[Congressional Record Volume 151, Number 144 (Thursday, November 3, 2005)]
[Senate]
[Pages S12355-S12358]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Mr. BROWNBACK (for himself and Mr. Inhofe):
  S. 1956. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
create a new three-tiered approval system for drugs, biological 
products, and devices that is responsive to the needs of seriously ill 
patients, and for other purposes; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. BROWNBACK. Mr. President, I ask unanimous consent that the text 
of the bill be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1956

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Access, Compassion, Care, 
     and Ethics for Seriously Ill Patients Act'' or the ``ACCESS 
     Act''.

     SEC. 2. FINDINGS.

       Congress finds the following:
       (1) The necessity of placebo controlled studies has been 
     questioned on both scientific and ethical grounds for 
     seriously ill patients.
       (2) The current standards of the Food and Drug 
     Administration for approval of drugs, biological products, 
     and devices deny the benefits of medical progress to 
     seriously ill patients who face morbidity or death from their 
     disease.
       (3) Promising therapies intended to treat serious or life 
     threatening conditions or diseases and which address unmet 
     medical needs have received unjustified delays and denials of 
     approval.
       (4) Seriously ill patients have a right to access available 
     investigational drugs, biological products, and devices.
       (5) The current Food and Drug Administration and National 
     Cancer Institute case-by-case exception for compassionate 
     access must be required to permit all seriously ill patients 
     access to available experimental therapies as a treatment 
     option.
       (6) The current emphasis on statistical analysis of 
     clinical information needs to be balanced by a greater 
     reliance on clinical evaluation of this information.
       (7) Food and Drug Administration advisory committees should 
     have greater representation of medical clinicians who 
     represent the interests of seriously ill patients in early 
     access to promising investigational therapies.
       (8) The use of available investigational products for 
     treatment is the responsibility of the physician and the 
     patient.
       (9) The use of combinations of available investigational 
     and approved products for treatment is the responsibility of 
     the physician and the patient.
       (10) The development and approval of drugs, biological 
     products, and devices intended to address serious or life-
     threatening conditions or diseases is often delayed by the 
     inability of sponsors to obtain prompt meetings with the Food 
     and Drug Administration and to obtain prompt resolution of 
     scientific and regulatory issues related to the investigation 
     and review of new technologies.

     SEC. 3. TIERED APPROVAL SYSTEM FOR DRUGS, BIOLOGICAL 
                   PRODUCTS, AND DEVICES.

       Section 506 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 356) is amended to read as follows:

     ``SEC. 506. TIERED APPROVAL SYSTEM.

       ``(a) In General.--Notwithstanding any other provision of 
     law, the sponsor of an investigational drug, biological 
     product, or device may submit an application to the Secretary 
     for Tier I or Tier II approval in accordance with this 
     section.
       ``(b) Tier I Approval.--
       ``(1) In general.--
       ``(A) Application content.--A sponsor of an investigational 
     drug, biological product, or device applying for Tier I 
     approval of the product shall submit to the Secretary an 
     application as described under section 505(b)(1) or 
     505(b)(2), section 351(a) of the Public Health Service Act, 
     or section 510(k) or 515(c)(1), as applicable, which shall 
     contain--
       ``(i) data and information from completed Phase I clinical 
     investigations and any other nonclinical or clinical 
     investigations;
       ``(ii) preliminary evidence that the product may be 
     effective against a serious or life-threatening condition or 
     disease, which evidence may be based on uncontrolled data 
     such as case histories, information about the pharmacological 
     mechanism of action, data from animal and computer models, 
     comparison with historical data, or other preliminary 
     information, and may be based on a small number of patients; 
     and
       ``(iii) an assurance that the sponsor will continue 
     clinical investigation to obtain Tier III approval.
       ``(B) Limitation.--Tier I approval shall be primarily based 
     upon clinical evaluation, not statistical analysis.
       ``(2) Determination by secretary.--
       ``(A) In general.--Not later than 30 days after the receipt 
     of an application for Tier I approval, the Secretary shall 
     either--
       ``(i) approve the application; or
       ``(ii) refer the application to the Accelerated Approval 
     Advisory Committee.
       ``(B) Recommendation.--Within 90 days after receipt of an 
     application for approval, the Accelerated Approval Advisory 
     Committee shall issue a recommendation to the Secretary on 
     whether the Secretary should approve the application.
       ``(C) Final decision.--Within 30 days after receipt of the 
     recommendation from the Accelerated Approval Advisory 
     Committee, the Secretary shall either approve the application 
     or shall issue an order setting forth a detailed explanation 
     of the reasons why the application was not approved and the 
     specific data that the sponsor must provide so that the 
     application may be approved.
       ``(3) Appeal.--If the Secretary does not approve an 
     application for which the Accelerated Approval Advisory 
     Committee recommended approval, the sponsor of the 
     application shall have the right to appeal the decision to 
     the Commissioner of Food and Drugs. The Commissioner shall 
     provide the sponsor with a hearing within 30 days following 
     the nonapproval of the application and shall issue an order 
     within 30 days following the hearing either concurring in the 
     nonapproval or approving the application. The Commissioner 
     shall not delegate the responsibility described in this 
     paragraph to any other person.
       ``(4) Criteria.--In making a determination under paragraph 
     (2), the Secretary shall consider whether the totality of the 
     information available to the Secretary regarding the safety 
     and effectiveness of an investigational drug, biological 
     product, or device, as compared to the risk of morbidity or 
     death from a condition or disease, indicates that a patient 
     (who may be representative of a small patient subpopulation) 
     may obtain more benefit than risk if treated with the drug, 
     biological product, or device. If the potential risk to a 
     patient of the condition or disease outweighs the potential 
     risk of the product, and the product may possibly provide 
     benefit to the patient, the Secretary shall approve the 
     application.
       ``(5) Product labeling.--The labeling approved by the 
     Secretary for the drug, biological product, or device--
       ``(A) shall state that the product is intended for use by a 
     patient whose physician has documented in writing that the 
     patient has--
       ``(i) exhausted all treatment options approved by Secretary 
     for the condition or disease for which the patient is a 
     reasonable candidate; and
       ``(ii) unsuccessfully sought treatment, or obtained 
     treatment that was not effective, with an investigational 
     drug, biological product, or device for which such individual 
     is a reasonable candidate (which may include consideration of 
     the lack of a source of supply or geographic factors); and
       ``(B) shall state that every patient to whom the product is 
     administered shall, as a

[[Page S12356]]

     mandatory condition of receiving the product, provide--
       ``(i) written informed consent, as described under part 50 
     of title 21, Code of Federal Regulations;
       ``(ii) a written waiver of the right to sue the 
     manufacturer or sponsor of the drug, biological product, or 
     device, or the physicians who prescribed the product or the 
     institution where it was administered, for an adverse event 
     caused by the product, which shall be binding in every State 
     and Federal court; and
       ``(iii) consent for the manufacturer of the product to 
     obtain data and information about the patient and the 
     patient's use of the product that may be used to support an 
     application for Tier II or Tier III approval.
       ``(6) Limitation on conditions.--Tier I approval may be 
     subject to the requirement that the sponsor conduct 
     appropriate post-approval studies.
       ``(c) Tier II Approval.--
       ``(1) In general.--A sponsor of an investigational drug, 
     biological product, or device applying for Tier II approval 
     shall submit to the Secretary an application as described 
     under section 505(b)(1) or 505(b)(2), section 351(a) of the 
     Public Health Service Act, or section 510(k) or 515(c)(1), as 
     applicable, which shall contain--
       ``(A) data and information that the drug, biological 
     product, or device has an effect on a clinical endpoint or on 
     a surrogate endpoint or biomarker that is reasonably likely 
     to predict clinical benefit to a patient (who may be 
     representative of a small patient subpopulation) suffering 
     from a serious or life-threatening condition or disease; and
       ``(B) an assurance that the sponsor will continue clinical 
     investigation to obtain Tier III approval.
       ``(2) Determination by secretary.--
       ``(A) In general.--Not later than 30 days after the receipt 
     of an application for Tier II approval, the Secretary shall 
     either--
       ``(i) approve the application; or
       ``(ii) refer the application to the Accelerated Approval 
     Advisory Committee.
       ``(B) Recommendation.--Within 90 days after receipt of an 
     application for approval, the Accelerated Approval Advisory 
     Committee shall issue a recommendation to the Secretary on 
     whether the Secretary should approve the application.
       ``(C) Final decision.--Within 30 days after receipt of the 
     recommendation from the Accelerated Approval Advisory 
     Committee, the Secretary shall either approve the application 
     or issue an order setting forth a detailed explanation of the 
     reasons why the application was not approved and the specific 
     data that the sponsor must provide so that the application 
     may be approved.
       ``(3) Appeal.--If the Secretary does not approve an 
     application for which the Accelerated Approval Advisory 
     Committee recommended approval, the sponsor of the 
     application shall have the right to appeal the decision to 
     the Commissioner of Food and Drugs. The Commissioner shall 
     provide the sponsor with a hearing within 30 days following 
     the nonapproval of the application and shall issue an order 
     within 30 days following the hearing either concurring in the 
     nonapproval or approving the application. The Commissioner 
     shall not delegate the responsibility described in this 
     paragraph to any other person.
       ``(4) Limitation on conditions.--
       ``(A) Post-approval studies.--Tier II approval may be 
     subject to the requirement that the sponsor conduct 
     appropriate post-approval studies to validate the surrogate 
     endpoint or biomarker or otherwise confirm the effect on the 
     clinical endpoint.
       ``(B) Rule of construction.--Nothing in this subsection 
     shall be construed to permit the Secretary to condition Tier 
     II approval on compliance with any other standards, including 
     any standard necessary to meet Tier III approval.
       ``(d) Tier III Approval.--For purposes of this Act, the 
     term `Tier III approval' means--
       ``(1) with respect to a new drug or new biological product, 
     approval of such drug or product under section 505(b)(1) or 
     505(b)(2) or section 351 of the Public Health Service Act, as 
     the case may be; and
       ``(2) with respect to a new device, clearance of such 
     device under section 510(k) or approval of such device under 
     section 515(c)(1).
       ``(e) Promotional Materials.--Approval of a product under 
     either Tier I or II may be subject to the requirements that--
       ``(1) the sponsor submit copies of all advertising and 
     promotional materials related to the product during the 
     preapproval review period and, following approval and for 
     such period thereafter as the Secretary determines to be 
     appropriate, and at least 30 days prior to the dissemination 
     of the materials;
       ``(2) all advertising and promotional materials prominently 
     disclose the limited approval for the product and data 
     available supporting the safety and effectiveness of the 
     product; and
       ``(3) the sponsor shall not disseminate advertising or 
     promotional material prior to obtaining written notification 
     from the Secretary that the advertising or promotional 
     material complies with this subchapter.
       ``(f) Expedited Withdrawal of Approval.--The Secretary may 
     withdraw Tier I or Tier II approval using expedited 
     procedures (as prescribed by the Secretary in regulations 
     which shall include an opportunity for a hearing) if--
       ``(1) the sponsor fails to conduct post-approval studies 
     with due diligence, considering all of the circumstances 
     involved;
       ``(2) a post-approval study fails to verify clinical 
     benefit of the product for even a small patient 
     subpopulation;
       ``(3) other evidence demonstrates that the product is not 
     safe or effective under the conditions of use for even a 
     small patient subpopulation; or
       ``(4) the sponsor disseminates false or misleading 
     promotional materials with respect to the product and fails 
     to correct the material promptly after written notice from 
     the Secretary.
       ``(g) Accelerated Approval Advisory Committee.--
       ``(1) In general.--In order to facilitate the development 
     and expedite the review of drugs, biological products, and 
     devices intended to treat serious or life threatening 
     conditions, the Secretary shall establish the Accelerated 
     Approval Advisory Committee.
       ``(2) Delegation.--The Secretary may delegate authority for 
     the Accelerated Approval Advisory Committee to the 
     Commissioner of Food and Drugs. The Accelerated Approval 
     Advisory Committee shall be staffed and administered in the 
     Office of the Commissioner.
       ``(3) Composition.--
       ``(A) In general.--The Committee shall be composed of 11 
     voting members, including 1 chairperson and 5 permanent 
     members each of whom shall serve a term of 3 years and may be 
     reappointed for a second 3-year term, and 5 nonpermanent 
     members who shall be appointed to the Committee for a 
     specific meeting, or part of a meeting, in order to provide 
     adequate expertise in the subject being reviewed. The 
     Committee shall include as voting members no less than 2 
     representatives of patient interests, of which 1 shall be a 
     permanent member of the Committee. The Committee shall 
     include as nonvoting members a representative of interests of 
     the drug, biological product, and device industry.
       ``(B) Appointments.--The Secretary shall appoint to the 
     Committee persons who are qualified by training and 
     experience to evaluate the safety and effectiveness of the 
     types of products to be referred to the Committee and who, to 
     the extent feasible, possess skill in the use of, or 
     experience in the development, manufacture, or utilization 
     of, such products. The Secretary shall make appointments to 
     the Committee so that the Committee shall consist of members 
     with adequately diversified expertise and practical 
     experience in such fields as clinical medicine, biological 
     and physical sciences, and other related professions. 
     Scientific, industry, and consumer organizations and members 
     of the public shall be afforded an opportunity to nominate 
     individuals for appointment to the Committee. No individual 
     who is in the regular full-time employ of the United States 
     and engaged in the administration of this chapter may be a 
     member of the Committee.
       ``(4) Compensation.--Committee members, while attending 
     meetings or conferences of the Committee or otherwise engaged 
     in its business, shall be entitled to receive compensation at 
     rates to be fixed by the Secretary, but not at rates 
     exceeding the daily equivalent of the rate in effect for 
     grade GS-18 of the General Schedule, for each day so engaged, 
     including traveltime, and while so serving away from their 
     homes or regular places of business each member may be 
     allowed travel expenses (including per diem in lieu of 
     subsistence) as authorized by section 5703 of title 5, for 
     persons in the Government service employed intermittently.
       ``(5) Assistance.--The Secretary shall furnish the 
     Committee with adequate clerical and other necessary 
     assistance.
       ``(6) Annual training.--The Secretary shall employ 
     nongovernmental experts to provide annual training to the 
     Committee on the statutory and regulatory standards for 
     product approval.
       ``(7) Timeline.--The Committee shall be scheduled to meet 
     at such times as may be appropriate for the Secretary to meet 
     applicable statutory deadlines.
       ``(8) Meetings.--
       ``(A) Opportunities for interested persons.--Any person 
     whose product is specifically the subject of review by the 
     Committee shall have--
       ``(i) the same access to data and information submitted to 
     the Committee as the Secretary;
       ``(ii) the opportunity to submit, for review by the 
     Committee, data or information, which shall be submitted to 
     the Secretary for prompt transmittal to the Committee; and
       ``(iii) the same opportunity as the Secretary to 
     participate in meetings of the Committee.
       ``(B) Adequate time; free and open participation.--Any 
     meetings of the Committee shall provide adequate time for 
     initial presentations and for response to any differing views 
     by persons whose products are specifically the subject of the 
     Committee review, and shall encourage free and open 
     participation by all interested persons.
       ``(C) Summaries.--At all meetings of the Committee, the 
     Secretary shall provide a summary to the Committee of all 
     Tier I and Tier II applications that the Committee did not 
     consider that were approved by the Secretary since the last 
     meeting of the Committee.
       ``(h) Commencement of Review.--If the Secretary determines, 
     after preliminary evaluation of the data and information 
     submitted by the sponsor, that the product may be effective, 
     the Secretary shall evaluate for filing, and may commence 
     review of portions

[[Page S12357]]

     of, an application for Tier I or Tier II approval before the 
     sponsor submits a complete application. The Secretary shall 
     commence such review only if the applicant provides a 
     schedule for submission of information necessary to make the 
     application complete.
       ``(i) Inapplicability of Provisions.--The following 
     provisions shall not apply to Tier I or Tier II applications 
     and approvals:
       ``(1) Chapter VII, subchapter C, parts 2 and 3 relating to 
     fees for drugs, biological products, and devices.
       ``(2) The provisions of the Drug Price Competition and 
     Patent Term Restoration Act of 1984 that authorize approval 
     of abbreviated new drug applications and applications 
     submitted under section 505(b)(2). Market exclusivity and 
     patent term restoration of Tier I and Tier II approved drugs, 
     biological products, and devices shall be determined solely 
     at the time of Tier III approval without regard to prior Tier 
     I or Tier II approval. Prior to Tier III approval, the 
     Secretary shall not approve any application submitted under 
     section 505(b)(2) or section 505(j) that references a drug 
     approved under subsections (b) or (c) of this section.''.

     SEC. 4. ETHICS IN HUMAN TESTING.

       Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 351 et seq.) is amended by adding at the end of 
     section 505(i) the following:
       ``(5) Notwithstanding any other provision of law, the 
     Secretary shall prohibit placebo-only or no-treatment-only 
     concurrent controls in any clinical investigation conducted 
     under this chapter or, in the use of the last-observation-
     carried-forward convention, in any clinical investigation 
     conducted under this chapter or section 351 of the Public 
     Health Service Act with respect to any life-threatening 
     condition or disease where reasonably effective approved 
     alternative therapies exist for the specific indication.''.

     SEC. 5. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS AND DEVICES.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 
     the end of section 561 the following:
       ``(f) Expanded Access Program.--The Food and Drug 
     Administration shall establish a new program to expand access 
     to investigational treatments for individuals with serious or 
     life threatening conditions and diseases. In carrying out 
     this expanded access program, the Secretary shall publish and 
     broadly disseminate written guidance that--
       ``(1) describes such expanded access programs for 
     investigational drugs, biological products, and devices 
     intended to treat serious or life-threatening conditions or 
     diseases;
       ``(2) encourages and facilitates submission of Tier I and 
     Tier II applications and approvals; and
       ``(3) facilitates the provision of investigational drugs 
     and devices to seriously ill individuals without unreasonable 
     delay by recognizing that the use of available 
     investigational products for treatment is the responsibility 
     of the physician and the patient.
       ``(g) Implementation of Expanded Access Programs.--
       ``(1) Training of personnel.--Not later than 90 days after 
     the date of enactment of this subsection, the Secretary shall 
     implement training programs at the Food and Drug 
     Administration with respect to the expanded access programs 
     established under this section.
       ``(2) Policies, regulations, and guidance.--The Secretary 
     shall establish policies, regulations, and guidance designed 
     to most directly benefit seriously ill patients.
       ``(h) Development of Surrogate Endpoints and Biomarkers.--
     The Secretary shall--
       ``(1) establish a program to encourage the development of 
     surrogate endpoints and biomarkers that are reasonably likely 
     to predict clinical benefit for serious or life-threatening 
     conditions for which there exist significant unmet medical 
     needs;
       ``(2) request the Institute of Medicine to undertake a 
     study to identify validated surrogate endpoints and 
     biomarkers, and recommend research to validate surrogate 
     endpoints and biomarkers, that may support approvals for 
     products intended for the treatment of serious or life-
     threatening conditions or diseases; and
       ``(3) make widely available to the public a list of drugs, 
     biological products, and devices that are being investigated 
     for serious or life-threatening conditions or diseases and 
     that have not yet received Tier I or Tier II approval for 
     marketing.''.
       (b) Conforming Amendment.--Section 561(c) of the Federal 
     Food, Drug, and Cosmetic Act is amended by striking the 
     heading and inserting ``Expanded Access to Investigational 
     Drugs and Devices for Seriously Ill Patients''.

     SEC. 6. MODERNIZATION OF THE FOOD AND DRUG ADMINISTRATION.

       Subchapter E of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding 
     at the end the following:

     ``SEC. 565. POLICIES RELATED TO STUDY EVALUATION INFORMATION.

       ``(a) In General.--
       ``(1) Nonstatistical measures.--The Secretary shall give 
     equal weight to clinical judgment and statistical analysis in 
     the evaluation of the safety and effectiveness of drugs, 
     biological products, and devices, and shall not disapprove a 
     product application solely on the basis of a statistical 
     analysis or the rigid use of the 95 percent confidence level 
     convention. This policy shall apply--
       ``(A) in evaluating clinical study designs and endpoints; 
     and
       ``(B) in making decisions with respect to product 
     applications.
       ``(2) Types of nonstatistical measures.--The policy 
     established under paragraph (1), for the purposes described 
     in such paragraph--
       ``(A) shall include but not be limited to such 
     nonstatistical information as--
       ``(i) clinical evaluation information, such as case history 
     reports;
       ``(ii) scientific and clinical studies designed to measure 
     or define mechanisms of action or molecular targeting;
       ``(iii) data from animal and computer models; and
       ``(iv) comparison with historical data; and
       ``(B) shall incorporate the use of--
       ``(i) evaluations of the adverse effect of delaying the 
     availability of an investigational drug to even a small 
     subpopulation of seriously ill patients; and
       ``(ii) scientific, observational, or clinical studies 
     designed and conducted to collect well-documented 
     information.
       ``(b) Meetings.--A meeting to address any pending 
     scientific, medical, regulatory, or other issue relating to 
     the development, investigation, review, or other aspect of a 
     drug, biological product, or device shall ordinarily be held 
     within 15 days of the receipt of a written request for the 
     meeting by the sponsor of the product, which may be extended 
     to 30 days for good cause. Such meetings shall ordinarily be 
     conducted in person, but may be conducted by telephone or 
     other form of communication if both parties agree. In order 
     to reduce the burden of meetings, only those Food and Drug 
     Administration employees who are intended to actively 
     participate in the discussion shall attend a meeting. Minutes 
     of a meeting shall be promptly prepared and exchanged by both 
     parties immediately following the meeting and shall 
     accurately summarize what occurred at the meeting
       ``(c) Rule of Construction.--The provisions of chapter V 
     and section 351 of the Public Health Service Act shall be 
     construed to incorporate the policy established in this 
     section.''.

     SEC. 7. MEMBERSHIP OF ONCOLOGY DRUGS ADVISORY COMMITTEE.

       Membership of the Oncology Drugs Advisory Committee of the 
     Food and Drug Administration shall consist of no less than 2 
     patient representatives who are voting members of the 
     committee.

      By Mr. KERRY (for himself, Mr. Obama, Mr. Levin, Ms. Stabenow, 
        Mr. Kennedy, Mr. Corzine, and Mr. Smith):
  S. 1959. A bill to direct the Architect of the Capitol to obtain a 
statue of Rosa Parks and to place the statue in the United States 
Capitol in National Statuary Hall; to the Committee on Rules and 
Administration.
  Mr. KERRY. Mr. President, our Nation is mourning the recent loss of 
an icon in this country's civil rights movement and a true national 
hero, Ms. Rosa Parks. Today, along with Senators Obama, Levin, 
Stabenow, Kennedy, Corzine and Smith, I am introducing legislation to 
honor the memory of Rosa Parks by placing her statue in the United 
States Capitol. This will help future generations understand her 
efforts to increase equality in the United States.
  When I met Rosa Parks, I was overwhelmed by this graceful, small 
woman's quiet strength and humility--her conviction in taking on the 
army of power that was deployed before her--her courage to dig in, 
knowing full well the power of the courthouse, the power of the 
sheriff's badge, the power of the vigilante, the power of the 
establishment--knowing that on dark country roads or after a knock on 
the door in the middle of the night, people still disappeared and died 
almost anonymous deaths. So many were killed just trying to be citizens 
in the land of the free.
  Rosa Parks reminded many and taught even more how to speak the truth 
to power. In an era when these words are thrown around too easily, she 
lived the words `courage' and `patriot'--she loved the dream of our 
country more than herself, and she was willing to risk it all to live 
the dream.
  In the struggle for civil rights, some were called to stand up to 
Bull Connor's fire hoses and police dogs--some to stand up to Klan 
terrorism--and some to stand up to state sponsored acts of violence. 
But some were called simply to sit down--at lunch counters in 
Greensboro and Nashville and Atlanta--or on a bus in Montgomery.
  Ms. Parks' dedication to civil rights has had an impact on the lives 
of all Americans. Her act of courage on December 1, 1955 inspired a 
movement that eventually brought about laws to

[[Page S12358]]

end segregation, ensure voting rights, end discrimination in housing, 
and create a greater equality throughout this Nation. Thanks to Rosa 
Parks, a path was forged for future generations to encourage freedom 
and social justice. Her legacy of courage and commitment plays an 
important role each time our Nation acts for equality and justice, and 
most of all, in the hope for a better America.
  If just one woman was able to do all this, then how much greater the 
responsibility is for those of us with privilege and power who pay 
tribute to her today. The life of Rosa Parks demands deeds, not 
epitaphs. Our final words cannot be spoken or written while her cause 
is still unfinished. No simple words can match what she did in that 
sacred moment on a municipal bus in Montgomery, Alabama. What matters 
now is what we do after the candles are quenched, the speeches have 
been exhausted, and the next bus comes by.
  I am grateful for the opportunity to join my colleagues in this body, 
as well as those in the House of Representatives, to honor the legacy 
of this graceful, humble, and courageous woman who embodies the 
American spirit. If this legislation is adopted, when our children and 
our grandchildren visit the United States Capitol, they will have the 
opportunity to learn more about the women who risked so much for their 
freedom. Ms. Parks belongs among the other great leaders that have 
shaped this country and made the world a better place.
  Sometimes the days seem heavy and the odds seem high, but that moment 
on a bus in Montgomery always comes. Someone gets on that bus, refuses 
to equivocate or yield and changes history. Today, that someone must be 
us, for Rosa Parks and for our country.
  The bus still comes by again and again and each time we have to 
decide whether to go quietly to the back, or by simple acts of courage 
and conviction, change the direction of our own country's journey. A 
statue of Rosa Parks in the Capitol can help future Senators and 
Congressmen find the courage necessary to make sure our Nation takes 
the right course in the future.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1959

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. PLACEMENT OF STATUE OF ROSA PARKS IN NATIONAL 
                   STATUARY HALL.

       (a) Obtaining Statue.--The Architect of the Capitol shall 
     enter into an agreement to obtain a statue of Rosa Parks, 
     under such terms and conditions as the Architect considers 
     appropriate and consistent with applicable law.
       (b) Placement.--Not later than 2 years after the date of 
     enactment of this Act, the Architect shall place the statue 
     obtained under subsection (a) in the United States Capitol in 
     a suitable permanent location in National Statuary Hall.

     SEC. 2. AUTHORIZATION OF APPROPRIATIONS.

       There are authorized to be appropriated such sums as may be 
     necessary to carry out this Act, and any amounts so 
     appropriated shall remain available until expended.

                          ____________________