H.R. 5501 (110th): Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act ...

...of 2008

110th Congress, 2007–2009. Text as of Jul 25, 2008 (Passed Congress/Enrolled Bill).

Status & Summary | PDF | Source: GPO

I

One Hundred Tenth Congress of the United States of America

At the Second Session

H. R. 5501

AN ACT

To authorize appropriations for fiscal years 2009 through 2013 to provide assistance to foreign countries to combat HIV/AIDS, tuberculosis, and malaria, and for other purposes.

1.

Short title; table of contents

(a)

Short title

This Act may be cited as the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008.

(b)

Table of contents

The table of contents for this Act is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. Findings.

Sec. 3. Definitions.

Sec. 4. Purpose.

Sec. 5. Authority to consolidate and combine reports.

TITLE I—Policy Planning and Coordination

Sec. 101. Development of an updated, comprehensive, 5-year, global strategy.

Sec. 102. Interagency working group.

Sec. 103. Sense of Congress.

TITLE II—Support for multilateral funds, programs, and public-private partnerships

Sec. 201. Voluntary contributions to international vaccine funds.

Sec. 202. Participation in the Global Fund to Fight AIDS, Tuberculosis and Malaria.

Sec. 203. Research on methods for women to prevent transmission of HIV and other diseases.

Sec. 204. Combating HIV/AIDS, tuberculosis, and malaria by strengthening health policies and health systems of partner countries.

Sec. 205. Facilitating effective operations of the Centers for Disease Control.

Sec. 206. Facilitating vaccine development.

TITLE III—Bilateral Efforts

Subtitle A—General Assistance and Programs

Sec. 301. Assistance to combat HIV/AIDS.

Sec. 302. Assistance to combat tuberculosis.

Sec. 303. Assistance to combat malaria.

Sec. 304. Malaria Response Coordinator.

Sec. 305. Amendment to Immigration and Nationality Act.

Sec. 306. Clerical amendment.

Sec. 307. Requirements.

Sec. 308. Annual report on prevention of mother-to-child transmission of HIV.

Sec. 309. Prevention of mother-to-child transmission expert panel.

TITLE IV—Funding allocations

Sec. 401. Authorization of appropriations.

Sec. 402. Sense of Congress.

Sec. 403. Allocation of funds.

TITLE V—Miscellaneous

Sec. 501. Machine readable visa fees.

TITLE VI—Emergency plan for Indian safety and health

Sec. 601. Emergency plan for Indian safety and health.

2.

Findings

Section 2 of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7601) is amended by adding at the end the following:

(29)

On May 27, 2003, the President signed this Act into law, launching the largest international public health program of its kind ever created.

(30)

Between 2003 and 2008, the United States, through the President’s Emergency Plan for AIDS Relief (PEPFAR) and in conjunction with other bilateral programs and the multilateral Global Fund has helped to—

(A)

provide antiretroviral therapy for over 1,900,000 people;

(B)

ensure that over 150,000 infants, most of whom would have likely been infected with HIV during pregnancy or childbirth, were not infected; and

(C)

provide palliative care and HIV prevention assistance to millions of other people.

(31)

While United States leadership in the battles against HIV/AIDS, tuberculosis, and malaria has had an enormous impact, these diseases continue to take a terrible toll on the human race.

(32)

According to the 2007 AIDS Epidemic Update of the Joint United Nations Programme on HIV/AIDS (UNAIDS)—

(A)

an estimated 2,100,000 people died of AIDS-related causes in 2007; and

(B)

an estimated 2,500,000 people were newly infected with HIV during that year.

(33)

According to the World Health Organization, malaria kills more than 1,000,000 people per year, 70 percent of whom are children under 5 years of age.

(34)

According to the World Health Organization, 1/3 of the world’s population is infected with the tuberculosis bacterium, and tuberculosis is 1 of the greatest infectious causes of death of adults worldwide, killing 1,600,000 people per year.

(35)

Efforts to promote abstinence, fidelity, the correct and consistent use of condoms, the delay of sexual debut, and the reduction of concurrent sexual partners represent important elements of strategies to prevent the transmission of HIV/AIDS.

(36)

According to UNAIDS—

(A)

women and girls make up nearly 60 percent of persons in sub-Saharan Africa who are HIV positive;

(B)

women and girls are more biologically, economically, and socially vulnerable to HIV infection; and

(C)

gender issues are critical components in the effort to prevent HIV/AIDS and to care for those affected by the disease.

(37)

Children who have lost a parent to HIV/AIDS, who are otherwise directly affected by the disease, or who live in areas of high HIV prevalence may be vulnerable to the disease or its socioeconomic effects.

(38)

Lack of health capacity, including insufficient personnel and inadequate infrastructure, in sub-Saharan Africa and other regions of the world is a critical barrier that limits the effectiveness of efforts to combat HIV/AIDS, tuberculosis, and malaria, and to achieve other global health goals.

(39)

On March 30, 2007, the Institute of Medicine of the National Academies released a report entitled PEPFAR Implementation: Progress and Promise, which found that budget allocations setting percentage levels for spending on prevention, care, and treatment and for certain subsets of activities within the prevention category—

(A)

have adversely affected implementation of the U.S. Global AIDS Initiative;

(B)

have inhibited comprehensive, integrated, evidence based approaches;

(C)

have been counterproductive;

(D)

may have been helpful initially in ensuring a balance of attention to activities within the 4 categories of prevention, treatment, care, and orphans and vulnerable children;

(E)

have also limited PEPFAR’s ability to tailor its activities in each country to the local epidemic and to coordinate with the level of activities in the countries’ national plans; and

(F)

should be removed by Congress and replaced with more appropriate mechanisms that—

(i)

ensure accountability for results from Country Teams to the U.S. Global AIDS Coordinator and to Congress; and

(ii)

ensure that spending is directly linked to and commensurate with necessary efforts to achieve both country and overall performance targets for prevention, treatment, care, and orphans and vulnerable children.

(40)

The United States Government has endorsed the principles of harmonization in coordinating efforts to combat HIV/AIDS commonly referred to as the Three Ones, which includes—

(A)

1 agreed HIV/AIDS action framework that provides the basis for coordination of the work of all partners;

(B)

1 national HIV/AIDS coordinating authority, with a broadbased multisectoral mandate; and

(C)

1 agreed HIV/AIDS country-level monitoring and evaluating system.

(41)

In the Abuja Declaration on HIV/AIDS, Tuberculosis and Other Related Infectious Diseases, of April 26–27, 2001 (referred to in this Act as the Abuja Declaration), the Heads of State and Government of the Organization of African Unity (OAU)—

(A)

declared that they would place the fight against HIV/AIDS at the forefront and as the highest priority issue in our respective national development plans;

(B)

committed TO TAKE PERSONAL RESPONSIBILITY AND PROVIDE LEADERSHIP for the activities of the National AIDS Commissions/Councils;

(C)

resolved to lead from the front the battle against HIV/AIDS, Tuberculosis and Other Related Infectious Diseases by personally ensuring that such bodies were properly convened in mobilizing our societies as a whole and providing focus for unified national policymaking and programme implementation, ensuring coordination of all sectors at all levels with a gender perspective and respect for human rights, particularly to ensure equal rights for people living with HIV/AIDS; and

(D)

pledged to set a target of allocating at least 15% of our annual budget to the improvement of the health sector.

.

3.

Definitions

Section 3 of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7602) is amended—

(1)

in paragraph (2), by striking Committee on International Relations and inserting Committee on Foreign Affairs of the House of Representatives, the Committee on Appropriations of the Senate, and the Committee on Appropriations;

(2)

by redesignating paragraph (6) as paragraph (12);

(3)

by redesignating paragraphs (3) through (5), as paragraphs (4) through (6), respectively;

(4)

by inserting after paragraph (2) the following:

(3)

Global AIDS coordinator

The term Global AIDS Coordinator means the Coordinator of United States Government Activities to Combat HIV/AIDS Globally.

; and

(5)

by inserting after paragraph (6), as redesignated, the following:

(7)

Impact evaluation research

The term impact evaluation research means the application of research methods and statistical analysis to measure the extent to which change in a population-based outcome can be attributed to program intervention instead of other environmental factors.

(8)

Operations research

The term operations research means the application of social science research methods, statistical analysis, and other appropriate scientific methods to judge, compare, and improve policies and program outcomes, from the earliest stages of defining and designing programs through their development and implementation, with the objective of the rapid dissemination of conclusions and concrete impact on programming.

(9)

Paraprofessional

The term paraprofessional means an individual who is trained and employed as a health agent for the provision of basic assistance in the identification, prevention, or treatment of illness or disability.

(10)

Partner government

The term partner government means a government with which the United States is working to provide assistance to combat HIV/AIDS, tuberculosis, or malaria on behalf of people living within the jurisdiction of such government.

(11)

Program monitoring

The term program monitoring means the collection, analysis, and use of routine program data to determine—

(A)

how well a program is carried out; and

(B)

how much the program costs.

.

4.

Purpose

Section 4 of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7603) is amended to read as follows:

4.

Purpose

The purpose of this Act is to strengthen and enhance United States leadership and the effectiveness of the United States response to the HIV/AIDS, tuberculosis, and malaria pandemics and other related and preventable infectious diseases as part of the overall United States health and development agenda by—

(1)

establishing comprehensive, coordinated, and integrated 5-year, global strategies to combat HIV/AIDS, tuberculosis, and malaria by—

(A)

building on progress and successes to date;

(B)

improving harmonization of United States efforts with national strategies of partner governments and other public and private entities; and

(C)

emphasizing capacity building initiatives in order to promote a transition toward greater sustainability through the support of country-driven efforts;

(2)

providing increased resources for bilateral and multilateral efforts to fight HIV/AIDS, tuberculosis, and malaria as integrated components of United States development assistance;

(3)

intensifying efforts to—

(A)

prevent HIV infection;

(B)

ensure the continued support for, and expanded access to, treatment and care programs;

(C)

enhance the effectiveness of prevention, treatment, and care programs; and

(D)

address the particular vulnerabilities of girls and women;

(4)

encouraging the expansion of private sector efforts and expanding public-private sector partnerships to combat HIV/AIDS, tuberculosis, and malaria;

(5)

reinforcing efforts to—

(A)

develop safe and effective vaccines, microbicides, and other prevention and treatment technologies; and

(B)

improve diagnostics capabilities for HIV/AIDS, tuberculosis, and malaria; and

(6)

helping partner countries to—

(A)

strengthen health systems;

(B)

expand health workforce; and

(C)

address infrastructural weaknesses.

.

5.

Authority to consolidate and combine reports

Section 5 of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7604) is amended by inserting , with the exception of the 5-year strategy before the period at the end.

I

Policy Planning and Coordination

101.

Development of an updated, comprehensive, 5-year, global strategy

(a)

Strategy

Section 101(a) of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7611(a)) is amended to read as follows:

(a)

Strategy

The President shall establish a comprehensive, integrated, 5-year strategy to expand and improve efforts to combat global HIV/AIDS. This strategy shall—

(1)

further strengthen the capability of the United States to be an effective leader of the international campaign against this disease and strengthen the capacities of nations experiencing HIV/AIDS epidemics to combat this disease;

(2)

maintain sufficient flexibility and remain responsive to—

(A)

changes in the epidemic;

(B)

challenges facing partner countries in developing and implementing an effective national response; and

(C)

evidence-based improvements and innovations in the prevention, care, and treatment of HIV/AIDS;

(3)

situate United States efforts to combat HIV/AIDS, tuberculosis, and malaria within the broader United States global health and development agenda, establishing a roadmap to link investments in specific disease programs to the broader goals of strengthening health systems and infrastructure and to integrate and coordinate HIV/AIDS, tuberculosis, or malaria programs with other health or development programs, as appropriate;

(4)

provide a plan to—

(A)

prevent 12,000,000 new HIV infections worldwide;

(B)

support—

(i)

the increase in the number of individuals with HIV/AIDS receiving antiretroviral treatment above the goal established under section 402(a)(3) and increased pursuant to paragraphs (1) through (3) of section 403(d); and

(ii)

additional treatment through coordinated multilateral efforts;

(C)

support care for 12,000,000 individuals infected with or affected by HIV/AIDS, including 5,000,000 orphans and vulnerable children affected by HIV/AIDS, with an emphasis on promoting a comprehensive, coordinated system of services to be integrated throughout the continuum of care;

(D)

help partner countries in the effort to achieve goals of 80 percent access to counseling, testing, and treatment to prevent the transmission of HIV from mother to child, emphasizing a continuum of care model;

(E)

help partner countries to provide care and treatment services to children with HIV in proportion to their percentage within the HIV-infected population in each country;

(F)

promote preservice training for health professionals designed to strengthen the capacity of institutions to develop and implement policies for training health workers to combat HIV/AIDS, tuberculosis, and malaria;

(G)

equip teachers with skills needed for HIV/AIDS prevention and support for persons with, or affected by, HIV/AIDS;

(H)

provide and share best practices for combating HIV/AIDS with health professionals;

(I)

promote pediatric HIV/AIDS training for physicians, nurses, and other health care workers, through public-private partnerships if possible, including through the designation, if appropriate, of centers of excellence for training in pediatric HIV/AIDS prevention, care, and treatment in partner countries; and

(J)

help partner countries to train and support retention of health care professionals and paraprofessionals, with the target of training and retaining at least 140,000 new health care professionals and paraprofessionals with an emphasis on training and in country deployment of critically needed doctors and nurses and to strengthen capacities in developing countries, especially in sub-Saharan Africa, to deliver primary health care with the objective of helping countries achieve staffing levels of at least 2.3 doctors, nurses, and midwives per 1,000 population, as called for by the World Health Organization;

(5)

include multisectoral approaches and specific strategies to treat individuals infected with HIV/AIDS and to prevent the further transmission of HIV infections, with a particular focus on the needs of families with children (including the prevention of mother-to-child transmission), women, young people, orphans, and vulnerable children;

(6)

establish a timetable with annual global treatment targets with country-level benchmarks for antiretroviral treatment;

(7)

expand the integration of timely and relevant research within the prevention, care, and treatment of HIV/AIDS;

(8)

include a plan for program monitoring, operations research, and impact evaluation and for the dissemination of a best practices report to highlight findings;

(9)

support the in-country or intra-regional training, preferably through public-private partnerships, of scientific investigators, managers, and other staff who are capable of promoting the systematic uptake of clinical research findings and other evidence-based interventions into routine practice, with the goal of improving the quality, effectiveness, and local leadership of HIV/AIDS health care;

(10)

expand and accelerate research on and development of HIV/AIDS prevention methods for women, including enhancing inter-agency collaboration, staffing, and organizational infrastructure dedicated to microbicide research;

(11)

provide for consultation with local leaders and officials to develop prevention strategies and programs that are tailored to the unique needs of each country and community and targeted particularly toward those most at risk of acquiring HIV infection;

(12)

make the reduction of HIV/AIDS behavioral risks a priority of all prevention efforts by—

(A)

promoting abstinence from sexual activity and encouraging monogamy and faithfulness;

(B)

encouraging the correct and consistent use of male and female condoms and increasing the availability of, and access to, these commodities;

(C)

promoting the delay of sexual debut and the reduction of multiple concurrent sexual partners;

(D)

promoting education for discordant couples (where an individual is infected with HIV and the other individual is uninfected or whose status is unknown) about safer sex practices;

(E)

promoting voluntary counseling and testing, addiction therapy, and other prevention and treatment tools for illicit injection drug users and other substance abusers;

(F)

educating men and boys about the risks of procuring sex commercially and about the need to end violent behavior toward women and girls;

(G)

supporting partner country and community efforts to identify and address social, economic, or cultural factors, such as migration, urbanization, conflict, gender-based violence, lack of empowerment for women, and transportation patterns, which directly contribute to the transmission of HIV;

(H)

supporting comprehensive programs to promote alternative livelihoods, safety, and social reintegration strategies for commercial sex workers and their families;

(I)

promoting cooperation with law enforcement to prosecute offenders of trafficking, rape, and sexual assault crimes with the goal of eliminating such crimes; and

(J)

working to eliminate rape, gender-based violence, sexual assault, and the sexual exploitation of women and children;

(13)

include programs to reduce the transmission of HIV, particularly addressing the heightened vulnerabilities of women and girls to HIV in many countries; and

(14)

support other important means of preventing or reducing the transmission of HIV, including—

(A)

medical male circumcision;

(B)

the maintenance of a safe blood supply;

(C)

promoting universal precautions in formal and informal health care settings;

(D)

educating the public to recognize and to avoid risks to contract HIV through blood exposures during formal and informal health care and cosmetic services;

(E)

investigating suspected nosocomial infections to identify and stop further nosocomial transmission; and

(F)

other mechanisms to reduce the transmission of HIV;

(15)

increase support for prevention of mother-to-child transmission;

(16)

build capacity within the public health sector of developing countries by improving health systems and public health infrastructure and developing indicators to measure changes in broader public health sector capabilities;

(17)

increase the coordination of HIV/AIDS programs with development programs;

(18)

provide a framework for expanding or developing existing or new country or regional programs, including—

(A)

drafting compacts or other agreements, as appropriate;

(B)

establishing criteria and objectives for such compacts and agreements; and

(C)

promoting sustainability;

(19)

provide a plan for national and regional priorities for resource distribution and a global investment plan by region;

(20)

provide a plan to address the immediate and ongoing needs of women and girls, which—

(A)

addresses the vulnerabilities that contribute to their elevated risk of infection;

(B)

includes specific goals and targets to address these factors;

(C)

provides clear guidance to field missions to integrate gender across prevention, care, and treatment programs;

(D)

sets forth gender-specific indicators to monitor progress on outcomes and impacts of gender programs;

(E)

supports efforts in countries in which women or orphans lack inheritance rights and other fundamental protections to promote the passage, implementation, and enforcement of such laws;

(F)

supports life skills training, especially among women and girls, with the goal of reducing vulnerabilities to HIV/AIDS;

(G)

addresses and prevents gender-based violence; and

(H)

addresses the posttraumatic and psychosocial consequences and provides postexposure prophylaxis protecting against HIV infection to victims of gender-based violence and rape;

(21)

provide a plan to—

(A)

determine the local factors that may put men and boys at elevated risk of contracting or transmitting HIV;

(B)

address male norms and behaviors to reduce these risks, including by reducing alcohol abuse;

(C)

promote responsible male behavior; and

(D)

promote male participation and leadership at the community level in efforts to promote HIV prevention, reduce stigma, promote participation in voluntary counseling and testing, and provide care, treatment, and support for persons with HIV/AIDS;

(22)

provide a plan to address the vulnerabilities and needs of orphans and children who are vulnerable to, or affected by, HIV/AIDS;

(23)

encourage partner countries to develop health care curricula and promote access to training tailored to individuals receiving services through, or exiting from, existing programs geared to orphans and vulnerable children;

(24)

provide a framework to work with international actors and partner countries toward universal access to HIV/AIDS prevention, treatment, and care programs, recognizing that prevention is of particular importance;

(25)

enhance the coordination of United States bilateral efforts to combat global HIV/AIDS with other major public and private entities;

(26)

enhance the attention given to the national strategic HIV/AIDS plans of countries receiving United States assistance by—

(A)

reviewing the planning and programmatic decisions associated with that assistance; and

(B)

helping to strengthen such national strategies, if necessary;

(27)

support activities described in the Global Plan to Stop TB, including—

(A)

expanding and enhancing the coverage of the Directly Observed Treatment Short-course (DOTS) in order to treat individuals infected with tuberculosis and HIV, including multi-drug resistant or extensively drug resistant tuberculosis; and

(B)

improving coordination and integration of HIV/AIDS and tuberculosis programming;

(28)

ensure coordination between the Global AIDS Coordinator and the Malaria Coordinator and address issues of comorbidity between HIV/AIDS and malaria; and

(29)

include a longer term estimate of the projected resource needs, progress toward greater sustainability and country ownership of HIV/AIDS programs, and the anticipated role of the United States in the global effort to combat HIV/AIDS during the 10-year period beginning on October 1, 2013.

.

(b)

Report

Section 101(b) of such Act (22 U.S.C. 7611(b)) is amended to read as follows:

(b)

Report

(1)

In general

Not later than October 1, 2009, the President shall submit a report to the appropriate congressional committees that sets forth the strategy described in subsection (a).

(2)

Contents

The report required under paragraph (1) shall include a discussion of the following elements:

(A)

The purpose, scope, methodology, and general and specific objectives of the strategy.

(B)

The problems, risks, and threats to the successful pursuit of the strategy.

(C)

The desired goals, objectives, activities, and outcome-related performance measures of the strategy.

(D)

A description of future costs and resources needed to carry out the strategy.

(E)

A delineation of United States Government roles, responsibility, and coordination mechanisms of the strategy.

(F)

A description of the strategy—

(i)

to promote harmonization of United States assistance with that of other international, national, and private actors as elucidated in the Three Ones; and

(ii)

to address existing challenges in harmonization and alignment.

(G)

A description of the manner in which the strategy will—

(i)

further the development and implementation of the national multisectoral strategic HIV/AIDS frameworks of partner governments; and

(ii)

enhance the centrality, effectiveness, and sustainability of those national plans.

(H)

A description of how the strategy will seek to achieve the specific targets described in subsection (a) and other targets, as appropriate.

(I)

A description of, and rationale for, the timetable for annual global treatment targets with country-level estimates of numbers of persons in need of antiretroviral treatment, country-level benchmarks for United States support for assistance for antiretroviral treatment, and numbers of persons enrolled in antiretroviral treatment programs receiving United States support. If global benchmarks are not achieved within the reporting period, the report shall include a description of steps being taken to ensure that global benchmarks will be achieved and a detailed breakdown and justification of spending priorities in countries in which benchmarks are not being met, including a description of other donor or national support for antiretroviral treatment in the country, if appropriate.

(J)

A description of how operations research is addressed in the strategy and how such research can most effectively be integrated into care, treatment, and prevention activities in order to—

(i)

improve program quality and efficiency;

(ii)

ascertain cost effectiveness;

(iii)

ensure transparency and accountability;

(iv)

assess population-based impact;

(v)

disseminate findings and best practices; and

(vi)

optimize delivery of services.

(K)

An analysis of United States-assisted strategies to prevent the transmission of HIV/AIDS, including methodologies to promote abstinence, monogamy, faithfulness, the correct and consistent use of male and female condoms, reductions in concurrent sexual partners, and delay of sexual debut, and of intended monitoring and evaluation approaches to measure the effectiveness of prevention programs and ensure that they are targeted to appropriate audiences.

(L)

Within the analysis required under subparagraph (K), an examination of additional planned means of preventing the transmission of HIV including medical male circumcision, maintenance of a safe blood supply, public education about risks to acquire HIV infection from blood exposures, promotion of universal precautions, investigation of suspected nosocomial infections and other tools.

(M)

A description of efforts to assist partner country and community to identify and address social, economic, or cultural factors, such as migration, urbanization, conflict, gender-based violence, lack of empowerment for women, and transportation patterns, which directly contribute to the transmission of HIV.

(N)

A description of the specific targets, goals, and strategies developed to address the needs and vulnerabilities of women and girls to HIV/AIDS, including—

(i)

activities directed toward men and boys;

(ii)

activities to enhance educational, microfinance, and livelihood opportunities for women and girls;

(iii)

activities to promote and protect the legal empowerment of women, girls, and orphans and vulnerable children;

(iv)

programs targeted toward gender-based violence and sexual coercion;

(v)

strategies to meet the particular needs of adolescents;

(vi)

assistance for victims of rape, sexual abuse, assault, exploitation, and trafficking; and

(vii)

programs to prevent alcohol abuse.

(O)

A description of strategies to address male norms and behaviors that contribute to the transmission of HIV, to promote responsible male behavior, and to promote male participation and leadership in HIV/AIDS prevention, care, treatment, and voluntary counseling and testing.

(P)

A description of strategies—

(i)

to address the needs of orphans and vulnerable children, including an analysis of—

(I)

factors contributing to children’s vulnerability to HIV/AIDS; and

(II)

vulnerabilities caused by the impact of HIV/AIDS on children and their families; and

(ii)

in areas of higher HIV/AIDS prevalence, to promote a community-based approach to vulnerability, maximizing community input into determining which children participate.

(Q)

A description of capacity-building efforts undertaken by countries themselves, including adherents of the Abuja Declaration and an assessment of the impact of International Monetary Fund macroeconomic and fiscal policies on national and donor investments in health.

(R)

A description of the strategy to—

(i)

strengthen capacity building within the public health sector;

(ii)

improve health care in those countries;

(iii)

help countries to develop and implement national health workforce strategies;

(iv)

strive to achieve goals in training, retaining, and effectively deploying health staff;

(v)

promote the use of codes of conduct for ethical recruiting practices for health care workers; and

(vi)

increase the sustainability of health programs.

(S)

A description of the criteria for selection, objectives, methodology, and structure of compacts or other framework agreements with countries or regional organizations, including—

(i)

the role of civil society;

(ii)

the degree of transparency;

(iii)

benchmarks for success of such compacts or agreements; and

(iv)

the relationship between such compacts or agreements and the national HIV/AIDS and public health strategies and commitments of partner countries.

(T)

A strategy to better coordinate HIV/AIDS assistance with nutrition and food assistance programs.

(U)

A description of transnational or regional initiatives to combat regionalized epidemics in highly affected areas such as the Caribbean.

(V)

A description of planned resource distribution and global investment by region.

(W)

A description of coordination efforts in order to better implement the Stop TB Strategy and to address the problem of coinfection of HIV/AIDS and tuberculosis and of projected challenges or barriers to successful implementation.

(X)

A description of coordination efforts to address malaria and comorbidity with malaria and HIV/AIDS.

.

(c)

Study

Section 101(c) of such Act (22 U.S.C. 7611(c)) is amended to read as follows:

(c)

Study of progress toward achievement of policy objectives

(1)

Design and budget plan for data evaluation

The Global AIDS Coordinator shall enter into a contract with the Institute of Medicine of the National Academies that provides that not later than 18 months after the date of the enactment of the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, the Institute, in consultation with the Global AIDS Coordinator and other relevant parties representing the public and private sector, shall provide the Global AIDS Coordinator with a design plan and budget for the evaluation and collection of baseline and subsequent data to address the elements set forth in paragraph (2)(B). The Global AIDS Coordinator shall submit the budget and design plan to the appropriate congressional committees.

(2)

Study

(A)

In general

Not later than 4 years after the date of the enactment of the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, the Institute of Medicine of the National Academies shall publish a study that includes—

(i)

an assessment of the performance of United States-assisted global HIV/AIDS programs; and

(ii)

an evaluation of the impact on health of prevention, treatment, and care efforts that are supported by United States funding, including multilateral and bilateral programs involving joint operations.

(B)

Content

The study conducted under this paragraph shall include—

(i)

an assessment of progress toward prevention, treatment, and care targets;

(ii)

an assessment of the effects on health systems, including on the financing and management of health systems and the quality of service delivery and staffing;

(iii)

an assessment of efforts to address gender-specific aspects of HIV/AIDS, including gender related constraints to accessing services and addressing underlying social and economic vulnerabilities of women and men;

(iv)

an evaluation of the impact of treatment and care programs on 5-year survival rates, drug adherence, and the emergence of drug resistance;

(v)

an evaluation of the impact of prevention programs on HIV incidence in relevant population groups;

(vi)

an evaluation of the impact on child health and welfare of interventions authorized under this Act on behalf of orphans and vulnerable children;

(vii)

an evaluation of the impact of programs and activities authorized in this Act on child mortality; and

(viii)

recommendations for improving the programs referred to in subparagraph (A)(i).

(C)

Methodologies

Assessments and impact evaluations conducted under the study shall utilize sound statistical methods and techniques for the behavioral sciences, including random assignment methodologies as feasible. Qualitative data on process variables should be used for assessments and impact evaluations, wherever possible.

(3)

Contract authority

The Institute of Medicine may enter into contracts or cooperative agreements or award grants to conduct the study under paragraph (2).

(4)

Authorization of appropriations

There are authorized to be appropriated such sums as may be necessary to carry out the study under this subsection.

.

(d)

Report

Section 101 of such Act, as amended by this section, is further amended by adding at the end the following:

(d)

Comptroller General report

(1)

Report Required

Not later than 3 years after the date of the enactment of the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, the Comptroller General of the United States shall submit a report on the global HIV/AIDS programs of the United States to the appropriate congressional committees.

(2)

Contents

The report required under paragraph (1) shall include—

(A)

a description and assessment of the monitoring and evaluation practices and policies in place for these programs;

(B)

an assessment of coordination within Federal agencies involved in these programs, examining both internal coordination within these programs and integration with the larger global health and development agenda of the United States;

(C)

an assessment of procurement policies and practices within these programs;

(D)

an assessment of harmonization with national government HIV/AIDS and public health strategies as well as other international efforts;

(E)

an assessment of the impact of global HIV/AIDS funding and programs on other United States global health programming; and

(F)

recommendations for improving the global HIV/AIDS programs of the United States.

(e)

Best practices report

(1)

In general

Not later than 1 year after the date of the enactment of the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, and annually thereafter, the Global AIDS Coordinator shall publish a best practices report that highlights the programs receiving financial assistance from the United States that have the potential for replication or adaption, particularly at a low cost, across global AIDS programs, including those that focus on both generalized and localized epidemics.

(2)

Dissemination of findings

(A)

Publication on Internet website

The Global AIDS Coordinator shall disseminate the full findings of the annual best practices report on the Internet website of the Office of the Global AIDS Coordinator.

(B)

Dissemination guidance

The Global AIDS Coordinator shall develop guidance to ensure timely submission and dissemination of significant information regarding best practices with respect to global AIDS programs.

(f)

Inspectors general

(1)

Oversight plan

(A)

Development

The Inspectors General of the Department of State and Broadcasting Board of Governors, the Department of Health and Human Services, and the United States Agency for International Development shall jointly develop 5 coordinated annual plans for oversight activity in each of the fiscal years 2009 through 2013, with regard to the programs authorized under this Act and sections 104A, 104B, and 104C of the Foreign Assistance Act of 1961 (22 U.S.C. 2151b–2, 2151b–3, and 2151b–4).

(B)

Contents

The plans developed under subparagraph (A) shall include a schedule for financial audits, inspections, and performance reviews, as appropriate.

(C)

Deadline

(i)

Initial plan

The first plan developed under subparagraph (A) shall be completed not later than the later of—

(I)

September 1, 2008; or

(II)

60 days after the date of the enactment of the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008.

(ii)

Subsequent plans

Each of the last four plans developed under subparagraph (A) shall be completed not later than 30 days before each of the fiscal years 2010 through 2013, respectively.

(2)

Coordination

In order to avoid duplication and maximize efficiency, the Inspectors General described in paragraph (1) shall coordinate their activities with—

(A)

the Government Accountability Office; and

(B)

the Inspectors General of the Department of Commerce, the Department of Defense, the Department of Labor, and the Peace Corps, as appropriate, pursuant to the 2004 Memorandum of Agreement Coordinating Audit Coverage of Programs and Activities Implementing the President’s Emergency Plan for AIDS Relief, or any successor agreement.

(3)

Funding

The Global AIDS Coordinator and the Coordinator of the United States Government Activities to Combat Malaria Globally shall make available necessary funds not exceeding $15,000,000 during the 5-year period beginning on October 1, 2008 to the Inspectors General described in paragraph (1) for the audits, inspections, and reviews described in that paragraph.

.

(e)

Annual study; message

Section 101 of such Act, as amended by this section, is further amended by adding at the end the following:

(g)

Annual study

(1)

In general

Not later than September 30, 2009, and annually thereafter through September 30, 2013, the Global AIDS Coordinator shall complete a study of treatment providers that—

(A)

represents a range of countries and service environments;

(B)

estimates the per-patient cost of antiretroviral HIV/AIDS treatment and the care of people with HIV/AIDS not receiving antiretroviral treatment, including a comparison of the costs for equivalent services provided by programs not receiving assistance under this Act;

(C)

estimates per-patient costs across the program and in specific categories of service providers, including—

(i)

urban and rural providers;

(ii)

country-specific providers; and

(iii)

other subcategories, as appropriate.

(2)

Publication

Not later than 90 days after the completion of each study under paragraph (1), the Global AIDS Coordinator shall make the results of such study available on a publicly accessible Web site.

(h)

Message

The Global AIDS Coordinator shall develop a message, to be prominently displayed by each program receiving funds under this Act, that—

(1)

demonstrates that the program is a commitment by citizens of the United States to the global fight against HIV/AIDS, tuberculosis, and malaria; and

(2)

enhances awareness by program recipients that the program is an effort on behalf of the citizens of the United States.

.

102.

Interagency working group

Section 1(f)(2) of the State Department Basic Authorities Act of 1956 (22 U.S.C. 2651a(f)(2)) is amended—

(1)

in subparagraph (A), by inserting , partner country finance, health, and other relevant ministries, after community based organizations) each place it appears;

(2)

in subparagraph (B)(ii)—

(A)

by striking subclauses (IV) and (V);

(B)

by inserting after subclause (III) the following:

(IV)

Establishing an interagency working group on HIV/AIDS headed by the Global AIDS Coordinator and comprised of representatives from the United States Agency for International Development and the Department of Health and Human Services, for the purposes of coordination of activities relating to HIV/AIDS, including—

(aa)

meeting regularly to review progress in partner countries toward HIV/AIDS prevention, treatment, and care objectives;

(bb)

participating in the process of identifying countries to consider for increased assistance based on the epidemiology of HIV/AIDS in those countries, including clear evidence of a public health threat, as well as government commitment to address the HIV/AIDS problem, relative need, and coordination and joint planning with other significant actors;

(cc)

assisting the Coordinator in the evaluation, execution, and oversight of country operational plans;

(dd)

reviewing policies that may be obstacles to reaching targets set forth for HIV/AIDS prevention, treatment, and care; and

(ee)

consulting with representatives from additional relevant agencies, including the National Institutes of Health, the Health Resources and Services Administration, the Department of Labor, the Department of Agriculture, the Millennium Challenge Corporation, the Peace Corps, and the Department of Defense.

(V)

Coordinating overall United States HIV/AIDS policy and programs, including ensuring the coordination of relevant executive branch agency activities in the field, with efforts led by partner countries, and with the assistance provided by other relevant bilateral and multilateral aid agencies and other donor institutions to promote harmonization with other programs aimed at preventing and treating HIV/AIDS and other health challenges, improving primary health, addressing food security, promoting education and development, and strengthening health care systems.

;

(C)

by redesignating subclauses (VII) and VIII) as subclauses (IX) and (XII), respectively;

(D)

by inserting after subclause (VI) the following:

(VII)

Holding annual consultations with nongovernmental organizations in partner countries that provide services to improve health, and advocating on behalf of the individuals with HIV/AIDS and those at particular risk of contracting HIV/AIDS, including organizations with members who are living with HIV/AIDS.

(VIII)

Ensuring, through interagency and international coordination, that HIV/AIDS programs of the United States are coordinated with, and complementary to, the delivery of related global health, food security, development, and education.

;

(E)

in subclause (IX), as redesignated by subparagraph (C)—

(i)

by inserting Vietnam, after Uganda,;

(ii)

by inserting after of 2003 the following: ‘‘and other countries in which the United States is implementing HIV/AIDS programs as part of its foreign assistance program’’; and

(iii)

by adding at the end the following: In designating additional countries under this subparagraph, the President shall give priority to those countries in which there is a high prevalence of HIV or risk of significantly increasing incidence of HIV within the general population and inadequate financial means within the country.;

(F)

by inserting after subclause (IX), as redesignated by subparagraph (C), the following:

(X)

Working with partner countries in which the HIV/AIDS epidemic is prevalent among injection drug users to establish, as a national priority, national HIV/AIDS prevention programs.

(XI)

Working with partner countries in which the HIV/AIDS epidemic is prevalent among individuals involved in commercial sex acts to establish, as a national priority, national prevention programs, including education, voluntary testing, and counseling, and referral systems that link HIV/AIDS programs with programs to eradicate trafficking in persons and support alternatives to prostitution.

;

(G)

in subclause (XII), as redesignated by subparagraph (C), by striking funds section and inserting funds appropriated for HIV/ AIDS assistance pursuant to the authorization of appropriations under section 401 of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7671); and

(H)

by adding at the end the following:

(XIII)

Publicizing updated drug pricing data to inform the purchasing decisions of pharmaceutical procurement partners.

.

103.

Sense of Congress

Section 102 of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7612) is amended by adding at the end the following:

(d)

Sense of Congress

It is the sense of Congress that—

(1)

full-time country level coordinators, preferably with management experience, should head each HIV/AIDS country team for United States missions overseeing significant HIV/AIDS programs;

(2)

foreign service nationals provide critically important services in the design and implementation of United States country-level HIV/AIDS programs and their skills and experience as public health professionals should be recognized within hiring and compensation practices; and

(3)

staffing levels for United States country-level HIV/AIDS teams should be adequately maintained to fulfill oversight and other obligations of the positions.

.

II

Support for multilateral funds, programs, and public-private partnerships

201.

Voluntary contributions to international vaccine funds

Section 302 of the Foreign Assistance Act of 1961 (22 U.S.C. 2222) is amended—

(1)

by inserting after subsection (c) the following:

(d)

Tuberculosis vaccine development programs

In addition to amounts otherwise available under this section, there are authorized to be appropriated to the President such sums as may be necessary for each of the fiscal years 2009 through 2013, which shall be used for United States contributions to tuberculosis vaccine development programs, which may include the Aeras Global TB Vaccine Foundation.

;

(2)

in subsection (k)—

(A)

by striking fiscal years 2004 through 2008 and inserting fiscal years 2009 through 2013; and

(B)

by striking Vaccine Fund and inserting GAVI Fund.

(3)

in subsection (l), by striking fiscal years 2004 through 2008 and inserting fiscal years 2009 through 2013; and

(4)

in subsection (m), by striking fiscal years 2004 through 2008 and inserting fiscal years 2009 through 2013.

202.

Participation in the Global Fund to Fight AIDS, Tuberculosis and Malaria

(a)

Findings; sense of Congress

Section 202(a) of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7622(a)) is amended to read as follows:

(a)

Findings; Sense of Congress

(1)

Findings

Congress makes the following findings:

(A)

The establishment of the Global Fund in January 2002 is consistent with the general principles for an international AIDS trust fund first outlined by Congress in the Global AIDS and Tuberculosis Relief Act of 2000 (Public Law 106–264).

(B)

The Global Fund is an innovative financing mechanism which—

(i)

has made progress in many areas in combating HIV/AIDS, tuberculosis, and malaria; and

(ii)

represents the multilateral component of this Act, extending United States efforts to more than 130 countries around the world.

(C)

The Global Fund and United States bilateral assistance programs—

(i)

are demonstrating increasingly effective coordination, with each possessing certain comparative advantages in the fight against HIV/AIDS, tuberculosis, and malaria; and

(ii)

often work most effectively in concert with each other.

(D)

The United States Government—

(i)

is the largest supporter of the Global Fund in terms of resources and technical support;

(ii)

made the founding contribution to the Global Fund; and

(iii)

is fully committed to the success of the Global Fund as a multilateral public-private partnership.

(2)

Sense of Congress

It is the sense of Congress that—

(A)

transparency and accountability are crucial to the long-term success and viability of the Global Fund;

(B)

the Global Fund has made significant progress toward addressing concerns raised by the Government Accountability Office by—

(i)

improving risk assessment and risk management capabilities;

(ii)

providing clearer guidance for and oversight of Local Fund Agents; and

(iii)

strengthening the Office of the Inspector General for the Global Fund;

(C)

the provision of sufficient resources and authority to the Office of the Inspector General for the Global Fund to ensure that office has the staff and independence necessary to carry out its mandate will be a measure of the commitment of the Global Fund to transparency and accountability;

(D)

regular, publicly published financial, programmatic, and reporting audits of the Fund, its grantees, and Local Fund Agents are also important benchmarks of transparency;

(E)

the Global Fund should establish and maintain a system to track—

(i)

the amount of funds disbursed to each subrecipient on the grant’s fiscal cycle; and

(ii)

the distribution of resources, by grant and principal recipient, for prevention, care, treatment, drug and commodity purchases, and other purposes;

(F)

relevant national authorities in recipient countries should exempt from duties and taxes all products financed by Global Fund grants and procured by any principal recipient or subrecipient for the purpose of carrying out such grants;

(G)

the Global Fund, UNAIDS, and the Global AIDS Coordinator should work together to standardize program indicators wherever possible;

(H)

for purposes of evaluating total amounts of funds contributed to the Global Fund under subsection (d)(4)(A)(i), the timetable for evaluations of contributions from sources other than the United States should take into account the fiscal calendars of other major contributors; and

(I)

the Global Fund should not support activities involving the Affordable Medicines Facility-Malaria or similar entities pending compelling evidence of success from pilot programs as evaluated by the Coordinator of United States Government Activities to Combat Malaria Globally.

.

(b)

Statement of policy

Section 202(b) of such Act is amended by adding at the end the following:

(3)

Statement of policy

The United States Government regards the imposition by recipient countries of taxes or tariffs on goods or services provided by the Global Fund, which are supported through public and private donations, including the substantial contribution of the American people, as inappropriate and inconsistent with standards of good governance. The Global AIDS Coordinator or other representatives of the United States Government shall work with the Global Fund to dissuade governments from imposing such duties, tariffs, or taxes.

.

(c)

United States financial participation

Section 202(d) of such Act (22 U.S.C. 7622(d)) is amended—

(1)

in paragraph (1)—

(A)

by striking $1,000,000,000 for the period of fiscal year 2004 beginning on January 1, 2004 and inserting $2,000,000,000 for fiscal year 2009,; and

(B)

by striking the fiscal years 2005–2008 and inserting each of the fiscal years 2010 through 2013;

(2)

in paragraph (4)—

(A)

in subparagraph (A)—

(i)

in clause (i), by striking fiscal years 2004 through 2008 and inserting fiscal years 2009 through 2013;

(ii)

in clause (ii)—

(I)

by striking during any of the fiscal years 2004 through 2008 and inserting during any of the fiscal years 2009 through 2013; and

(II)

by adding at the end the following: The President may waive the application of this clause with respect to assistance for Sudan that is overseen by the Southern Country Coordinating Mechanism, including Southern Sudan, Southern Kordofan, Blue Nile State, and Abyei, if the President determines that the national interest or humanitarian reasons justify such a waiver. The President shall publish each waiver of this clause in the Federal Register and, not later than 15 days before the waiver takes effect, shall consult with the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives regarding the proposed waiver.; and

(iii)

in clause (vi)—

(I)

by striking for the purposes and inserting For the purposes;

(II)

by striking fiscal years 2004 through 2008 and inserting fiscal years 2009 through 2013; and

(III)

by striking prior to fiscal year 2004 and inserting before fiscal year 2009;

(B)

in subparagraph (B)(iv), by striking fiscal years 2004 through 2008 and inserting fiscal years 2009 through 2013; and

(C)

in subparagraph (C)(ii), by striking Committee on International Relations and inserting Committee on Foreign Affairs; and

(3)

by adding at the end the following:

(5)

Withholding funds

Notwithstanding any other provision of this Act, 20 percent of the amounts appropriated pursuant to this Act for a contribution to support the Global Fund for each of the fiscal years 2010 through 2013 shall be withheld from obligation to the Global Fund until the Secretary of State certifies to the appropriate congressional committees that the Global Fund—

(A)

has established an evaluation framework for the performance of Local Fund Agents (referred to in this paragraph as LFAs);

(B)

is undertaking a systematic assessment of the performance of LFAs;

(C)

has adopted, and is implementing, a policy to publish on a publicly available Web site—

(i)

grant performance reviews;

(ii)

all reports of the Inspector General of the Global Fund, in a manner that is consistent with the Policy for Disclosure of Reports of the Inspector General, approved at the 16th Meeting of the Board of the Global Fund;

(iii)

decision points of the Board of the Global Fund;

(iv)

reports from Board committees to the Board; and

(v)

a regular collection and analysis of performance data and funding of grants of the Global Fund, which shall cover all principal recipients and all subrecipients;

(D)

is maintaining an independent, well-staffed Office of the Inspector General that—

(i)

reports directly to the Board of the Global Fund; and

(ii)

compiles regular, publicly published audits of financial, programmatic, and reporting aspects of the Global Fund, its grantees, and LFAs;

(E)

has established, and is reporting publicly on, standard indicators for all program areas;

(F)

has established a methodology to track and is publicly reporting on—

(i)

all subrecipients and the amount of funds disbursed to each subrecipient on the grant’s fiscal cycle; and

(ii)

the distribution of resources, by grant and principal recipient, for prevention, care, treatment, drugs and commodities purchase, and other purposes;

(G)

has established a policy on tariffs imposed by national governments on all goods and services financed by the Global Fund;

(H)

through its Secretariat, has taken meaningful steps to prevent national authorities in recipient countries from imposing taxes or tariffs on goods or services provided by the Fund;

(I)

is maintaining its status as a financing institution focused on programs directly related to HIV/AIDS, malaria, and tuberculosis;

(J)

is maintaining and making progress on—

(i)

sustaining its multisectoral approach, through country coordinating mechanisms; and

(ii)

the implementation of grants, as reflected in the proportion of resources allocated to different sectors, including governments, civil society, and faith- and community-based organizations; and

(K)

has established procedures providing access by the Office of Inspector General of the Department of State and Broadcasting Board of Governors, as cognizant Inspector General, and the Inspector General of the Health and Human Services and the Inspector General of the United States Agency for International Development, to Global Fund financial data, and other information relevant to United States contributions (as determined by the Inspector General in consultation with the Global AIDS Coordinator).

(6)

Summaries of Board decisions and United States positions

Following each meeting of the Board of the Global Fund, the Coordinator of United States Government Activities to Combat HIV/AIDS Globally shall report on the public website of the Coordinator a summary of Board decisions and how the United States Government voted and its positions on such decisions.

.

203.

Research on methods for women to prevent transmission of HIV and other diseases

(a)

Sense of Congress

Congress recognizes the need and urgency to expand the range of interventions for preventing the transmission of human immunodeficiency virus (HIV), including nonvaccine prevention methods that can be controlled by women.

(b)

NIH Office of AIDS Research

Subpart 1 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:

2351A.

Microbicide research

(a)

Federal Strategic Plan

The Director of the Office shall—

(1)

expedite the implementation of the Federal strategic plans required by section 403(a) of the Public Health Service Act (42 U.S.C. 283(a)(5)) regarding the conduct and support of research on, and development of, a microbicide to prevent the transmission of the human immunodeficiency virus; and

(2)

review and, as appropriate, revise such plan to prioritize funding and activities relative to their scientific urgency and potential market readiness.

(b)

Coordination

In implementing, reviewing, and prioritizing elements of the plan described in subsection (a), the Director of the Office shall consult, as appropriate, with—

(1)

representatives of other Federal agencies involved in microbicide research, including the Coordinator of United States Government Activities to Combat HIV/AIDS Globally, the Director of the Centers for Disease Control and Prevention, and the Administrator of the United States Agency for International Development;

(2)

the microbicide research and development community; and

(3)

health advocates.

.

(c)

National institute of allergy and infectious diseases

Subpart 6 of part C of title IV of the Public Health Service Act (42 U.S.C. 285f et seq.) is amended by adding at the end the following:

447C.

Microbicide research and development

The Director of the Institute, acting through the head of the Division of AIDS, shall, consistent with the peer-review process of the National Institutes of Health, carry out research on, and development of, safe and effective methods for use by women to prevent the transmission of the human immunodeficiency virus, which may include microbicides.

.

(d)

CDC

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:

317T.

Microbicide research

(a)

In general

The Director of the Centers for Disease Control and Prevention is strongly encouraged to fully implement the Centers’ microbicide agenda to support research and development of microbicides for use to prevent the transmission of the human immunodeficiency virus.

(b)

Authorization of appropriations

There are authorized to be appropriated such sums as may be necessary for each of fiscal years 2009 through 2013 to carry out this section.

.

(e)

United States Agency for International Development

(1)

In general

The Administrator of the United States Agency for International Development, in coordination with the Coordinator of United States Government Activities to Combat HIV/AIDS Globally, may facilitate availability and accessibility of microbicides, provided that such pharmaceuticals are approved, tentatively approved, or otherwise authorized for use by—

(A)

the Food and Drug Administration;

(B)

a stringent regulatory agency acceptable to the Secretary of Health and Human Services; or

(C)

a quality assurance mechanism acceptable to the Secretary of Health and Human Services.

(2)

Authorization of appropriations

Of the amounts authorized to be appropriated under section 401 of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7671) for HIV/AIDS assistance, there are authorized to be appropriated to the President such sums as may be necessary for each of the fiscal years 2009 through 2013 to carry out this subsection.

204.

Combating HIV/AIDS, tuberculosis, and malaria by strengthening health policies and health systems of partner countries

(a)

In general

Title II of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7621) is amended by adding at the end the following:

204.

Combating HIV/AIDS, tuberculosis, and malaria by strengthening health policies and health systems of partner countries

(a)

Statement of policy

It shall be the policy of the United States Government—

(1)

to invest appropriate resources authorized under this Act—

(A)

to carry out activities to strengthen HIV/AIDS, tuberculosis, and malaria health policies and health systems; and

(B)

to provide workforce training and capacity-building consistent with the goals and objectives of this Act; and

(2)

to support the development of a sound policy environment in partner countries to increase the ability of such countries—

(A)

to maximize utilization of health care resources from donor countries;

(B)

to increase national investments in health and education and maximize the effectiveness of such investments;

(C)

to improve national HIV/AIDS, tuberculosis, and malaria strategies;

(D)

to deliver evidence-based services in an effective and efficient manner; and

(E)

to reduce barriers that prevent recipients of services from achieving maximum benefit from such services.

(b)

Assistance To improve public finance management systems

(1)

In general

Consistent with the authority under section 129 of the Foreign Assistance Act of 1961 (22 U.S.C. 2152), the Secretary of the Treasury, acting through the head of the Office of Technical Assistance, is authorized to provide assistance for advisors and partner country finance, health, and other relevant ministries to improve the effectiveness of public finance management systems in partner countries to enable such countries to receive funding to carry out programs to combat HIV/AIDS, tuberculosis, and malaria and to manage such programs.

(2)

Authorization of appropriations

Of the amounts authorized to be appropriated under section 401 for HIV/AIDS assistance, there are authorized to be appropriated to the Secretary of the Treasury such sums as may be necessary for each of the fiscal years 2009 through 2013 to carry out this subsection.

(c)

Plan required

The Global AIDS Coordinator, in collaboration with the Administrator of the United States Agency for International Development (USAID), shall develop and implement a plan to combat HIV/AIDS by strengthening health policies and health systems of partner countries as part of USAID’s Health Systems 2020 project. Recognizing that human and institutional capacity form the core of any health care system that can sustain the fight against HIV/AIDS, tuberculosis, and malaria, the plan shall include a strategy to encourage postsecondary educational institutions in partner countries, particularly in Africa, in collaboration with United States postsecondary educational institutions, including historically black colleges and universities, to develop such human and institutional capacity and in the process further build their capacity to sustain the fight against these diseases.

.

(b)

Clerical amendment

The table of contents for the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7601 note) is amended by inserting after the item relating to section 203, as added by section 203 of this Act, the following:

Sec. 204. Combating HIV/AIDS, tuberculosis, and malaria by strengthening health policies and health systems of partner countries.

.

205.

Facilitating effective operations of the Centers for Disease Control

Section 307 of the Public Health Service Act (42 U.S.C. 242l) is amended—

(1)

by amending subsection (a) to read as follows:

(a)

The Secretary may participate with other countries in cooperative endeavors in—

(1)

biomedical research, health care technology, and the health services research and statistical analysis authorized under section 306 and title IX; and

(2)

biomedical research, health care services, health care research, or other related activities in furtherance of the activities, objectives or goals authorized under the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008.

; and

(2)

in subsection (b)—

(A)

in paragraph (7), by striking and after the semicolon at the end;

(B)

by striking The Secretary may not, in the exercise of his authority under this section, provide financial assistance for the construction of any facility in any foreign country.

(C)

in paragraph (8), by striking for any purpose. and inserting for the purpose of any law administered by the Office of Personnel Management;; and

(D)

by adding at the end the following:

(9)

provide such funds by advance or reimbursement to the Secretary of State, as may be necessary, to pay the costs of acquisition, lease, construction, alteration, equipping, furnishing or management of facilities outside of the United States; and

(10)

in consultation with the Secretary of State, through grant or cooperative agreement, make funds available to public or nonprofit private institutions or agencies in foreign countries in which the Secretary is participating in activities described under subsection (a) to acquire, lease, construct, alter, or renovate facilities in those countries.

.

(3)

in subsection (c)—

(A)

by striking 1990 and inserting 1980; and

(B)

by inserting or or section 903 of the Foreign Service Act of 1980 (22 U.S.C. 4083) after Code.

206.

Facilitating vaccine development

(a)

Technical assistance for developing countries

The Administrator of the United States Agency for International Development, utilizing public-private partners, as appropriate, and working in coordination with other international development agencies, is authorized to strengthen the capacity of developing countries’ governmental institutions to—

(1)

collect evidence for informed decision-making and introduction of new vaccines, including potential HIV/AIDS, tuberculosis, and malaria vaccines, if such vaccines are determined to be safe and effective;

(2)

review protocols for clinical trials and impact studies and improve the implementation of clinical trials; and

(3)

ensure adequate supply chain and delivery systems.

(b)

Advanced market commitments

(1)

Purpose

The purpose of this subsection is to improve global health by requiring the United States to participate in negotiations for advance market commitments for the development of future vaccines, including potential vaccines for HIV/AIDS, tuberculosis, and malaria.

(2)

Negotiation requirement

The Secretary of the Treasury shall enter into negotiations with the appropriate officials of the International Bank of Reconstruction and Development (World Bank) and the GAVI Alliance, the member nations of such entities, and other interested parties to establish advanced market commitments to purchase vaccines to combat HIV/AIDS, tuberculosis, malaria, and other related infectious diseases.

(3)

Requirements

In negotiating the United States participation in programs for advanced market commitments, the Secretary of the Treasury shall take into account whether programs for advance market commitments include—

(A)

legally binding contracts for product purchase that include a fair market price for up to a maximum number of treatments, creating a strong market incentive;

(B)

clearly defined and transparent rules of program participation for qualified developers and suppliers of the product;

(C)

clearly defined requirements for eligible vaccines to ensure that they are safe and effective and can be delivered in developing country contexts;

(D)

dispute settlement mechanisms; and

(E)

sufficient flexibility to enable the contracts to be adjusted in accord with new information related to projected market size and other factors while still maintaining the purchase commitment at a fair price.

(4)

Report

Not later than 1 year after the date of the enactment of this Act—

(A)

the Secretary of the Treasury shall submit a report to the appropriate congressional committees on the status of the United States negotiations to participate in programs for the advanced market commitments under this subsection; and

(B)

the President shall produce a comprehensive report, written by a study group of qualified professionals from relevant Federal agencies and initiatives, nongovernmental organizations, and industry representatives, that sets forth a coordinated strategy to accelerate development of vaccines for infectious diseases, such as HIV/AIDS, malaria, and tuberculosis, which includes—

(i)

initiatives to create economic incentives for the research, development, and manufacturing of vaccines for HIV/AIDS, tuberculosis, malaria, and other infectious diseases;

(ii)

an expansion of public-private partnerships and the leveraging of resources from other countries and the private sector; and

(iii)

efforts to maximize United States capabilities to support clinical trials of vaccines in developing countries and to address the challenges of delivering vaccines in developing countries to minimize delays in access once vaccines are available.

III

Bilateral Efforts

A

General Assistance and Programs

301.

Assistance to combat HIV/AIDS

(a)

Amendments to the Foreign Assistance Act of 1961

(1)

Finding

Section 104A(a) of the Foreign Assistance Act of 1961 (22 U.S.C. 2151b–2(a)) is amended by inserting Central Asia, Eastern Europe, Latin America after Caribbean,.

(2)

Policy

Section 104A(b) of such Act is amended to read as follows:

(b)

Policy

(1)

Objectives

It is a major objective of the foreign assistance program of the United States to provide assistance for the prevention and treatment of HIV/AIDS and the care of those affected by the disease. It is the policy objective of the United States, by 2013, to—

(A)

assist partner countries to—

(i)

prevent 12,000,000 new HIV infections worldwide;

(ii)

support—

(I)

the increase in the number of individuals with HIV/AIDS receiving antiretroviral treatment above the goal established under section 402(a)(3) and increased pursuant to paragraphs (1) through (3) of section 403(d); and

(II)

additional treatment through coordinated multilateral efforts;

(iii)

support care for 12,000,000 individuals infected with or affected by HIV/AIDS, including 5,000,000 orphans and vulnerable children affected by HIV/AIDS, with an emphasis on promoting a comprehensive, coordinated system of services to be integrated throughout the continuum of care;

(iv)

provide at least 80 percent of the target population with access to counseling, testing, and treatment to prevent the transmission of HIV from mother-to-child;

(v)

provide care and treatment services to children with HIV in proportion to their percentage within the HIV-infected population of a given partner country; and

(vi)

train and support retention of health care professionals, paraprofessionals, and community health workers in HIV/AIDS prevention, treatment, and care, with the target of providing such training to at least 140,000 new health care professionals and paraprofessionals with an emphasis on training and in country deployment of critically needed doctors and nurses;

(B)

strengthen the capacity to deliver primary health care in developing countries, especially in sub-Saharan Africa;

(C)

support and help countries in their efforts to achieve staffing levels of at least 2.3 doctors, nurses, and midwives per 1,000 population, as called for by the World Health Organization; and

(D)

help partner countries to develop independent, sustainable HIV/AIDS programs.

(2)

Coordinated global strategy

The United States and other countries with the sufficient capacity should provide assistance to countries in sub-Saharan Africa, the Caribbean, Central Asia, Eastern Europe, and Latin America, and other countries and regions confronting HIV/AIDS epidemics in a coordinated global strategy to help address generalized and concentrated epidemics through HIV/AIDS prevention, treatment, care, monitoring and evaluation, and related activities.

(3)

Priorities

The United States Government’s response to the global HIV/AIDS pandemic and the Government’s efforts to help countries assume leadership of sustainable campaigns to combat their local epidemics should place high priority on—

(A)

the prevention of the transmission of HIV;

(B)

moving toward universal access to HIV/AIDS prevention counseling and services;

(C)

the inclusion of cost sharing assurances that meet the requirements under section 110; and

(D)

the inclusion of transition strategies to ensure sustainability of such programs and activities, including health care systems, under other international donor support, or budget support by respective foreign governments.

.

(b)

Authorization

Section 104A(c) of such Act is amended—

(1)

in paragraph (1), by striking and other countries and areas. and inserting Central Asia, Eastern Europe, Latin America, and other countries and areas, particularly with respect to refugee populations or those in postconflict settings in such countries and areas with significant or increasing HIV incidence rates.;

(2)

in paragraph (2), by striking and other countries and areas affected by the HIV/AIDS pandemic and inserting Central Asia, Eastern Europe, Latin America, and other countries and areas affected by the HIV/AIDS pandemic, particularly with respect to refugee populations or those in post-conflict settings in such countries and areas with significant or increasing HIV incidence rates.; and

(3)

in paragraph (3)—

(A)

by striking foreign countries and inserting partner countries, other international actors,; and

(B)

by inserting within the framework of the principles of the Three Ones before the period at the end.

(c)

Activities supported

Section 104A(d) of such Act is amended—

(1)

in paragraph (1)—

(A)

in subparagraph (A)—

(i)

by inserting and multiple concurrent sexual partnering, after casual sexual partnering; and

(ii)

by striking condoms and inserting male and female condoms;

(B)

in subparagraph (B)—

(i)

by striking programs that and inserting programs that are designed with local input and; and

(ii)

by striking those organizations and inserting those locally based organizations;

(C)

in subparagraph (D), by inserting and promoting the use of provider-initiated or opt-out voluntary testing in accordance with World Health Organization guidelines before the semicolon at the end;

(D)

by redesignating subparagraphs (F), (G), and (H) as subparagraphs (H), (I), and (J), respectively;

(E)

by inserting after subparagraph (E) the following:

(F)

assistance to—

(i)

achieve the goal of reaching 80 percent of pregnant women for prevention and treatment of mother-to-child transmission of HIV in countries in which the United States is implementing HIV/AIDS programs by 2013; and

(ii)

promote infant feeding options and treatment protocols that meet the most recent criteria established by the World Health Organization;

(G)

medical male circumcision programs as part of national strategies to combat the transmission of HIV/AIDS;

;

(F)

in subparagraph (I), as redesignated, by striking and at the end; and

(G)

by adding at the end the following:

(K)

assistance for counseling, testing, treatment, care, and support programs, including—

(i)

counseling and other services for the prevention of reinfection of individuals with HIV/AIDS;

(ii)

counseling to prevent sexual transmission of HIV, including—

(I)

life skills development for practicing abstinence and faithfulness;

(II)

reducing the number of sexual partners;

(III)

delaying sexual debut; and

(IV)

ensuring correct and consistent use of condoms;

(iii)

assistance to engage underlying vulnerabilities to HIV/AIDS, especially those of women and girls;

(iv)

assistance for appropriate HIV/AIDS education programs and training targeted to prevent the transmission of HIV among men who have sex with men;

(v)

assistance to provide male and female condoms;

(vi)

diagnosis and treatment of other sexually transmitted infections;

(vii)

strategies to address the stigma and discrimination that impede HIV/AIDS prevention efforts; and

(viii)

assistance to facilitate widespread access to microbicides for HIV prevention, if safe and effective products become available, including financial and technical support for culturally appropriate introductory programs, procurement, distribution, logistics management, program delivery, acceptability studies, provider training, demand generation, and postintroduction monitoring.

; and

(2)

in paragraph (2)—

(A)

in subparagraph (B), by striking and at the end;

(B)

in subparagraph (C)—

(i)

by inserting pain management, after opportunistic infections,; and

(ii)

by striking the period at the end and inserting a semicolon; and

(C)

by adding at the end the following:

(D)

as part of care and treatment of HIV/AIDS, assistance (including prophylaxis and treatment) for common HIV/AIDS-related opportunistic infections for free or at a rate at which it is easily affordable to the individuals and populations being served;

(E)

as part of care and treatment of HIV/AIDS, assistance or referral to available and adequately resourced service providers for nutritional support, including counseling and where necessary the provision of commodities, for persons meeting malnourishment criteria and their families;

;

(3)

in paragraph (4)—

(A)

in subparagraph (C), by striking and at the end;

(B)

in subparagraph (D), by striking the period at the end and inserting a semicolon; and

(C)

by adding at the end the following:

(E)

carrying out and expanding program monitoring, impact evaluation research and analysis, and operations research and disseminating data and findings through mechanisms to be developed by the Coordinator of United States Government Activities to Combat HIV/AIDS Globally, in coordination with the Director of the Centers for Disease Control, in order to—

(i)

improve accountability, increase transparency, and ensure the delivery of evidence-based services through the collection, evaluation, and analysis of data regarding gender-responsive interventions, disaggregated by age and sex;

(ii)

identify and replicate effective models; and

(iii)

develop gender indicators to measure outcomes and the impacts of interventions; and

(F)

establishing appropriate systems to—

(i)

gather epidemiological and social science data on HIV; and

(ii)

evaluate the effectiveness of prevention efforts among men who have sex with men, with due consideration to stigma and risks associated with disclosure.

;

(4)

in paragraph (5)—

(A)

by redesignating subparagraph (C) as subparagraph (D); and

(B)

by inserting after subparagraph (B) the following:

(C)

Mechanism to ensure cost-effective drug purchasing

Subject to subparagraph (B), mechanisms to ensure that safe and effective pharmaceuticals, including antiretrovirals and medicines to treat opportunistic infections, are purchased at the lowest possible price at which such pharmaceuticals may be obtained in sufficient quantity on the world market, provided that such pharmaceuticals are approved, tentatively approved, or otherwise authorized for use by—

(i)

the Food and Drug Administration;

(ii)

a stringent regulatory agency acceptable to the Secretary of Health and Human Services; or

(iii)

a quality assurance mechanism acceptable to the Secretary of Health and Human Services.

;

(5)

in paragraph (6)—

(A)

by amending the paragraph heading to read as follows:

(6)

Related and coordinated activities

;

(B)

in subparagraph (B), by striking and at the end;

(C)

in subparagraph (C), by striking the period at the end and inserting ; and; and

(D)

by adding at the end the following:

(D)

coordinated or referred activities to—

(i)

enhance the clinical impact of HIV/AIDS care and treatment; and

(ii)

ameliorate the adverse social and economic costs often affecting AIDS-impacted families and communities through the direct provision, as necessary, or through the referral, if possible, of support services, including—

(I)

nutritional and food support;

(II)

safe drinking water and adequate sanitation;

(III)

nutritional counseling;

(IV)

income-generating activities and livelihood initiatives;

(V)

maternal and child health care;

(VI)

primary health care;

(VII)

the diagnosis and treatment of other infectious or sexually transmitted diseases;

(VIII)

substance abuse and treatment services; and

(IX)

legal services;

(E)

coordinated or referred activities to link programs addressing HIV/AIDS with programs addressing gender-based violence in areas of significant HIV prevalence to assist countries in the development and enforcement of women’s health, children’s health, and HIV/AIDS laws and policies that—

(i)

prevent and respond to violence against women and girls;

(ii)

promote the integration of screening and assessment for gender-based violence into HIV/AIDS programming;

(iii)

promote appropriate HIV/AIDS counseling, testing, and treatment into gender-based violence programs; and

(iv)

assist governments to develop partnerships with civil society organizations to create networks for psychosocial, legal, economic, or other support services;

(F)

coordinated or referred activities to—

(i)

address the frequent coinfection of HIV and tuberculosis, in accordance with World Health Organization guidelines;

(ii)

promote provider-initiated or opt-out HIV/AIDS counseling and testing and appropriate referral for treatment and care to individuals with tuberculosis or its symptoms, particularly in areas with significant HIV prevalence; and

(iii)

strengthen programs to ensure that individuals testing positive for HIV receive tuberculosis screening and to improve laboratory capacities, infection control, and adherence; and

(G)

activities to—

(i)

improve the effectiveness of national responses to HIV/AIDS;

(ii)

strengthen overall health systems in high-prevalence countries, including support for workforce training, retention, and effective deployment, capacity building, laboratory development, equipment maintenance and repair, and public health and related public financial management systems and operations; and

(iii)

encourage fair and transparent procurement practices among partner countries; and

(iv)

promote in-country or intra-regional pediatric training for physicians and other health professionals, preferably through public-private partnerships involving colleges and universities, with the goal of increasing pediatric HIV workforce capacity.

; and

(6)

by adding at the end the following:

(8)

Compacts and framework agreements

The development of compacts or framework agreements, tailored to local circumstances, with national governments or regional partnerships in countries with significant HIV/AIDS burdens to promote host government commitment to deeper integration of HIV/AIDS services into health systems, contribute to health systems overall, and enhance sustainability, including—

(A)

cost sharing assurances that meet the requirements under section 110; and

(B)

transition strategies to ensure sustainability of such programs and activities, including health care systems, under other international donor support, or budget support by respective foreign governments.

.

(d)

Compacts and framework agreements

Section 104A of such Act is amended—

(1)

by redesignating subsections (e) through (g) as subsections (f) through (h); and

(2)

by inserting after subsection (d) the following:

(e)

Compacts and framework agreements

(1)

Findings

Congress makes the following findings:

(A)

The congressionally mandated Institute of Medicine report entitled PEPFAR Implementation: Progress and Promise states: The next strategy [of the U.S. Global AIDS Initiative] should squarely address the needs and challenges involved in supporting sustainable country HIV/AIDS programs, thereby transitioning from a focus on emergency relief..

(B)

One mechanism to promote the transition from an emergency to a public health and development approach to HIV/AIDS is through compacts or framework agreements between the United States Government and each participating nation.

(2)

Elements

Compacts on HIV/AIDS authorized under subsection (d)(8) shall include the following elements:

(A)

Compacts whose primary purpose is to provide direct services to combat HIV/AIDS are to be made between—

(i)

the United States Government; and

(ii)
(I)

national or regional entities representing low-income countries served by an existing United States Agency for International Development or Department of Health and Human Services presence or regional platform; or

(II)

countries or regions—

(aa)

experiencing significantly high HIV prevalence or risk of significantly increasing incidence within the general population;

(bb)

served by an existing United States Agency for International Development or Department of Health and Human Services presence or regional platform; and

(cc)

that have inadequate financial means within such country or region.

(B)

Compacts whose primary purpose is to provide limited technical assistance to a country or region connected to services provided within the country or region—

(i)

may be made with other countries or regional entities served by an existing United States Agency for International Development or Department of Health and Human Services presence or regional platform;

(ii)

shall require significant investments in HIV prevention, care, and treatment services by the host country;

(iii)

shall be time-limited in terms of United States contributions; and

(iv)

shall be made only upon prior notification to Congress—

(I)

justifying the need for such compacts;

(II)

describing the expected investment by the country or regional entity; and

(III)

describing the scope, nature, expected total United States investment, and time frame of the limited technical assistance under the compact and its intended impact.

(C)

Compacts shall include provisions to—

(i)

promote local and national efforts to reduce stigma associated with HIV/AIDS; and

(ii)

work with and promote the role of civil society in combating HIV/AIDS.

(D)

Compacts shall take into account the overall national health and development and national HIV/AIDS and public health strategies of each country.

(E)

Compacts shall contain—

(i)

consideration of the specific objectives that the country and the United States expect to achieve during the term of a compact;

(ii)

consideration of the respective responsibilities of the country and the United States in the achievement of such objectives;

(iii)

consideration of regular benchmarks to measure progress toward achieving such objectives;

(iv)

an identification of the intended beneficiaries, disaggregated by gender and age, and including information on orphans and vulnerable children, to the maximum extent practicable;

(v)

consideration of the methods by which the compact is intended to—

(I)

address the factors that put women and girls at greater risk of HIV/AIDS; and

(II)

strengthen elements such as the economic, educational, and social status of women, girls, orphans, and vulnerable children and the inheritance rights and safety of such individuals;

(vi)

consideration of the methods by which the compact will—

(I)

strengthen the health care capacity, including factors such as the training, retention, deployment, recruitment, and utilization of health care workers;

(II)

improve supply chain management; and

(III)

improve the health systems and infrastructure of the partner country, including the ability of compact participants to maintain and operate equipment transferred or purchased as part of the compact;

(vii)

consideration of proposed mechanisms to provide oversight;

(viii)

consideration of the role of civil society in the development of a compact and the achievement of its objectives;

(ix)

a description of the current and potential participation of other donors in the achievement of such objectives, as appropriate; and

(x)

consideration of a plan to ensure appropriate fiscal accountability for the use of assistance.

(F)

For regional compacts, priority shall be given to countries that are included in regional funds and programs in existence as of the date of the enactment of the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008.

(G)

Amounts made available for compacts described in subparagraphs (A) and (B) shall be subject to the inclusion of—

(i)

cost sharing assurances that meet the requirements under section 110; and

(ii)

transition strategies to ensure sustainability of such programs and activities, including health care systems, under other international donor support, and budget support by respective foreign governments.

(3)

Local input

In entering into a compact on HIV/AIDS authorized under subsection (d)(8), the Coordinator of United States Government Activities to Combat HIV/AIDS Globally shall seek to ensure that the government of a country—

(A)

takes into account the local perspectives of the rural and urban poor, including women, in each country; and

(B)

consults with private and voluntary organizations, including faith-based organizations, the business community, and other donors in the country.

(4)

Congressional and public notification after entering into a compact

Not later than 10 days after entering into a compact authorized under subsection (d)(8), the Global AIDS Coordinator shall—

(A)

submit a report containing a detailed summary of the compact and a copy of the text of the compact to—

(i)

the Committee on Foreign Relations of the Senate;

(ii)

the Committee on Appropriations of the Senate;

(iii)

the Committee on Foreign Affairs of the House of Representatives; and

(iv)

the Committee on Appropriations of the House of Representatives; and

(B)

publish such information in the Federal Register and on the Internet website of the Office of the Global AIDS Coordinator.

.

(e)

Annual report

Section 104A(f) of such Act, as redesignated, is amended—

(1)

in paragraph (1), by striking Committee on International Relations and inserting Committee on Foreign Affairs; and

(2)

in paragraph (2)—

(A)

in subparagraph (B), by striking and at the end;

(B)

by striking subparagraph (C) and inserting the following:

(C)

a detailed breakdown of funding allocations, by program and by country, for prevention activities; and

(D)

a detailed assessment of the impact of programs established pursuant to such sections, including—

(i)
(I)

the effectiveness of such programs in reducing—

(aa)

the transmission of HIV, particularly in women and girls;

(bb)

mother-to-child transmission of HIV, including through drug treatment and therapies, either directly or by referral; and

(cc)

mortality rates from HIV/AIDS;

(II)

the number of patients receiving treatment for AIDS in each country that receives assistance under this Act;

(III)

an assessment of progress towards the achievement of annual goals set forth in the timetable required under the 5-year strategy established under section 101 of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 and, if annual goals are not being met, the reasons for such failure; and

(IV)

retention and attrition data for programs receiving United States assistance, including mortality and loss to follow-up rates, organized overall and by country;

(ii)

the progress made toward—

(I)

improving health care delivery systems (including the training of health care workers, including doctors, nurses, midwives, pharmacists, laboratory technicians, and compensated community health workers, and the use of codes of conduct for ethical recruiting practices for health care workers);

(II)

advancing safe working conditions for health care workers; and

(III)

improving infrastructure to promote progress toward universal access to HIV/AIDS prevention, treatment, and care by 2013;

(iii)

a description of coordination efforts with relevant executive branch agencies to link HIV/AIDS clinical and social services with non-HIV/AIDS services as part of the United States health and development agenda;

(iv)

a detailed description of integrated HIV/AIDS and food and nutrition programs and services, including—

(I)

the amount spent on food and nutrition support;

(II)

the types of activities supported; and

(III)

an assessment of the effectiveness of interventions carried out to improve the health status of persons with HIV/AIDS receiving food or nutritional support;

(v)

a description of efforts to improve harmonization, in terms of relevant executive branch agencies, coordination with other public and private entities, and coordination with partner countries’ national strategic plans as called for in the Three Ones;

(vi)

a description of—

(I)

the efforts of partner countries that were signatories to the Abuja Declaration on HIV/AIDS, Tuberculosis and Other Related Infectious Diseases to adhere to the goals of such Declaration in terms of investments in public health, including HIV/AIDS; and

(II)

a description of the HIV/AIDS investments of partner countries that were not signatories to such Declaration;

(vii)

a detailed description of any compacts or framework agreements reached or negotiated between the United States and any partner countries, including a description of the elements of compacts described in subsection (e);

(viii)

a description of programs serving women and girls, including—

(I)

HIV/AIDS prevention programs that address the vulnerabilities of girls and women to HIV/AIDS;

(II)

information on the number of individuals served by programs aimed at reducing the vulnerabilities of women and girls to HIV/AIDS and data on the types, objectives, and duration of programs to address these issues;

(III)

information on programs to address the particular needs of adolescent girls and young women; and

(IV)

programs to prevent gender-based violence or to assist victims of gender based violence as part of, or in coordination with, HIV/AIDS programs;

(ix)

a description of strategies, goals, programs, and interventions to—

(I)

address the needs and vulnerabilities of youth populations;

(II)

expand access among young men and women to evidence-based HIV/AIDS health care services and HIV prevention programs, including abstinence education programs; and

(III)

expand community-based services to meet the needs of orphans and of children and adolescents affected by or vulnerable to HIV/AIDS without increasing stigmatization;

(x)

a description of—

(I)

the specific strategies funded to ensure the reduction of HIV infection among injection drug users;

(II)

the number of injection drug users, by country, reached by such strategies; and

(III)

medication-assisted drug treatment for individuals with HIV or at risk of HIV;

(xi)

a detailed description of program monitoring, operations research, and impact evaluation research, including—

(I)

the amount of funding provided for each research type;

(II)

an analysis of cost-effectiveness models; and

(III)

conclusions regarding the efficiency, effectiveness, and quality of services as derived from previous or ongoing research and monitoring efforts;

(xii)

building capacity to identify, investigate, and stop nosocomial transmission of infectious diseases, including HIV and tuberculosis; and

(xiii)

a description of staffing levels of United States government HIV/AIDS teams in countries with significant HIV/AIDS programs, including whether or not a full-time coordinator was on staff for the year.

.

(f)

Authorization of appropriations

Section 301(b) of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7631(b)) is amended—

(1)

in paragraph (1), by striking fiscal years 2004 through 2008 and inserting fiscal years 2009 through 2013; and

(2)

in paragraph (3), by striking fiscal years 2004 through 2008 and inserting fiscal years 2009 through 2013.

(g)

Relationship To assistance programs To enhance nutrition

Section 301(c) of such Act is amended to read as follows:

(c)

Food and nutritional support

(1)

In general

As indicated in the report produced by the Institute of Medicine, entitled PEPFAR Implementation: Progress and Promise, inadequate caloric intake has been clearly identified as a principal reason for failure of clinical response to antiretroviral therapy. In recognition of the impact of malnutrition as a clinical health issue for many persons living with HIV/AIDS that is often associated with health and economic impacts on these individuals and their families, the Global AIDS Coordinator and the Administrator of the United States Agency for International Development shall—

(A)

follow World Health Organization guidelines for HIV/AIDS food and nutrition services;

(B)

integrate nutrition programs with HIV/AIDS activities through effective linkages among the health, agricultural, and livelihood sectors and establish additional services in circumstances in which referrals are inadequate or impossible;

(C)

provide, as a component of care and treatment programs for persons with HIV/AIDS, food and nutritional support to individuals infected with, and affected by, HIV/AIDS who meet established criteria for nutritional support (including clinically malnourished children and adults, and pregnant and lactating women in programs in need of supplemental support), including—

(i)

anthropometric and dietary assessment;

(ii)

counseling; and

(iii)

therapeutic and supplementary feeding;

(D)

provide food and nutritional support for children affected by HIV/AIDS and to communities and households caring for children affected by HIV/AIDS; and

(E)

in communities where HIV/AIDS and food insecurity are highly prevalent, support programs to address these often intersecting health problems through community-based assistance programs, with an emphasis on sustainable approaches.

(2)

Authorization of appropriations

Of the amounts authorized to be appropriated under section 401, there are authorized to be appropriated to the President such sums as may be necessary for each of the fiscal years 2009 through 2013 to carry out this subsection.

.

(h)

Eligibility for assistance

Section 301(d) of such Act is amended to read as follows:

(d)

Eligibility for assistance

An organization, including a faith-based organization, that is otherwise eligible to receive assistance under section 104A of the Foreign Assistance Act of 1961, under this Act, or under any amendment made by this Act or by the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, for HIV/AIDS prevention, treatment, or care—

(1)

shall not be required, as a condition of receiving such assistance—

(A)

to endorse or utilize a multisectoral or comprehensive approach to combating HIV/AIDS; or

(B)

to endorse, utilize, make a referral to, become integrated with, or otherwise participate in any program or activity to which the organization has a religious or moral objection; and

(2)

shall not be discriminated against in the solicitation or issuance of grants, contracts, or cooperative agreements under such provisions of law for refusing to meet any requirement described in paragraph (1).

.

302.

Assistance to combat tuberculosis

(a)

Policy

Section 104B(b) of the Foreign Assistance Act of 1961 (22 U.S.C. 2151b–3(b)) is amended to read as follows:

(b)

Policy

It is a major objective of the foreign assistance program of the United States to control tuberculosis. In all countries in which the Government of the United States has established development programs, particularly in countries with the highest burden of tuberculosis and other countries with high rates of tuberculosis, the United States should support the objectives of the Global Plan to Stop TB, including through achievement of the following goals:

(1)

Reduce by half the tuberculosis death and disease burden from the 1990 baseline.

(2)

Sustain or exceed the detection of at least 70 percent of sputum smear-positive cases of tuberculosis and the successful treatment of at least 85 percent of the cases detected in countries with established United States Agency for International Development tuberculosis programs.

(3)

In support of the Global Plan to Stop TB, the President shall establish a comprehensive, 5-year United States strategy to expand and improve United States efforts to combat tuberculosis globally, including a plan to support—

(A)

the successful treatment of 4,500,000 new sputum smear tuberculosis patients under DOTS programs by 2013, primarily through direct support for needed services, commodities, health workers, and training, and additional treatment through coordinated multilateral efforts; and

(B)

the diagnosis and treatment of 90,000 new multiple drug resistant tuberculosis cases by 2013, and additional treatment through coordinated multilateral efforts.

.

(b)

Priority To Stop TB Strategy

Section 104B(e) of such Act is amended to read as follows:

(e)

Priority To Stop TB Strategy

In furnishing assistance under subsection (c), the President shall give priority to—

(1)

direct services described in the Stop TB Strategy, including expansion and enhancement of Directly Observed Treatment Short-course (DOTS) coverage, rapid testing, treatment for individuals infected with both tuberculosis and HIV, and treatment for individuals with multi-drug resistant tuberculosis (MDR–TB), strengthening of health systems, use of the International Standards for Tuberculosis Care by all providers, empowering individuals with tuberculosis, and enabling and promoting research to develop new diagnostics, drugs, and vaccines, and program-based operational research relating to tuberculosis; and

(2)

funding for the Global Tuberculosis Drug Facility, the Stop Tuberculosis Partnership, and the Global Alliance for TB Drug Development.

.

(c)

Assistance for the World Health Organization and the Stop Tuberculosis Partnership

Section 104B of such Act is amended—

(1)

by redesignating subsection (f) as subsection (h); and

(2)

by inserting after subsection (e) the following:

(f)

Assistance for the World Health Organization and the Stop Tuberculosis Partnership

In carrying out this section, the President, acting through the Administrator of the United States Agency for International Development, is authorized to provide increased resources to the World Health Organization and the Stop Tuberculosis Partnership to improve the capacity of countries with high rates of tuberculosis and other affected countries to implement the Stop TB Strategy and specific strategies related to addressing multiple drug resistant tuberculosis (MDR–TB) and extensively drug resistant tuberculosis (XDR–TB).

.

(d)

Annual report

Section 104B of such Act is amended by inserting after subsection (f), as added by subsection (c) of this section, the following:

(g)

Annual report

The President shall submit an annual report to Congress that describes the impact of United States foreign assistance on efforts to control tuberculosis, including—

(1)

the number of tuberculosis cases diagnosed and the number of cases cured in countries receiving United States bilateral foreign assistance for tuberculosis control purposes;

(2)

a description of activities supported with United States tuberculosis resources in each country, including a description of how those activities specifically contribute to increasing the number of people diagnosed and treated for tuberculosis;

(3)

in each country receiving bilateral United States foreign assistance for tuberculosis control purposes, the percentage provided for direct tuberculosis services in countries receiving United States bilateral foreign assistance for tuberculosis control purposes;

(4)

a description of research efforts and clinical trials to develop new tools to combat tuberculosis, including diagnostics, drugs, and vaccines supported by United States bilateral assistance;

(5)

the number of persons who have been diagnosed and started treatment for multidrug-resistant tuberculosis in countries receiving United States bilateral foreign assistance for tuberculosis control programs;

(6)

a description of the collaboration and coordination of United States anti-tuberculosis efforts with the World Health Organization, the Global Fund, and other major public and private entities within the Stop TB Strategy;

(7)

the constraints on implementation of programs posed by health workforce shortages and capacities;

(8)

the number of people trained in tuberculosis control; and

(9)

a breakdown of expenditures for direct patient tuberculosis services, drugs and other commodities, drug management, training in diagnosis and treatment, health systems strengthening, research, and support costs.

.

(e)

Definitions

Section 104B(h) of such Act, as redesignated by subsection (c), is amended—

(1)

in paragraph (1), by striking the period at the end and inserting the following: “including—

(A)

low-cost and effective diagnosis, treatment, and monitoring of tuberculosis;

(B)

a reliable drug supply;

(C)

a management strategy for public health systems;

(D)

health system strengthening;

(E)

promotion of the use of the International Standards for Tuberculosis Care by all care providers;

(F)

bacteriology under an external quality assessment framework;

(G)

short-course chemotherapy; and

(H)

sound reporting and recording systems.

; and

(2)

by redesignating paragraph (5) as paragraph (6); and

(3)

by inserting after paragraph (4) the following:

(5)

Stop TB strategy

The term Stop TB Strategy means the 6-point strategy to reduce tuberculosis developed by the World Health Organization, which is described in the Global Plan to Stop TB 2006–2015: Actions for Life, a comprehensive plan developed by the Stop TB Partnership that sets out the actions necessary to achieve the millennium development goal of cutting tuberculosis deaths and disease burden in half by 2015.

.

(f)

Authorization of appropriations

Section 302 (b) of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7632(b)) is amended—

(1)

in paragraph (1), by striking such sums as may be necessary for each of the fiscal years 2004 through 2008 and inserting a total of $4,000,000,000 for the 5-year period beginning on October 1, 2008.; and

(2)

in paragraph (3), by striking fiscal years 2004 through 2008 and inserting fiscal years 2009 through 2013..

303.

Assistance to combat malaria

(a)

Amendment to the Foreign Assistance Act of 1961

Section 104C(b) of the Foreign Assistance Act of 1961 (22 U.S.C. 2151–4(b)) is amended by inserting treatment, after control,.

(b)

Authorization of Appropriations

Section 303 of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003, and Malaria Act of 2003 (22 U.S.C. 7633) is amended—

(1)

in subsection (b)—

(A)

in paragraph (1), by striking such sums as may be necessary for fiscal years 2004 through 2008 and inserting $5,000,000,000 during the 5-year period beginning on October 1, 2008; and

(B)

in paragraph (3), by striking fiscal years 2004 through 2008 and inserting fiscal years 2009 through 2013; and

(2)

by adding at the end the following:

(c)

Statement of policy

Providing assistance for the prevention, control, treatment, and the ultimate eradication of malaria is—

(1)

a major objective of the foreign assistance program of the United States; and

(2)

1 component of a comprehensive United States global health strategy to reduce disease burdens and strengthen communities around the world.

(d)

Development of a Comprehensive 5-Year Strategy

The President shall establish a comprehensive, 5-year strategy to combat global malaria that—

(1)

strengthens the capacity of the United States to be an effective leader of international efforts to reduce malaria burden;

(2)

maintains sufficient flexibility and remains responsive to the ever-changing nature of the global malaria challenge;

(3)

includes specific objectives and multisectoral approaches and strategies to reduce the prevalence, mortality, incidence, and spread of malaria;

(4)

describes how this strategy would contribute to the United States’ overall global health and development goals;

(5)

clearly explains how outlined activities will interact with other United States Government global health activities, including the 5-year global AIDS strategy required under this Act;

(6)

expands public-private partnerships and leverage of resources;

(7)

coordinates among relevant Federal agencies to maximize human and financial resources and to reduce duplication among these agencies, foreign governments, and international organizations;

(8)

coordinates with other international entities, including the Global Fund;

(9)

maximizes United States capabilities in the areas of technical assistance and training and research, including vaccine research; and

(10)

establishes priorities and selection criteria for the distribution of resources based on factors such as—

(A)

the size and demographics of the population with malaria;

(B)

the needs of that population;

(C)

the country’s existing infrastructure; and

(D)

the ability to closely coordinate United States Government efforts with national malaria control plans of partner countries.

.

304.

Malaria Response Coordinator

Section 304 of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7634) is amended to read as follows:

304.

Malaria Response Coordinator

(a)

In general

There is established within the United States Agency for International Development a Coordinator of United States Government Activities to Combat Malaria Globally (referred to in this section as the Malaria Coordinator), who shall be appointed by the President.

(b)

Authorities

The Malaria Coordinator, acting through nongovernmental organizations (including faith-based and community-based organizations), partner country finance, health, and other relevant ministries, and relevant executive branch agencies as may be necessary and appropriate to carry out this section, is authorized to—

(1)

operate internationally to carry out prevention, care, treatment, support, capacity development, and other activities to reduce the prevalence, mortality, and incidence of malaria;

(2)

provide grants to, and enter into contracts and cooperative agreements with, nongovernmental organizations (including faith-based organizations) to carry out this section; and

(3)

transfer and allocate executive branch agency funds that have been appropriated for the purposes described in paragraphs (1) and (2).

(c)

Duties

(1)

In general

The Malaria Coordinator has primary responsibility for the oversight and coordination of all resources and international activities of the United States Government relating to efforts to combat malaria.

(2)

Specific duties

The Malaria Coordinator shall—

(A)

facilitate program and policy coordination of antimalarial efforts among relevant executive branch agencies and nongovernmental organizations by auditing, monitoring, and evaluating such programs;

(B)

ensure that each relevant executive branch agency undertakes antimalarial programs primarily in those areas in which the agency has the greatest expertise, technical capability, and potential for success;

(C)

coordinate relevant executive branch agency activities in the field of malaria prevention and treatment;

(D)

coordinate planning, implementation, and evaluation with the Global AIDS Coordinator in countries in which both programs have a significant presence;

(E)

coordinate with national governments, international agencies, civil society, and the private sector; and

(F)

establish due diligence criteria for all recipients of funds appropriated by the Federal Government for malaria assistance.

(d)

Assistance for the World Health Organization

In carrying out this section, the President may provide financial assistance to the Roll Back Malaria Partnership of the World Health Organization to improve the capacity of countries with high rates of malaria and other affected countries to implement comprehensive malaria control programs.

(e)

Coordination of Assistance Efforts

In carrying out this section and in accordance with section 104C of the Foreign Assistance Act of 1961 (22 U.S.C. 2151b–4), the Malaria Coordinator shall coordinate the provision of assistance by working with—

(1)

relevant executive branch agencies, including—

(A)

the Department of State (including the Office of the Global AIDS Coordinator);

(B)

the Department of Health and Human Services;

(C)

the Department of Defense; and

(D)

the Office of the United States Trade Representative;

(2)

relevant multilateral institutions, including—

(A)

the World Health Organization;

(B)

the United Nations Children’s Fund;

(C)

the United Nations Development Programme;

(D)

the Global Fund;

(E)

the World Bank; and

(F)

the Roll Back Malaria Partnership;

(3)

program delivery and efforts to lift barriers that would impede effective and comprehensive malaria control programs; and

(4)

partner or recipient country governments and national entities including universities and civil society organizations (including faith- and community-based organizations).

(f)

Research

To carry out this section, the Malaria Coordinator, in accordance with section 104C of the Foreign Assistance Act of 1961 (22 U.S.C. 1151d–4), shall ensure that operations and implementation research conducted under this Act will closely complement the clinical and program research being undertaken by the National Institutes of Health. The Centers for Disease Control and Prevention should advise the Malaria Coordinator on priorities for operations and implementation research and should be a key implementer of this research.

(g)

Monitoring

To ensure that adequate malaria controls are established and implemented, the Centers for Disease Control and Prevention should advise the Malaria Coordinator on monitoring, surveillance, and evaluation activities and be a key implementer of such activities under this Act. Such activities shall complement, rather than duplicate, the work of the World Health Organization.

(h)

Annual report

(1)

Submission

Not later than 1 year after the date of the enactment of the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, and annually thereafter, the President shall submit a report to the appropriate congressional committees that describes United States assistance for the prevention, treatment, control, and elimination of malaria.

(2)

Contents

The report required under paragraph (1) shall describe—

(A)

the countries and activities to which malaria resources have been allocated;

(B)

the number of people reached through malaria assistance programs, including data on children and pregnant women;

(C)

research efforts to develop new tools to combat malaria, including drugs and vaccines;

(D)

the collaboration and coordination of United States antimalarial efforts with the World Health Organization, the Global Fund, the World Bank, other donor governments, major private efforts, and relevant executive agencies;

(E)

the coordination of United States antimalarial efforts with the national malarial strategies of other donor or partner governments and major private initiatives;

(F)

the estimated impact of United States assistance on childhood mortality and morbidity from malaria;

(G)

the coordination of antimalarial efforts with broader health and development programs; and

(H)

the constraints on implementation of programs posed by health workforce shortages or capacities; and

(I)

the number of personnel trained as health workers and the training levels achieved.

.

305.

Amendment to Immigration and Nationality Act

Section 212(a)(1)(A)(i) of the Immigration and Nationality Act (8 U.S.C. 1182(a)(1)(A)(i)) is amended by striking , which shall include infection with the etiologic agent for acquired immune deficiency syndrome, and inserting a semicolon.

306.

Clerical amendment

Title III of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7631 et seq.) is amended by striking the heading for subtitle B and inserting the following:

B

Assistance for women, children, and families

.

307.

Requirements

Section 312(b) of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7652(b)) is amended by striking paragraphs (1), (2), and (3) and inserting the following:

(1)

establish a target for the prevention and treatment of mother-to-child transmission of HIV that, by 2013, will reach at least 80 percent of pregnant women in those countries most affected by HIV/AIDS in which the United States has HIV/AIDS programs;

(2)

establish a target that, by 2013, the proportion of children receiving care and treatment under this Act is proportionate to their numbers within the population of HIV infected individuals in each country;

(3)

integrate care and treatment with prevention of mother-to-child transmission of HIV programs to improve outcomes for HIV-affected women and families as soon as is feasible and support strategies that promote successful follow-up and continuity of care of mother and child;

(4)

expand programs designed to care for children orphaned by, affected by, or vulnerable to HIV/AIDS;

(5)

ensure that women in prevention of mother-to-child transmission of HIV programs are provided with, or referred to, appropriate maternal and child services; and

(6)

develop a timeline for expanding access to more effective regimes to prevent mother-to-child transmission of HIV, consistent with the national policies of countries in which programs are administered under this Act and the goal of achieving universal use of such regimes as soon as possible.

.

308.

Annual report on prevention of mother-to-child transmission of HIV

Section 313(a) of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7653(a)) is amended by striking 5 years and inserting 10 years.

309.

Prevention of mother-to-child transmission expert panel

Section 312 of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7652) is amended by adding at the end the following:

(c)

Prevention of mother-to-child transmission expert panel

(1)

Establishment

The Global AIDS Coordinator shall establish a panel of experts to be known as the Prevention of Mother-to-Child Transmission Panel (referred to in this subsection as the Panel) to—

(A)

provide an objective review of activities to prevent mother-to-child transmission of HIV; and

(B)

provide recommendations to the Global AIDS Coordinator and to the appropriate congressional committees for scale-up of mother-to-child transmission prevention services under this Act in order to achieve the target established in subsection (b)(1).

(2)

Membership

The Panel shall be convened and chaired by the Global AIDS Coordinator, who shall serve as a nonvoting member. The Panel shall consist of not more than 15 members (excluding the Global AIDS Coordinator), to be appointed by the Global AIDS Coordinator not later than 1 year after the date of the enactment of this Act, including—

(A)

2 members from the Department of Health and Human Services with expertise relating to the prevention of mother-to-child transmission activities;

(B)

2 members from the United States Agency for International Development with expertise relating to the prevention of mother-to-child transmission activities;

(C)

2 representatives from among health ministers of national governments of foreign countries in which programs under this Act are administered;

(D)

3 members representing organizations implementing prevention of mother-to-child transmission activities under this Act;

(E)

2 health care researchers with expertise relating to global HIV/AIDS activities; and

(F)

representatives from among patient advocate groups, health care professionals, persons living with HIV/AIDS, and non-governmental organizations with expertise relating to the prevention of mother-to-child transmission activities, giving priority to individuals in foreign countries in which programs under this Act are administered.

(3)

Duties of panel

The Panel shall—

(A)

assess the effectiveness of current activities in reaching the target described in subsection (b)(1);

(B)

review scientific evidence related to the provision of mother-to-child transmission prevention services, including programmatic data and data from clinical trials;

(C)

review and assess ways in which the Office of the United States Global AIDS Coordinator collaborates with international and multilateral entities on efforts to prevent mother-to-child transmission of HIV in affected countries;

(D)

identify barriers and challenges to increasing access to mother-to-child transmission prevention services and evaluate potential mechanisms to alleviate those barriers and challenges;

(E)

identify the extent to which stigma has hindered pregnant women from obtaining HIV counseling and testing or returning for results, and provide recommendations to address such stigma and its effects;

(F)

identify opportunities to improve linkages between mother-to-child transmission prevention services and care and treatment programs; and

(G)

recommend specific activities to facilitate reaching the target described in subsection (b)(1).

(4)

Report

(A)

In general

Not later than 1 year after the date on which the Panel is first convened, the Panel shall submit a report containing a detailed statement of the recommendations, findings, and conclusions of the Panel to the appropriate congressional committees.

(B)

Availability

The report submitted under subparagraph (A) shall be made available to the public.

(C)

Consideration by coordinator

The Coordinator shall—

(i)

consider any recommendations contained in the report submitted under subparagraph (A); and

(ii)

include in the annual report required under section 104A(f) of the Foreign Assistance Act of 1961 a description of the activities conducted in response to the recommendations made by the Panel and an explanation of any recommendations not implemented at the time of the report.

(5)

Authorization of appropriations

There are authorized to be appropriated to the Panel such sums as may be necessary for each of the fiscal years 2009 through 2011 to carry out this section.

(6)

Termination

The Panel shall terminate on the date that is 60 days after the date on which the Panel submits the report to the appropriate congressional committees under paragraph (4).

.

IV

Funding allocations

401.

Authorization of appropriations

(a)

In general

Section 401(a) of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7671(a)) is amended by striking $3,000,000,000 for each of the fiscal years 2004 through 2008 and inserting $48,000,000,000 for the 5-year period beginning on October 1, 2008.

(b)

Sense of Congress

It is the sense of the Congress that the appropriations authorized under section 401(a) of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003, as amended by subsection (a), should be allocated among fiscal years 2009 through 2013 in a manner that allows for the appropriations to be gradually increased in a manner that is consistent with program requirements, absorptive capacity, and priorities set forth in such Act, as amended by this Act.

402.

Sense of Congress

Section 402(b) of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7672(b)) is amended by striking an effective distribution of such amounts would be and all that follows through 10 percent of such amounts and inserting 10 percent should be used.

403.

Allocation of funds

Section 403 of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (22 U.S.C. 7673) is amended—

(1)

by amending subsection (a) to read as follows:

(a)

Balanced funding requirement

(1)

In general

The Global AIDS Coordinator shall—

(A)

provide balanced funding for prevention activities for sexual transmission of HIV/AIDS; and

(B)

ensure that activities promoting abstinence, delay of sexual debut, monogamy, fidelity, and partner reduction are implemented and funded in a meaningful and equitable way in the strategy for each host country based on objective epidemiological evidence as to the source of infections and in consultation with the government of each host county involved in HIV/AIDS prevention activities.

(2)

Prevention strategy

(A)

Establishment

In carrying out paragraph (1), the Global AIDS Coordinator shall establish an HIV sexual transmission prevention strategy governing the expenditure of funds authorized under this Act to prevent the sexual transmission of HIV in any host country with a generalized epidemic.

(B)

Report

In each host country described in subparagraph (A), if the strategy established under subparagraph (A) provides less than 50 percent of the funds described in subparagraph (A) for activities promoting abstinence, delay of sexual debut, monogamy, fidelity, and partner reduction, the Global AIDS Coordinator shall, not later than 30 days after the issuance of this strategy, report to the appropriate congressional committees on the justification for this decision.

(3)

Exclusion

Programs and activities that implement or purchase new prevention technologies or modalities, such as medical male circumcision, public education about risks to acquire HIV infection from blood exposures, promoting universal precautions, investigating suspected nosocomial infections, pre-exposure pharmaceutical prophylaxis to prevent transmission of HIV, or microbicides and programs and activities that provide counseling and testing for HIV or prevent mother-to-child prevention of HIV, shall not be included in determining compliance with paragraph (2).

(4)

Report

Not later than 1 year after the date of the enactment of the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, and annually thereafter as part of the annual report required under section 104A(e) of the Foreign Assistance Act of 1961 (22 U.S.C. 2151b–2(e)), the President shall—

(A)

submit a report on the implementation of paragraph (2) for the most recently concluded fiscal year to the appropriate congressional committees; and

(B)

make the report described in subparagraph (A) available to the public.

;

(2)

in subsection (b)—

(A)

by striking fiscal years 2006 through 2008 and inserting fiscal years 2009 through 2013; and

(B)

by striking vulnerable children affected by and inserting other children affected by, or vulnerable to,; and

(3)

by adding at the end the following:

(c)

Funding allocation

For each of the fiscal years 2009 through 2013, more than half of the amounts appropriated for bilateral global HIV/AIDS assistance pursuant to section 401 shall be expended for—

(1)

antiretroviral treatment for HIV/AIDS;

(2)

clinical monitoring of HIV-seropositive people not in need of antiretroviral treatment;

(3)

care for associated opportunistic infections;

(4)

nutrition and food support for people living with HIV/AIDS; and

(5)

other essential HIV/AIDS-related medical care for people living with HIV/AIDS.

(d)

Treatment, prevention, and care goals

For each of the fiscal years 2009 through 2013—

(1)

the treatment goal under section 402(a)(3) shall be increased above 2,000,000 by at least the percentage increase in the amount appropriated for bilateral global HIV/AIDS assistance for such fiscal year compared with fiscal year 2008;

(2)

any increase in the treatment goal under section 402(a)(3) above the percentage increase in the amount appropriated for bilateral global HIV/AIDS assistance for such fiscal year compared with fiscal year 2008 shall be based on long-term requirements, epidemiological evidence, the share of treatment needs being met by partner governments and other sources of treatment funding, and other appropriate factors;

(3)

the treatment goal under section 402(a)(3) shall be increased above the number calculated under paragraph (1) by the same percentage that the average United States Government cost per patient of providing treatment in countries receiving bilateral HIV/AIDS assistance has decreased compared with fiscal year 2008; and

(4)

the prevention and care goals established in clauses (i) and (iv) of section 104A(b)(1)(A) of the Foreign Assistance Act of 1961 (22 U.S.C. 2151b–2(b)(1)(A)) shall be increased consistent with epidemiological evidence and available resources.

.

V

Miscellaneous

501.

Machine readable visa fees

(a)

Fee increase

Notwithstanding any other provision of law—

(1)

not later than October 1, 2010, the Secretary of State shall increase by $1 the fee or surcharge authorized under section 140(a) of the Foreign Relations Authorization Act, Fiscal Years 1994 and 1995 (Public Law 103–236; 8 U.S.C. 1351 note) for processing machine readable nonimmigrant visas and machine readable combined border crossing identification cards and nonimmigrant visas; and

(2)

not later than October 1, 2013, the Secretary shall increase the fee or surcharge described in paragraph (1) by an additional $1.

(b)

Deposit of amounts

Notwithstanding section 140(a)(2) of the Foreign Relations Authorization Act, Fiscal Years 1994 and 1995 (Public Law 103–236; 8 U.S.C. 1351 note), fees collected under the authority of subsection (a) shall be deposited in the Treasury.

VI

Emergency plan for Indian safety and health

601.

Emergency plan for Indian safety and health

(a)

Establishment of Fund

There is established in the Treasury of the United States a fund, to be known as the Emergency Fund for Indian Safety and Health (referred to in this section as the Fund), consisting of such amounts as are appropriated to the Fund under subsection (b).

(b)

Transfers to Fund

(1)

In general

There is authorized to be appropriated to the Fund, out of funds of the Treasury not otherwise appropriated, $2,000,000,000 for the 5-year period beginning on October 1, 2008.

(2)

Availability of amounts

Amounts deposited in the Fund under this section shall—

(A)

be made available without further appropriation;

(B)

be in addition to amounts made available under any other provision of law; and

(C)

remain available until expended.

(c)

Expenditures from Fund

On request by the Attorney General, the Secretary of the Interior, or the Secretary of Health and Human Services, the Secretary of the Treasury shall transfer from the Fund to the Attorney General, the Secretary of the Interior, or the Secretary of Health and Human Services, as appropriate, such amounts as the Attorney General, the Secretary of the Interior, or the Secretary of Health and Human Services determines to be necessary to carry out the emergency plan under subsection (f).

(d)

Transfers of amounts

(1)

In general

The amounts required to be transferred to the Fund under this section shall be transferred at least monthly from the general fund of the Treasury to the Fund on the basis of estimates made by the Secretary of the Treasury.

(2)

Adjustments

Proper adjustment shall be made in amounts subsequently transferred to the extent prior estimates were in excess of or less than the amounts required to be transferred.

(e)

Remaining amounts

Any amounts remaining in the Fund on September 30 of an applicable fiscal year may be used by the Attorney General, the Secretary of the Interior, or the Secretary of Health and Human Services to carry out the emergency plan under subsection (f) for any subsequent fiscal year.

(f)

Emergency plan

Not later than 1 year after the date of enactment of this Act, the Attorney General, the Secretary of the Interior, and the Secretary of Health and Human Services, in consultation with Indian tribes (as defined in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b)), shall jointly establish an emergency plan that addresses law enforcement, water, and health care needs of Indian tribes under which, for each of fiscal years 2010 through 2019, of amounts in the Fund—

(1)

the Attorney General shall use—

(A)

18.5 percent for the construction, rehabilitation, and replacement of Federal Indian detention facilities;

(B)

1.5 percent to investigate and prosecute crimes in Indian country (as defined in section 1151 of title 18, United States Code);

(C)

1.5 percent for use by the Office of Justice Programs for Indian and Alaska Native programs; and

(D)

0.5 percent to provide assistance to—

(i)

parties to cross-deputization or other cooperative agreements between State or local governments and Indian tribes (as defined in section 102 of the Federally Recognized Indian Tribe List Act of 1994 (25 U.S.C. 479a)) carrying out law enforcement activities in Indian country; and

(ii)

the State of Alaska (including political subdivisions of that State) for carrying out the Village Public Safety Officer Program and law enforcement activities on Alaska Native land (as defined in section 3 of Public Law 103–399 (25 U.S.C. 3902));

(2)

the Secretary of the Interior shall—

(A)

deposit 15.5 percent in the public safety and justice account of the Bureau of Indian Affairs for use by the Office of Justice Services of the Bureau in providing law enforcement or detention services, directly or through contracts or compacts with Indian tribes under the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450 et seq.); and

(B)

use 50 percent to implement requirements of Indian water settlement agreements that are approved by Congress (or the legislation to implement such an agreement) under which the United States shall plan, design, rehabilitate, or construct, or provide financial assistance for the planning, design, rehabilitation, or construction of, water supply or delivery infrastructure that will serve an Indian tribe (as defined in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b)); and

(3)

the Secretary of Health and Human Services, acting through the Director of the Indian Health Service, shall use 12.5 percent to provide, directly or through contracts or compacts with Indian tribes under the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450 et seq.)—

(A)

contract health services;

(B)

construction, rehabilitation, and replacement of Indian health facilities; and

(C)

domestic and community sanitation facilities serving members of Indian tribes (as defined in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b)) pursuant to section 7 of the Act of August 5, 1954 (42 U.S.C. 2004a).

Speaker of the House of Representatives.

Vice President of the United States and President of the Senate.