional mediation fees relating 
     to flood insurance claims associated with a State-sponsored 
     mediation program in which such representative of the 
     Administrator participates.
       ``(i) Exception.--In the case of the occurrence of a major 
     disaster that results in flood damage claims under the 
     national flood insurance program and that does not result in 
     any loss covered by a personal lines residential property 
     insurance policy--
       ``(1) this section shall not apply; and
       ``(2) the provisions of the standard flood insurance policy 
     under the national flood insurance program and the appeals 
     process established under section 205 of the Bunning-
     Bereuter-Blumenauer Flood Insurance Reform Act of 2004 (42 
     U.S.C. 4011 note) and the regulations issued pursuant to such 
     section shall apply exclusively.
       ``(j) Representatives of the Administrator.--For purposes 
     of this section, the term `representatives of the 
     Administrator' means representatives of the national flood 
     insurance program who participate in the appeals process 
     established under section 205 of

[[Page 7640]]

     the Bunning-Bereuter-Blumenauer Flood Insurance Reform Act of 
     2004 (42 U.S.C. 4011 note).''.

     SEC. 127. ADDITIONAL AUTHORITY OF FEMA TO COLLECT INFORMATION 
                   ON CLAIMS PAYMENTS.

       (a) In General.--The Administrator shall collect, from 
     property and casualty insurance companies that are authorized 
     by the Administrator to participate in the Write Your Own 
     program any information and data needed to determine the 
     accuracy of the resolution of flood claims filed on any 
     property insured with a standard flood insurance policy 
     obtained under the program that was subject to a flood.
       (b) Type of Information To Be Collected.--The information 
     and data to be collected under subsection (a) may include--
       (1) any adjuster estimates made as a result of flood 
     damage, and if the insurance company also insures the 
     property for wind damage--
       (A) any adjuster estimates for both wind and flood damage;
       (B) the amount paid to the property owner for wind and 
     flood claims;
       (C) the total amount paid to the policyholder for damages 
     as a result of the event that caused the flooding and other 
     losses;
       (2) any amounts paid to the policyholder by the insurance 
     company for damages to the insured property other than flood 
     damages; and
       (3) the total amount paid to the policyholder by the 
     insurance company for all damages incurred to the insured 
     property as a result of the flood.

     SEC. 128. OVERSIGHT AND EXPENSE REIMBURSEMENTS OF INSURANCE 
                   COMPANIES.

       (a) Submission of Biennial Reports.--
       (1) To the administrator.--Not later than 20 days after the 
     date of the enactment of this Act, each property and casualty 
     insurance company that is authorized by the Administrator to 
     participate in the Write Your Own program shall submit to the 
     Administrator any biennial report required by the Federal 
     Emergency Management Agency to be prepared in the prior 5 
     years by such company.
       (2) To gao.--Not later than 10 days after the submission of 
     the biennial reports under paragraph (1), the Administrator 
     shall submit all such reports to the Comptroller General of 
     the United States.
       (3) Notice to congress of failure to comply.--The 
     Administrator shall notify and report to the Committee on 
     Banking, Housing, and Urban Affairs of the Senate and the 
     Committee on Financial Services of the House of 
     Representatives on any property and casualty insurance 
     company participating in the Write Your Own program that 
     failed to submit its biennial reports as required under 
     paragraph (1).
       (4) Failure to comply.--A property and casualty insurance 
     company that is authorized by the Administrator to 
     participate in the Write Your Own program which fails to 
     comply with the reporting requirement under this subsection 
     or the requirement under section 62.23(j)(1) of title 44, 
     Code of Federal Regulations (relating to biennial audit of 
     the flood insurance financial statements) shall be subject to 
     a civil penalty in an amount equal to $1,000 per day for each 
     day that the company remains in noncompliance with either 
     such requirement.
       (b) Methodology To Determine Reimbursed Expenses.--Not 
     later than 180 days after the date of the enactment of this 
     Act, the Administrator shall develop a methodology for 
     determining the appropriate amounts that participating 
     property and casualty insurance companies should be 
     reimbursed for selling, writing, and servicing flood 
     insurance policies and adjusting flood insurance claims on 
     behalf of the National Flood Insurance Program. The 
     methodology shall be developed using actual expense data for 
     the flood insurance line and can be derived from--
       (1) flood insurance expense data produced by participating 
     property and casualty insurance companies;
       (2) flood insurance expense data collected by the National 
     Association of Insurance Commissioners; or
       (3) a combination of the methodologies described in 
     paragraphs (1) and (2).
       (c) Submission of Expense Reports.--To develop the 
     methodology established under subsection (b), the 
     Administrator may require each property and casualty 
     insurance company participating in the Write Your Own program 
     to submit a report to the Administrator, in a format 
     determined by the Administrator and within 60 days of the 
     request, that details the expense levels of each such company 
     for selling, writing, and servicing standard flood insurance 
     policies and adjusting and servicing claims.
       (d) FEMA Rulemaking on Reimbursement of Expenses Under the 
     WYO Program.--Not later than 12 months after the date of the 
     enactment of this Act, the Administrator shall conduct a 
     rulemaking proceeding to formulate revised expense 
     reimbursements to property and casualty insurance companies 
     participating in the Write Your Own program for their 
     expenses (including their operating and administrative 
     expenses for adjustment of claims) in selling, writing, and 
     servicing standard flood insurance policies, including how 
     such companies shall be reimbursed in both catastrophic and 
     noncatastrophic years. Such reimbursements shall be 
     structured to ensure reimbursements track the actual 
     expenses, including standard business costs and operating 
     expenses, of such companies as close as practicably possible.
       (e) Report of the Administrator.--Not later than 60 days 
     after the effective date of any final rule established 
     pursuant to subsection (d), the Administrator shall submit to 
     the Committee on Banking, Housing, and Urban Affairs of the 
     Senate and the Committee on Financial Services of the House 
     of Representatives a report containing--
       (1) the specific rationale and purposes of such rule;
       (2) the reasons for the adoption of the policies contained 
     in such rule; and
       (3) the degree to which such rule accurately represents the 
     true operating costs and expenses of property and casualty 
     insurance companies participating in the Write Your Own 
     program.
       (f) GAO Study and Report on Expenses of WYO Program.--
       (1) Study.--Not later than 180 days after the effective 
     date of the final rule established pursuant to subsection 
     (d), the Comptroller General of the United States shall--
       (A) conduct a study on the efficacy, adequacy, and 
     sufficiency of the final rules established pursuant to 
     subsection (d); and
       (B) report to the Committee on Banking, Housing, and Urban 
     Affairs of the Senate and the Committee on Financial Services 
     of the House of Representatives on the findings of the study 
     conducted under subparagraph (A).
       (2) GAO authority.--In conducting the study and report 
     required under paragraph (1), the Comptroller General--
       (A) may use any previous findings, studies, or reports that 
     the Comptroller General previously completed on the Write 
     Your Own program;
       (B) shall determine if--
       (i) the final rules established pursuant to subsection (d) 
     allow the Federal Emergency Management Agency to access 
     adequate information regarding the actual expenses of 
     property and casualty insurance companies participating in 
     the Write Your Own program; and
       (ii) the actual reimbursements paid out under the final 
     rule established in subsection (d) accurately reflect the 
     expenses reported by property and casualty insurance 
     companies participating in the Write Your Own program, 
     including the standard business costs and operating expenses 
     of such companies; and
       (C) shall analyze the effect of such rules on the level of 
     participation of property and casualty insurers in the Write 
     Your Own program.

     SEC. 129. MITIGATION.

       (a) Mitigation Assistance Grants.--Section 1366 of the 
     National Flood Insurance Act of 1968 (42 U.S.C. 4104c) is 
     amended--
       (1) by striking subsections (b), (d), (f), (g), (h), (k), 
     and (m);
       (2) by redesignating subsections (c), (e), (i), and (j) as 
     subsections (b), (c), (e), and (f), respectively;
       (3) in subsection (a), by striking the last sentence and 
     inserting the following: ``Such financial assistance shall be 
     made available--
       ``(1) to States and communities in the form of grants under 
     this section for carrying out mitigation activities;
       ``(2) to States and communities in the form of grants under 
     this section for carrying out mitigation activities that 
     reduce flood damage to severe repetitive loss structures; and
       ``(3) to property owners in the form of direct grants under 
     this section for carrying out mitigation activities that 
     reduce flood damage to individual structures for which 2 or 
     more claim payments for losses have been made under flood 
     insurance coverage under this title if the Administrator, 
     after consultation with the State and community, determines 
     that neither the State nor community in which such a 
     structure is located has the capacity to manage such 
     grants.'';
       (4) in subsection (b), as so redesignated, in the first 
     sentence--
       (A) by striking ``and provides protection against'' and 
     inserting ``provides for reduction of''; and
       (B) by inserting before the period at the end the 
     following: ``, and may be included in a multi-hazard 
     mitigation plan'';
       (5) in subsection (c), as so redesignated--
       (A) in paragraph (1), by striking ``(1) Use of amounts.--'' 
     and all that follows through the end of the first sentence 
     and inserting the following:
       ``(1) Requirement of consistency with approved mitigation 
     plan.--Amounts provided under this section may be used only 
     for mitigation activities that are consistent with mitigation 
     plans that are approved by the Administrator and identified 
     under paragraph (4).'';
       (B) by striking paragraphs (2), (3), and (4) and inserting 
     the following new paragraphs:
       ``(2) Requirements of technical feasibility, cost 
     effectiveness, and interest of nfif.--The Administrator may 
     approve only mitigation activities that the Administrator 
     determines are technically feasible and cost-effective and in 
     the interest of, and represent savings to, the National Flood 
     Insurance Fund. In making such determinations, the 
     Administrator shall take into consideration recognized 
     ancillary benefits.

[[Page 7641]]

       ``(3) Priority for mitigation assistance.--In providing 
     grants under this section for mitigation activities, the 
     Administrator shall give priority for funding to activities 
     that the Administrator determines will result in the greatest 
     savings to the National Flood Insurance Fund, including 
     activities for--
       ``(A) severe repetitive loss structures;
       ``(B) repetitive loss structures; and
       ``(C) other subsets of structures as the Administrator may 
     establish.'';
       (C) by redesignating paragraph (5) as paragraph (4);
       (D) in paragraph (4), as so redesignated--
       (i) in the matter preceding subparagraph (A), by striking 
     ``The Director'' and all that follows through ``Such 
     activities may'' and inserting ``Eligible activities under a 
     mitigation plan may'';
       (ii) by striking subparagraphs (E) and (H);
       (iii) by redesignating subparagraphs (D), (F), and (G) as 
     subparagraphs (E), (G), and (H), respectively;
       (iv) by inserting after subparagraph (C) the following new 
     subparagraph:
       ``(D) elevation, relocation, or floodproofing of utilities 
     (including equipment that serve structures);'';
       (v) by inserting after subparagraph (E), as so 
     redesignated, the following new subparagraph:
       ``(F) the development or update of mitigation plans by a 
     State or community which meet the planning criteria 
     established by the Administrator, except that the amount from 
     grants under this section that may be used under this 
     subparagraph may not exceed $50,000 for any mitigation plan 
     of a State or $25,000 for any mitigation plan of a 
     community;'';
       (vi) in subparagraph (H); as so redesignated, by striking 
     ``and'' at the end; and
       (vii) by adding at the end the following new subparagraphs:
       ``(I) other mitigation activities not described in 
     subparagraphs (A) through (G) or the regulations issued under 
     subparagraph (H), that are described in the mitigation plan 
     of a State or community; and
       ``(J) without regard to the requirements under subsections 
     (d)(1) and (d)(2), and if the State applied for and was 
     awarded at least $1,000,000 in grants available under this 
     section in the prior fiscal year, technical assistance to 
     communities to identify eligible activities, to develop grant 
     applications, and to implement grants awarded under this 
     section, not to exceed $50,000 to any one State in any fiscal 
     year.'';
       (E) by adding at the end the following new paragraph:
       ``(5) Eligibility of demolition and rebuilding of 
     properties.--The Administrator shall consider as an eligible 
     activity the demolition and rebuilding of properties to at 
     least base flood elevation or greater, if required by the 
     Administrator or if required by any State regulation or local 
     ordinance, and in accordance with criteria established by the 
     Administrator.''; and
       (6) by inserting after subsection (c), as so redesignated, 
     the following new subsection:
       ``(d) Matching Requirement.--The Administrator may provide 
     grants for eligible mitigation activities as follows:
       ``(1) Severe repetitive loss structures.--In the case of 
     mitigation activities to severe repetitive loss structures, 
     in an amount up to 100 percent of all eligible costs.
       ``(2) Repetitive loss structures.--In the case of 
     mitigation activities to repetitive loss structures, in an 
     amount up to 90 percent of all eligible costs.
       ``(3) Other mitigation activities.--In the case of all 
     other mitigation activities, in an amount up to 75 percent of 
     all eligible costs.'';
       (7) in subsection (e)(2), as so redesignated--
       (A) by striking ``certified under subsection (g)'' and 
     inserting ``required under subsection (d)''; and
       (B) by striking ``3 times the amount'' and inserting ``the 
     amount'';
       (8) in subsection (f)(1), as so redesignated, by striking 
     ``Riegle Community Development and Regulatory Improvement Act 
     of 1994'' and inserting ``Flood Insurance Reform and 
     Modernization Act of 2012''; and
       (9) by adding at the end the following new subsections:
       ``(g) Failure To Make Grant Award Within 5 Years.--For any 
     application for a grant under this section for which the 
     Administrator fails to make a grant award within 5 years of 
     the date of the application, the grant application shall be 
     considered to be denied and any funding amounts allocated for 
     such grant applications shall remain in the National Flood 
     Mitigation Fund under section 1367 of this title and shall be 
     made available for grants under this section.
       ``(h) Definitions.--For purposes of this section, the 
     following definitions shall apply:
       ``(1) Community.--The term `community' means--
       ``(A) a political subdivision that--
       ``(i) has zoning and building code jurisdiction over a 
     particular area having special flood hazards; and
       ``(ii) is participating in the national flood insurance 
     program; or
       ``(B) a political subdivision of a State, or other 
     authority, that is designated by political subdivisions, all 
     of which meet the requirements of subparagraph (A), to 
     administer grants for mitigation activities for such 
     political subdivisions.
       ``(2) Repetitive loss structure.--The term `repetitive loss 
     structure' has the meaning given such term in section 1370.
       ``(3) Severe repetitive loss structure.--The term `severe 
     repetitive loss structure' means a structure that--
       ``(A) is covered under a contract for flood insurance made 
     available under this title; and
       ``(B) has incurred flood-related damage--
       ``(i) for which 4 or more separate claims payments have 
     been made under flood insurance coverage under this title, 
     with the amount of each such claim exceeding $5,000, and with 
     the cumulative amount of such claims payments exceeding 
     $20,000; or
       ``(ii) for which at least 2 separate claims payments have 
     been made under such coverage, with the cumulative amount of 
     such claims exceeding the value of the insured structure.''.
       (b) Elimination of Grants Program for Repetitive Insurance 
     Claims Properties.--Chapter I of the National Flood Insurance 
     Act of 1968 is amended by striking section 1323 (42 U.S.C. 
     4030).
       (c) Elimination of Pilot Program for Mitigation of Severe 
     Repetitive Loss Properties.--Chapter III of the National 
     Flood Insurance Act of 1968 is amended by striking section 
     1361A (42 U.S.C. 4102a).
       (d) National Flood Insurance Fund.--Section 1310(a) of the 
     National Flood Insurance Act of 1968 (42 U.S.C. 4017(a)) is 
     amended--
       (1) in paragraph (6), by inserting ``and'' after the 
     semicolon;
       (2) in paragraph (7), by striking the semicolon and 
     inserting a period; and
       (3) by striking paragraphs (8) and (9).
       (e) National Flood Mitigation Fund.--Section 1367 of the 
     National Flood Insurance Act of 1968 (42 U.S.C. 4104d) is 
     amended--
       (1) in subsection (b)--
       (A) by striking paragraph (1) and inserting the following 
     new paragraph:
       ``(1) in each fiscal year, amounts from the National Flood 
     Insurance Fund not to exceed $90,000,000 and to remain 
     available until expended, of which--
       ``(A) not more than $40,000,000 shall be available pursuant 
     to subsection (a) of this section for assistance described in 
     section 1366(a)(1);
       ``(B) not more than $40,000,000 shall be available pursuant 
     to subsection (a) of this section for assistance described in 
     section 1366(a)(2); and
       ``(C) not more than $10,000,000 shall be available pursuant 
     to subsection (a) of this section for assistance described in 
     section 1366(a)(3);''; and
       (B) in paragraph (3), by striking ``section 1366(i)'' and 
     inserting ``section 1366(e)'';
       (2) in subsection (c), by striking ``sections 1366 and 
     1323'' and inserting ``section 1366'';
       (3) by redesignating subsections (d) and (e) as subsections 
     (f) and (g), respectively; and
       (4) by inserting after subsection (c) the following new 
     subsections:
       ``(d) Prohibition on Offsetting Collections.--
     Notwithstanding any other provision of this title, amounts 
     made available pursuant to this section shall not be subject 
     to offsetting collections through premium rates for flood 
     insurance coverage under this title.
       ``(e) Continued Availability and Reallocation.--Any amounts 
     made available pursuant to subparagraph (A), (B), or (C) of 
     subsection (b)(1) that are not used in any fiscal year shall 
     continue to be available for the purposes specified in such 
     subparagraph of subsection (b)(1) pursuant to which such 
     amounts were made available, unless the Administrator 
     determines that reallocation of such unused amounts to meet 
     demonstrated need for other mitigation activities under 
     section 1366 is in the best interest of the National Flood 
     Insurance Fund.''.
       (f) Increased Cost of Compliance Coverage.--Section 
     1304(b)(4) of the National Flood Insurance Act of 1968 (42 
     U.S.C. 4011(b)(4)) is amended--
       (1) by striking subparagraph (B); and
       (2) by redesignating subparagraphs (C), (D), and (E) as 
     subparagraphs (B), (C), and (D), respectively.

     SEC. 130. FLOOD PROTECTION STRUCTURE ACCREDITATION TASK 
                   FORCE.

       (a) Definitions.--In this section--
       (1) the term ``flood protection structure accreditation 
     requirements'' means the requirements established under 
     section 65.10 of title 44, Code of Federal Regulations, for 
     levee systems to be recognized on maps created for purposes 
     of the National Flood Insurance Program;
       (2) the term ``National Committee on Levee Safety'' means 
     the Committee on Levee Safety established under section 9003 
     of the National Levee Safety Act of 2007 (33 U.S.C. 3302); 
     and
       (3) the term ``task force'' means the Flood Protection 
     Structure Accreditation Task Force established under 
     subsection (b).
       (b) Establishment.--
       (1) In general.--The Administrator and the Secretary of the 
     Army, acting through the Chief of Engineers, in cooperation 
     with the National Committee on Levee Safety, shall jointly 
     establish a Flood Protection Structure Accreditation Task 
     Force.
       (2) Duties.--

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       (A) Developing process.--The task force shall develop a 
     process to better align the information and data collected by 
     or for the United States Army Corps of Engineers under the 
     Inspection of Completed Works Program with the flood 
     protection structure accreditation requirements so that--
       (i) information and data collected for either purpose can 
     be used interchangeably; and
       (ii) information and data collected by or for the United 
     States Army Corps of Engineers under the Inspection of 
     Completed Works Program is sufficient to satisfy the flood 
     protection structure accreditation requirements.
       (B) Gathering recommendations.--The task force shall 
     gather, and consider in the process developed under 
     subparagraph (A), recommendations from interested persons in 
     each region relating to the information, data, and 
     accreditation requirements described in subparagraph (A).
       (3) Considerations.--In developing the process under 
     paragraph (2), the task force shall consider changes to--
       (A) the information and data collected by or for the United 
     States Army Corps of Engineers under the Inspection of 
     Completed Works Program; and
       (B) the flood protection structure accreditation 
     requirements.
       (4) Rule of construction.--Nothing in this section shall be 
     construed to require a reduction in the level of public 
     safety and flood control provided by accredited levees, as 
     determined by the Administrator for purposes of this section.
       (c) Implementation.--The Administrator and the Secretary of 
     the Army, acting through the Chief of Engineers, shall 
     implement the process developed by the task force under 
     subsection (b).
       (d) Reports.--The Administrator and the Secretary of the 
     Army, acting through the Chief of Engineers, in cooperation 
     with the National Committee on Levee Safety, shall jointly 
     submit to the Committee on Banking, Housing, and Urban 
     Affairs and the Committee on Environment and Public Works of 
     the Senate and the Committee on Financial Services, the 
     Committee on Transportation and Infrastructure, and the 
     Committee on Natural Resources of the House of 
     Representatives reports concerning the activities of the task 
     force and the implementation of the process developed by the 
     task force under subsection (b), including--
       (1) an interim report, not later than 180 days after the 
     date of enactment of this Act; and
       (2) a final report, not later than 1 year after the date of 
     enactment of this Act.
       (e) Termination.--The task force shall terminate on the 
     date of submission of the report under subsection (d)(2).

     SEC. 131. FLOOD IN PROGRESS DETERMINATIONS.

       (a) Report.--
       (1) Review.--The Administrator shall review--
       (A) the processes and procedures for determining that a 
     flood event has commenced or is in progress for purposes of 
     flood insurance coverage made available under the National 
     Flood Insurance Program;
       (B) the processes and procedures for providing public 
     notification that such a flood event has commenced or is in 
     progress;
       (C) the processes and procedures regarding the timing of 
     public notification of flood insurance requirements and 
     availability; and
       (D) the effects and implications that weather conditions, 
     including rainfall, snowfall, projected snowmelt, existing 
     water levels, and other conditions, have on the determination 
     that a flood event has commenced or is in progress.
       (2) Report.--Not later than 6 months after the date of 
     enactment of this Act, the Administrator shall submit a 
     report to Congress that describes--
       (A) the results and conclusions of the review under 
     paragraph (1); and
       (B) any actions taken, or proposed actions to be taken, by 
     the Administrator to provide for more precise and technical 
     processes and procedures for determining that a flood event 
     has commenced or is in progress.
       (b) Effective Date of Policies Covering Properties Affected 
     by Flooding of the Missouri River in 2011.--
       (1) Eligible coverage.--For purposes of this subsection, 
     the term ``eligible coverage'' means coverage under a new 
     contract for flood insurance coverage under the National 
     Flood Insurance Program, or a modification to coverage under 
     an existing flood insurance contract, for property damaged by 
     the flooding of the Missouri River that commenced on June 1, 
     2011, that was purchased or made during the period beginning 
     May 1, 2011, and ending June 6, 2011.
       (2) Effective dates.--Notwithstanding section 1306(c) of 
     the National Flood Insurance Act of 1968 (42 U.S.C. 4013(c)), 
     or any other provision of law, any eligible coverage shall--
       (A) be deemed to take effect on the date that is 30 days 
     after the date on which all obligations for the eligible 
     coverage (including completion of the application and payment 
     of any initial premiums owed) are satisfactorily completed; 
     and
       (B) cover damage to property occurring after the effective 
     date described in subparagraph (A) that resulted from the 
     flooding of the Missouri River that commenced on June 1, 
     2011, if the property did not suffer damage or loss as a 
     result of such flooding before the effective date described 
     in subparagraph (A).

     SEC. 132. CLARIFICATION OF RESIDENTIAL AND COMMERCIAL 
                   COVERAGE LIMITS.

       Section 1306(b) of the National Flood Insurance Act of 1968 
     (42 U.S.C. 4013(b)) is amended--
       (1) in paragraph (2)--
       (A) by striking ``in the case of any residential property'' 
     and inserting ``in the case of any residential building 
     designed for the occupancy of from one to four families''; 
     and
       (B) by striking ``shall be made available to every insured 
     upon renewal and every applicant for insurance so as to 
     enable such insured or applicant to receive coverage up to a 
     total amount (including such limits specified in paragraph 
     (1)(A)(i)) of $250,000'' and inserting ``shall be made 
     available, with respect to any single such building, up to an 
     aggregate liability (including such limits specified in 
     paragraph (1)(A)(i)) of $250,000''; and
       (2) in paragraph (4)--
       (A) by striking ``in the case of any nonresidential 
     property, including churches,'' and inserting ``in the case 
     of any nonresidential building, including a church,''; and
       (B) by striking ``shall be made available to every insured 
     upon renewal and every applicant for insurance, in respect to 
     any single structure, up to a total amount (including such 
     limit specified in subparagraph (B) or (C) of paragraph (1), 
     as applicable) of $500,000 for each structure and $500,000 
     for any contents related to each structure'' and inserting 
     ``shall be made available with respect to any single such 
     building, up to an aggregate liability (including such limits 
     specified in subparagraph (B) or (C) of paragraph (1), as 
     applicable) of $500,000, and coverage shall be made available 
     up to a total of $500,000 aggregate liability for contents 
     owned by the building owner and $500,000 aggregate liability 
     for each unit within the building for contents owned by the 
     tenant''.

     SEC. 133. LOCAL DATA REQUIREMENT.

       (a) In General.--Notwithstanding any other provision of 
     this title, an area that is within or includes a community 
     that is identified by the Administrator as Community 
     Identification Number 360467 and impacted by the Jamaica Bay 
     flooding source or identified by the Administrator as 
     Community Identification Number 360495 may not be or become 
     designated as an area having special flood hazards for 
     purposes of the National Flood Insurance Program, unless the 
     designation is made on the basis of--
       (1) flood hazard analyses of hydrologic, hydraulic, or 
     coastal flood hazards that have been properly calibrated and 
     validated, and are specific and directly relevant to the 
     geographic area being studied; and
       (2) ground elevation information of sufficient accuracy and 
     precision to meet the guidelines of the Administration for 
     accuracy at the 95 percent confidence level.
       (b) Remapping.--
       (1) Remapping required.--If the Administrator determines 
     that an area described in subsection (a) has been designated 
     as an area of special flood hazard on the basis of 
     information that does not comply with the requirements under 
     subsection (a), the Administrator shall revise and update any 
     National Flood Insurance Program rate map for the area--
       (A) using information that complies with the requirements 
     under subsection (a); and
       (B) in accordance with the procedures established under 
     section 1363 of the National Flood Insurance Act of 1968 (42 
     U.S.C. 4104) for flood elevation determinations.
       (2) Interim period.--A National Flood Insurance Program 
     rate map in effect on the date of enactment of this Act for 
     an area for which the Administrator has made a determination 
     under paragraph (1) shall continue in effect with respect to 
     the area during the period--
       (A) beginning on the date of enactment of this Act; and
       (B) ending on the date on which the Administrator 
     determines that the requirements under section 1363 of the 
     National Flood Insurance Act of 1968 (42 U.S.C. 4104) for 
     flood elevation determinations have been met with respect to 
     a revision and update under paragraph (1) of a National Flood 
     Insurance rate map for the area.
       (3) Deadline.--The Administrator shall issue a preliminary 
     National Flood Insurance Program rate map resulting from a 
     revision and update required under paragraph (1) not later 
     than 1 year after the date of enactment of this Act.
       (4) Risk premium rate clarification.--
       (A) In general.--If a revision and update required under 
     paragraph (1) results in a reduction in the risk premium rate 
     for a property in an area for which the Administrator has 
     made a determination under paragraph (1), the Administrator 
     shall--
       (i) calculate the difference between the reduced risk 
     premium rate and the risk premium rate paid by a policyholder 
     with respect to the property during the period--

       (I) beginning on the date on which the National Flood 
     Insurance Program rate map in effect for the area on the date 
     of enactment of this Act took effect; and

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       (II) ending on the date on which the revised or updated 
     National Flood Insurance Program rate map takes effect; and

       (ii) reimburse the policyholder an amount equal to such 
     difference.
       (B) Funding.--Notwithstanding section 1310 of the National 
     Flood Insurance Act of 1968 (42 U.S.C. 4017), there shall be 
     available to the Administrator from premiums deposited in the 
     National Flood Insurance Fund pursuant to subsection (d) of 
     such section 1310, of amounts not otherwise obligated, the 
     amount necessary to carry out this paragraph.
       (c) Termination.--
       (1) In general.--Except as provided in paragraph (2), this 
     section shall cease to have effect on the effective date of a 
     National Flood Insurance Program rate map revised and updated 
     under subsection (b)(1).
       (2) Reimbursements.--Subsection (b)(4) shall cease to have 
     effect on the date on which the Administrator has made all 
     reimbursements required under subsection (b)(4).

     SEC. 134. ELIGIBILITY FOR FLOOD INSURANCE FOR PERSONS 
                   RESIDING IN COMMUNITIES THAT HAVE MADE ADEQUATE 
                   PROGRESS ON THE CONSTRUCTION, RECONSTRUCTION, 
                   OR IMPROVEMENT OF A FLOOD PROTECTION SYSTEM.

       (a) Eligibility for Flood Insurance Coverage.--
       (1) In general.--Notwithstanding any other provision of 
     law, a person residing in a community that the Administrator 
     determines has made adequate progress on the reconstruction 
     or improvement of a flood protection system that will afford 
     flood protection for a 100-year floodplain (without regard to 
     the level of Federal funding of or participation in the 
     construction, reconstruction, or improvement), shall be 
     eligible for flood insurance coverage under the National 
     Flood Insurance Program--
       (A) if the person resides in a community that is a 
     participant in the National Flood Insurance Program; and
       (B) at a risk premium rate that does not exceed the risk 
     premium rate that would be chargeable if the flood protection 
     system had been completed.
       (2) Adequate progress.--
       (A) Reconstruction or improvement.--For purposes of 
     paragraph (1), the Administrator shall determine that a 
     community has made adequate progress on the reconstruction or 
     improvement of a flood protection system if--
       (i) 100 percent of the project cost has been authorized;
       (ii) not less than 60 percent of the project cost has been 
     secured or appropriated;
       (iii) not less than 50 percent of the flood protection 
     system has been assessed as being without deficiencies; and
       (iv) the reconstruction or improvement has a project 
     schedule that does not exceed 5 years, beginning on the date 
     on which the reconstruction or construction of the 
     improvement commences.
       (B) Considerations.--In determining whether a flood 
     protection system have been assessed as being without 
     deficiencies, the Administrator shall consider the 
     requirements under section 65.10 of chapter 44, Code of 
     Federal Regulations, or any successor thereto.
       (b) Termination of Eligibility.--
       (1) Adequate continuing progress.--The Administrator shall 
     issue rules to establish a method of determining whether a 
     community has made adequate continuing progress on the 
     reconstruction or improvement of a flood protection system 
     that includes--
       (A) a requirement that the Administrator shall--
       (i) consult with the owner of the flood protection system--

       (I) 6 months after the date of a determination under 
     subsection (a);
       (II) 18 months after the date of a determination under 
     subsection (a); and
       (III) 36 months after the date of a determination under 
     subsection (a); and

       (ii) after each consultation under clause (i), determine 
     whether the reconstruction or improvement is reasonably 
     likely to be completed in accordance with the project 
     schedule described in subsection (a)(2)(A)(iv); and
       (B) a requirement that, if the Administrator makes a 
     determination under subparagraph (A)(ii) that reconstruction 
     or improvement is not reasonably likely to be completed in 
     accordance with the project schedule, the Administrator 
     shall--
       (i) not later than 30 days after the date of the 
     determination, notify the owner of the flood protection 
     system of the determination and provide the rationale and 
     evidence for the determination; and
       (ii) provide the owner of the flood protection system the 
     opportunity to appeal the determination.
       (2) Termination.--The Administrator shall terminate the 
     eligibility for flood insurance coverage under the National 
     Flood Insurance Program of persons residing in a community 
     with respect to which the Administrator made a determination 
     under subsection (a) if--
       (A) the Administrator determines that the community has not 
     made adequate continuing progress; or
       (B) on the date that is 5 years after the date on which the 
     reconstruction or construction of the improvement commences, 
     the project has not been completed.
       (3) Waiver.--A person whose eligibility would otherwise be 
     terminated under paragraph (2)(B) shall continue to be 
     eligible to purchase flood insurance coverage described in 
     subsection (a) if the Administrator determines--
       (A) the community has made adequate continuing progress on 
     the reconstruction or improvement of a flood protection 
     system; and
       (B) there is a reasonable expectation that the 
     reconstruction or improvement of the flood protection system 
     will be completed not later than 1 year after the date of the 
     determination under this paragraph.
       (4) Risk premium rate.--If the Administrator terminates the 
     eligibility of persons residing in a community to purchase 
     flood insurance coverage described in subsection (a), the 
     Administrator shall establish an appropriate risk premium 
     rate for flood insurance coverage under the National Flood 
     Insurance Program for persons residing in the community that 
     purchased flood insurance coverage before the date on which 
     the termination of eligibility takes effect, taking into 
     consideration the then-current state of the flood protection 
     system.

     SEC. 135. STUDIES AND REPORTS.

       (a) Report on Expanding the National Flood Insurance 
     Program.--Not later than 1 year after the date of the 
     enactment of this Act, the Comptroller General of the United 
     States shall conduct a study and submit a report to the 
     Committee on Banking, Housing, and Urban Affairs of the 
     Senate and the Committee on Financial Services of the House 
     of Representatives, on--
       (1) the number of flood insurance policy holders currently 
     insuring--
       (A) a residential structure up to the maximum available 
     coverage amount, as established in section 61.6 of title 44, 
     Code of Federal Regulations, of--
       (i) $250,000 for the structure; and
       (ii) $100,000 for the contents of such structure; or
       (B) a commercial structure up to the maximum available 
     coverage amount, as established in section 61.6 of title 44, 
     Code of Federal Regulations, of $500,000;
       (2) the increased losses the National Flood Insurance 
     Program would have sustained during the 2004 and 2005 
     hurricane season if the National Flood Insurance Program had 
     insured all policyholders up to the maximum conforming loan 
     limit for fiscal year 2006 of $417,000, as established under 
     section 302(b)(2) of the Federal National Mortgage 
     Association Charter Act (12 U.S.C. 1717(b)(2));
       (3) the availability in the private marketplace of flood 
     insurance coverage in amounts that exceed the current limits 
     of coverage amounts established in section 61.6 of title 44, 
     Code of Federal Regulations; and
       (4) what effect, if any--
       (A) raising the current limits of coverage amounts 
     established in section 61.6 of title 44, Code of Federal 
     Regulations, would have on the ability of private insurers to 
     continue providing flood insurance coverage; and
       (B) reducing the current limits of coverage amounts 
     established in section 61.6 of title 44, Code of Federal 
     Regulations, would have on the ability of private insurers to 
     provide sufficient flood insurance coverage to effectively 
     replace the current level of flood insurance coverage being 
     provided under the National Flood Insurance Program.
       (b) Report of the Administrator on Activities Under the 
     National Flood Insurance Program.--
       (1) In general.--The Administrator shall, on an annual 
     basis, submit a full report on the operations, activities, 
     budget, receipts, and expenditures of the National Flood 
     Insurance Program for the preceding 12-month period to the 
     Committee on Banking, Housing, and Urban Affairs of the 
     Senate and the Committee on Financial Services of the House 
     of Representatives.
       (2) Timing.--Each report required under paragraph (1) shall 
     be submitted to the committees described in paragraph (1) not 
     later than 3 months following the end of each fiscal year.
       (3) Contents.--Each report required under paragraph (1) 
     shall include--
       (A) the current financial condition and income statement of 
     the National Flood Insurance Fund established under section 
     1310 of the National Flood Insurance Act of 1968 (42 U.S.C. 
     4017), including--
       (i) premiums paid into such Fund;
       (ii) policy claims against such Fund; and
       (iii) expenses in administering such Fund;
       (B) the number and face value of all policies issued under 
     the National Flood Insurance Program that are in force;
       (C) a description and summary of the losses attributable to 
     repetitive loss structures;
       (D) a description and summary of all losses incurred by the 
     National Flood Insurance Program due to--
       (i) hurricane related damage; and
       (ii) nonhurricane related damage;
       (E) the amounts made available by the Administrator for 
     mitigation assistance under section 1366(c)(4) of the 
     National Flood Insurance Act of 1968 (42 U.S.C. 4104c(c)(4) 
     for the purchase of properties substantially damaged by flood 
     for that fiscal year, and the actual number of flood damaged 
     properties purchased and the total cost expended to purchase 
     such properties;

[[Page 7644]]

       (F) the estimate of the Administrator as to the average 
     historical loss year, and the basis for that estimate;
       (G) the estimate of the Administrator as to the maximum 
     amount of claims that the National Flood Insurance Program 
     would have to expend in the event of a catastrophic year;
       (H) the average--
       (i) amount of insurance carried per flood insurance policy;
       (ii) premium per flood insurance policy; and
       (iii) loss per flood insurance policy; and
       (I) the number of claims involving damages in excess of the 
     maximum amount of flood insurance available under the 
     National Flood Insurance Program and the sum of the amount of 
     all damages in excess of such amount.
       (c) GAO Study on Pre-FIRM Structures.--Not later than 1 
     year after the date of the enactment of this Act, the 
     Comptroller General of the United States shall conduct a 
     study and submit a report to the Committee on Banking, 
     Housing, and Urban Affairs of the Senate and the Committee on 
     Financial Services of the House of Representatives, on the--
       (1) composition of the remaining pre-FIRM structures that 
     are explicitly receiving discounted premium rates under 
     section 1307 of the National Flood Insurance Act of 1968 (42 
     U.S.C. 4014), including the historical basis for the receipt 
     of such subsidy and the extent to which pre-FIRM structures 
     are currently owned by the same owners of the property at the 
     time of the original FIRM;
       (2) number and fair market value of such structures;
       (3) respective income level of the owners of such 
     structures;
       (4) number of times each such structure has been sold since 
     1968, including specific dates, sales price, and any other 
     information the Secretary determines appropriate;
       (5) total losses incurred by such structures since the 
     establishment of the National Flood Insurance Program 
     compared to the total losses incurred by all structures that 
     are charged a nondiscounted premium rate;
       (6) total cost of foregone premiums since the establishment 
     of the National Flood Insurance Program, as a result of the 
     subsidies provided to such structures;
       (7) annual cost as a result of the subsidies provided to 
     such structures;
       (8) the premium income collected and the losses incurred by 
     the National Flood Insurance Program as a result of such 
     explicitly subsidized structures compared to the premium 
     income collected and the losses incurred by such Program as a 
     result of structures that are charged a nondiscounted premium 
     rate, on a State-by-State basis; and
       (9) the options for eliminating the subsidy to such 
     structures.
       (d) GAO Review of FEMA Contractors.--The Comptroller 
     General of the United States, in conjunction with the Office 
     of the Inspector General of the Department of Homeland 
     Security, shall--
       (1) conduct a review of the 3 largest contractors the 
     Administrator uses in administering the National Flood 
     Insurance Program; and
       (2) not later than 18 months after the date of the 
     enactment of this Act, submit a report on the findings of 
     such review to the Administrator, the Committee on Banking, 
     Housing, and Urban Affairs of the Senate, and the Committee 
     on Financial Services of the House of Representatives.

     SEC. 136. REINSURANCE.

       (a) Reinsurance Assessment.--
       (1) Private market pricing assessment.--Not later than 12 
     months after the date of the enactment of this Act, the 
     Administrator shall submit to Congress a report that--
       (A) assesses the capacity of the private reinsurance, 
     capital, and financial markets to assist communities, on a 
     voluntary basis, in managing the full range of financial 
     risks associated with flooding by requesting proposals to 
     assume a portion of the insurance risk of the National Flood 
     Insurance Program;
       (B) describes any responses to the request for proposals 
     under subparagraph (A);
       (C) assesses whether the rates and terms contained in any 
     proposals received by the Administrator are--
       (i) reasonable and appropriate; and
       (ii) in an amount sufficient to maintain the ability of the 
     National Flood Insurance Program to pay claims;
       (D) describes the extent to which carrying out the 
     proposals received by the Administrator would minimize the 
     likelihood that the Administrator would use the borrowing 
     authority under section 1309 of the National Flood Insurance 
     Act of 1968 (42 U.S.C. 4016);
       (E) describes fluctuations in historical reinsurance rates; 
     and
       (F) includes an economic cost-benefit analysis of the 
     impact on the National Flood Insurance Program if the 
     Administrator were to exercise the authority under section 
     1335(a)(2) of the National Flood Insurance Act of 1968 (42 
     U.S.C. 4055(a)(2)), as added by this section, to secure 
     reinsurance of coverage provided by the National Flood 
     Insurance Program from the private market.
       (2) Protocol for release of data.--The Administrator shall 
     develop a protocol, including adequate privacy protections, 
     to provide for the release of data sufficient to conduct the 
     assessment required under paragraph (1).
       (b) Reinsurance.--The National Flood Insurance Act of 1968 
     (42 U.S.C. 4011 et seq.) is amended--
       (1) in section 1331(a)(2) (42 U.S.C. 4051(a)(2)), by 
     inserting ``, including as reinsurance of coverage provided 
     by the flood insurance program'' before ``, on such terms'';
       (2) in section 1332(c)(2) (42 U.S.C. 4052(c)(2)), by 
     inserting ``or reinsurance'' after ``flood insurance 
     coverage'';
       (3) in section 1335(a) (42 U.S.C. 4055(a))--
       (A) by striking ``The Director'' and inserting the 
     following:
       ``(1) In general.--The Administrator''; and
       (B) by adding at the end the following:
       ``(2) Private reinsurance.--The Administrator is authorized 
     to secure reinsurance of coverage provided by the flood 
     insurance program from the private market at rates and on 
     terms determined by the Administrator to be reasonable and 
     appropriate, in an amount sufficient to maintain the ability 
     of the program to pay claims.'';
       (4) in section 1346(a) (12 U.S.C. 4082(a))--
       (A) in the matter preceding paragraph (1), by inserting 
     after ``for the purpose of'' the following: ``securing 
     reinsurance of insurance coverage provided by the program or 
     for the purpose of'';
       (B) in paragraph (1)--
       (i) by striking ``estimating'' and inserting 
     ``Estimating''; and
       (ii) by striking the semicolon at the end and inserting a 
     period;
       (C) in paragraph (2)--
       (i) by striking ``receiving'' and inserting ``Receiving''; 
     and
       (ii) by striking the semicolon at the end and inserting a 
     period;
       (D) in paragraph (3)--
       (i) by striking ``making'' and inserting ``Making''; and
       (ii) (ii) by striking `` `; and' '' and inserting a period;
       (E) by redesignating paragraph (4) as paragraph (5);
       (F) in paragraph (5), as so redesignated, by striking 
     ``otherwise'' and inserting ``Otherwise''; and
       (G) by inserting after paragraph (3) the following new 
     paragraph:
       ``(4) Placing reinsurance coverage on insurance provided by 
     such program;''; and
       (5) in section 1370(a)(3) (42 U.S.C. 4121(a)(3)), by 
     striking ``include any'' and all that follows and inserting 
     the following: ``include any organization or person that is 
     authorized to engage in the business of insurance under the 
     laws of any State, subject to the reporting requirements of 
     the Securities Exchange Act of 1934 pursuant to section 13(a) 
     or 15(d) of such Act (15 U.S.C. 78m(a) and 78o(d)), or 
     authorized by the Administrator to assume reinsurance on 
     risks insured by the flood insurance program;''.
       (c) Assessment of Claims-paying Ability.--
       (1) Assessment.--
       (A) Assessment required.--
       (i) In general.--Not later than September 30 of each year, 
     the Administrator shall conduct an assessment of the ability 
     of the National Flood Insurance Program to pay claims.
       (ii) Private market reinsurance.--The assessment under this 
     paragraph for any year in which the Administrator exercises 
     the authority under section 1335(a)(2) of the National Flood 
     Insurance Act of 1968 (42 U.S.C. 4055(a)(2)), as added by 
     this section, to secure reinsurance of coverage provided by 
     the National Flood Insurance Program from the private market 
     shall include information relating the use of private sector 
     reinsurance and reinsurance equivalents by the Administrator, 
     whether or not the Administrator used the borrowing authority 
     under section 1309 of the National Flood Insurance Act of 
     1968 (42 U.S.C. 4016).
       (iii) First assessment.--The Administrator shall conduct 
     the first assessment required under this paragraph not later 
     than September 30, 2012.
       (B) Considerations.--In conducting an assessment under 
     subparagraph (A), the Administrator shall take into 
     consideration regional concentrations of coverage written by 
     the National Flood Insurance Program, peak flood zones, and 
     relevant mitigation measures.
       (2) Annual report of the administrator of activities under 
     the national flood insurance program.--The Administrator 
     shall--
       (A) include the results of each assessment in the report 
     required under section 135(b); and
       (B) not later than 30 days after the date on which the 
     Administrator completes an assessment required under 
     paragraph (1), make the results of the assessment available 
     to the public.

     SEC. 137. GAO STUDY ON BUSINESS INTERRUPTION AND ADDITIONAL 
                   LIVING EXPENSES COVERAGES.

       (a) Study.--The Comptroller General of the United States 
     shall conduct a study concerning--
       (1) the availability of additional living expenses and 
     business interruption coverage in the private marketplace for 
     flood insurance;
       (2) the feasibility of allowing the National Flood 
     Insurance Program to offer such coverage at the option of the 
     consumer;

[[Page 7645]]

       (3) the estimated cost to consumers if the National Flood 
     Insurance Program priced such optional coverage at true 
     actuarial rates;
       (4) the impact such optional coverage would have on 
     consumer participation in the National Flood Insurance 
     Program; and
       (5) the fiscal impact such optional coverage would have 
     upon the National Flood Insurance Fund if such optional 
     coverage were included in the National Flood Insurance 
     Program, as described in paragraph (2), at the price 
     described in paragraph (3).
       (b) Report.--Not later than 1 year after the date of the 
     enactment of this Act, the Comptroller General shall submit 
     to the Committee on Banking, Housing, and Urban Affairs of 
     the Senate and the Committee on Financial Services of the 
     House of Representatives a report containing the results of 
     the study under subsection (a).

     SEC. 138. POLICY DISCLOSURES.

       (a) In General.--Notwithstanding any other provision of 
     law, in addition to any other disclosures that may be 
     required, each policy under the National Flood Insurance 
     Program shall state all conditions, exclusions, and other 
     limitations pertaining to coverage under the subject policy, 
     regardless of the underlying insurance product, in plain 
     English, in boldface type, and in a font size that is twice 
     the size of the text of the body of the policy.
       (b) Violations.--Any person that violates the requirements 
     of this section shall be subject to a fine of not more than 
     $50,000 at the discretion of the Administrator.

     SEC. 139. REPORT ON INCLUSION OF BUILDING CODES IN FLOODPLAIN 
                   MANAGEMENT CRITERIA.

       Not later than 6 months after the date of the enactment of 
     this Act, the Administrator of the Federal Emergency 
     Management Agency shall conduct a study and submit a report 
     to the Committee on Banking, Housing, and Urban Affairs of 
     the Senate and the Committee on Financial Services of the 
     House of Representatives regarding the impact, effectiveness, 
     and feasibility of amending section 1361 of the National 
     Flood Insurance Act of 1968 (42 U.S.C. 4102) to include 
     widely used and nationally recognized building codes as part 
     of the floodplain management criteria developed under such 
     section, and shall determine--
       (1) the regulatory, financial, and economic impacts of such 
     a building code requirement on homeowners, States and local 
     communities, local land use policies, and the Federal 
     Emergency Management Agency;
       (2) the resources required of State and local communities 
     to administer and enforce such a building code requirement;
       (3) the effectiveness of such a building code requirement 
     in reducing flood-related damage to buildings and contents;
       (4) the impact of such a building code requirement on the 
     actuarial soundness of the National Flood Insurance Program;
       (5) the effectiveness of nationally recognized codes in 
     allowing innovative materials and systems for flood-resistant 
     construction;
       (6) the feasibility and effectiveness of providing an 
     incentive in lower premium rates for flood insurance coverage 
     under such Act for structures meeting whichever of such 
     widely used and nationally recognized building codes or any 
     applicable local building codes provides greater protection 
     from flood damage;
       (7) the impact of such a building code requirement on rural 
     communities with different building code challenges than 
     urban communities; and
       (8) the impact of a such a building code requirement on 
     Indian reservations.

     SEC. 140. STUDY OF PARTICIPATION AND AFFORDABILITY FOR 
                   CERTAIN POLICYHOLDERS.

       (a) FEMA Study.--The Administrator shall conduct a study 
     of--
       (1) methods to encourage and maintain participation in the 
     National Flood Insurance Program;
       (2) methods to educate consumers about the National Flood 
     Insurance Program and the flood risk associated with their 
     property;
       (3) methods for establishing an affordability framework for 
     the National Flood Insurance Program, including methods to 
     aid individuals to afford risk-based premiums under the 
     National Flood Insurance Program through targeted assistance 
     rather than generally subsidized rates, including means-
     tested vouchers; and
       (4) the implications for the National Flood Insurance 
     Program and the Federal budget of using each such method.
       (b) National Academy of Sciences Economic Analysis.--To 
     inform the Administrator in the conduct of the study under 
     subsection (a), the National Academy of Sciences, in 
     consultation with the Comptroller General of the United 
     States, shall conduct and submit to the Administrator an 
     economic analysis of the costs and benefits to the Federal 
     Government of a flood insurance program with full risk-based 
     premiums, combined with means-tested Federal assistance to 
     aid individuals who cannot afford coverage, through an 
     insurance voucher program. The analysis shall compare the 
     costs of a program of risk-based rates and means-tested 
     assistance to the current system of subsidized flood 
     insurance rates and federally funded disaster relief for 
     people without coverage.
       (c) Report.--Not later than 270 days after the date of 
     enactment of this Act, the Administrator shall submit to the 
     Committee on Banking, Housing, and Urban Affairs of the 
     Senate and the Committee on Financial Services of the House 
     of Representatives a report that contains the results of the 
     study and analysis under this section.
       (d) Funding.--Notwithstanding section 1310 of the National 
     Flood Insurance Act of 1968 (42 U.S.C. 4017), there shall be 
     available to the Administrator from the National Flood 
     Insurance Fund, of amounts not otherwise obligated, not more 
     than $750,000 to carry out this section.

     SEC. 141. STUDY AND REPORT CONCERNING THE PARTICIPATION OF 
                   INDIAN TRIBES AND MEMBERS OF INDIAN TRIBES IN 
                   THE NATIONAL FLOOD INSURANCE PROGRAM.

       (a) Definition.--In this section, the term ``Indian tribe'' 
     has the meaning given that term in section 4 of the Indian 
     Self-Determination and Education Assistance Act (25 U.S.C. 
     450b).
       (b) Findings.--Congress finds that participation by Indian 
     tribes in the National Flood Insurance Program is low. Only 
     45 of 565 Indian tribes participate in the National Flood 
     Insurance Program.
       (c) Study.--The Comptroller General of the United States, 
     in coordination and consultation with Indian tribes and 
     members of Indian tribes throughout the United States, shall 
     carry out a study that examines--
       (1) the factors contributing to the current rates of 
     participation by Indian tribes and members of Indian tribes 
     in the National Flood Insurance Program; and
       (2) methods of encouraging participation by Indian tribes 
     and members of Indian tribes in the National Flood Insurance 
     Program.
       (d) Report.--Not later than 6 months after the date of 
     enactment of this Act, the Comptroller General shall submit 
     to Congress a report that--
       (1) contains the results of the study carried out under 
     subsection (c);
       (2) describes the steps that the Administrator should take 
     to increase awareness and encourage participation by Indian 
     tribes and members of Indian tribes in the National Flood 
     Insurance Program; and
       (3) identifies any legislative changes that would encourage 
     participation by Indian tribes and members of Indian tribes 
     in the National Flood Insurance Program.

     SEC. 142. TECHNICAL CORRECTIONS.

       (a) Flood Disaster Protection Act of 1973.--The Flood 
     Disaster Protection Act of 1973 (42 U.S.C. 4002 et seq.) is 
     amended--
       (1) by striking ``Director'' each place that term appears, 
     except in section 102(f)(3) (42 U.S.C. 4012a(f)(3)), and 
     inserting ``Administrator''; and
       (2) in section 201(b) (42 U.S.C. 4105(b)), by striking 
     ``Director's'' and inserting ``Administrator's''.
       (b) National Flood Insurance Act of 1968.--The National 
     Flood Insurance Act of 1968 (42 U.S.C. 4001 et seq.) is 
     amended--
       (1) by striking ``Director'' each place that term appears 
     and inserting ``Administrator''; and
       (2) in sections 1363 (42 U.S.C. 4104), by striking 
     ``Director's'' each place that term appears and inserting 
     ``Administrator's''.
       (c) Federal Flood Insurance Act of 1956.--Section 15(e) of 
     the Federal Flood Insurance Act of 1956 (42 U.S.C. 2414(e)) 
     is amended by striking ``Director'' each place that term 
     appears and inserting ``Administrator''.

     SEC. 143. PRIVATE FLOOD INSURANCE POLICIES.

       (a) Definitions.--In this section the following definitions 
     shall apply:
       (1) Guidelines.--The term ``Guidelines'' means the 
     Mandatory Purchase of Flood Insurance Guidelines issued by 
     the Administrator.
       (2) State entity for lending regulation.--The term ``State 
     entity for lending regulation'' means, with respect to a 
     State, the entity or agency with primary responsibility for 
     the supervision of lending institutions chartered by the 
     State and not insured by the Federal Deposit Insurance 
     Corporation or the National Credit Union Administration.
       (b) Amendments Required.--
       (1) In general.--Not later than 120 days after the date of 
     enactment of this Act, the Administrator shall amend the 
     Guidelines to clarify that a lender or a lending institution 
     chartered by a State and not insured by the Federal Deposit 
     Insurance Corporation or the National Credit Union 
     Administration may accept a private primary flood insurance 
     policy in lieu of a National Flood Insurance Program flood 
     policy to satisfy the mandatory purchase requirements under 
     section 102 of the Flood Disaster Protection Act of 1973 (42 
     U.S.C. 4012a), if the private primary flood insurance 
     policy--
       (A) is available for sale under the laws of the State in 
     which the private primary flood insurance policy is to be 
     written;
       (B) meets the minimum requirements for flood insurance 
     coverage under subsections (a) and (b) of such section 102; 
     and
       (C) complies with applicable Federal regulations.
       (2) State law considerations.--Neither the Guidelines nor 
     the amendments to the Guidelines made under paragraph (1) 
     shall be construed to preempt State insurance law, 
     regulation, or guidance.

[[Page 7646]]

       (c) Notification.--
       (1) To federal and state entities for lending regulation.--
     Not later than 30 days after the date on which the 
     Administrator amends the Guidelines under subsection (b), the 
     Administrator shall notify the Federal entities for lending 
     regulation and the State entities for lending regulation of 
     the amendment, in order to encourage the acceptance of 
     private primary flood insurance in lieu of a National Flood 
     Insurance Program flood policy to satisfy the mandatory 
     purchase requirements under section 102 of the Flood Disaster 
     Protection Act of 1973 (42 U.S.C. 4012a).
       (2) To lenders.--The Administrator and each Federal entity 
     for lending regulation shall include the notification 
     required under paragraph (1) in any edition of a publication 
     that the Administrator or Federal entity for lending 
     regulation provides to lenders that is published after the 
     date of enactment of this Act.
       (d) Training.--Not later than 60 days after the date on 
     which the Administrator makes the notification under 
     subsection (c), the Federal entities for lending regulation 
     shall train each employee having responsibility for 
     compliance audits to implement the amendments to the 
     Guidelines under subsection (b).

     SEC. 144. TREATMENT OF SWIMMING POOL ENCLOSURES OUTSIDE OF 
                   HURRICANE SEASON.

       Notwithstanding any other provision of law, the adequate 
     land use and control measures developed pursuant to section 
     1361 of the National Flood Insurance Act of 1968 (42 U.S.C. 
     4102) and applicable to non-residential structures located 
     within coastal areas as identified by the Administrator may 
     permit, at the discretion of the appropriate State and local 
     authority, the use of non-supporting breakaway walls in V 
     Zones and openings in walls in coastal A Zones in the space 
     below the lowest floor used solely for swimming pools after 
     November 30 and before June 1 of any year. Permitting this 
     use does not alter the terms and conditions of eligibility 
     and insurability of coverage for a building as set out in the 
     Standard Flood Insurance Policy of the Federal Emergency 
     Management Agency.

    TITLE II--COMMISSION ON NATURAL CATASTROPHE RISK MANAGEMENT AND 
                               INSURANCE

     SEC. 201. SHORT TITLE.

       This title may be cited as the ``Commission on Natural 
     Catastrophe Risk Management and Insurance Act of 2012''.

     SEC. 202. FINDINGS.

       Congress finds that--
       (1) Hurricanes Katrina, Rita, and Wilma, which struck the 
     United States in 2005, caused, by some estimates, in excess 
     of $200,000,000,000 in total economic losses;
       (2) many meteorologists predict that the United States is 
     in a period of increased hurricane activity;
       (3) the Federal Government and State governments have 
     provided billions of dollars to pay for losses from natural 
     catastrophes, including hurricanes, earthquakes, volcanic 
     eruptions, tsunamis, tornados, flooding, wildfires, droughts, 
     and other natural catastrophes;
       (4) many Americans are finding it increasingly difficult to 
     obtain and afford property and casualty insurance coverage;
       (5) some insurers are not renewing insurance policies, are 
     excluding certain risks, such as wind damage, and are 
     increasing rates and deductibles in some markets;
       (6) the inability of property and business owners in 
     vulnerable areas to obtain and afford property and casualty 
     insurance coverage endangers the national economy and public 
     health and safety;
       (7) almost every State in the United States is at risk of a 
     natural catastrophe, including hurricanes, earthquakes, 
     volcanic eruptions, tsunamis, tornados, flooding, wildfires, 
     droughts, and other natural catastrophes;
       (8) building codes and land use regulations play an 
     indispensable role in managing catastrophe risks, by 
     preventing building in high risk areas and ensuring that 
     appropriate mitigation efforts are completed where building 
     has taken place;
       (9) several proposals have been introduced in Congress to 
     address the affordability and availability of natural 
     catastrophe insurance across the United States, but there is 
     no consensus on what, if any, role the Federal Government 
     should play; and
       (10) an efficient and effective approach to assessing 
     natural catastrophe risk management and insurance is to 
     establish a nonpartisan commission to study the management of 
     natural catastrophe risk, and to require such commission to 
     timely report to Congress on its findings.

     SEC. 203. ESTABLISHMENT.

       There is established a nonpartisan Commission on Natural 
     Catastrophe Risk Management and Insurance (in this title 
     referred to as the ``Commission'').

     SEC. 204. MEMBERSHIP.

       (a) Appointment.--The Commission shall be composed of 16 
     members, of whom--
       (1) 2 members shall be appointed by the majority leader of 
     the Senate;
       (2) 2 members shall be appointed by the minority leader of 
     the Senate;
       (3) 2 members shall be appointed by the Speaker of the 
     House of Representatives;
       (4) 2 members shall be appointed by the minority leader of 
     the House of Representatives;
       (5) 2 members shall be appointed by the Chairman of the 
     Committee on Banking, Housing, and Urban Affairs of the 
     Senate;
       (6) 2 members shall be appointed by the Ranking Member of 
     the Committee on Banking, Housing, and Urban Affairs of the 
     Senate;
       (7) 2 members shall be appointed by the Chairman of the 
     Committee on Financial Services of the House of 
     Representatives; and
       (8) 2 members shall be appointed by the Ranking Member of 
     the Committee on Financial Services of the House of 
     Representatives.
       (b) Qualification of Members.--
       (1) In general.--Members of the Commission shall be 
     appointed under subsection (a) from among persons who--
       (A) have expertise in insurance, reinsurance, insurance 
     regulation, policyholder concerns, emergency management, risk 
     management, public finance, financial markets, actuarial 
     analysis, flood mapping and planning, structural engineering, 
     building standards, land use planning, natural catastrophes, 
     meteorology, seismology, environmental issues, or other 
     pertinent qualifications or experience; and
       (B) are not officers or employees of the United States 
     Government or of any State or local government.
       (2) Diversity.--In making appointments to the Commission--
       (A) every effort shall be made to ensure that the members 
     are representative of a broad cross section of perspectives 
     within the United States; and
       (B) each member of Congress described in subsection (a) 
     shall appoint not more than 1 person from any single primary 
     area of expertise described in paragraph (1)(A) of this 
     subsection.
       (c) Period of Appointment.--
       (1) In general.--Each member of the Commission shall be 
     appointed for the duration of the Commission.
       (2) Vacancies.--A vacancy on the Commission shall not 
     affect its powers, but shall be filled in the same manner as 
     the original appointment.
       (d) Quorum.--
       (1) Majority.--A majority of the members of the Commission 
     shall constitute a quorum, but a lesser number, as determined 
     by the Commission, may hold hearings.
       (2) Approval actions.--All recommendations and reports of 
     the Commission required by this title shall be approved only 
     by a majority vote of all of the members of the Commission.
       (e) Chairperson.--The Commission shall, by majority vote of 
     all of the members, select 1 member to serve as the 
     Chairperson of the Commission (in this title referred to as 
     the ``Chairperson'').
       (f) Meetings.--The Commission shall meet at the call of its 
     Chairperson or a majority of the members.

     SEC. 205. DUTIES OF THE COMMISSION.

       The Commission shall examine the risks posed to the United 
     States by natural catastrophes, and means for mitigating 
     those risks and for paying for losses caused by natural 
     catastrophes, including assessing--
       (1) the condition of the property and casualty insurance 
     and reinsurance markets prior to and in the aftermath of 
     Hurricanes Katrina, Rita, and Wilma in 2005, and the 4 major 
     hurricanes that struck the United States in 2004;
       (2) the current condition of, as well as the outlook for, 
     the availability and affordability of insurance in all 
     regions of the country;
       (3) the current ability of States, communities, and 
     individuals to mitigate their natural catastrophe risks, 
     including the affordability and feasibility of such 
     activities;
       (4) the ongoing exposure of the United States to natural 
     catastrophes, including hurricanes, earthquakes, volcanic 
     eruptions, tsunamis, tornados, flooding, wildfires, droughts, 
     and other natural catastrophes;
       (5) the catastrophic insurance and reinsurance markets and 
     the relevant practices in providing insurance protection to 
     different sectors of the American population;
       (6) implementation of a catastrophic insurance system that 
     can resolve key obstacles currently impeding broader 
     implementation of catastrophic risk management and financing 
     with insurance;
       (7) the financial feasibility and sustainability of a 
     national, regional, or other pooling mechanism designed to 
     provide adequate insurance coverage and increased 
     underwriting capacity to insurers and reinsurers, including 
     private-public partnerships to increase insurance capacity in 
     constrained markets;
       (8) methods to promote public or private insurance policies 
     to reduce losses caused by natural catastrophes in the 
     uninsured sectors of the American population;
       (9) approaches for implementing a public or private 
     insurance scheme for low-income communities, in order to 
     promote risk reduction and insurance coverage in such 
     communities;

[[Page 7647]]

       (10) the impact of Federal and State laws, regulations, and 
     policies (including rate regulation, market access 
     requirements, reinsurance regulations, accounting and tax 
     policies, State residual markets, and State catastrophe 
     funds) on--
       (A) the affordability and availability of catastrophe 
     insurance;
       (B) the capacity of the private insurance market to cover 
     losses inflicted by natural catastrophes;
       (C) the commercial and residential development of high-risk 
     areas; and
       (D) the costs of natural catastrophes to Federal and State 
     taxpayers;
       (11) the present and long-term financial condition of State 
     residual markets and catastrophe funds in high-risk regions, 
     including the likelihood of insolvency following a natural 
     catastrophe, the concentration of risks within such funds, 
     the reliance on post-event assessments and State funding, and 
     the adequacy of rates;
       (12) the role that innovation in financial services could 
     play in improving the affordability and availability of 
     natural catastrophe insurance, specifically addressing 
     measures that would foster the development of financial 
     products designed to cover natural catastrophe risk, such as 
     risk-linked securities;
       (13) the need for strengthened land use regulations and 
     building codes in States at high risk for natural 
     catastrophes, and methods to strengthen the risk assessment 
     and enforcement of structural mitigation and vulnerability 
     reduction measures, such as zoning and building code 
     compliance;
       (14) the benefits and costs of proposed Federal natural 
     catastrophe insurance programs (including the Federal 
     Government's provision of reinsurance to State catastrophe 
     funds, private insurers, or other entities), specifically 
     addressing the costs to taxpayers, tax equity considerations, 
     and the record of other government insurance programs 
     (particularly with regard to charging actuarially sound 
     prices);
       (15) the ability of the United States private insurance 
     market--
       (A) to cover insured losses caused by natural catastrophes, 
     including an estimate of the maximum amount of insured losses 
     that could be sustained during a single year and the 
     probability of natural catastrophes occurring in a single 
     year that would inflict more insured losses than the United 
     States insurance and reinsurance markets could sustain; and
       (B) to recover after covering substantial insured losses 
     caused by natural catastrophes;
       (16) the impact that demographic trends could have on the 
     amount of insured losses inflicted by future natural 
     catastrophes;
       (17) the appropriate role, if any, for the Federal 
     Government in stabilizing the property and casualty insurance 
     and reinsurance markets; and
       (18) the role of the Federal, State, and local governments 
     in providing incentives for feasible risk mitigation efforts.

     SEC. 206. REPORT.

       (a) In General.--Not later than 9 months after the date of 
     the enactment of this Act, the Commission shall submit to the 
     Committee on Banking, Housing, and Urban Affairs of the 
     Senate and the Committee on Financial Services of the House 
     of Representatives a final report containing--
       (1) a detailed statement of the findings and assessments 
     conducted by the Commission pursuant to section 205; and
       (2) any recommendations for legislative, regulatory, 
     administrative, or other actions at the Federal, State, or 
     local levels that the Commission considers appropriate, in 
     accordance with the requirements of section 205.
       (b) Extension of Time.--The Commission may request Congress 
     to extend the period of time for the submission of the report 
     required under subsection (a) for an additional 3 months.

     SEC. 207. POWERS OF THE COMMISSION.

       (a) Meetings; Hearings.--The Commission may hold such 
     hearings, sit and act at such times and places, take such 
     testimony, and receive such evidence as the Commission 
     considers necessary to carry out the purposes of this title. 
     Members may attend meetings of the Commission and vote in 
     person, via telephone conference, or via video conference.
       (b) Authority of Members or Agents of the Commission.--Any 
     member or agent of the Commission may, if authorized by a 
     vote of the Commission, take any action which the Commission 
     is authorized to take by this title.
       (c) Obtaining Official Data.--
       (1) Authority.--Notwithstanding any provision of section 
     552a of title 5, United States Code, the Commission may 
     secure directly from any department or agency of the United 
     States any information necessary to enable the Commission to 
     carry out this title.
       (2) Procedure.--Upon the request of the Chairperson, the 
     head of such department or agency shall furnish to the 
     Commission the information requested.
       (d) Postal Services.--The Commission may use the United 
     States mails in the same manner and under the same conditions 
     as other departments and agencies of the Federal Government.
       (e) Administrative Support Services.--Upon the request of 
     the Commission, the Administrator of General Services shall 
     provide to the Commission, on a reimbursable basis, any 
     administrative support services necessary for the Commission 
     to carry out its responsibilities under this title.
       (f) Acceptance of Gifts.--The Commission may accept, hold, 
     administer, and utilize gifts, donations, and bequests of 
     property, both real and personal, for the purposes of aiding 
     or facilitating the work of the Commission. The Commission 
     shall issue internal guidelines governing the receipt of 
     donations of services or property.
       (g) Volunteer Services.--Notwithstanding the provisions of 
     section 1342 of title 31, United States Code, the Commission 
     may accept and utilize the services of volunteers serving 
     without compensation. The Commission may reimburse such 
     volunteers for local travel and office supplies, and for 
     other travel expenses, including per diem in lieu of 
     subsistence, as authorized by section 5703 of title 5, United 
     States Code.
       (h) Federal Property and Administrative Services Act of 
     1949.--Subject to the Federal Property and Administrative 
     Services Act of 1949, the Commission may enter into contracts 
     with Federal and State agencies, private firms, institutions, 
     and individuals for the conduct of activities necessary to 
     the discharge of its duties and responsibilities.
       (i) Limitation on Contracts.--A contract or other legal 
     agreement entered into by the Commission may not extend 
     beyond the date of the termination of the Commission.

     SEC. 208. COMMISSION PERSONNEL MATTERS.

       (a) Travel Expenses.--The members of the Commission shall 
     be allowed travel expenses, including per diem in lieu of 
     subsistence, at rates authorized for employees of agencies 
     under subchapter I of chapter 57 of title 5, United States 
     Code, while away from their homes or regular places of 
     business in the performance of services for the Commission.
       (b) Subcommittees.--The Commission may establish 
     subcommittees and appoint members of the Commission to such 
     subcommittees as the Commission considers appropriate.
       (c) Staff.--Subject to such policies as the Commission may 
     prescribe, the Chairperson may appoint and fix the pay of 
     such additional personnel as the Chairperson considers 
     appropriate to carry out the duties of the Commission. The 
     Commission shall confirm the appointment of the executive 
     director by majority vote of all of the members of the 
     Commission.
       (d) Applicability of Certain Civil Service Laws.--Staff of 
     the Commission may be--
       (1) appointed without regard to the provisions of title 5, 
     United States Code, governing appointments in the competitive 
     service; and
       (2) paid without regard to the provisions of chapter 51 and 
     subchapter III of chapter 53 of that title relating to 
     classification and General Schedule pay rates, except that an 
     individual so appointed may not receive pay in excess of the 
     annual rate of basic pay prescribed for GS-15 of the General 
     Schedule under section 5332 of that title.
       (e) Experts and Consultants.--In carrying out its 
     objectives, the Commission may procure temporary and 
     intermittent services of consultants and experts under 
     section 3109(b) of title 5, United States Code, at rates for 
     individuals which do not exceed the daily equivalent of the 
     annual rate of basic pay prescribed for GS-15 of the General 
     Schedule under section 5332 of that title.
       (f) Detail of Government Employees.--Upon request of the 
     Chairperson, any Federal Government employee may be detailed 
     to the Commission to assist in carrying out the duties of the 
     Commission--
       (1) on a reimbursable basis; and
       (2) such detail shall be without interruption or loss of 
     civil service status or privilege.

     SEC. 209. TERMINATION.

       The Commission shall terminate 90 days after the date on 
     which the Commission submits its report under section 206.

     SEC. 210. AUTHORIZATION OF APPROPRIATIONS.

       There are authorized to be appropriated to the Commission, 
     such sums as may be necessary to carry out this title, to 
     remain available until expended.

                 TITLE III--ALTERNATIVE LOSS ALLOCATION

     SEC. 301. SHORT TITLE.

       This title may be cited as the ``Consumer Option for an 
     Alternative System to Allocate Losses Act of 2012'' or the 
     ``COASTAL Act of 2012''.

     SEC. 302. ASSESSING AND MODELING NAMED STORMS OVER COASTAL 
                   STATES.

       Subtitle C of title XII of the Omnibus Public Land 
     Management Act of 2009 (33 U.S.C. 3601 et seq.) (also known 
     as the ``Integrated Coastal and Ocean Observation System Act 
     of 2009'') is amended by adding at the end the following:

     ``SEC. 12312. ASSESSING AND MODELING NAMED STORMS OVER 
                   COASTAL STATES.

       ``(a) Definitions.--In this section:
       ``(1) COASTAL formula.--The term `COASTAL Formula' has the 
     meaning given the term in section 1337(a) of the National 
     Flood Insurance Act of 1968.

[[Page 7648]]

       ``(2) Coastal state.--The term `coastal State' has the 
     meaning given the term `coastal state' in section 304 of the 
     Coastal Zone Management Act of 1972 (16 U.S.C. 1453).
       ``(3) Coastal waters.--The term `coastal waters' has the 
     meaning given the term in such section.
       ``(4) Covered data.--The term `covered data' means, with 
     respect to a named storm identified by the Administrator 
     under subsection (b)(2)(A), empirical data that are--
       ``(A) collected before, during, or after such storm; and
       ``(B) necessary to determine magnitude and timing of wind 
     speeds, rainfall, the barometric pressure, river flows, the 
     extent, height, and timing of storm surge, topographic and 
     bathymetric data, and other measures required to accurately 
     model and assess damage from such storm.
       ``(5) Indeterminate loss.--The term `indeterminate loss' 
     has the meaning given the term in section 1337(a) of the 
     National Flood Insurance Act of 1968.
       ``(6) Named storm.--The term `named storm' means any 
     organized weather system with a defined surface circulation 
     and maximum winds of at least 39 miles per hour which the 
     National Hurricane Center of the United States National 
     Weather Service names as a tropical storm or a hurricane.
       ``(7) Named storm event model.--The term `Named Storm Event 
     Model' means the official meteorological and oceanographic 
     computerized model, developed by the Administrator under 
     subsection (b)(1)(A), which utilizes covered data to 
     replicate the magnitude, timing, and spatial variations of 
     winds, rainfall, and storm surges associated with named 
     storms that threaten any portion of a coastal State.
       ``(8) Participant.--The term `participant' means a Federal, 
     State, or private entity that chooses to cooperate with the 
     Administrator in carrying out the provisions of this section 
     by collecting, contributing, and maintaining covered data.
       ``(9) Post-storm assessment.--The term `post-storm 
     assessment' means a scientific assessment produced and 
     certified by the Administrator to determine the magnitude, 
     timing, and spatial variations of winds, rainfall, and storm 
     surges associated with a specific named storm to be used in 
     the COASTAL Formula.
       ``(10) State.--The term `State' means a State of the United 
     States, the District of Columbia, the Commonwealth of Puerto 
     Rico, and any other territory or possession of the United 
     States.
       ``(b) Named Storm Event Model and Post-storm Assessment.--
       ``(1) Establishment of named storm event model.--
       ``(A) In general.--Not later than 540 days after the date 
     of the enactment of the Consumer Option for an Alternative 
     System to Allocate Losses Act of 2012, the Administrator 
     shall develop by regulation the Named Storm Event Model.
       ``(B) Accuracy.--The Named Storm Event Model shall be 
     designed to generate post-storm assessments, as provided in 
     paragraph (2), that have a degree of accuracy of not less 
     than 90 percent for every indeterminate loss for which a 
     post-storm assessment is utilized.
       ``(2) Post-storm assessment.--
       ``(A) Identification of named storms threatening coastal 
     states.--After the establishment of the COASTAL Formula, the 
     Administrator shall, in consultation with the Secretary of 
     Homeland Security, identify named storms that may reasonably 
     constitute a threat to any portion of a coastal State.
       ``(B) Post-storm assessment required.--Upon identification 
     of a named storm under subparagraph (A), the Administrator 
     shall develop a post-storm assessment for such named storm 
     using the Named Storm Event Model and covered data collected 
     for such named storm pursuant to the protocol established 
     under subsection (c)(1).
       ``(C) Submittal of post-storm assessment.--Not later than 
     90 days after an identification of a named storm is made 
     under subparagraph (A), the Administrator shall submit to the 
     Secretary of Homeland Security the post-storm assessment 
     developed for such storm under subparagraph (B).
       ``(3) Accuracy.--The Administrator shall ensure, to the 
     greatest extent practicable, that each post-storm assessment 
     developed under paragraph (2) has a degree of accuracy of not 
     less than 90 percent.
       ``(4) Certification.--For each post-storm assessment 
     carried out under paragraph (2), the Administrator shall--
       ``(A) certify the degree of accuracy for such assessment, 
     including specific reference to any segments or geographic 
     areas for which the assessment is less than 90 percent 
     accurate; and
       ``(B) report such certification to the Secretary of 
     Homeland Security for the purposes of use with indeterminate 
     loss claims under section 1337 of the National Flood 
     Insurance Act of 1968.
       ``(5) Finality of determinations.--A certification of the 
     degree of accuracy of a post-storm assessment under this 
     subsection by the Administrator shall be final and shall not 
     be subject to judicial review.
       ``(6) Availability.--The Administrator shall make available 
     to the public the Named Storm Event Model and any post-storm 
     assessment developed under this subsection.
       ``(c) Establishment of a Protocol for Post-storm 
     Assessment.--
       ``(1) In general.--Not later than 540 days after the date 
     of the enactment of the Consumer Option for an Alternative 
     System to Allocate Losses Act of 2012, the Administrator 
     shall establish a protocol, based on the plan submitted under 
     subsection (d)(3), to collect and assemble all covered data 
     required by the Administrator to produce post-storm 
     assessments required by subsection (b), including assembling 
     data collected by participants and stored in the database 
     established under subsection (f) and from such other sources 
     as the Administrator considers appropriate.
       ``(2) Acquisition of sensors and structures.--If the 
     Administrator is unable to use a public or private asset to 
     obtain covered data as part of the protocol established under 
     paragraph (1), the Administrator may acquire such sensors and 
     structures for the placement of sensors as may be necessary 
     to obtain such data.
       ``(3) Use of federal assets.--If the protocol requires 
     placement of a sensor to develop assessments pursuant to 
     subsection (b), the Administrator shall, to the extent 
     practicable, use Federal assets for the placement of such 
     sensors.
       ``(4) Use of acquired structures.--
       ``(A) In general.--If the Administrator acquires a 
     structure for the placement of a sensor for purposes of such 
     protocol, the Administrator shall to the extent practical 
     permit other public and private entities to place sensors on 
     such structure to collect--
       ``(i) meteorological data;
       ``(ii) national security-related data;
       ``(iii) navigation-related data;
       ``(iv) hydrographic data; or
       ``(v) such other data as the Administrator considers 
     appropriate.
       ``(B) Receipt of consideration.--The Administrator may 
     receive consideration for the placement of a sensor on a 
     structure under subparagraph (A).
       ``(C) In-kind consideration.--Consideration received under 
     subparagraph (B) may be received in-kind.
       ``(D) Use of consideration.--To the extent practicable, 
     consideration received under subparagraph (B) shall be used 
     for the maintenance of sensors used to collect covered data.
       ``(5) Coordinated deployments and data collection 
     practices.--The Administrator shall, in consultation with the 
     Office of the Federal Coordinator for Meteorology, coordinate 
     the deployment of sensors as part of the protocol established 
     under paragraph (1) and related data collection carried out 
     by Federal, State, academic, and private entities who choose 
     to cooperate with the Administrator in carrying out this 
     subsection.
       ``(6) Priority acquisition and deployment.--The 
     Administrator shall give priority in the acquisition for and 
     deployment of sensors under the protocol required by 
     paragraph (1) to areas of coastal States that have the 
     highest risk of being harmed by named storms.
       ``(d) Assessment of Systems and Efforts to Collect Covered 
     Data.--
       ``(1) Identification of systems and efforts to collect 
     covered data.--Not later than 180 days after the date of the 
     enactment of the Consumer Option for an Alternative System to 
     Allocate Losses Act of 2012, the Administrator shall, in 
     consultation with the Office of the Federal Coordinator for 
     Meteorology--
       ``(A) carry out a survey to identify all Federal and State 
     efforts and systems that are capable of collecting covered 
     data; and
       ``(B) consult with private and academic sector entities to 
     identify domestic private and academic systems that are 
     capable of collecting covered data.
       ``(2) Identification of gaps.--The Administrator shall, in 
     consultation with the Office of the Federal Coordinator for 
     Meteorology and individuals and entities consulted under 
     subsection (e)(3), assess the systems identified under 
     paragraph (1) and identify which systems meet the needs of 
     the National Oceanic and Atmospheric Administration for the 
     collection of covered data, including with respect to the 
     accuracy requirement for post-storm assessment under 
     subsection (b)(3).
       ``(3) Plan.--Not later than 270 days after the date of the 
     enactment of the Consumer Option for an Alternative System to 
     Allocate Losses Act of 2012, the Administrator shall, in 
     consultation with the Office of the Federal Coordinator for 
     Meteorology, submit to Congress a plan for the collection of 
     covered data necessary to develop the Named Storm Event Model 
     and post-storm assessment required by subsection (b) that 
     addresses any gaps identified in paragraph (2).
       ``(e) Coordination of Covered Data Collection and 
     Maintenance by Participants.--
       ``(1) In general.--The Administrator shall, in consultation 
     with the Office of the Federal Coordinator for Meteorology, 
     coordinate the collection and maintenance of covered data by 
     participants under this section--
       ``(A) to streamline the process of collecting covered data 
     in accordance with the protocol established under subsection 
     (c)(1); and

[[Page 7649]]

       ``(B) to maintain transparency of such process and the 
     database established under subsection (f).
       ``(2) Sharing information.--The Administrator shall 
     establish a process for sharing among participants 
     information relevant to collecting and using covered data 
     for--
       ``(A) academic research;
       ``(B) private sector use;
       ``(C) public outreach; and
       ``(D) such other purposes as the Administrator considers 
     appropriate.
       ``(3) Consultation.--In carrying out paragraphs (1) and 
     (2), the Administrator shall consult with the following:
       ``(A) The Commanding General of the United States Army 
     Corps of Engineers.
       ``(B) The Administrator of the Federal Emergency Management 
     Agency.
       ``(C) The Commandant of the Coast Guard.
       ``(D) The Director of the United States Geological Survey.
       ``(E) The Office of the Federal Coordinator for 
     Meteorology.
       ``(F) The Director of the National Science Foundation.
       ``(G) The Administrator of the National Aeronautics and 
     Space Administration.
       ``(H) Such public, private, and academic sector entities as 
     the Administrator considers appropriate for purposes of 
     carrying out the provisions of this section.
       ``(f) Establishment of Coastal Wind and Water Event 
     Database.--
       ``(1) In general.--Not later than 1 year after the date of 
     the enactment of the Consumer Option for an Alternative 
     System to Allocate Losses Act of 2012, the Administrator 
     shall establish a database for the collection and compilation 
     of covered data--
       ``(A) to support the protocol established under subsection 
     (c)(1); and
       ``(B) for the purposes listed in subsection (e)(2).
       ``(2) Designation.--The database established under 
     paragraph (1) shall be known as the `Coastal Wind and Water 
     Event Database'.
       ``(g) Comptroller General Study.--Not later than 1 year 
     after the date of the enactment of the Consumer Option for an 
     Alternative System to Allocate Losses Act of 2012, the 
     Comptroller General of the United States shall--
       ``(1) complete an audit of Federal efforts to collect 
     covered data for purposes of the Consumer Option for an 
     Alternative System to Allocate Losses Act of 2012, which 
     audit shall--
       ``(A) examine duplicated Federal efforts to collect covered 
     data; and
       ``(B) determine the cost effectiveness of such efforts; and
       ``(2) submit to the Committee on Banking, Housing, and 
     Urban Affairs and the Commerce, Science, and Transportation 
     of the Senate and the Committee on Financial Services and the 
     Committee on Science, Space, and Technology of the House of 
     Representatives a report on the findings of the Comptroller 
     General with respect to the audit completed under paragraph 
     (1).''.

     SEC. 303. ALTERNATIVE LOSS ALLOCATION SYSTEM FOR 
                   INDETERMINATE CLAIMS.

       Part A of chapter II of the National Flood Insurance Act of 
     1968 (42 U.S.C. 4051 et seq.) is amended by adding at the end 
     the following:

     ``SEC. 1337. ALTERNATIVE LOSS ALLOCATION SYSTEM FOR 
                   INDETERMINATE CLAIMS.

       ``(a) Definitions.--In this section:
       ``(1) Administrator.--The term `Administrator' means the 
     Administrator of the Federal Emergency Management Agency.
       ``(2) COASTAL formula.--The term `COASTAL Formula' means 
     the formula established under subsection (b).
       ``(3) Coastal state.--The term `coastal State' has the 
     meaning given the term `coastal state' in section 304 of the 
     Coastal Zone Management Act of 1972 (16 U.S.C. 1453).
       ``(4) Indeterminate loss.--
       ``(A) In general.--The term `indeterminate loss' means, as 
     determined by an insurance claims adjuster certified under 
     the national flood insurance program and in consultation with 
     an engineer as appropriate, a loss resulting from physical 
     damage to, or loss of, property located in any coastal State 
     arising from the combined perils of flood and wind associated 
     with a named storm.
       ``(B) Requirements.--An insurance claims adjuster certified 
     under the national flood insurance program shall only 
     determine that a loss is an indeterminate loss if the claims 
     adjuster determines that--
       ``(i) no material remnant of physical buildings or man-made 
     structures remain except building foundations for the 
     specific property for which the claim is made; and
       ``(ii) there is insufficient or no tangible evidence 
     created, yielded, or otherwise left behind of the specific 
     property for which the claim is made as a result of the named 
     storm.
       ``(5) Named storm.--The term `named storm' means any 
     organized weather system with a defined surface circulation 
     and maximum winds of not less than 39 miles per hour which 
     the National Hurricane Center of the United States National 
     Weather Service names as a tropical storm or a hurricane.
       ``(6) Post-storm assessment.--The term `post-storm 
     assessment' means the post-storm assessment developed under 
     section 12312(b) of the Omnibus Public Land Management Act of 
     2009.
       ``(7) State.--The term `State' means a State of the United 
     States, the District of Columbia, the Commonwealth of Puerto 
     Rico, and any other territory or possession of the United 
     States.
       ``(8) Secretary.--The term `Secretary' means the Secretary 
     of Homeland Security.
       ``(9) Standard insurance policy.--The term `standard 
     insurance policy' means any insurance policy issued under the 
     national flood insurance program that covers loss or damage 
     to property resulting from water peril.
       ``(10) Property.--The term `property' means real or 
     personal property that is insured under a standard insurance 
     policy for loss or damage to structure or contents.
       ``(11) Under secretary.--The term `Under Secretary' means 
     the Under Secretary of Commerce for Oceans and Atmosphere, in 
     the Under Secretary's capacity as Administrator of the 
     National Oceanic and Atmospheric Administration.
       ``(b) Establishment of Flood Loss Allocation Formula for 
     Indeterminate Claims.--
       ``(1) In general.--Not later than 180 days after the date 
     on which the protocol is established under section 
     12312(c)(1) of the Omnibus Public Land Management Act of 
     2009, the Secretary, acting through the Administrator and in 
     consultation with the Under Secretary, shall establish by 
     rule a standard formula to determine and allocate wind losses 
     and flood losses for claims involving indeterminate losses.
       ``(2) Contents.--The standard formula established under 
     paragraph (1) shall--
       ``(A) incorporate data available from the Coastal Wind and 
     Water Event Database established under section 12312(f) of 
     the Omnibus Public Land Management Act of 2009;
       ``(B) use relevant data provided on the National Flood 
     Insurance Program Elevation Certificate for each 
     indeterminate loss for which the formula is used;
       ``(C) consider any sufficient and credible evidence, 
     approved by the Administrator, of the pre-event condition of 
     a specific property, including the findings of any 
     policyholder or insurance claims adjuster in connection with 
     the indeterminate loss to that specific property;
       ``(D) include other measures, as the Administrator 
     considers appropriate, required to determine and allocate by 
     mathematical formula the property damage caused by flood or 
     storm surge associated with a named storm; and
       ``(E) subject to paragraph (3), for each indeterminate 
     loss, use the post-storm assessment to allocate water damage 
     (flood or storm surge) associated with a named storm.
       ``(3) Degree of accuracy required.--The standard formula 
     established under paragraph (1) shall specify that the 
     Administrator may only use the post-storm assessment for 
     purposes of the formula if the Under Secretary certifies that 
     the post-storm assessment has a degree of accuracy of not 
     less than 90 percent in connection with the specific 
     indeterminate loss for which the assessment and formula are 
     used.
       ``(c) Authorized Use of Post-storm Assessment and COASTAL 
     Formula.--
       ``(1) In general.--Subject to paragraph (3), the 
     Administrator may use the post-storm assessment and the 
     COASTAL Formula to--
       ``(A) review flood loss payments for indeterminate losses, 
     including as part of the quality assurance reinspection 
     program of the Federal Emergency Management Agency for claims 
     under the national flood insurance program and any other 
     process approved by the Administrator to review and validate 
     payments under the national flood insurance program for 
     indeterminate losses following a named storm; and
       ``(B) assist the national flood insurance program to--
       ``(i) properly cover qualified flood loss for claims for 
     indeterminate losses; and
       ``(ii) avoid paying for any loss or damage to property 
     caused by any peril (including wind), other than flood or 
     storm surge, that is not covered under a standard policy 
     under the national flood insurance program.
       ``(2) Federal disaster declaration.--Subject to paragraph 
     (3), in order to expedite claims and reduce costs to the 
     national flood insurance program, following any major 
     disaster declared by the President under section 401 of the 
     Robert T. Stafford Disaster Relief and Emergency Assistance 
     Act (42 U.S.C. 5170) relating to a named storm in a coastal 
     State, the Administrator may use the COASTAL Formula to 
     determine and pay for any flood loss covered under a standard 
     insurance policy under the national flood insurance program, 
     if the loss is an indeterminate loss.
       ``(3) National academy of sciences evaluation.--
       ``(A) Evaluation required.--
       ``(i) Evaluation.--Upon the issuance of the rule 
     establishing the COASTAL Formula, and each time the 
     Administrator modifies the COASTAL Formula, the National 
     Academy of Sciences shall--

       ``(I) evaluate the expected financial impact on the 
     national flood insurance program of the use of the COASTAL 
     Formula as so established or modified; and
       ``(II) evaluate the validity of the scientific assumptions 
     upon which the formula is based

[[Page 7650]]

     and determine whether the COASTAL formula can achieve a 
     degree of accuracy of not less than 90 percent in allocating 
     flood losses for indeterminate losses.

       ``(ii) Report.--The National Academy of Sciences shall 
     submit a report containing the results of each evaluation 
     under clause (i) to the Administrator, the Committee on 
     Banking, Housing, and Urban Affairs of the Senate, and the 
     Committee on Financial Services of the House of 
     Representatives.
       ``(B) Effective date and applicability.--
       ``(i) Effective date.--Paragraphs (1) and (2) of this 
     subsection shall not take effect unless the report under 
     subparagraph (A) relating to the establishment of the COASTAL 
     Formula concludes that the use of the COASTAL Formula for 
     purposes of paragraph (1) and (2) would not have an adverse 
     financial impact on the national flood insurance program and 
     that the COASTAL Formula is based on valid scientific 
     assumptions that would allow a degree of accuracy of not less 
     than 90 percent to be achieved in allocating flood losses for 
     indeterminate losses.
       ``(ii) Effect of modifications.--Unless the report under 
     subparagraph (A) relating to a modification of the COASTAL 
     Formula concludes that the use of the COASTAL Formula, as so 
     modified, for purposes of paragraphs (1) and (2) would not 
     have an adverse financial impact on the national flood 
     insurance program and that the COASTAL Formula is based on 
     valid scientific assumptions that would allow a degree of 
     accuracy of not less than 90 percent to be achieved in 
     allocating flood losses for indeterminate losses the 
     Administrator may not use the COASTAL Formula, as so 
     modified, for purposes of paragraphs (1) and (2).
       ``(C) Funding.--Notwithstanding section 1310 of the 
     National Flood Insurance Act of 1968 (42 U.S.C. 4017), there 
     shall be available to the Administrator from the National 
     Flood Insurance Fund, of amounts not otherwise obligated, not 
     more than $750,000 to carry out this paragraph.
       ``(d) Disclosure of COASTAL Formula.--Not later than 30 
     days after the date on which a post-storm assessment is 
     submitted to the Secretary under section 12312(b)(2)(C) of 
     the Omnibus Public Land Management Act of 2009, for each 
     indeterminate loss for which the COASTAL Formula is used 
     pursuant to subsection (c)(2), the Administrator shall 
     disclose to the policyholder that makes a claim relating to 
     the indeterminate loss--
       ``(1) that the Administrator used the COASTAL Formula with 
     respect to the indeterminate loss; and
       ``(2) a summary of the results of the use of the COASTAL 
     Formula.
       ``(e) Consultation.--In carrying out subsections (b) and 
     (c), the Secretary shall consult with--
       ``(1) the Under Secretary for Oceans and Atmosphere;
       ``(2) the Director of the National Institute of Standards 
     and Technology;
       ``(3) the Chief of Engineers of the United States Army 
     Corps of Engineers;
       ``(4) the Director of the United States Geological Survey;
       ``(5) the Office of the Federal Coordinator for 
     Meteorology;
       ``(6) State insurance regulators of coastal States; and
       ``(7) such public, private, and academic sector entities as 
     the Secretary considers appropriate for purposes of carrying 
     out such subsections.
       ``(f) Recordkeeping.--Each consideration and measure the 
     Administrator determines necessary to carry out subsection 
     (b) may be required, with advanced approval of the 
     Administrator, to be provided for on the National Flood 
     Insurance Program Elevation Certificate, or maintained 
     otherwise on record if approved by the Administrator, for any 
     property that qualifies for the COASTAL Formula under 
     subsection (c).
       ``(g) Civil Penalty.--
       ``(1) In general.--If an insurance claims adjuster 
     knowingly and willfully makes a false or inaccurate 
     determination relating to an indeterminate loss, the 
     Administrator may, after notice and opportunity for hearing, 
     impose on the insurance claims adjuster a civil penalty of 
     not more than $1,000.
       ``(2) Deposit.--Notwithstanding section 3302 of title 31, 
     United States Code, or any other law relating to the 
     crediting of money, the Administrator shall deposit in the 
     National Flood Insurance Fund any amounts received under this 
     subsection, which shall remain available until expended and 
     be available to the Administrator for purposes authorized for 
     the National Flood Insurance Fund without further 
     appropriation.
       ``(h) Rule of Construction.--Nothing in this subsection 
     shall be construed to require the Administrator to make any 
     payment under the national flood insurance program, or an 
     insurance company to make any payment, for an indeterminate 
     loss based upon post-storm assessment or the COASTAL Formula.
       ``(i) Applicability.--Subsection (c) shall apply with 
     respect to an indeterminate loss associated with a named 
     storm that occurs after the date on which the Administrator 
     issues the rule establishing the COASTAL Formula under 
     subsection (b).
       ``(j) Rule of Construction.--Nothing in this subsection 
     shall be construed to negate, set aside, or void any policy 
     limit, including any loss limitation, set forth in a standard 
     insurance policy.''.
                                 ______
                                 
  SA 2139. Mr. SCHUMER submitted an amendment intended to be proposed 
by him to the bill S. 3187, to amend the Federal Food, Drug, and 
Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, add the following:

                 Subtitle D--Theft of Medical Products

     SEC. 1141. SHORT TITLE.

       This subtitle may be cited as the ``Safe Doses Act''.

     SEC. 1142. THEFT OF MEDICAL PRODUCTS.

       (a) Prohibited Conduct and Penalties.--Chapter 31 of title 
     18, United States Code, is amended by adding at the end the 
     following:

     ``Sec.  670. Theft of medical products

       ``(a) Prohibited Conduct.--Whoever, in, or using any means 
     or facility of, interstate or foreign commerce--
       ``(1) embezzles, steals, or by fraud or deception obtains, 
     or knowingly and unlawfully takes, carries away, or conceals, 
     a pre-retail medical product;
       ``(2) knowingly and falsely makes, alters, forges, or 
     counterfeits the labeling or documentation (including 
     documentation relating to origination or shipping) of a pre-
     retail medical product;
       ``(3) knowingly possesses, transports, or traffics in a 
     pre-retail medical product that was involved in a violation 
     of paragraph (1) or (2);
       ``(4) with intent to defraud, buys, or otherwise obtains, a 
     pre-retail medical product that has expired or been stolen;
       ``(5) with intent to defraud, sells, or distributes, a pre-
     retail medical product that is expired or stolen; or
       ``(6) attempts or conspires to violate any of paragraphs 
     (1) through (5);
     shall be punished as provided in subsection (c) and subject 
     to the other sanctions provided in this section.
       ``(b) Aggravated Offenses.--An offense under this section 
     is an aggravated offense if--
       ``(1) the defendant is employed by, or is an agent of, an 
     organization in the supply chain for the pre-retail medical 
     product; or
       ``(2) the violation--
       ``(A) involves the use of violence, force, or a threat of 
     violence or force;
       ``(B) involves the use of a deadly weapon;
       ``(C) results in serious bodily injury or death, including 
     serious bodily injury or death resulting from the use of the 
     medical product involved; or
       ``(D) is subsequent to a prior conviction for an offense 
     under this section.
       ``(c) Criminal Penalties.--Whoever violates subsection 
     (a)--
       ``(1) if the offense is an aggravated offense under 
     subsection (b)((2)(C), shall be fined under this title or 
     imprisoned not more than 30 years, or both;
       ``(2) if the value of the medical products involved in the 
     offense is $5,000 or greater, shall be fined under this 
     title, imprisoned for not more than 15 years, or both, but if 
     the offense is an aggravated offense other than one under 
     subsection (b)(2)(C), the maximum term of imprisonment is 20 
     years; and
       ``(3) in any other case, shall be fined under this title, 
     imprisoned for not more than 3 years, or both, but if the 
     offense is an aggravated offense other than one under 
     subsection (b)(2)(C), the maximum term of imprisonment is 5 
     years.
       ``(d) Civil Penalties.--Whoever violates subsection (a) is 
     subject to a civil penalty in an amount not more than the 
     greater of--
       ``(1) three times the economic loss attributable to the 
     violation; or
       ``(2) $1,000,000.
       ``(e) Definitions.--In this section--
       ``(1) the term `pre-retail medical product' means a medical 
     product that has not yet been made available for retail 
     purchase by a consumer;
       ``(2) the term `medical product' means a drug, biological 
     product, device, medical food, or infant formula;
       ``(3) the terms `device', `drug', `infant formula', and 
     `labeling' have, respectively, the meanings given those terms 
     in section 201 of the Federal Food, Drug, and Cosmetic Act;
       ``(4) the term `biological product' has the meaning given 
     the term in section 351 of the Public Health Service Act;
       ``(5) the term `medical food' has the meaning given the 
     term in section 5(b) of the Orphan Drug Act; and
       ``(6) the term `supply chain' includes manufacturer, 
     wholesaler, repacker, own-labeled distributor, private-label 
     distributor, jobber, broker, drug trader, transportation 
     company, hospital, pharmacy, or security company.''.
       (b) Clerical Amendment.--The table of sections at the 
     beginning of chapter 31 of title 18, United States Code, is 
     amended by adding after the item relating to section 669 the 
     following:

``670. Theft of medical products.''.

[[Page 7651]]



     SEC. 1143. CIVIL FORFEITURE.

       Section 981(a)(1)(C) of title 18, United States Code, is 
     amended by inserting ``670,'' after ``657,''.

     SEC. 1144. PENALTIES FOR THEFT-RELATED OFFENSES.

       (a) Interstate or Foreign Shipments by Carrier.--Section 
     659 of title 18, United States Code, is amended by adding at 
     the end of the fifth undesignated paragraph the following: 
     ``If the offense involves a pre-retail medical product (as 
     defined in section 670), it shall be punished under section 
     670 unless the penalties provided for under this section are 
     greater.''.
       (b) Racketeering.--
       (1) Travel act violations.--Section 1952 of title 18, 
     United States Code, is amended by adding that the end the 
     following:
       ``(d) If the offense under this section involves an act 
     described in paragraph (1) or (3) of subsection (a) and also 
     involves a pre-retail medical product (as defined in section 
     670), the punishment for the offense shall be the same as the 
     punishment for an offense under section 670, unless the 
     punishment under subsection (a) is greater.''.
       (2) Money laundering.--Section 1957(b)(1) of title 18, 
     United States Code, is amended by adding at the end the 
     following: ``If the offense involves a pre-retail medical 
     product (as defined in section 670) the punishment for the 
     offense shall be the same as the punishment for an offense 
     under section 670 unless the punishment under this subsection 
     is greater.''
       (c) Breaking or Entering Carrier Facilities.--Section 2117 
     of title 18, United States Code, is amended by adding at the 
     end of the first undesignated paragraph the following: ``If 
     the offense involves a pre-retail medical product (as defined 
     in section 670) the punishment for the offense shall be the 
     same as the punishment for an offense under section 670 
     unless the punishment under this section is greater.''.
       (d) Stolen Property.--
       (1) Transportation of stolen goods and related offenses.--
     Section 2314 of title 18, United States Code, is amended by 
     adding at the end of the sixth undesignated paragraph the 
     following: ``If the offense involves a pre-retail medical 
     product (as defined in section 670) the punishment for the 
     offense shall be the same as the punishment for an offense 
     under section 670 unless the punishment under this section is 
     greater.''.
       (2) Sale or receipt of stolen goods and related offenses.--
     Section 2315 of title 18, United States Code, is amended by 
     adding at the end of the fourth undesignated paragraph the 
     following: ``If the offense involves a pre-retail medical 
     product (as defined in section 670) the punishment for the 
     offense shall be the same as the punishment for an offense 
     under section 670 unless the punishment under this section is 
     greater.''.

     SEC. 1145. INCLUSION OF NEW OFFENSE AS RICO PREDICATE.

       Section 1961(1)(B) of title 18, United States Code, is 
     amended by inserting ``, section 670 (relating to theft of 
     medical products)'' before ``, sections 891''.

     SEC. 1146. AMENDMENT TO EXTEND WIRETAPPING AUTHORITY TO NEW 
                   OFFENSE.

       Section 2516(1) of title 18, United States Code, is 
     amended--
       (1) by redesignating paragraph (s) as paragraph (t);
       (2) by striking ``or'' at the end of paragraph (r); and
       (3) by inserting after paragraph (r) the following:
       ``(s) any violation of section 670 (relating to theft of 
     medical products); or''.

     SEC. 1147. REQUIRED RESTITUTION.

       Section 3663A(c)(1)(A) of title 18, United States Code, is 
     amended--
       (1) in clause (ii), by striking ``or'' at the end;
       (2) in clause (iii), by striking ``and'' at the end and 
     inserting ``or''; and
       (3) by adding at the end the following:
       ``(iv) an offense under section 670 (relating to theft of 
     medical products); and''.

     SEC. 1148. DIRECTIVE TO THE UNITED STATES SENTENCING 
                   COMMISSION.

       (a) In General.--Pursuant to its authority under section 
     994 of title 28, United States Code, and in accordance with 
     this section, the United States Sentencing Commission shall 
     review and, if appropriate, amend the Federal sentencing 
     guidelines and policy statements applicable to persons 
     convicted of offenses under section 670 of title 18, United 
     States Code, as added by this Act, section 2118 of title 18, 
     United States Code, or any another section of title 18, 
     United States Code, amended by this Act, to reflect the 
     intent of Congress that penalties for such offenses be 
     sufficient to deter and punish such offenses, and 
     appropriately account for the actual harm to the public from 
     these offenses.
       (b) Requirements.--In carrying out this section, the United 
     States Sentencing Commission shall--
       (1) consider the extent to which the Federal sentencing 
     guidelines and policy statements appropriately reflect--
       (A) the serious nature of such offenses;
       (B) the incidence of such offenses; and
       (C) the need for an effective deterrent and appropriate 
     punishment to prevent such offenses;
       (2) consider establishing a minimum offense level under the 
     Federal sentencing guidelines and policy statements for 
     offenses covered by this Act;
       (3) account for any additional aggravating or mitigating 
     circumstances that might justify exceptions to the generally 
     applicable sentencing ranges;
       (4) ensure reasonable consistency with other relevant 
     directives, Federal sentencing guidelines and policy 
     statements;
       (5) make any necessary conforming changes to the Federal 
     sentencing guidelines and policy statements; and
       (6) ensure that the Federal sentencing guidelines and 
     policy statements adequately meet the purposes of sentencing 
     set forth in section 3553(a)(2) of title 18, United States 
     Code.
                                 ______
                                 
  SA 2140. Mr. SCHUMER (for himself, Mr. Merkley, and Mr. Blumenthal) 
submitted an amendment intended to be proposed by him to the bill S. 
3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and 
extend the user-fee programs for prescription drugs and medical 
devices, to establish user-fee programs for generic drugs and 
biosimilars, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end, insert the following:

   TITLE __--PROTECTING PATIENTS AND HOSPITALS FROM PRICE GOUGING ACT

     SEC. _01. SHORT TITLE.

       This title may be cited as the ``Protecting Patients and 
     Hospitals From Price Gouging Act''.

     SEC. _02. FINDINGS AND PURPOSE.

       (a) Findings.--Congress finds that--
       (1) many pharmaceutical drugs are necessary to maintain the 
     health and welfare of the American people;
       (2) currently the Nation is facing a chronic shortage of 
     vital drugs necessary in surgery, to treat cancer, and to 
     fight other life-threatening illnesses; and
       (3) in order to prevent any party within the chain of 
     distribution of any vital drugs from taking unfair advantage 
     of consumers during market shortages, the public interest 
     requires that such conduct be prohibited and made subject to 
     criminal penalties.
       (b) Purpose.--The purpose of this title is to prohibit 
     excessive pricing during market shortages.

     SEC. _03. DEFINITIONS.

       As used in this title--
       (1) the term ``market shortage'' means a situation in which 
     the total supply of all clinically interchangeable versions 
     of an FDA-regulated drug is inadequate to meet the current or 
     projected demand at the user level;
       (2) the term ``drug'' means a drug intended for use by 
     human beings, which--
       (A) because of its toxicity or other potentiality for 
     harmful effect, or the method of its use, or the collateral 
     measures necessary to its use, is not safe for use except 
     under the supervision of a practitioner licensed by law to 
     administer such drug; or
       (B) is limited by an approved application under section 505 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
     to use under the professional supervision of a practitioner 
     licensed by law to administer such drug;
       (3) the term ``biologic'' means a virus, therapeutic serum, 
     toxin, antitoxin, vaccine, blood, blood component or 
     derivative, allergenic product, or analogous product, or 
     arsphenamine or derivative of arsphenamine (or any other 
     trivalent organic arsenic compound), applicable to the 
     prevention, treatment, or cure of a disease or condition of 
     human beings; and
       (4) the term ``vital drug'' means any drug or biologic used 
     to prevent or treat a serious or life-threatening disease or 
     medical condition, for which there is no other available 
     source with sufficient supply of that drug or biologic or 
     alternative drug or biologic available.

     SEC. _04. UNREASONABLY EXCESSIVE DRUG PRICING.

       (a) In General.--
       (1) Authority.--The President may issue an Executive Order 
     declaring a market shortage for a period of 6 months with 
     regard to one or more vital drugs due to a market shortage 
     under this title.
       (2) Unlawful act.--If the President issues an Executive 
     Order under paragraph (1), it shall be unlawful for any 
     person to sell vital drugs at a price that is unreasonably 
     excessive and indicates that the seller is taking unfair 
     advantage of the circumstances related to a market shortage 
     to unreasonably increase prices during such period.
       (b) Authority.--The Attorney General is authorized to 
     enforce penalties under this title.

     SEC. _05. ENFORCEMENT.

       (a) Enforcement.--
       (1) In general.--Whoever sells, or offers to sell, any 
     vital drug during a declared market shortage with the 
     knowledge and intent to charge a price that is unreasonably 
     excessive under the circumstances shall be guilty of an 
     offense under this section and subject to injunction and 
     penalties as provided in paragraphs (2) and (3).
       (2) Action in district court for injunction.--Whenever it 
     shall appear to the Attorney General that any person is 
     engaged in or

[[Page 7652]]

     about to engage in acts or practices constituting a violation 
     of any provision of this section and until such complaint is 
     dismissed by the Attorney General or set aside by a court on 
     review, the Attorney General may in his or her discretion 
     bring an action in the proper district court of the United 
     States, the United States District Court for the District of 
     Columbia, or the United States courts of any territory or 
     other place subject to the jurisdiction of the United States 
     to enjoin such acts or practices, and upon a proper showing a 
     permanent or temporary injunction or restraining order shall 
     be granted without bond in the interest of the public.
       (3) Criminal penalties.--Any person acting with the 
     knowledge and intent to charge a price that is unreasonably 
     excessive under the circumstances shall be guilty of an 
     offense under this section and title 18, United States Code, 
     and subject to imprisonment for a term not to exceed 3 years, 
     fined an amount not to exceed $5,000,000, or both.
       (b) Enforcement.--The criminal penalty provided by 
     subsection (a) may be imposed only pursuant to a criminal 
     action brought by the Attorney General or other officer of 
     the Department of Justice.
       (c) Multiple Offenses.--In assessing the penalty provided 
     by subsection (a) each day of a continuing violation shall be 
     considered a separate violation.
       (d) Application.--
       (1) In general.--This section shall apply--
       (A) in the geographical area where the vital drug market 
     shortage has been declared; and
       (B) to all wholesalers and distributors in the chain of 
     distribution.
       (2) Inapplicable.--This section shall not apply to a 
     hospital (as defined in section 1861(e) of the Social 
     Security Act (42 U.S.C. 1395x(e)) or a physician (as defined 
     in section 1861(q) of the Social Security Act (42 U.S.C. 
     1395x(q)).

     SEC. _06. DETERMINATION OF UNREASONABLY EXCESSIVE.

       (a) In General.--The Attorney General, in determining 
     whether an alleged violator's price was unreasonably 
     excessive, shall consider whether--
       (1) the price reasonably reflected additional costs, not 
     within the control of that person or company, that were paid, 
     incurred, or reasonably anticipated by that person or 
     company;
       (2) the price reasonably reflected additional risks taken 
     by that person or company to produce, distribute, obtain, or 
     sell such product under the circumstances;
       (3) there is a gross disparity between the challenged price 
     and the price at which the same or similar goods were readily 
     available in the same region and during the same 
     Presidentially-declared market shortage;
       (4) the marginal benefit received by the wholesaler or 
     distributor is significantly changed in comparison with 
     marginal earnings in the year before a market shortage was 
     declared;
       (5) the price charged was comparable to the price at which 
     the goods were generally available in the trade area if the 
     wholesaler or distributor did not sell or offer to sell the 
     prescription drug in question prior to the time a market 
     shortage was declared; and
       (6) the price was substantially attributable to local, 
     regional, national, or international market conditions.
       (b) Consultation.--Not later than 1 year after the date of 
     enactment of this title and annually thereafter, the Attorney 
     General or designee, shall consult with representatives of 
     the National Association of Wholesalers, Group Purchasing 
     Organizations, Pharmaceutical Distributors, Hospitals, 
     Manufacturers, patients, and other interested community 
     organizations to reassess the criteria set forth in 
     subsection (a) in determining unreasonably excessive and 
     prepare and submit to Congress a report on the results of the 
     reassessment.

     SEC. _07. DURATION.

       (a) In General.--Any market shortage declared by the 
     President in accordance with this title shall be in effect 
     for a period of not to exceed 6 months from the date on which 
     the President issues the Executive Order.
       (b) Termination.--Any market shortage declared by the 
     President in accordance with this title shall terminate if--
       (1) there is enacted a law terminating the market shortage 
     which shall be passed by Congress after a national market 
     shortage is declared; or
       (2) the President issues a proclamation terminating the 
     market shortage;
     whichever comes first.
       (c) Declaration Renewal.--The President may renew the state 
     of market shortage declared under subsection (a), if the 
     President declares that the severe shortage continues to 
     affect the health and well being of citizens beyond the 
     initial 6-month period.
                                 ______
                                 
  SA 2141. Mr. CARDIN (for himself and Ms. Landrieu) submitted an 
amendment intended to be proposed by him to the bill S. 3187, to amend 
the Federal Food, Drug, and Cosmetic Act to revise and extend the user-
fee programs for prescription drugs and medical devices, to establish 
user-fee programs for generic drugs and biosimilars, and for other 
purposes; which was ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. REPORT ON SMALL BUSINESSES.

       Not later than 1 year after the date of enactment of this 
     Act, the Commissioner of Food and Drugs shall submit a report 
     to Congress that includes--
       (1) a listing of and staffing levels of all small business 
     offices at the Food and Drug Administration, including the 
     small business liaison program;
       (2) the status of partnership efforts between the Food and 
     Drug Administration and the Small Business Administration;
       (3) a summary of outreach efforts to small businesses and 
     small business associations, including availability of toll-
     free telephone help lines;
       (4) with respect to the program under the Orphan Drug Act 
     (Public Law 97-414), the number of applications made by small 
     businesses and number of applications approved for research 
     grants, the amount of tax credits issued for clinical 
     research, and the number of companies receiving protocol 
     assistance for the development of drugs for rare diseases and 
     disorders;
       (5) with respect to waivers and reductions for small 
     business under the Prescription Drug User Fee Act, the number 
     of small businesses applying for and receiving waivers and 
     reductions from drug user fees under subchapter C of chapter 
     VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379f et seq.);
       (6) the number of small businesses submitting applications 
     and receiving approval for unsolicited grant applications 
     from the Food and Drug Administration;
       (7) the number of small businesses submitting applications 
     and receiving approval for solicited grant applications from 
     the Food and Drug Administration;
       (8) barriers small businesses encounter in the drug and 
     medical device approval process; and
       (9) recommendations for changes in the user fee structure 
     to help alleviate generic drug shortages.
                                 ______
                                 
  SA 2142. Mr. LEAHY submitted an amendment intended to be proposed by 
him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic 
Act to revise and extend the user-fee programs for prescription drugs 
and medical devices, to establish user-fee programs for generic drugs 
and biosimilars, and for other purposes; which was ordered to lie on 
the table; as follows:

       On page 192, strike line 10 through line 21 and insert the 
     following:
       (2) by adding at the end the following:
       ``(b) Ability to Receive and Protect Confidential 
     Information Obtained From Foreign Government Agencies 
     Relating to Drug Inspections.--
       ``(1) In general.--The Secretary shall not be required to 
     disclose under section 552 of title 5, United States Code 
     (commonly referred to as the Freedom of Information Act), or 
     any other provision of law, any information relating to drug 
     inspections obtained from a foreign government agency, if--
       ``(A) the information is provided or made available to the 
     United States Government voluntarily and on the condition 
     that the information not be released to the public;
       ``(B) the foreign government agency, in writing, requests 
     that the information be kept confidential; and
       ``(C) the Secretary determines that the requirements under 
     subparagraphs (A) and (B) have been satisfied.
       ``(2) Time limitations.--A foreign government agency may 
     specify in a request described in paragraph (1)(B) that the 
     voluntarily-provided information be withheld from disclosure 
     for a specified time period. Such information may not be 
     withheld under this subsection after the date specified. If 
     no such date is specified, the withholding period shall not 
     exceed 3 years.
       ``(3) Disclosures not affected.--Nothing in this subsection 
     authorizes any official to withhold, or to authorize the 
     withholding of, information from Congress or information 
     required to be disclosed pursuant to an order of a court of 
     the United States. For purposes of section 552 of title 5, 
     United States Code, this subsection shall be considered a 
     statute described in section 552(b)(3)(B).
                                 ______
                                 
  SA 2143. Mr. PAUL submitted an amendment intended to be proposed by 
him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic 
Act to revise and extend the user-fee programs for prescription drugs 
and medical devices, to establish user-fee programs for generic drugs 
and biosimilars, and for other purposes; which was ordered to lie on 
the table; as follows:

       At the appropriate place, insert the following:

[[Page 7653]]



     SEC. 11__. LIMITATION ON SUPPRESSION BY FEDERAL GOVERNMENT OF 
                   CLAIMS IN FOOD AND DIETARY SUPPLEMENTS.

       (a) In General.--The Federal Government may not take any 
     action to prevent use of a claim describing any nutrient in a 
     food or dietary supplement (as such terms are defined in 
     section 201 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 321)) as mitigating, treating, or preventing any 
     disease, disease symptom, or health-related condition, unless 
     a Federal court in a final order following a trial on the 
     merits finds clear and convincing evidence based on qualified 
     expert opinion and published peer-reviewed scientific 
     research that--
       (1) the claim is false and misleading in a material 
     respect; and
       (2) there is no less speech restrictive alternative to 
     claim suppression, such as use of disclaimers or 
     qualifications, that can render the claim non-misleading.
       (b) Definition.--In this section, the term ``material'' 
     means that the Food and Drug Administration has identified a 
     competent consumer survey demonstrating that consumers 
     decided to purchase the food or dietary supplement based on 
     the portion of the claim alleged to be false or misleading.

     SEC. 11__. DEFINITION OF DRUG.

       (a) In General.--Subparagraph (1) of section 201(g) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is 
     amended by striking the second and third sentences and 
     inserting the following: ``A food or dietary supplement for 
     which a claim is made in accordance with section 403(r)(1)(B) 
     is not a drug solely because of such claim.''.
       (b) Rules.--All rules of the Food and Drug Administration 
     in existence on the date of the enactment of this Act 
     prohibiting nutrient-disease relationship claims are revoked.

     SEC. 11__. MISBRANDED FOOD.

       Section 403(r) (21 U.S.C. 343(r)) is amended--
       (1) by striking clause (B) of subparagraph (1) and 
     inserting the following:
       ``(B) describes any nutrient as mitigating, treating, or 
     preventing any disease, disease symptom, or health-related 
     condition if, and only if, the claim has been adjudicated 
     false and misleading in a material respect by final order of 
     a Federal court of competent jurisdiction in accordance with 
     section 1202 of the Health Freedom Act.'';
       (2) by striking subparagraph (3);
       (3) in the first sentence of subparagraph (4)(A)(i)--
       (A) by striking ``or (3)(B)''; and
       (B) by striking ``or (1)(B)'';
       (4) by striking clause (C) of subparagraph (4);
       (5) by striking clause (D) of subparagraph (5); and
       (6) in subparagraph (6), in the matter following clause 
     (C), by striking the first sentence.

     SEC. 11__. DIETARY SUPPLEMENT LABELING EXEMPTIONS.

       Section 403B (21 U.S.C. 343 2) is amended to read as 
     follows:


                 ``food and dietary supplement labeling

       ``Sec. 403B. The Federal Government shall take no action to 
     prevent distribution of any publication in connection with 
     the sale of a food or dietary supplement to consumers unless 
     it establishes that a claim contained in the publication--
       ``(1) names the specific food or dietary supplement sold by 
     the person causing the publication to be distributed;
       ``(2) represents that the specific food or dietary 
     supplement mitigates, treats, or prevents a disease; and
       ``(3) proves the claim to be false and misleading in a 
     material respect by final order of a Federal court of 
     competent jurisdiction.''.

     SEC. 11__. PROHIBITIONS ON FDA OFFICIALS CARRYING FIREARMS 
                   AND MAKING ARRESTS WITHOUT WARRANTS.

       Section 702(e) (21 U.S.C. 372(e)) is amended--
       (1) by striking paragraph (1);
       (2) by redesignating paragraphs (2) and (3) as paragraphs 
     (1) and (2) respectively;
       (3) in paragraph (2), as so redesignated, by adding ``and'' 
     after the semicolon at the end;
       (4) by striking paragraph (4); and
       (5) by redesignating paragraph (5) as paragraph (3).

     SEC. 11__. PROHIBITED ACTS.

       Section 301 (21 U.S.C. 331) is amended--
       (1) in subsection (a), by inserting ``knowing and willful'' 
     before ``introduction or delivery'';
       (2) in subsection (b), by inserting ``knowing and willful'' 
     before ``adulteration'';
       (3) in subsection (c), by inserting ``knowing and willful'' 
     before ``receipt'';
       (4) in subsection (d), by inserting ``knowing and willful'' 
     before ``introduction or delivery'';
       (5) in subsection (e), by striking ``The refusal'' and 
     inserting ``The knowing and willful refusal'';
       (6) in subsection (f), by inserting ``knowing and willful'' 
     before ``refusal'';
       (7) in subsection (g), by inserting ``knowing and willful'' 
     before ``manufacture'';
       (8) in subsection (h), by striking ``The giving'' and 
     inserting ``The knowing and willful giving'';
       (9) in subsection (i)--
       (A) in paragraph (1)--
       (i) by striking ``Forging'' and inserting ``Knowingly and 
     willfully forging''; and
       (ii) by inserting ``knowingly and willfully'' after 
     ``proper authority'';
       (B) in paragraph (2), by striking ``Making'' and inserting 
     ``Knowingly and willfully making''; and
       (C) in paragraph (3), by striking ``The doing'' and 
     inserting ``The knowing and willful doing'';
       (10) in subsection (j), by striking ``The using'' and 
     inserting ``The knowing and willful using'';
       (11) in subsection (k)--
       (A) by inserting ``knowing and willful'' before 
     ``alteration''; and
       (B) by inserting ``knowing and willful'' before ``doing'';
       (12) in subsection (m), by striking ``The sale'' and 
     inserting ``The knowing and willful sale'';
       (13) in subsection (n), by striking ``The using'' and 
     inserting ``The knowing and willful using'';
       (14) in subsection (o), by inserting ``knowing and 
     willful'' before ``failure'';
       (15) in subsection (p), by striking ``The failure'' and 
     inserting ``The knowing and willful failure'';
       (16) in subsection (q)--
       (A) in paragraph (1), by striking ``The failure'' and 
     inserting ``The knowing and willful failure''; and
       (B) in paragraph (2), by inserting ``knowing and willful'' 
     before ``submission'';
       (17) in subsection (r), by inserting ``knowing and 
     willful'' before ``movement'';
       (18) in subsection (s), by striking ``The failure'' and 
     inserting ``The knowing and willful failure'';
       (19) in subsection (t), by striking ``The importation'' and 
     inserting ``The knowing and willful importation'';
       (20) in subsection (u), by inserting ``knowing and 
     willful'' before ``failure'';
       (21) in subsection (v), by striking ``The introduction'' 
     and inserting ``The knowing and willful introduction'';
       (22) in subsection (w), by inserting ``The making'' and 
     inserting ``The knowing and willful making'';
       (23) in subsection (x), by inserting ``knowing and 
     willful'' before falsification;
       (24) in subsection (y)--
       (A) in paragraph (1), by inserting ``knowing and willful'' 
     before ``submission'';
       (B) in paragraph (2), by inserting ``knowing and willful'' 
     before ``disclosure''; and
       (C) in paragraph (3), by inserting ``knowing and willful'' 
     before ``receipt'';
       (25) in subsection (aa), by inserting ``knowing and 
     willful'' before ``importation'';
       (26) in subsection (bb), by inserting ``knowing and 
     willful'' before ``transfer'';
       (27) in subsection (cc), by inserting ``knowing and 
     willful'' before ``importing'';
       (28) in subsection (dd), by inserting ``knowing and 
     willful'' before ``failure'';
       (29) in subsection (ee), by inserting ``knowing and 
     willful'' before ``importing'';
       (30) in subsection (ff), by inserting ``knowing and 
     willful'' before ``importing'';
       (31) in subsection (gg), by inserting ``and willful'' after 
     ``knowing'' each place such term appears;
       (32) in subsection (hh), by inserting ``knowing and 
     willful'' before ``failure'';
       (33) in subsection (ii), by inserting ``knowing and 
     willful'' before ``falsification of a report'';
       (34) in subsection (jj)--
       (A) in paragraph (1)--
       (i) by inserting ``knowing and willful'' before 
     ``failure''; and
       (ii) by inserting ``and willfully'' after ``knowingly'';
       (B) in paragraph (2), by inserting ``knowing and willful'' 
     before ``failure''; and
       (C) in paragraph (3), by inserting ``knowing and willful'' 
     before ``submission'';
       (35) in subsection (kk), by inserting ``knowing and 
     willful'' before ``dissemination'';
       (36) in subsection (ll), by striking ``The introduction'' 
     and inserting ``The knowing and willful introduction'';
       (37) in subsection (mm), by inserting ``knowing and 
     willful'' before ``failure'';
       (38) in subsection (nn), by inserting ``knowing and 
     willful'' before ``falsification'';
       (39) in subsection (oo), by inserting ``knowing and 
     willful'' before ``introduction or delivery'';
       (40) in subsection (pp), by inserting ``knowing and 
     willful'' before ``introduction or delivery'';
       (41) in subsection (qq)--
       (A) in paragraph (1), by striking ``Forging'' and inserting 
     ``Knowingly and willfully forging'';
       (B) in paragraph (2), by striking ``Making'' and inserting 
     ``Knowingly and willfully making''; and
       (C) in paragraph (3), by inserting ``knowingly and 
     willfully'' before ``doing'';
       (42) in subsection (rr), by inserting ``knowing and 
     willful'' before ``charitable'';
       (43) in subsection (ss), by inserting ``knowing and 
     willful'' before ``failure'';
       (44) in subsection (tt), by striking ``Making'' and 
     inserting ``Knowingly and willfully making'';
       (45) in subsection (vv), by inserting ``knowing and 
     willful'' before ``failure'';
       (46) in subsection (ww), by inserting ``knowing and 
     willful'' before ``failure'';
       (47) in subsection (xx), by inserting ``knowing and 
     willful'' before ``refusal'';

[[Page 7654]]

       (48) in subsection (aaa), as added by section 712, by 
     inserting ``knowing and willful'' before ``failure''; and
       (49) in subsection (bbb), as added by section 722, by 
     inserting ``knowing and willful'' before ``violation''.
                                 ______
                                 
  SA 2144. Mr. HATCH (for himself, Mr. Burr, Mr. Alexander, and Mr. 
Roberts) submitted an amendment intended to be proposed by him to the 
bill S. 3187, to amend the Federal Food, Drug, and Cosmetic Act to 
revise and extend the user-fee programs for prescription drugs and 
medical devices, to establish user-fee programs for generic drugs and 
biosimilars, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 150, between lines 2 and 3, insert the following:
       ``(C)(i) Reclassification by administrative order under 
     subparagraph (A) shall apply only in the case of 
     reclassification of a class III or class II device as a class 
     II or class I device. The Secretary may reclassify a class I 
     or class II device as a class II or class III device by 
     regulation and revoke, because of the change in 
     classification, any regulation or requirement in effect under 
     section 514 or 515 with respect to such device. In the 
     promulgation of such a regulation respecting a device's 
     classification, the Secretary may secure from the panel to 
     which the device was last referred pursuant to subsection (c) 
     a recommendation respecting the proposed change in the 
     device's classification and shall publish in the Federal 
     Register any recommendation submitted to the Secretary by the 
     panel respecting such change. A regulation under this 
     subsection changing the classification of a device from class 
     III to class II may provide that such classification shall 
     not take effect until the effective date of a performance 
     standard established under section 514 for such device.
       ``(ii) In the case of a device reclassified as described in 
     clause (i), paragraph (2), section 514(a)(1), and section 
     517(a)(1) shall apply to a regulation promulgated under 
     clause (i) in the same manner such provisions apply to an 
     order issued under subparagraph (A).''.
                                 ______
                                 
  SA 2145. Mr. PORTMAN submitted an amendment intended to be proposed 
by him to the bill S. 3187, to amend the Federal Food, Drug, and 
Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, add the following:

   Subtitle D--Interstate Drug Monitoring Efficiency and Data Sharing

     SECTION 1141. SHORT TITLE.

       This subtitle may be cited as the ``Interstate Drug 
     Monitoring Efficiency and Data Sharing Act of 2012'' or the 
     ``ID MEDS Act''.

     SEC. 1142. NATIONAL INTEROPERABILITY STANDARDS.

       (a) In General.--Not later than 1 year after the date of 
     enactment of this Act, the Attorney General shall establish 
     national interoperability standards to facilitate the 
     exchange of prescription information across State lines by 
     States receiving grant funds under--
       (1) the Harold Rogers Prescription Drug Monitoring Program 
     established under the Departments of Commerce, Justice, and 
     State, the Judiciary, and Related Agencies Appropriations 
     Act, 2002 (Public Law 107-77; 115 Stat. 748); and
       (2) the Controlled Substance Monitoring Program established 
     under section 399O of the Public Health Service Act (42 
     U.S.C. 280g 3).
       (b) Requirements.--The Attorney General, in consultation 
     with the Secretary of Health and Human Services, shall ensure 
     that the national interoperability standards established 
     under subsection (a)--
       (1) implement open standards that are freely available, 
     without cost and without restriction, in order to promote 
     broad implementation;
       (2) provide for the use of exchange intermediaries, or 
     hubs, as necessary to facilitate interstate interoperability 
     by accommodating State-to-hub and direct State-to-State 
     communication;
       (3) support transmissions that are fully secured as 
     required, using industry standard methods of encryption, to 
     ensure that Protected Health Information and Personally 
     Identifiable Information (PHI and PII) are not compromised at 
     any point during such transmission; and
       (4) employ access control methodologies to share protected 
     information solely in accordance with State laws and 
     regulations.

     SEC. 1143. STATE RECIPIENT REQUIREMENTS.

       (a) Harold Rogers Prescription Drug Monitoring Program.--
       (1) In general.--Not later than 1 year after the date on 
     which the Attorney General establishes national 
     interoperability standards under section 1142(a), a recipient 
     of a grant under the Harold Rogers Prescription Drug 
     Monitoring Program established under the Departments of 
     Commerce, Justice, and State, the Judiciary, and Related 
     Agencies Appropriations Act, 2002 (Public Law 107-77; 115 
     Stat. 748) shall ensure that the databases of the State 
     comply with such national interoperability standards.
       (2) Use of enhancement grant funds.--A recipient of an 
     enhancement grant under the Harold Rogers Prescription Drug 
     Monitoring Program established under the Departments of 
     Commerce, Justice, and State, the Judiciary, and Related 
     Agencies Appropriations Act, 2002 (Public Law 107-77; 115 
     Stat. 748) may use enhancement grant funds to standardize the 
     technology architecture used by the recipient to comply with 
     the national interoperability standards established under 
     section 1142(a).
       (b) Controlled Substance Monitoring Program.--Section 
     399O(e) of the Public Health Service Act (42 U.S.C. 280g-
     3(e)) is amended by adding at the end the following:
       ``(5) Not later than 1 year after the date on which the 
     Attorney General establishes national interoperability 
     standards under section 1142(a) of the ID MEDS Act, the State 
     shall ensure that the database complies with such national 
     interoperability standards.''.

     SEC. 1144. REPORT.

       (a) In General.--Not later than 1 year after the date of 
     enactment of this Act, the Attorney General, in consultation 
     with the Secretary of Health and Human Services, shall submit 
     to the Committee on the Judiciary of the Senate and the 
     Committee on the Judiciary of the House of Representatives a 
     report on enhancing the interoperability of State 
     prescription monitoring programs with other technologies and 
     databases used for detecting and reducing fraud, diversion, 
     and abuse of prescription drugs.
       (b) Contents.--The report required under subsection (a) 
     shall include--
       (1) a discussion of the feasibility of making State 
     prescription monitoring programs interoperable with other 
     relevant technologies and databases, including--
       (A) electronic prescribing systems;
       (B) databases operated by the Drug Enforcement Agency;
       (C) electronic health records; and
       (D) pre-payment fraud-detecting analytics technologies;
       (2) an assessment of legal, technical, fiscal, privacy, or 
     security challenges that have an impact on interoperability;
       (3) a discussion of how State prescription monitoring 
     programs could increase the production and distribution of 
     unsolicited reports to prescribers and dispensers of 
     prescription drugs, law enforcement officials, and health 
     professional licensing agencies, including the enhancement of 
     such reporting through interoperability with other States and 
     relevant technology and databases; and
       (4) any recommendations for addressing challenges that 
     impact interoperability of State prescription monitoring 
     programs in order to reduce fraud, diversion, and abuse of 
     prescription drugs.
                                 ______
                                 
  SA 2146. Mr. PORTMAN submitted an amendment intended to be proposed 
by him to the bill S. 3187, to amend the Federal Food, Drug, and 
Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, insert the following:

                      Subtitle D--Synthetic Drugs

     SECTION 1141. SHORT TITLE.

       This subtitle may be cited as the ``Synthetic Drug Abuse 
     Prevention Act of 2012''.

     SEC. 1142. ADDITION OF SYNTHETIC DRUGS TO SCHEDULE I OF THE 
                   CONTROLLED SUBSTANCES ACT.

       (a) Cannabimimetic Agents.--Schedule I, as set forth in 
     section 202(c) of the Controlled Substances Act (21 U.S.C. 
     812(c)) is amended by adding at the end the following:
       ``(d)(1) Unless specifically exempted or unless listed in 
     another schedule, any material, compound, mixture, or 
     preparation which contains any quantity of cannabimimetic 
     agents, or which contains their salts, isomers, and salts of 
     isomers whenever the existence of such salts, isomers, and 
     salts of isomers is possible within the specific chemical 
     designation.
       ``(2) In paragraph (1):
       ``(A) The term `cannabimimetic agents' means any substance 
     that is a cannabinoid receptor type 1 (CB1 receptor) agonist 
     as demonstrated by binding studies and functional assays 
     within any of the following structural classes:
       ``(i) 2-(3-hydroxycyclohexyl)phenol with substitution at 
     the 5-position of the phenolic ring by alkyl or alkenyl, 
     whether or not substituted on the cyclohexyl ring to any 
     extent.
       ``(ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole 
     by substitution at the nitrogen atom of the indole ring, 
     whether or not further substituted on the indole ring to any 
     extent, whether or not substituted on the naphthoyl or 
     naphthyl ring to any extent.
       ``(iii) 3-(1-naphthoyl)pyrrole by substitution at the 
     nitrogen atom of the pyrrole ring, whether or not further 
     substituted in

[[Page 7655]]

     the pyrrole ring to any extent, whether or not substituted on 
     the naphthoyl ring to any extent.
       ``(iv) 1-(1-naphthylmethylene)indene by substitution of the 
     3-position of the indene ring, whether or not further 
     substituted in the indene ring to any extent, whether or not 
     substituted on the naphthyl ring to any extent.
       ``(v) 3-phenylacetylindole or 3-benzoylindole by 
     substitution at the nitrogen atom of the indole ring, whether 
     or not further substituted in the indole ring to any extent, 
     whether or not substituted on the phenyl ring to any extent.
       ``(B) Such term includes--
       ``(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-
     hydroxycyclohexyl]-phenol (CP-47,497);
       ``(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-
     hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 
     C8-homolog);
       ``(iii) 1-pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678);
       ``(iv) 1-butyl-3-(1-naphthoyl)indole (JWH-073);
       ``(v) 1-hexyl-3-(1-naphthoyl)indole (JWH-019);
       ``(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole 
     (JWH-200);
       ``(vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250);
       ``(viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-
     081);
       ``(ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122);
       ``(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398);
       ``(xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201);
       ``(xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);
       ``(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19 and 
     RCS-4);
       ``(xiv) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole 
     (SR-18 and RCS-8); and
       ``(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-
     203).''.
       (b) Other Drugs.--Schedule I of section 202(c) of the 
     Controlled Substances Act (21 U.S.C. 812(c)) is amended in 
     subsection (c) by adding at the end the following:
       ``(18) 4-methylmethcathinone (Mephedrone).
       ``(19) 3,4-methylenedioxypyrovalerone (MDPV).
       ``(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).
       ``(21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).
       ``(22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).
       ``(23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I).
       ``(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-
     T-2).
       ``(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine 
     (2C-T-4).
       ``(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).
       ``(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).
       ``(28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-
     P).''.

     SEC. 1143. TEMPORARY SCHEDULING TO AVOID IMMINENT HAZARDS TO 
                   PUBLIC SAFETY EXPANSION.

       Section 201(h)(2) of the Controlled Substances Act (21 
     U.S.C. 811(h)(2)) is amended--
       (1) by striking ``one year'' and inserting ``2 years''; and
       (2) by striking ``six months'' and inserting ``1 year''.
                                 ______
                                 
  SA 2147. Mr. HATCH (for himself, Mr. Brown of Massachusetts, Mr. 
Burr, Mr. Coburn, Mr. Cornyn, Mr. Lugar, Mr. Roberts, Mr. Hoeven, Mrs. 
Hutchison, Mr. Lee, Mr. Wicker, Mr. Coats, Mr. Barrasso, Mr. Toomey, 
Mr. Moran, Ms. Collins, Mr. Inhofe, Mr. Blunt, Mr. Portman, Mr. 
Alexander, Ms. Ayotte, and Mr. Crapo) submitted an amendment intended 
to be proposed by him to the bill S. 3187, to amend the Federal Food, 
Drug, and Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. REPEAL OF MEDICAL DEVICE EXCISE TAX.

       Subsections (a), (b), and (c) of section 1405 of the Health 
     Care and Education Reconciliation Act of 2010, and the 
     amendments made thereby, are hereby repealed; and the 
     Internal Revenue Code of 1986 shall be applied as if such 
     section and amendments had never been enacted.
                                 ______
                                 
  SA 2148. Mr. KOHL (for himself, Mr. Grassley, Ms. Klobuchar, Mr. 
Franken, Mr. Johnson of South Dakota, Mr. Brown of Ohio, Mr. Bingaman, 
and Mr. Sanders) submitted an amendment intended to be proposed by him 
to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic Act 
to revise and extend the user-fee programs for prescription drugs and 
medical devices, to establish user-fee programs for generic drugs and 
biosimilars, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end of the bill, insert the following:

         TITLE __.--PRESERVE ACCESS TO AFFORDABLE GENERICS ACT

     SEC. _01. SHORT TITLE.

       This title may be cited as the ``Preserve Access to 
     Affordable Generics Act''.

     SEC. _02. CONGRESSIONAL FINDINGS AND DECLARATION OF PURPOSES.

       (a) Findings.--Congress finds the following:
       (1) In 1984, the Drug Price Competition and Patent Term 
     Restoration Act (Public Law 98-417) (referred to in this 
     title as the ``1984 Act''), was enacted with the intent of 
     facilitating the early entry of generic drugs while 
     preserving incentives for innovation.
       (2) Prescription drugs make up 10 percent of the national 
     health care spending but for the past decade have been one of 
     the fastest growing segments of health care expenditures.
       (3) Until recently, the 1984 Act was successful in 
     facilitating generic competition to the benefit of consumers 
     and health care payers--although 67 percent of all 
     prescriptions dispensed in the United States are generic 
     drugs, they account for only 20 percent of all expenditures.
       (4) Generic drugs cost substantially less than brand name 
     drugs, with discounts off the brand price sometimes exceeding 
     90 percent.
       (5) Federal dollars currently account for an estimated 30 
     percent of the $235,000,000,000 spent on prescription drugs 
     in 2008, and this share is expected to rise to 40 percent by 
     2018.
       (6)(A) In recent years, the intent of the 1984 Act has been 
     subverted by certain settlement agreements between brand 
     companies and their potential generic competitors that make 
     ``reverse payments'' which are payments by the brand company 
     to the generic company.
       (B) These settlement agreements have unduly delayed the 
     marketing of low-cost generic drugs contrary to free 
     competition, the interests of consumers, and the principles 
     underlying antitrust law.
       (C) Because of the price disparity between brand name and 
     generic drugs, such agreements are more profitable for both 
     the brand and generic manufacturers than competition, and 
     will become increasingly common unless prohibited.
       (D) These agreements result in consumers losing the 
     benefits that the 1984 Act was intended to provide.
       (b) Purposes.--The purposes of this title are--
       (1) to enhance competition in the pharmaceutical market by 
     stopping anticompetitive agreements between brand name and 
     generic drug manufacturers that limit, delay, or otherwise 
     prevent competition from generic drugs; and
       (2) to support the purpose and intent of antitrust law by 
     prohibiting anticompetitive practices in the pharmaceutical 
     industry that harm consumers.

     SEC. _03. UNLAWFUL COMPENSATION FOR DELAY.

       (a) In General.--The Federal Trade Commission Act (15 
     U.S.C. 44 et seq.) is amended by--
       (1) redesignating section 28 as section 29; and
       (2) inserting before section 29, as redesignated, the 
     following:

     ``SEC. 28. PRESERVING ACCESS TO AFFORDABLE GENERICS.

       ``(a) In General.--
       ``(1) Enforcement proceeding.--The Federal Trade Commission 
     may initiate a proceeding to enforce the provisions of this 
     section against the parties to any agreement resolving or 
     settling, on a final or interim basis, a patent infringement 
     claim, in connection with the sale of a drug product.
       ``(2) Presumption.--
       ``(A) In general.--Subject to subparagraph (B), in such a 
     proceeding, an agreement shall be presumed to have 
     anticompetitive effects and be unlawful if--
       ``(i) an ANDA filer receives anything of value; and
       ``(ii) the ANDA filer agrees to limit or forego research, 
     development, manufacturing, marketing, or sales of the ANDA 
     product for any period of time.
       ``(B) Exception.--The presumption in subparagraph (A) shall 
     not apply if the parties to such agreement demonstrate by 
     clear and convincing evidence that the procompetitive 
     benefits of the agreement outweigh the anticompetitive 
     effects of the agreement.
       ``(b) Competitive Factors.--In determining whether the 
     settling parties have met their burden under subsection 
     (a)(2)(B), the fact finder shall consider--
       ``(1) the length of time remaining until the end of the 
     life of the relevant patent, compared with the agreed upon 
     entry date for the ANDA product;
       ``(2) the value to consumers of the competition from the 
     ANDA product allowed under the agreement;
       ``(3) the form and amount of consideration received by the 
     ANDA filer in the agreement

[[Page 7656]]

     resolving or settling the patent infringement claim;
       ``(4) the revenue the ANDA filer would have received by 
     winning the patent litigation;
       ``(5) the reduction in the NDA holder's revenues if it had 
     lost the patent litigation;
       ``(6) the time period between the date of the agreement 
     conveying value to the ANDA filer and the date of the 
     settlement of the patent infringement claim; and
       ``(7) any other factor that the fact finder, in its 
     discretion, deems relevant to its determination of 
     competitive effects under this subsection.
       ``(c) Limitations.--In determining whether the settling 
     parties have met their burden under subsection (a)(2)(B), the 
     fact finder shall not presume--
       ``(1) that entry would not have occurred until the 
     expiration of the relevant patent or statutory exclusivity; 
     or
       ``(2) that the agreement's provision for entry of the ANDA 
     product prior to the expiration of the relevant patent or 
     statutory exclusivity means that the agreement is pro-
     competitive, although such evidence may be relevant to the 
     fact finder's determination under this section.
       ``(d) Exclusions.--Nothing in this section shall prohibit a 
     resolution or settlement of a patent infringement claim in 
     which the consideration granted by the NDA holder to the ANDA 
     filer as part of the resolution or settlement includes only 
     one or more of the following:
       ``(1) The right to market the ANDA product in the United 
     States prior to the expiration of--
       ``(A) any patent that is the basis for the patent 
     infringement claim; or
       ``(B) any patent right or other statutory exclusivity that 
     would prevent the marketing of such drug.
       ``(2) A payment for reasonable litigation expenses not to 
     exceed $7,500,000.
       ``(3) A covenant not to sue on any claim that the ANDA 
     product infringes a United States patent.
       ``(e) Regulations and Enforcement.--
       ``(1) Regulations.--The Federal Trade Commission may issue, 
     in accordance with section 553 of title 5, United States 
     Code, regulations implementing and interpreting this section. 
     These regulations may exempt certain types of agreements 
     described in subsection (a) if the Commission determines such 
     agreements will further market competition and benefit 
     consumers. Judicial review of any such regulation shall be in 
     the United States District Court for the District of Columbia 
     pursuant to section 706 of title 5, United States Code.
       ``(2) Enforcement.--A violation of this section shall be 
     treated as a violation of section 5.
       ``(3) Judicial review.--Any person, partnership or 
     corporation that is subject to a final order of the 
     Commission, issued in an administrative adjudicative 
     proceeding under the authority of subsection (a)(1), may, 
     within 30 days of the issuance of such order, petition for 
     review of such order in the United States Court of Appeals 
     for the District of Columbia Circuit or the United States 
     Court of Appeals for the circuit in which the ultimate parent 
     entity, as defined at 16 CFR 801.1(a)(3), of the NDA holder 
     is incorporated as of the date that the NDA is filed with the 
     Secretary of the Food and Drug Administration, or the United 
     States Court of Appeals for the circuit in which the ultimate 
     parent entity of the ANDA filer is incorporated as of the 
     date that the ANDA is filed with the Secretary of the Food 
     and Drug Administration. In such a review proceeding, the 
     findings of the Commission as to the facts, if supported by 
     evidence, shall be conclusive.
       ``(f) Antitrust Laws.--Nothing in this section shall be 
     construed to modify, impair or supersede the applicability of 
     the antitrust laws as defined in subsection (a) of the 1st 
     section of the Clayton Act (15 U.S.C. 12(a)) and of section 5 
     of this Act to the extent that section 5 applies to unfair 
     methods of competition. Nothing in this section shall modify, 
     impair, limit or supersede the right of an ANDA filer to 
     assert claims or counterclaims against any person, under the 
     antitrust laws or other laws relating to unfair competition.
       ``(g) Penalties.--
       ``(1) Forfeiture.--Each person, partnership or corporation 
     that violates or assists in the violation of this section 
     shall forfeit and pay to the United States a civil penalty 
     sufficient to deter violations of this section, but in no 
     event greater than 3 times the value received by the party 
     that is reasonably attributable to a violation of this 
     section. If no such value has been received by the NDA 
     holder, the penalty to the NDA holder shall be shall be 
     sufficient to deter violations, but in no event greater than 
     3 times the value given to the ANDA filer reasonably 
     attributable to the violation of this section. Such penalty 
     shall accrue to the United States and may be recovered in a 
     civil action brought by the Federal Trade Commission, in its 
     own name by any of its attorneys designated by it for such 
     purpose, in a district court of the United States against any 
     person, partnership or corporation that violates this 
     section. In such actions, the United States district courts 
     are empowered to grant mandatory injunctions and such other 
     and further equitable relief as they deem appropriate.
       ``(2) Cease and desist.--
       ``(A) In general.--If the Commission has issued a cease and 
     desist order with respect to a person, partnership or 
     corporation in an administrative adjudicative proceeding 
     under the authority of subsection (a)(1), an action brought 
     pursuant to paragraph (1) may be commenced against such 
     person, partnership or corporation at any time before the 
     expiration of one year after such order becomes final 
     pursuant to section 5(g).
       ``(B) Exception.--In an action under subparagraph (A), the 
     findings of the Commission as to the material facts in the 
     administrative adjudicative proceeding with respect to such 
     person's, partnership's or corporation's violation of this 
     section shall be conclusive unless--
       ``(i) the terms of such cease and desist order expressly 
     provide that the Commission's findings shall not be 
     conclusive; or
       ``(ii) the order became final by reason of section 5(g)(1), 
     in which case such finding shall be conclusive if supported 
     by evidence.
       ``(3) Civil penalty.--In determining the amount of the 
     civil penalty described in this section, the court shall take 
     into account--
       ``(A) the nature, circumstances, extent, and gravity of the 
     violation;
       ``(B) with respect to the violator, the degree of 
     culpability, any history of violations, the ability to pay, 
     any effect on the ability to continue doing business, profits 
     earned by the NDA holder, compensation received by the ANDA 
     filer, and the amount of commerce affected; and
       ``(C) other matters that justice requires.
       ``(4) Remedies in addition.--Remedies provided in this 
     subsection are in addition to, and not in lieu of, any other 
     remedy provided by Federal law. Nothing in this paragraph 
     shall be construed to affect any authority of the Commission 
     under any other provision of law.
       ``(h) Definitions.--In this section:
       ``(1) Agreement.--The term `agreement' means anything that 
     would constitute an agreement under section 1 of the Sherman 
     Act (15 U.S.C. 1) or section 5 of this Act.
       ``(2) Agreement resolving or settling a patent infringement 
     claim.--The term `agreement resolving or settling a patent 
     infringement claim' includes any agreement that is entered 
     into within 30 days of the resolution or the settlement of 
     the claim, or any other agreement that is contingent upon, 
     provides a contingent condition for, or is otherwise related 
     to the resolution or settlement of the claim.
       ``(3) ANDA.--The term `ANDA' means an abbreviated new drug 
     application, as defined under section 505(j) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).
       ``(4) ANDA filer.--The term `ANDA filer' means a party who 
     has filed an ANDA with the Food and Drug Administration.
       ``(5) ANDA product.--The term `ANDA product' means the 
     product to be manufactured under the ANDA that is the subject 
     of the patent infringement claim.
       ``(6) Drug product.--The term `drug product' means a 
     finished dosage form (e.g., tablet, capsule, or solution) 
     that contains a drug substance, generally, but not 
     necessarily, in association with 1 or more other ingredients, 
     as defined in section 314.3(b) of title 21, Code of Federal 
     Regulations.
       ``(7) NDA.--The term `NDA' means a new drug application, as 
     defined under section 505(b) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(b)).
       ``(8) NDA holder.--The term `NDA holder' means--
       ``(A) the party that received FDA approval to market a drug 
     product pursuant to an NDA;
       ``(B) a party owning or controlling enforcement of the 
     patent listed in the Approved Drug Products With Therapeutic 
     Equivalence Evaluations (commonly known as the `FDA Orange 
     Book') in connection with the NDA; or
       ``(C) the predecessors, subsidiaries, divisions, groups, 
     and affiliates controlled by, controlling, or under common 
     control with any of the entities described in subparagraphs 
     (A) and (B) (such control to be presumed by direct or 
     indirect share ownership of 50 percent or greater), as well 
     as the licensees, licensors, successors, and assigns of each 
     of the entities.
       ``(9) Patent infringement.--The term `patent infringement' 
     means infringement of any patent or of any filed patent 
     application, extension, reissue, renewal, division, 
     continuation, continuation in part, reexamination, patent 
     term restoration, patents of addition and extensions thereof.
       ``(10) Patent infringement claim.--The term `patent 
     infringement claim' means any allegation made to an ANDA 
     filer, whether or not included in a complaint filed with a 
     court of law, that its ANDA or ANDA product may infringe any 
     patent held by, or exclusively licensed to, the NDA holder of 
     the drug product.
       ``(11) Statutory exclusivity.--The term `statutory 
     exclusivity' means those prohibitions on the approval of drug 
     applications under clauses (ii) through (iv) of section 
     505(c)(3)(E) (5- and 3-year data exclusivity), section 527 
     (orphan drug exclusivity), or section 505A (pediatric 
     exclusivity) of the Federal Food, Drug, and Cosmetic Act.''.

[[Page 7657]]

       (b) Effective Date.--Section 28 of the Federal Trade 
     Commission Act, as added by this section, shall apply to all 
     agreements described in section 28(a)(1) of that Act entered 
     into after November 15, 2009. Section 28(g) of the Federal 
     Trade Commission Act, as added by this section, shall not 
     apply to agreements entered into before the date of enactment 
     of this Act.

     SEC. _04. NOTICE AND CERTIFICATION OF AGREEMENTS.

       (a) Notice of All Agreements.--Section 1112(c)(2) of the 
     Medicare Prescription Drug, Improvement, and Modernization 
     Act of 2003 (21 U.S.C. 355 note) is amended by--
       (1) striking ``the Commission the'' and inserting the 
     following: ``the Commission--
       ``(1) the'';
       (2) striking the period and inserting ``; and''; and
       (3) inserting at the end the following:
       ``(2) any other agreement the parties enter into within 30 
     days of entering into an agreement covered by subsection (a) 
     or (b).''.
       (b) Certification of Agreements.--Section 1112 of such Act 
     is amended by adding at the end the following:
       ``(d) Certification.--The Chief Executive Officer or the 
     company official responsible for negotiating any agreement 
     required to be filed under subsection (a), (b), or (c) shall 
     execute and file with the Assistant Attorney General and the 
     Commission a certification as follows: `I declare that the 
     following is true, correct, and complete to the best of my 
     knowledge: The materials filed with the Federal Trade 
     Commission and the Department of Justice under section 1112 
     of subtitle B of title XI of the Medicare Prescription Drug, 
     Improvement, and Modernization Act of 2003, with respect to 
     the agreement referenced in this certification: (1) represent 
     the complete, final, and exclusive agreement between the 
     parties; (2) include any ancillary agreements that are 
     contingent upon, provide a contingent condition for, or are 
     otherwise related to, the referenced agreement; and (3) 
     include written descriptions of any oral agreements, 
     representations, commitments, or promises between the parties 
     that are responsive to subsection (a) or (b) of such section 
     1112 and have not been reduced to writing.'.''.

     SEC. _05. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.

       Section 505(j)(5)(D)(i)(V) of the Federal Food, Drug and 
     Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is amended by 
     inserting ``section 28 of the Federal Trade Commission Act 
     or'' after ``that the agreement has violated''.

     SEC. _06. COMMISSION LITIGATION AUTHORITY.

       Section 16(a)(2) of the Federal Trade Commission Act (15 
     U.S.C. 56(a)(2)) is amended--
       (1) in subparagraph (D), by striking ``or'' after the 
     semicolon;
       (2) in subparagraph (E), by inserting ``or'' after the 
     semicolon; and
       (3) inserting after subparagraph (E) the following:
       ``(F) under section 28;''.

     SEC. _07. STATUTE OF LIMITATIONS.

       The Commission shall commence any enforcement proceeding 
     described in section 28 of the Federal Trade Commission Act, 
     as added by section 03, except for an action described in 
     section 28(g)(2) of the Federal Trade Commission Act, not 
     later than 3 years after the date on which the parties to the 
     agreement file the Notice of Agreement as provided by 
     sections 1112(c)(2) and (d) of the Medicare Prescription Drug 
     Improvement and Modernization Act of 2003 (21 U.S.C. 355 
     note).

     SEC. _08. SEVERABILITY.

       If any provision of this title, an amendment made by this 
     title, or the application of such provision or amendment to 
     any person or circumstance is held to be unconstitutional, 
     the remainder of this title, the amendments made by this 
     title, and the application of the provisions of such title or 
     amendments to any person or circumstance shall not be 
     affected thereby.
                                 ______
                                 
  SA 2149. Mr. KOHL (for himself, Mr. Grassley, and Mr. Blumenthal) 
submitted an amendment intended to be proposed by him to the bill S. 
3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and 
extend the user-fee programs for prescription drugs and medical 
devices, to establish user-fee programs for generic drugs and 
biosimilars, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. STANDARDIZED PROTOCOL FOR OBTAINING INFORMED 
                   CONSENT FROM AN OLDER INDIVIDUAL WITH DEMENTIA 
                   PRIOR TO ADMINISTERING AN ANTIPSYCHOTIC FOR A 
                   USE NOT APPROVED BY THE FOOD AND DRUG 
                   ADMINISTRATION.

       Part P of title III of the Public Health Service Act (42 
     U.S.C. 280g et seq.) is amended by adding at the end the 
     following:

     ``SEC. 399V-6. STANDARDIZED PROTOCOL FOR OBTAINING INFORMED 
                   CONSENT FROM AN OLDER INDIVIDUAL WITH DEMENTIA 
                   PRIOR TO ADMINISTERING AN ANTIPSYCHOTIC FOR A 
                   USE NOT APPROVED BY THE FOOD AND DRUG 
                   ADMINISTRATION.

       ``(a) Protocol.--Not later than 180 days after the date of 
     the enactment of this section, the Secretary shall develop a 
     standardized protocol for designated health care providers to 
     obtain informed consent from an older individual with 
     dementia prior to administering an antipsychotic to the 
     individual for a use not approved by the Food and Drug 
     Administration. Such protocol shall include an alternative 
     protocol for obtaining such informed consent in the case of 
     emergencies.
       ``(b) Definition of Informed Consent.--In this section, the 
     term `informed consent' means, with respect to an older 
     individual with dementia, that--
       ``(1) the health care provider has informed the individual 
     (or, if applicable, the individual's designated health care 
     agent or legal representative) of--
       ``(A) possible side effects and risks associated with the 
     antipsychotic;
       ``(B) treatment modalities that were attempted prior to the 
     use of the antipsychotic; and
       ``(C) any other information the Secretary determines 
     appropriate;
       ``(2) the individual (or, if applicable, the individual's 
     designated health care agent or legal representative) has 
     provided authorization for the administration of the 
     antipsychotic; and
       ``(3) the administration of the antipsychotic is in 
     accordance with any plan of care that the individual has in 
     place, including non-pharmacological interventions as 
     appropriate that can effectively address underlying medical 
     and environmental causes of behavioral disorders.''.

     SEC. 11__. PRESCRIBER EDUCATION PROGRAMS.

       (a) In General.--Part P of title III of the Public Health 
     Service Act (42 U.S.C. 280g et seq.), as amended by section 
     11_, is amended by adding at the end the following:

     ``SEC. 399V-7. PRESCRIBER EDUCATION PROGRAMS.

       ``(a) In General.--The Secretary, acting through the 
     Director of the Agency for Healthcare Research and Quality 
     and in consultation with the Commissioner of Food and Drugs, 
     shall establish and implement prescriber education programs.
       ``(b) Implementation.--The Secretary shall establish and 
     begin implementation of prescriber education programs under 
     this section by not later than 6 months after the date on 
     which funds are first made available under section 3734 of 
     title 31, United States Code.
       ``(c) Prescriber Education Program Defined.--In this 
     section, the term `prescriber education program' means a 
     program to promote high quality evidence-based treatment and 
     non-pharmacological interventions through the provision of 
     objective, educational, and informational materials to 
     physicians and other prescribing practitioners, including 
     such a program developed by the Agency for Healthcare 
     Research and Quality.''.
       (b) Funding.--
       (1) In general.--Chapter 37 of title 31, United States 
     Code, is amended by adding at the end the following:

     ``SEC. 3734. FUNDING FOR PRESCRIBER EDUCATION PROGRAMS.

       ``(a) Funding.--In each fiscal year, the Attorney General 
     may make some portion of the covered funds paid to the United 
     States in that fiscal year available for prescriber education 
     programs in accordance with section 399V-7 of the Public 
     Health Service Act.
       ``(b) Definitions.--In this section:
       ``(1) Covered funds.--The term `covered funds' means all 
     funds payable to the United States Government from any 
     judgement or settlement of a civil action brought by the 
     Attorney General under section 3730 of this title, relating 
     to off-label marketing of any prescription drug.
       ``(2) Off-label marketing.--The term `off-label marketing' 
     means the marketing of a prescription drug for an indication 
     or use in a manner for which the drug has not been approved 
     by the Food and Drug Administration.''.

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