after the date of the enactment of the National In-
stitutes of Health Revitalization Act of 1993.
‘‘(5) REQUIRED AGREEMENTS.—For any fiscal
year beginning after the date on which the regula-
tions required in paragraph (1) are issued, the Sec-
retary may not provide a grant, cooperative agree-
ment, or contract under this Act for biomedical or
behavioral research unless the entity seeking such fi-
nancial assistance agrees that the entity—
‘‘(A) will maintain the procedures de-
scribed in the regulations; and
‘‘(B) will otherwise be subject to the regu-
lations.’’.
SEC. 154. REQUIREMENT OF REGULATIONS REGARDING
PROTECTION 
AGAINST 
FINANCIAL 
CON-
FLICTS OF INTEREST IN CERTAIN PROJECTS
OF RESEARCH.
Part H of title IV of the Public Health Service Act,
as redesignated by section 141(a)(2) of this Act, is amend-
ed by inserting after section 493 the following new section:
‘‘PROTECTION AGAINST FINANCIAL CONFLICTS OF
INTEREST IN CERTAIN PROJECTS OF RESEARCH
‘‘SEC. 493A. (a) ISSUANCE OF REGULATIONS.—
‘‘(1) IN GENERAL.—The Secretary shall define
by regulation, the specific circumstances that con-
stitute the existence of a financial interest in a
project on the part of an entity or individual that
will, or may be reasonably expected to, create a bias
in favor of obtaining results in such project that are
consistent with such financial interest. Such defini-
tion shall apply uniformly to each entity or individ-
ual conducting a research project under this Act. In
the case of any entity or individual receiving assist-
ance from the Secretary for a project of research de-
scribed in paragraph (2), the Secretary shall by reg-
ulation establish standards for responding to, includ-
ing managing, reducing, or eliminating, the existence
of such a financial interest. The entity may adopt
individualized procedures for implementing the
standards.
‘‘(2) RELEVANT PROJECTS.—A project of re-
search referred to in paragraph (1) is a project of
clinical research whose purpose is to evaluate the
safety or effectiveness of a drug, medical device, or
treatment and for which such entity is receiving as-
sistance from the Secretary.
‘‘(3) IDENTIFYING AND REPORTING TO THE DI-
RECTOR.—The Secretary shall ensure that the
standards established under paragraph (1) specify
that as a condition of receiving assistance from the
Secretary for the project involved, an entity de-
scribed in such subsection is required—
‘‘(A) to have in effect at the time the en-
tity applies for the assistance and throughout
the period during which the assistance is re-
ceived, a process for identifying such financial
interests as defined in paragraph (1) that exist
regarding the project; and
‘‘(B) to report to the Director such finan-
cial interest as defined in paragraph (1) identi-
fied by the entity and how any such financial
interest identified by the entity will be managed
or eliminated such that the project in question
will be protected from bias that may stem from
such financial interest.
‘‘(4) MONITORING OF PROCESS.—The Secretary
shall monitor the establishment and conduct of the
process established by an entity pursuant to para-
graph (1).
‘‘(5) RESPONSE.—In any case in which the Sec-
retary determines that an entity has failed to comply
with paragraph (3) regarding a project of research
described in paragraph (1), the Secretary—
‘‘(A) shall require that, as a condition of
receiving assistance, the entity disclose the ex-
istence of a financial interest as defined in
paragraph (1) in each public presentation of the
results of such project; and
‘‘(B) may take such other actions as the
Secretary determines to be appropriate.
‘‘(6) DEFINITION.—As used in this section:
‘‘(A) The term ‘financial interest’ includes
the receipt of consulting fees or honoraria and
the ownership of stock or equity.
‘‘(B) The term ‘assistance’, with respect to
conducting a project of research, means a
grant, contract, or cooperative agreement.
‘‘(b) FINAL RULE
FOR REGULATIONS.—The Sec-
retary shall issue a final rule for the regulations required
in subsection (a) not later than 180 days after the date
of the enactment of the National Institutes of Health Re-
vitalization Act of 1993.’’.
SEC. 155. EFFECTIVE DATES.
(a) IN GENERAL.—The amendments made by this
subtitle shall become effective on the date that occurs 180
days after the date on which the final rule required under
section 493(f)(4) of the Public Health Service Act, as
amended by sections 151 and 153, is published in the Fed-
eral Register.
(b) AGREEMENTS AS A CONDITION OF FUNDING.—
The requirements of subsection (f)(5) of section 493 of
the Public Health Service Act, as amended by sections 151
and 153, with respect to agreements as a condition of
funding shall not be effective in the case of projects of
research for which initial funding under the Public Health
Service Act was provided prior to the effective date de-
scribed in subsection (a).
TITLE II—NATIONAL INSTITUTES
OF HEALTH IN GENERAL
SEC. 201. HEALTH PROMOTION RESEARCH DISSEMINA-
TION.
Section 402(f) of the Public Health Service Act (42
U.S.C. 282(f)) is amended by striking ‘‘other public and
private entities.’’ and all that follows through the end and
inserting ‘‘other public and private entities, including ele-
mentary, secondary, and post-secondary schools. The As-
sociate Director shall—
‘‘(1) annually review the efficacy of existing
policies and techniques used by the national research
institutes to disseminate the results of disease pre-
vention and behavioral research programs;
‘‘(2) recommend, coordinate, and oversee the
modification or reconstruction of such policies and
techniques to ensure maximum dissemination, using
advanced technologies to the maximum extent prac-
ticable, of research results to such entities; and
‘‘(3) annually prepare and submit to the Direc-
tor of NIH a report concerning the prevention and
dissemination activities undertaken by the Associate
Director, including—
‘‘(A) a summary of the Associate Direc-
tor’s review of existing dissemination policies
and techniques together with a detailed state-
ment concerning any modification or restructur-
ing, or recommendations for modification or re-
structuring, of such policies and techniques;
and
‘‘(B) a detailed statement of the expendi-
tures made for the prevention and dissemina-
tion activities reported on and the personnel
used in connection with such activities.’’.
SEC. 202. PROGRAMS FOR INCREASED SUPPORT REGARD-
ING CERTAIN STATES AND RESEARCHERS.
Section 402 of the Public Health Service Act (42
U.S.C. 282) is amended by adding at the end the following
new subsection:
‘‘(g)(1)(A) In the case of entities described in sub-
paragraph (B), the Director of NIH, acting through the
Director of the National Center for Research Resources,