In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.

[Q]: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Standardization of Collegiate
Oversight of Revenues and Expenditures Act'' or ''SCORE Act''.

SEC. 2. REPORTING BY INSTITUTIONS OF HIGHER EDUCATION ON ATHLETIC
REVENUE AND EXPENSES.

Section 485(g) of the Higher Education Act of 1965 (20 U.S.C.
1092(g)) is amended--
(1) in paragraph (1), by adding at the end the following:
''(K) The amount of revenue generated by each of
the following categories, disaggregated by each sports
team, if applicable:
''(i) Ticket sales.
''(ii) Student fees.
''(iii) Distributions from any other
intercollegiate athletic association,
conference, or tournament.
''(iv) Appearance guarantees and options.
''(v) Contributions from alumni and others.
''(vi) Compensation and benefits provided
by third-party support.
''(vii) Concessions, programs, novelties,
and parking.
''(viii) Broadcast and media rights,
reported separately for television, radio,
internet, and print.
''(ix) Royalties, advertising, and
sponsorship.
''(x) Sports camps.
''(xi) Endowment and investment income,
reported separately for each source of such
income.
''(xii) Direct institutional support.
''(xiii) Indirect institutional support for
facilities, services, and administrative
support.
''(xiv) Direct government support, reported
separately by State government, local
government, Federal Government.
''(L) The expenses attributable to each of the
following categories, disaggregated by each sports
team, as applicable:
''(i) Grants-in-aid.
''(ii) Guarantees and options.
''(iii) Total salaries and benefits, and
salaries and benefits paid by the institution
and by third parties, respectively, to head
coaches, to assistant coaches, and for
administrative salaries.
''(iv) Severance pay.
''(v) Team travel.
''(vi) Recruiting.
''(vii) Equipment, uniforms, and supplies.
''(viii) Fundraising.
''(ix) Marketing and promotion.
''(x) Game expenses.
''(xi) Medical.
''(xii) Membership dues.
''(xiii) Sports camps.
''(xiv) Spirit groups.
''(xv) Transfers to the institution.
''(xvi) Debt service payments.
''(xvii) Athletic facility maintenance and
rental.
''(xviii) Indirect facilities and
administrative support.
''(xix) Education and general expenses of
the institution--
''(I) including instruction,
research, public service, academic
support, student services,
instructional support, and scholarships
and fellowships; and
''(II) which do not include
expenses with respect to auxiliary
enterprises, hospitals, or independent
operations.'';
(2) in paragraph (5)--
(A) by striking ''the term'' and inserting the
following:
''(A) the term'';
(B) by striking the period at the end inserting '';
and''; and
(C) by adding at the end the following:
''(B) the terms listed in each of the categories
under subparagraphs (K) through (L) of paragraph (1)
shall be defined by the Secretary by regulation,
developed in consultation with the Secretary of the
Treasury and the task force described in paragraph
(6)(A), and such definitions shall be updated in
accordance with paragraph (6)(B).''; and
(3) by adding at the end the following:
''(6) Task force; definition updates.--
''(A) Task force.--The Secretary shall appoint a
task force of nonprofit and higher education accounting
experts, professionals, and organizations representing
each of the following:
''(i) Institutions of higher education that
are members of division I of National
Collegiate Athletic Association.
''(ii) Institutions of higher education
that are members of division II of National
Collegiate Athletic Association.
''(iii) Institutions of higher education
that are members of division III of National
Collegiate Athletic Association.
''(B) Updating definitions.--The Secretary, on a
biannual basis and in consultation with the task force
described in subparagraph (A), shall review each
definition under paragraph (5)(B) and, if necessary,
update such definition in accordance with generally
accepted accounting principles or significant changes
in the national system of intercollegiate athletics.
''(7) Special rule.--An institution of higher education
that submits the information described in subparagraphs (K)
through (L) of paragraph (1) to an intercollegiate athletic
association for an academic year, and such information is
verified by an independent audit and certified by chancellor of
the institution, may, in lieu of submitting such information
under paragraph (1), request such association to directly
submit such information to the Secretary on behalf of the
institution for such academic year.''.

SEC. 3. PROGRAM REQUIREMENTS.

Section 487(a) of the Higher Education Act of 1965 (20 U.S.C.
1094(a)) is amended by adding at the end the following:
''(30)(A) An institution will not be a member of any
intercollegiate athletic association or participate in any
national intercollegiate athletics competition organized by any
person, unless such association or person reports, on an annual
basis, to the Secretary the following, disaggregated by sport,
athletic event, or contract, as applicable:
''(i) Total generated revenue and amount of
revenue generated by each of the following
categories:
''(I) Total ticket sales.
''(II) Distributions from other
intercollegiate athletic organization
or person.
''(III) Cash contributions.
''(IV) Dues and other assessments
from member institutions of higher
education.
''(V) Third-party support.
''(VI) Merchandise.
''(VII) Concessions, programs, and
novelties.
''(VIII) Broadcast and media
rights, reported separately for
television, radio, internet, and print.
''(IX) Endowment and investment
income, reported separately for each
source of such income.
''(X) Other corporate sponsorship.
''(XI) Royalties, advertising, and
sponsorship.
''(XII) Net assets.
''(XIII) Direct government support,
reported separately by State
government, local government, or
Federal Government.
''(XIV) Any other category
determined appropriate by the
Secretary.
''(ii) Amount of expenses attributable to
each of the following categories:
''(I) Disbursements to institutions
of higher educations, athletic
conferences, or other persons.
''(II) Salaries and benefits.
''(III) Severance pay.
''(IV) Equipment, uniforms, and
supplies.
''(V) Fundraising.
''(VI) Marketing and promotion.
''(VII) Game expenses.
''(VIII) Medical.
''(IX) Facility construction.
''(X) Facility maintenance and
rental.
''(XI) Capital investment.
''(XII) Debt service payments.
''(XIII) Charitable donations.
''(XIV) Any other category
determined appropriate by the
Secretary.
''(iii) Executive compensation schedules.
''(B) The Secretary shall--
''(i) define by regulation, developed in
consultation with the Secretary of the Treasury
and the task force described in section
485(g)(6)(A), the terms listed in each of the
categories under subparagraphs (A); and
''(ii) on a biannual basis and in
consultation with such task force, review each
definition under clause (i) and, if necessary,
update such definition in accordance with
generally accepted accounting principles or
significant changes in the national system of
intercollegiate athletics.''.
[A]: Standardization of Collegiate Oversight of Revenues and Expenditures Act or the SCORE Act - Amends title IV (Student Assistance) of the Higher Education Act of 1965 to require each coeducational institution of higher education (IHE) that is participating in a title IV program and has an intercollegiate athletic program to include in its annual report on its intercollegiate athletic program: (1) the amount of revenue generated by each item on a list of categorized sources, disaggregated by each sports team; and (2) the expenses attributable to each item on a list of categorized activities or obligations, disaggregated by each sports team. Prohibits an IHE from being a member of any intercollegiate athletic association or participating in any national intercollegiate athletics competition organized by any person, unless such association or person annually reports and disaggregates by sport, athletic event, or contract, as applicable: (1) the total generated revenue and amount of revenue generated by each item on a list of categorized sources, (2) the amount of expenses attributable to each item on a list of categorized activities or obligations, and (3) executive compensation schedules. Directs the Secretary of Education to: (1) define the categories of information that must be reported pursuant to this Act; and (2) biannually review and, as necessary, update each definition in accordance with generally accepted accounting principles or significant changes in the national system of intercollegiate athletics. Directs the Secretary to appoint a task force, made up of representatives from division I, II, and III schools in the National Collegiate Athletic Association (NCAA), with which the Secretary is to consult in defining or redefining each category.

[Q]: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Safe and Secure Federal Websites Act
of 2015''.

SEC. 2. ENSURING FUNCTIONALITY AND SECURITY OF NEW FEDERAL WEBSITES
THAT COLLECT PERSONALLY IDENTIFIABLE INFORMATION.

(a) Certification Requirement.--
(1) In general.--Except as otherwise provided under this
subsection, an agency may not deploy or make available to the
public a new Federal PII website until the date on which the
chief information officer of the agency submits a certification
to Congress that the website is fully functional and secure.
(2) Transition.--In the case of a new Federal PII website
that is operational on the date of the enactment of this Act,
paragraph (1) shall not apply until the end of the 90-day
period beginning on such date of enactment. If the
certification required under paragraph (1) for such website has
not been submitted to Congress before the end of such period,
the head of the responsible agency shall render the website
inaccessible to the public until such certification is
submitted to Congress.
(3) Exception for beta website with explicit permission.--
Paragraph (1) shall not apply to a website (or portion thereof)
that is in a development or testing phase, if the following
conditions are met:
(A) A member of the public may access PII-related
portions of the website only after executing an
agreement that acknowledges the risks involved.
(B) No agency compelled, enjoined, or otherwise
provided incentives for such a member to access the
website for such purposes.
(4) Construction.--Nothing in this section shall be
construed as applying to a website that is operated entirely by
an entity (such as a State or locality) that is independent of
the Federal Government, regardless of the receipt of funding in
support of such website from the Federal Government.
(b) Definitions.--In this section:
(1) Agency.--The term ''agency'' has the meaning given that
term under section 551 of title 5, United States Code.
(2) Fully functional.--The term ''fully functional'' means,
with respect to a new Federal PII website, that the website can
fully support the activities for which it is designed or
intended with regard to the eliciting, collection, storage, or
maintenance of personally identifiable information, including
handling a volume of queries relating to such information
commensurate with the purpose for which the website is
designed.
(3) New federal personally identifiable information website
(new federal pii website).--The terms ''new Federal personally
identifiable information website'' and ''new Federal PII
website'' mean a website that--
(A) is operated by (or under a contract with) an
agency;
(B) elicits, collects, stores, or maintains
personally identifiable information of individuals and
is accessible to the public; and
(C) is first made accessible to the public and
collects or stores personally identifiable information
of individuals, on or after October 1, 2012.
(4) Operational.--The term ''operational'' means, with
respect to a website, that such website elicits, collects,
stores, or maintains personally identifiable information of
members of the public and is accessible to the public.
(5) Personally identifiable information (pii).--The terms
''personally identifiable information'' and ''PII'' mean any
information about an individual elicited, collected, stored, or
maintained by an agency, including--
(A) any information that can be used to distinguish
or trace the identity of an individual, such as a name,
a social security number, a date and place of birth, a
mother's maiden name, or biometric records; and
(B) any other information that is linked or
linkable to an individual, such as medical,
educational, financial, and employment information.
(6) Responsible agency.--The term ''responsible agency''
means, with respect to a new Federal PII website, the agency
that is responsible for the operation (whether directly or
through contracts with other entities) of the website.
(7) Secure.--The term ''secure'' means, with respect to a
new Federal PII website, that the following requirements are
met:
(A) The website is in compliance with subchapter II
of chapter 35 of title 44, United States Code.
(B) The website ensures that personally
identifiable information elicited, collected, stored,
or maintained in connection with the website is
captured at the latest possible step in a user input
sequence.
(C) The responsible agency for the website has
encrypted, masked, or taken other similar actions to
protect personally identifiable information elicited,
collected, stored, or maintained in connection with the
website.
(D) The responsible agency for the website has
taken reasonable efforts to minimize domain name
confusion, including through additional domain
registrations.
(E) The responsible agency requires all personnel
who have access to personally identifiable information
in connection with the website to have completed a
Standard Form 85P and signed a non-disclosure agreement
with respect to personally identifiable information,
and the agency takes proper precautions to ensure that
only the fewest reasonable number of trustworthy
persons may access such information.
(F) The responsible agency maintains (either
directly or through contract) sufficient personnel to
respond in a timely manner to issues relating to the
proper functioning and security of the website, and to
monitor on an ongoing basis existing and emerging
security threats to the website.
(8) State.--The term ''State'' means each State of the
United States, the District of Columbia, each territory or
possession of the United States, and each federally recognized
Indian tribe.

SEC. 3. PRIVACY BREACH REQUIREMENTS.

(a) Information Security Amendment.--Subchapter II of chapter 35 of
title 44, United States Code, is amended by adding at the end the
following:
''Sec. 3559. Privacy breach requirements
''(a) Policies and Procedures.--The Director of the Office of
Management and Budget shall establish and oversee policies and
procedures for agencies to follow in the event of a breach of
information security involving the disclosure of personally
identifiable information, including requirements for--
''(1) not later than 72 hours after the agency discovers
such a breach, or discovers evidence that reasonably indicates
such a breach has occurred, notice to the individuals whose
personally identifiable information could be compromised as a
result of such breach;
''(2) timely reporting to a Federal cybersecurity center,
as designated by the Director of the Office of Management and
Budget; and
''(3) any additional actions that the Director finds
necessary and appropriate, including data breach analysis,
fraud resolution services, identity theft insurance, and credit
protection or monitoring services.
''(b) Required Agency Action.--The head of each agency shall ensure
that actions taken in response to a breach of information security
involving the disclosure of personally identifiable information under
the authority or control of the agency comply with policies and
procedures established by the Director of the Office of Management and
Budget under subsection (a).
''(c) Report.--Not later than March 1 of each year, the Director of
the Office of Management and Budget shall report to Congress on agency
compliance with the policies and procedures established under
subsection (a).
''(d) Federal Cybersecurity Center Defined.--The term 'Federal
cybersecurity center' means any of the following:
''(1) The Department of Defense Cyber Crime Center.
''(2) The Intelligence Community Incident Response Center.
''(3) The United States Cyber Command Joint Operations
Center.
''(4) The National Cyber Investigative Joint Task Force.
''(5) Central Security Service Threat Operations Center of
the National Security Agency.
''(6) The United States Computer Emergency Readiness Team.
''(7) Any successor to a center, team, or task force
described in paragraphs (1) through (6).
''(8) Any center that the Director of the Office of
Management and Budget determines is appropriate to carry out
the requirements of this section.''.
(b) Technical and Conforming Amendment.--The table of sections for
subchapter II of chapter 35 of title 44, United States Code, is amended
by adding at the end the following:

''3559. Privacy breach requirements.''.
[A]: Safe and Secure Federal Websites Act of 2015 This bill establishes security and privacy requirements for new federal websites that collect personally identifiable information (PII) (i.e., information that can be used to distinguish or trace the identity of an individual or that is linked or linkable to an individual). (Sec. 2) A federal agency may not deploy or make available to the public a new federal PII website until the agency's chief information officer (CIO) certifies to Congress that the website is fully functional and secure. The CIO must make such certification within 90 days after enactment of this Act. After such 90-day period, any new federal PII website that has not been certified must be rendered inaccessible until certification is submitted. The prohibition does not apply to a website that is: (1) operated entirely by an entity that is independent of the federal government, or (2) in a development or testing phase (beta website). The exemption for beta websites applies only if: (1) a member of the public may access PII-related portions of the website only after executing an agreement that acknowledges the risks involved; and (2) no agency compelled, enjoined, or otherwise provided incentives for a member of the public to access such website. The bill defines a "new federal PII website" as a website that: (1) is operated by (or under contract with) an agency; (2) elicits, collects, stores, or maintains PII and is accessible to the public; and (3) is first made accessible to the public and collects or stores PII on or after October 1, 2012. The bill also sets forth requirements that must be met to deem a new federal PII website as "secure." (Sec. 3) The Director of the Office of Management and Budget (OMB) must establish and oversee policies and procedures for federal agencies to follow in the event of a breach of information security involving the disclosure of PII, including: (1) notice, not later than 72 hours after discovery of a breach or possible breach, to individuals whose PII could be compromised; and (2) timely reporting to a federal cybersecurity center designated by the OMB and defined in this Act. Agency heads must ensure that agency actions taken in response to a breach of information security involving the disclosure of PII comply with OMB policies and procedures established by this Act. The OMB must report to Congress, not later than March 1 of each year, on agency compliance with such policies and procedures. A "federal cybersecurity center" is defined to include: (1) the Department of Defense Cyber Crime Center, (2) the Intelligence Community Incident Response Center, (3) the U.S. Cyber Command Joint Operations Center, (4) the National Cyber Investigative Task Force, (5) the Central Security Service Threat Operations Center of the National Security Agency, (6) the U.S. Computer Emergency Readiness Team, and (7) any center that the OMB determines is appropriate to carry out privacy breach notice and reporting requirements.

[Q]: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Microbicide Development Act of
2001''.

SEC. 2. FINDINGS.

The Congress finds as follows:
(1) Sexually transmitted diseases (''STDs'') and the human
immunodeficiency virus (''HIV'') are producing serious and
costly epidemics of infectious disease in populations
worldwide.
(2) This year, 15,400,000 people in the United States will
acquire a new STD.
(3) Globally, 36,100,000 people are infected with HIV, with
more than 15,000 new infections occurring daily.
(4) Racial and ethnic minorities have been
disproportionately infected with STDs, especially HIV. For
example, although together African American and Latina women
represent roughly 25 percent of the total U.S. female
population, they account for 77 percent of all reported female
HIV cases.
(5) STDs cause serious, costly, even deadly conditions for
women and their children: infertility, pregnancy complications,
cervical cancer, infant mortality, and higher risk of
contracting HIV.
(6) Estimated annual costs of STDs and their complications
in the United States range from $8,400,000,000 in direct
medical costs to nearly $20,000,000,000, including out-of-
pocket costs and lost productivity.
(7) Microbicides are a promising new technology for STD and
HIV prevention.
(8) Microbicides are user-controlled products that could
kill or inactivate the bacteria and viruses that cause STDs and
HIV.
(9) Microbicides would fill a critical gap in the array of
STD-prevention technologies, first as an important backup or
alternative to the condom, and second, as a technology that,
unlike most vaccines, could offer protection against various
STDs, not just HIV.
(10) Several potential microbicides are poised for
successful development; more than 20 products are in clinical
trials and nearly 35 promising compounds exist that could be
investigated further.
(11) Studies into the market potential for microbicides
indicate that they would have broad appeal. One nationally
representative survey indicated that at least 21,000,000
sexually active women in the United States would be interested
in such products, if they were available.
(12) Federal support for microbicide research and
development is crucial.
(13) At present, there appear to be insufficient perceived
economic incentives for pharmaceutical companies to become
actively engaged in microbicide research and development.
(14) Numerous small biotechnology companies and university
researchers are actively engaged in microbicide research, but
they are almost totally dependent on public-sector grants to
continue their work and test their products.
(15) Despite public health need and tremendous scientific
opportunity, microbicide research and development currently
receives less than 1 percent of the Federal HIV research
budget--not nearly enough to keep pace with the raging STD and
HIV epidemics.
(16) Existing public sector grants for microbicides are too
small and too short-term to move product leads forward, and the
availability of clinical trial sites is limited by funding
constraints.
(17) There is a backlog in the research and development
pipeline, so that innovative and promising product concepts are
languishing, while infection rates are growing.
(18) For significant progress to be made, the current
amount of Federal investment needs to increase to $75,000,000
in fiscal year 2002, to $100,000,000 in fiscal year 2003, with
$100,000,000 yearly in the successive out-years as required, in
order to sustain multiyear funding at a productive level.

TITLE I--MICROBICIDE RESEARCH AT THE NATIONAL INSTITUTES OF HEALTH

SEC. 101. NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES;
PROGRAM REGARDING MICROBICIDES FOR PREVENTING
TRANSMISSION OF HIV AND OTHER SEXUALLY TRANSMITTED
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
section:

''microbicides for preventing transmission of hiv and other sexually
transmitted diseases

''Sec. 447C. (a) Expansion and Coordination of Activities.--The
Director of the Institute shall expand, intensify, and coordinate the
activities of the Institute with respect to research on the development
of microbicides to prevent the transmission of HIV and other sexually
transmitted diseases (in this section referred to as 'microbicide
research').
''(b) Coordination With Other Institutes.--The Director of the
Institute shall coordinate the activities under subsection (a) among
all appropriate institutes and components of the National Institutes of
Health to the extent such institutes and components have
responsibilities that are related to the development of microbicides.
''(c) Research Plan.--
''(1) In general.--The Director of the Institute, acting in
consultation with the Director of the Office of AIDS Research,
shall develop a comprehensive research plan for the conduct and
support of research and development of microbicides (in this
section referred to as the 'Research Plan'), and shall annually
review and as appropriate revise the plan.
''(2) Requirements.--The Research Plan shall--
''(A) identify current microbicide research and
development activities conducted or supported by the
National Institutes of Health, including a description
of each current grant and contract mechanism explicitly
designed to facilitate microbicide research, including
support for preclinical product development and
clinical trial capacity; and
''(B) describe microbicide research and development
opportunities for the five year period beginning six
months after the date of the enactment of the
Microbicide Development Act of 2001, including
professional judgment funding projections, description
of objectives with respect to microbicide research,
description of the institutes involved and their role
in microbicide research, plans for enhancing the
capacity of such institutes to carry out the research
opportunities, including staffing and resources
necessary for carrying out the activities of this
section, and discussion of plans for increasing number
of investigators in this area of research.
''(3) Consultation.--In developing the Research Plan, the
Director of the Institute shall work in close consultation with
all appropriate institutes and components at the National
Institutes for Health that have responsibilities that are
related to the development of microbicides, with the
microbicide research community, and with health advocates.
''(4) Submission of initial plan to president and
congress.--
''(A) In general.--The initial Research Plan shall
be developed not later than six months after the date
of the enactment of the Microbicide Development Act of
2001. The Director of the Institute shall transmit such
Plan to the Director of NIH, who shall submit the Plan
to the President and the Congress.
''(B) Relation to requirement of biennial nih
report.--Subparagraph (A) shall be carried out
independently of the process of reporting that is
required in section 403.
''(d) Program for Microbicide Development.--
''(1) In general.--In carrying out subsection (a), the
Director of the Institute shall establish a program to support
research to develop microbicides that can substantially reduce
transmission of HIV and other sexually transmitted diseases.
Activities under such program shall provide for an expansion
and intensification of the conduct and support of--
''(A) basic research on the initial mechanisms of
infection by sexually transmitted pathogens;
''(B) development of appropriate animal models for
evaluating safety and efficacy of microbicides;
''(C) development of formulation and delivery
approaches;
''(D) research on targeted designs of microbicides;
''(E) manufacture of candidate products for testing
in animals and humans;
''(F) conduct of HIV incidence and microbicide
feasibility studies;
''(G) evaluation of microbicides in clinical
trials, both domestically and internationally; and
''(H) behavioral research on use, acceptability,
and adherence to microbicides.
''(2) Research branch.--The Director of the Institute shall
establish, within the Vaccine and Prevention Research Program
of the Division of AIDS in the Institute, an organizational
unit to be known as the Microbicide Research Branch. Such
Branch shall carry out the program under this subsection.
''(e) Construction of Facilities.--The Director of the Institute
may make awards of grants and contracts to public and nonprofit private
entities for the construction of facilities to conduct microbicide
research, including clinical trials.
''(f) Centers for Microbicide Research and Development.--
''(1) In general.--The Director of the Institute, after
consultation with the advisory council for the Institute, and
in consultation with the Director of the Office of AIDS
Research, shall make awards of grants or contracts to public
and nonprofit private entities for the development and
operation of not less than four multidisciplinary research
centers to conduct microbicide research.
''(2) Requirements.--Each center assisted under this
subsection shall--
''(A) use the facilities of a single institution,
or be formed from a consortium of cooperating
institutions, meeting such requirements as may be
prescribed by the Director of the Institute; and
''(B) conduct basic research on muscosal
transmission to design novel microbicide strategies for
the prevention of HIV and STD infection, including
research into HIV and STD pathogenesis, reproductive
tract biology and toxicology, concept testing in animal
models, and formulation and delivery design.
''(g) Report to Congress.--Not later than one year after the date
of the initial submission of the Research Plan under subsection (c)(1),
and annually thereafter, the Director of the Institute shall submit to
the Committee on Energy and Commerce in the House of Representatives
and the Committee on Health, Education, Labor and Pensions in the
Senate a report that describes the activities of the Institute
regarding microbicide research. Each such report shall include--
''(1) an updated Research Plan, including professional
judgment funding projections;
''(2) an assessment of the implementation of such plan;
''(3) a description and evaluation of the progress made,
during the period for which such report is prepared, in the
research on microbicides;
''(4) a summary and analysis of expenditures made, during
the period for which the report is made, for activities with
respect to microbicides research conducted and supported by the
National Institutes of Health, including the number of full-
time equivalent employees; and
''(5) such comments and recommendations as the Director of
the Institute considers appropriate.
''(h) Coordination With Other Federal Agencies.--The Director of
the Institute shall consult with the Director for the Centers for
Disease Control and Prevention and the United States Agency for
International Development in developing the Research Plan that takes
into consideration research on HIV and other sexually transmitted
diseases and microbicides carried out at the Centers for Disease
Control and Prevention and the United States Agency for International
Development.
''(i) Definition.--For purposes of this section, the term 'HIV'
means the human immunodeficiency virus. Such term includes acquired
immune deficiency syndrome.
''(j) Authorization of Appropriations.--For the purposes of
carrying out this section, there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years 2002 through
2004.''.

TITLE II--MICROBICIDE RESEARCH AT THE CENTERS FOR DISEASE CONTROL AND
PREVENTION

SEC. 201. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV AND OTHER
SEXUALLY TRANSMITTED DISEASES.

Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended by inserting after section 317P the following
section:

''microbicides for preventing transmission of hiv and other sexually
transmitted diseases

''Sec. 317Q. (a) Expansion and Coordination of Microbicide Research
Activities.--The Secretary, acting through the Director of the Centers
for Disease Control and Prevention, shall expand, intensify, and
coordinate the activities of such Centers with respect to research on
microbicides to prevent the transmission of HIV and other sexually
transmitted diseases.
''(b) Grants Regarding Microbicide Research.--In order to
contribute to the rapid evaluation of safe and effective microbicides
for the prevention of HIV and other sexually transmitted diseases, the
Secretary may in carrying out subsection (a) make grants to public and
nonprofit private entities for the purpose of--
''(1) laboratory research in preparation for, and support
of, clinical microbicide trials;
''(2) conducting behavioral research in preparation for,
and support of, clinical microbicide trials;
''(3) developing and characterizing domestic populations
and international cohorts appropriate for Phase I, II, and III
clinical trials of candidate topical microbicides;
''(4) conducting Phase I and II clinical trials to assess
the safety and acceptability of candidate microbicides;
''(5) conducting Phase III clinical trials to assess the
efficacy of candidate microbicides;
''(6) provide technical assistance to, and consultation
with, a wide variety of domestic and international entities
involved in developing and evaluating topical microbicides,
including health agencies, extramural researchers, industry,
health advocates, and non-profit organizations; and
''(7) developing and evaluating the diffusion and effects
of implementation strategies for use of effective topical
microbicides.
''(c) Selection of Agents and Trial Designs; Coordination With
Other Agencies.--In coordination and collaboration with the Director of
the National Institutes of Health and the Administrator of the United
States Agency for International Development, the Secretary shall select
agents and trial designs, develop clinical trial capacity as described
in subsection (b), share experience, and avoid duplication of effort.
''(d) Annual Reports.--Not later than six months after the date of
the enactment of the Microbicide Development Act of 2001, and annually
thereafter, the Secretary shall submit to the Energy and Commerce
Committee in the House of Representatives and the Health, Education,
Labor and Pensions Committee in the Senate a report on the activities
carried out under this section by the Secretary. Each such report shall
include--
''(1) description of research with respect to microbicide
research and development;
''(2) description and evaluation of the progress made,
during the period for which such report is prepared, in the
research on microbicides; and
''(3) summary and analysis of expenditures made, during the
period for which the report is made, for activities with
respect to microbicides conducted and supported by the Centers
for Disease Control and Prevention.
''(e) Definition.--For the purposes of this section, the term 'HIV'
means the human immunodeficiency virus. Such term includes acquired
immune deficiency syndrome.
''(f) Authorization of Appropriations.--For the purposes of
carrying out this section, there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years 2002 through
2004.''.
[A]:
Microbicide Development Act of 2001 - Amends the Public Health Service Act to direct the Director of the National Institute of Allergy and Infectious Diseases to expand, intensify, and coordinate the activities of the Institute with respect to research on the development of microbicides to prevent the transmission of HIV and other sexually transmitted diseases.Directs the Secretary of Health and Human Services to expand, intensify, and coordinate the activities of such Centers with respect to research on microbicides to prevent the transmission of HIV and other sexually transmitted diseases.