text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Microbicide Development Act''.
  
  SEC. 2. FINDINGS.
  
      Congress makes the following findings:
              (1) Women and girls are the new face of HIV/AIDS, and are 
          increasingly affected by the disease in every region of the 
          world. As of 2006, nearly half of the 37,200,000 adults living 
          with HIV and AIDS worldwide were women. In sub-Saharan Africa, 
          that proportion was 59 percent.
              (2) Because of their social and biological vulnerabilities, 
          young women are particularly at risk of HIV infection. In sub-
          Saharan Africa, the prevalence of HIV/AIDS is three times 
          higher among women ages 15 to 24 than it is among men in that 
          same age group.
              (3) Women infected with HIV can transmit the infection to 
          their infants during pregnancy, labor, delivery, or breast-
          feeding. The most effective way to interrupt mother-to-child 
          transmission is to ensure that mothers are not infected in the 
          first place.
              (4) Many women who become infected with HIV have just one 
          sexual partner--their husband. Marriage is not necessarily 
          effective protection against HIV, because to protect themselves 
          from HIV, women have to rely on their male partners to be 
          faithful or to use condoms. Many women, especially in the 
          developing world, are unable to insist on mutual monogamy or 
          negotiate condom use, particularly in long-term relationships.
              (5) Scientists are working on a promising new prevention 
          tool that could slow down the spread of the HIV/AIDS epidemic--
          microbicides. Formulated as gels, creams, tablets or rings, 
          microbicides are being designed to stop the transmission of the 
          pathogens that cause AIDS and other sexually transmitted 
          infections (referred to in this section as ``STIs''). 
          Microbicides could allow a woman to protect herself from 
          disease.
              (6) Couples need a method of HIV protection that will allow 
          them to conceive a child and start a family. No existing HIV 
          prevention method also allows conception. Some microbicides in 
          development may allow women to become pregnant while at the 
          same time protecting them from infection.
              (7) According to UNICEF, worldwide, the lack of HIV/AIDS 
          prevention and treatment has left over 15,000,000 children as 
          orphans. Of these, more than 12,000,000 live in sub-Saharan 
          Africa. The number of AIDS orphans in sub-Saharan Africa alone 
          is expected to grow to nearly 16,000,000 by 2010.
              (8) HIV prevention tools like microbicides could also be 
          valuable for women in the United States, who account for an 
          increasing proportion of new HIV and AIDS cases among 
          Americans. Minority women in the United States are particularly 
          affected. Both African-American and Latina women account for a 
          disproportionate number of new AIDS cases, and HIV/AIDS was the 
          leading cause of death in 2002 for African-American women ages 
          25 to 34.
              (9) With nearly 20,000,000 new cases of sexually 
          transmitted infections occurring every year, the United States 
          has the highest STI rates of any industrialized nation. Like 
          HIV, STIs pose significant health threats and costs, with young 
          people and women bearing a disproportionate burden. Nearly half 
          of new STI cases each year occur in people under 25 years of 
          age with women both more vulnerable to infection and more 
          likely to experience serious and lasting health consequences 
          when they do become infected. Some microbicides could help 
          prevent STIs.
              (10) HIV/AIDS threatens national and global security. 
          Beyond its burdens on individuals, families, and communities, 
          the pandemic reduces economic growth, decimates health budgets, 
          undermines civil society, and burdens the armed forces of many 
          nations, including the United States military.
              (11) The microbicide field has gained considerable 
          scientific momentum. Several first-generation products are in 
          large-scale human trials to measure effectiveness, and new 
          products based on recent advances in HIV treatment are well 
          into safety trials.
              (12) Microbicides are a public health good with potential 
          for large social benefits but limited economic incentives for 
          private investment, so that public funding is required to fill 
          the gap. As is the case for vaccines and other public goods, 
          microbicide development must depend heavily on government 
          leadership and investment.
              (13) The Federal Government needs to make a strong 
          commitment to microbicide research and development. Three 
          agencies, the National Institutes of Health, Centers for 
          Disease Control and Prevention, and United States Agency for 
          International Development, have played important roles in the 
          progress to date, and each makes a valuable and unique 
          contribution. As the primary Federal agency for conducting and 
          supporting medical research and the largest single Federal 
          Government contributor to microbicide research, the National 
          Institutes of Health supports the Microbicide Trials Network as 
          well as other important research activities. The United States 
          Agency for International Development sustains strong 
          partnerships with public and private organizations working on 
          microbicide research, including trials in developing countries 
          where its experience is extensive, and is well positioned to 
          facilitate introduction of microbicides once available. The 
          Centers for Disease Control and Prevention has a long history 
          of conducting field trials in developing countries, but the 
          extent of its current engagement remains quite limited.
              (14) According to the National Institutes of Health's 
          strategic plan, microbicides may provide ``one of the most 
          promising primary preventative interventions that could be 
          safe, effective, readily available, affordable, and widely 
          acceptable''. In a recent report to Congress, the United States 
          Agency for International Development states that ``the US 
          government is firmly committed to accelerating the development 
          of safe and effective microbicides to prevent HIV''. In 
          addition, the President's Emergency Plan for AIDS Relief 
          recognizes the urgency of developing safe and effective 
          microbicides.
              (15) The National Institutes of Health, United States 
          Agency for International Development, and the Centers for 
          Disease Control and Prevention have expanded their microbicide 
          portfolios, but overall Federal leadership and coordination is 
          required to eliminate costly inefficiencies and unproductive 
          duplication of effort.
              (16) HIV prevention options available as of 2006 are 
          insufficient in general. Most critically, they fail to 
          recognize women's particular needs and vulnerabilities. If 
          women are to have a genuine opportunity to protect themselves, 
          their best option is the rapid development of new HIV-
          prevention technologies like microbicides, which women can 
          initiate.
  
     TITLE I--MICROBICIDE RESEARCH AT THE NATIONAL INSTITUTES OF HEALTH
  
  SEC. 101. OFFICE OF AIDS RESEARCH; PROGRAM REGARDING MICROBICIDES FOR 
                PREVENTING TRANSMISSION OF HIV/AIDS AND OTHER DISEASES.
  
      Subpart I of part D of title XXIII of the Public Health Service Act 
  (42 U.S.C. 300cc-40 et seq.) is amended by inserting after section 2351 
  the following:
  
  ``SEC. 2351A. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV/AIDS AND 
                OTHER DISEASES.
  
      ``(a) Federal Strategic Plan.--
              ``(1) In general.--The Director of the Office of AIDS 
          Research shall--
                      ``(A) expedite the implementation of a Federal 
                  strategic plan for the conduct and support of 
                  microbicide research and development; and
                      ``(B) annually review and, as appropriate, revise 
                  such plan, to prioritize funding and activities in 
                  terms of their scientific urgency.
              ``(2) Coordination.--In implementing, reviewing, and 
          prioritizing elements of the plan described under paragraph 
          (1), the Director of the Office of AIDS Research shall 
          coordinate with--
                      ``(A) other Federal agencies, including the 
                  Director of the Centers for Disease Control and 
                  Prevention and the Administrator of the United States 
                  Agency for International Development, involved in 
                  microbicide research;
                      ``(B) the microbicide research and development 
                  community; and
                      ``(C) health advocates.
      ``(b) Expansion and Coordination of Activities.--The Director of 
  the Office of AIDS Research, acting in coordination with relevant 
  institutes and offices, shall expand, intensify, and coordinate the 
  activities of all appropriate institutes and components of the National 
  Institutes of Health with respect to research and development of 
  microbicides to prevent the transmission of the human immunodeficiency 
  virus (`HIV') and other sexually transmitted infections.
      ``(c) Microbicide Development Branch.--In carrying out subsection 
  (b), the Director of the National Institute of Allergy and Infectious 
  Diseases shall establish within the Division of AIDS in the Institute, 
  a clearly defined organizational branch charged with carrying out 
  microbicide research and development. In establishing such branch, the 
  Director shall ensure that there are a sufficient number of employees 
  dedicated to carrying out its mission.
      ``(d) Microbicide Clinical Trials.--In carrying out subsection (c), 
  the Director of the National Institute of Allergy and Infectious 
  Diseases shall assign priority to ensuring adequate funding and support 
  for the Microbicide Trials Network and other programs for supporting 
  microbicides clinical trials, with particular emphasis on 
  implementation of trials leading to product licensure.
      ``(e) Reports to Congress.--
              ``(1) In general.--Not later than 6 months after the date 
          of enactment of the Microbicide Development Act, and annually 
          thereafter, the Director of the Office of AIDS Research shall 
          submit to the appropriate committees of Congress a report that 
          describes the strategies being implemented by the Federal 
          Government regarding microbicide research and development.
              ``(2) Contents of reports.--Each report submitted under 
          paragraph (1) shall include--
                      ``(A) a description of activities with respect to 
                  microbicide research and development conducted and 
                  supported by the Federal Government;
                      ``(B) a summary and analysis of the expenditures 
                  made by the Director of the Office of AIDS Research 
                  during the preceding year for activities with respect 
                  to microbicide-specific research and development, 
                  including basic research, preclinical product 
                  development, clinical trials, and behavioral science; 
                  and
                      ``(C) a description and evaluation of the progress 
                  made, during the preceding year, toward the development 
                  of effective microbicides.
              ``(3) Appropriate committees of congress defined.--In this 
          subsection, the term `appropriate committees of Congress' means 
          the Committee on Health, Education, Labor, and Pensions and the 
          Committee on Appropriations of the Senate and the Committee on 
          Energy and Commerce and the Committee on Appropriations of the 
          House of Representatives.
      ``(f) Authorization of Appropriations.--There are authorized to be 
  appropriated such sums as may be necessary for each fiscal year to 
  carry out this section.''.
  
   TITLE II--MICROBICIDE RESEARCH AT THE CENTERS FOR DISEASE CONTROL AND 
                                 PREVENTION
  
  SEC. 201. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV/AIDS AND 
                OTHER DISEASES.
  
      Part B of title III of the Public Health Service Act (42 U.S.C. 243 
  et seq.) is amended by inserting after section 317S the following:
  
  ``SEC. 317T. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV/AIDS AND 
                OTHER DISEASES.
  
      ``(a) Development and Implementation of the Centers for Disease 
  Control and Prevention's Microbicide Agenda.--The Director of the 
  Centers for Disease Control and Prevention shall fully implement such 
  Centers' microbicide agenda to support microbicide research and 
  development. Such an agenda shall include--
              ``(1) conducting laboratory research in preparation for, 
          and support of, clinical microbicide trials; and
              ``(2) conducting behavioral research in preparation for, 
          and support of, clinical microbicide trials.
      ``(b) Personnel.--The Centers for Disease Control and Prevention 
  shall ensure that there are sufficient numbers of dedicated employees 
  for carrying out the microbicide agenda under subsection (a).
      ``(c) Report to Congress.--
              ``(1) In general.--Not later than 1 year after the date of 
          enactment of the Microbicide Development Act, and annually 
          thereafter, the Director of the Centers for Disease Control and 
          Prevention shall submit to the appropriate committees of 
          Congress, a report on the strategies being implemented by the 
          Centers for Disease Control and Prevention with respect to 
          microbicide research and development. Such report shall be 
          submitted alone or as part of the overall Federal strategic 
          plan on microbicides compiled annually by the National 
          Institutes of Health Office of AIDS Research as required under 
          section 2351A.
              ``(2) Contents of report.--Such report shall include--
                      ``(A) a description of activities with respect to 
                  microbicides conducted or supported by the Director of 
                  the Centers for Disease Control and Prevention;
                      ``(B) a summary and analysis of the expenditures 
                  made by such Director during the preceding year, for 
                  activities with respect to microbicide-specific 
                  research and development, including the number of 
                  employees of such Centers involved in such activities; 
                  and
                      ``(C) a description and evaluation of the progress 
                  made, during the preceding year, toward the development 
                  of effective microbicides.
              ``(3) Appropriate committees of congress defined.--For the 
          purposes of this subsection, the term `appropriate committees 
          of Congress' means the Committee on Health, Education, Labor, 
          and Pensions and the Committee on Appropriations of the Senate 
          and the Committee on Energy and Commerce and the Committee on 
          Appropriations of the House of Representatives.
      ``(d) Authorization of Appropriations.--There are authorized to be 
  appropriated such sums as may be necessary for each fiscal year to 
  carry out this section.''.
  
   TITLE III--MICROBICIDE RESEARCH AND DEVELOPMENT AT THE UNITED STATES 
                    AGENCY FOR INTERNATIONAL DEVELOPMENT
  
  SEC. 301. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV/AIDS AND 
                OTHER DISEASES.
  
      Section 104A of the Foreign Assistance Act of 1961 (22 U.S.C. 
  2151b-2) is amended by adding at the end the following new subsection:
      ``(h) Microbicides for Preventing Transmission of HIV/AIDS and 
  Other Diseases.--
              ``(1) Development and implementation of the microbicide 
          agenda.--The President shall direct the head of the Office of 
          HIV/AIDS of the United States Agency for International 
          Development, in conjunction with other offices of such Agency, 
          to develop and implement a program to support the development 
          of microbicides for the prevention of the transmission of HIV/
          AIDS and other diseases, and facilitate wide-scale availability 
          of such products after such development.
              ``(2) Staffing.--The head of the Office of HIV/AIDS shall 
          ensure that the Agency has a sufficient number of dedicated 
          employees to carry out the microbicide agenda.
              ``(3) Reports to congress.--
                      ``(A) In general.--Not later than one year after 
                  the date of enactment of the Microbicide Development 
                  Act, and annually thereafter, the President shall 
                  submit to the appropriate congressional committees a 
                  report on the activities of the Agency to carry out the 
                  microbicide agenda and on any other activities carried 
                  out by the Agency related to microbicide research and 
                  development.
                      ``(B) Contents of report.--Each report submitted 
                  under subparagraph (A) shall include--
                              ``(i) a description of activities with 
                          respect to microbicides conducted or supported 
                          by the Agency;
                              ``(ii) a summary and analysis of the 
                          expenditures made by the Agency during the 
                          preceding year for activities with respect to 
                          microbicide-specific research and development, 
                          including the number of employees of the Agency 
                          who are involved in such activities; and
                              ``(iii) a description and evaluation of the 
                          progress made during the preceding year toward 
                          the development of effective microbicides, 
                          including activities in support of eventual 
                          product access.
                      ``(C) Consultation.--The President shall consult 
                  with the Director of the Office of AIDS Research of the 
                  National Institutes of Health in preparing the report 
                  required under subparagraph (A).
                      ``(D) Appropriate congressional committees 
                  defined.--In this paragraph, the term `appropriate 
                  congressional committees' means the Committee on 
                  Foreign Affairs and the Committee on Appropriations of 
                  the House of Representatives and the Committee on 
                  Foreign Relations and the Committee on Appropriations 
                  of the Senate.
              ``(4) Authorization of appropriations.--There are 
          authorized to be appropriated to the Agency such sums as may be 
          necessary for each fiscal year to carry out this subsection.''.
target: Microbicide Development Act - Amends the Public Health Service Act to require the Director of the Office of AIDS Research to: (1) expedite the implementation of the federal strategic plan for the conduct and support of microbicide research and development; and (2) expand, intensify, and coordinate all activities with respect to research and development of microbicides to prevent the transmission of HIV and other sexually transmitted diseases.
  
  Requires the Director of the National Institute of Allergy and Infectious Diseases to: (1) establish within the Division of AIDS an organizational branch to carry out microbicide research and development; and (2) assign priority to ensuring adequate funding and support for the Microbicide Trials Network and other programs for supporting microbicides clinical trials. Requires the Director of the Centers for Disease Control and Prevention (CDC) to fully implement the CDC's microbicide agenda to support microbicide research and development. Requires the President to direct the head of the Office of HIV/AIDS of the U.S. Agency for International Development (USAID) to develop and implement a program to support the development of microbicides products for the prevention of the transmission of HIV/AIDS and other diseases and facilitate wide-scale availability of such products.
feat_title: To amend the Public Health Service Act with respect to facilitating the development of microbicides for preventing transmission of HIV/AIDS and other diseases, and for other purposes.