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‘‘(2) an increase in the number of career development
awards for health professionals who intend to build careers
in pediatric basic and clinical research.
‘‘(b) AUTHORIZATION.—For the purpose of carrying out sub-
section (a), there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 2001 through
2005.’’.
(b) PEDIATRIC RESEARCH LOAN REPAYMENT PROGRAM.—Part
G of title IV of the Public Health Service Act (42 U.S.C. 288
et seq.) is amended by inserting after section 487E the following
section:
‘‘PEDIATRIC RESEARCH LOAN REPAYMENT PROGRAM
‘‘SEC. 487F. (a) IN GENERAL.—The Secretary, in consultation
with the Director of NIH, may establish a pediatric research loan
repayment program. Through such program—
‘‘(1) the Secretary shall enter into contracts with qualified
health professionals under which such professionals will agree
to conduct pediatric research, in consideration of the Federal
Government agreeing to repay, for each year of such service,
not more than $35,000 of the principal and interest of the
educational loans of such professionals; and
‘‘(2) the Secretary shall, for the purpose of providing
reimbursements for tax liability resulting from payments made
under paragraph (1) on behalf of an individual, make payments,
in addition to payments under such paragraph, to the individual
in an amount equal to 39 percent of the total amount of loan
repayments made for the taxable year involved.
‘‘(b) APPLICATION
OF OTHER PROVISIONS.—The provisions of
sections 338B, 338C, and 338E shall, except as inconsistent with
paragraph (1), apply to the program established under such para-
graph to the same extent and in the same manner as such provisions
apply to the National Health Service Corps Loan Repayment Pro-
gram established under subpart III of part D of title III.
‘‘(c) FUNDING.—
‘‘(1) IN GENERAL.—For the purpose of carrying out this
section with respect to a national research institute the Sec-
retary may reserve, from amounts appropriated for such
institute for the fiscal year involved, such amounts as the
Secretary determines to be appropriate.
‘‘(2) AVAILABILITY OF FUNDS.—Amounts made available to
carry out this section shall remain available until the expiration
of the second fiscal year beginning after the fiscal year for
which such amounts were made available.’’.
SEC. 1003. REVIEW OF REGULATIONS.
(a) REVIEW.—By not later than 6 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall conduct a review of the regulations under subpart
D of part 46 of title 45, Code of Federal Regulations, consider
any modifications necessary to ensure the adequate and appropriate
protection of children participating in research, and report the
findings of the Secretary to Congress.
(b) AREAS OF REVIEW.—In conducting the review under sub-
section (a), the Secretary of Health and Human Services shall
consider—
H. R. 4365—30
(1) the appropriateness of the regulations for children of
differing ages and maturity levels, including legal status;
(2) the definition of ‘‘minimal risk’’ for a healthy child
or for a child with an illness;
(3) the definitions of ‘‘assent’’ and ‘‘permission’’ for child
clinical research participants and their parents or guardians
and of ‘‘adequate provisions’’ for soliciting assent or permission
in research as such definitions relate to the process of obtaining
the agreement of children participating in research and the
parents or guardians of such children;
(4) the definitions of ‘‘direct benefit to the individual sub-
jects’’ and ‘‘generalizable knowledge about the subject’s disorder
or condition’’;
(5) whether payment (financial or otherwise) may be pro-
vided to a child or his or her parent or guardian for the
participation of the child in research, and if so, the amount
and type given;
(6) the expectations of child research participants and their
parent or guardian for the direct benefits of the child’s research
involvement;
(7) safeguards for research involving children conducted
in emergency situations with a waiver of informed assent;
(8) parent and child notification in instances in which
the regulations have not been complied with;
(9) compliance with the regulations in effect on the date
of the enactment of this Act, the monitoring of such compliance,
and enforcement actions for violations of such regulations; and
(10) the appropriateness of current practices for recruiting
children for participation in research.
(c) CONSULTATION.—In conducting the review under subsection
(a), the Secretary of Health and Human Services shall consult
broadly with experts in the field, including pediatric pharma-
cologists, pediatricians, pediatric professional societies, bioethics
experts, clinical investigators, institutional review boards, industry
experts, appropriate Federal agencies, and children who have
participated in research studies and the parents, guardians, or
families of such children.
(d) CONSIDERATION OF ADDITIONAL PROVISIONS.—In conducting
the review under subsection (a), the Secretary of Health and Human
Services shall consider and, not later than 6 months after the
date of the enactment of this Act, report to Congress concerning—
(1) whether the Secretary should establish data and safety
monitoring boards or other mechanisms to review adverse
events associated with research involving children; and
(2) whether the institutional review board oversight of clin-
ical trials involving children is adequate to protect children.
SEC. 1004. LONG-TERM CHILD DEVELOPMENT STUDY.
(a) PURPOSE.—It is the purpose of this section to authorize
the National Institute of Child Health and Human Development
to conduct a national longitudinal study of environmental influences
(including physical, chemical, biological, and psychosocial) on chil-
dren’s health and development.
(b) IN GENERAL.—The Director of the National Institute of
Child Health and Human Development shall establish a consortium
of representatives from appropriate Federal agencies (including the
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Centers for Disease Control and Prevention, the Environmental
Protection Agency) to—
(1) plan, develop, and implement a prospective cohort study,
from birth to adulthood, to evaluate the effects of both chronic
and intermittent exposures on child health and human develop-
ment; and
(2) investigate basic mechanisms of developmental dis-
orders and environmental factors, both risk and protective,
that influence health and developmental processes.
(c) REQUIREMENT.—The study under subsection (b) shall—
(1) incorporate behavioral, emotional, educational, and
contextual consequences to enable a complete assessment of
the physical, chemical, biological and psychosocial environ-
mental influences on children’s well-being;
(2) gather data on environmental influences and outcomes
on diverse populations of children, which may include the
consideration of prenatal exposures; and
(3) consider health disparities among children which may
include the consideration of prenatal exposures.
(d) REPORT.—Beginning not later than 3 years after the date
of the enactment of this Act, and periodically thereafter for the
duration of the study under this section, the Director of the National
Institute of Child Health and Human Development shall prepare
and submit to the appropriate committees of Congress a report
on the implementation and findings made under the planning and
feasibility study conducted under this section.
(e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section $18,000,000 for fiscal
year 2001, and such sums as may be necessary for each the fiscal
years 2002 through 2005.
TITLE XI—CHILDHOOD MALIGNANCIES
SEC. 1101. PROGRAMS OF CENTERS FOR DISEASE CONTROL AND
PREVENTION AND NATIONAL INSTITUTES OF HEALTH.
Part P of title III of the Public Health Service Act, as amended
by section 702 of this Act, is amended by adding at the end the
following section:
‘‘SEC. 399N. CHILDHOOD MALIGNANCIES.
‘‘(a) IN GENERAL.—The Secretary, acting as appropriate through
the Director of the Centers for Disease Control and Prevention
and the Director of the National Institutes of Health, shall study
environmental and other risk factors for childhood cancers
(including skeletal malignancies, leukemias, malignant tumors of
the central nervous system, lymphomas, soft tissue sarcomas, and
other malignant neoplasms) and carry out projects to improve out-
comes among children with childhood cancers and resultant sec-
ondary conditions, including limb loss, anemia, rehabilitation, and
palliative care. Such projects shall be carried out by the Secretary
directly and through awards of grants or contracts.
‘‘(b) CERTAIN
ACTIVITIES.—Activities under subsection (a)
include—
‘‘(1) the expansion of current demographic data collection
and population surveillance efforts to include childhood cancers
nationally;
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‘‘(2) the development of a uniform reporting system under
which treating physicians, hospitals, clinics, and States report
the diagnosis of childhood cancers, including relevant associated
epidemiological data; and
‘‘(3) support for the National Limb Loss Information Center
to address, in part, the primary and secondary needs of persons
who experience childhood cancers in order to prevent or mini-
mize the disabling nature of these cancers.
‘‘(c) COORDINATION OF ACTIVITIES.—The Secretary shall assure
that activities under this section are coordinated as appropriate
with other agencies of the Public Health Service that carry out
activities focused on childhood cancers and limb loss.
‘‘(d) DEFINITION.—For purposes of this section, the term ‘child-
hood cancer’ refers to a spectrum of different malignancies that
vary by histology, site of disease, origin, race, sex, and age. The
Secretary may for purposes of this section revise the definition
of such term to the extent determined by the Secretary to be
appropriate.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2001
through 2005.’’.
TITLE XII—ADOPTION AWARENESS
Subtitle A—Infant Adoption Awareness
SEC. 1201. GRANTS REGARDING INFANT ADOPTION AWARENESS.
Subpart I of part D of title III of the Public Health Service
Act, as amended by section 801 of this Act, is amended by adding
at the end the following section:
‘‘SEC. 330F. CERTAIN SERVICES FOR PREGNANT WOMEN.
‘‘(a) INFANT ADOPTION AWARENESS.—
‘‘(1) IN
GENERAL.—The Secretary shall make grants to
national, regional, or local adoption organizations for the pur-
pose of developing and implementing programs to train the
designated staff of eligible health centers in providing adoption
information and referrals to pregnant women on an equal basis
with all other courses of action included in nondirective coun-
seling to pregnant women.
‘‘(2) BEST-PRACTICES GUIDELINES.—
‘‘(A) IN
GENERAL.—A condition for the receipt of a
grant under paragraph (1) is that the adoption organization
involved agree that, in providing training under such para-
graph, the organization will follow the guidelines developed
under subparagraph (B).
‘‘(B) PROCESS FOR DEVELOPMENT OF GUIDELINES.—
‘‘(i) IN
GENERAL.—The Secretary shall establish
and supervise a process described in clause (ii) in which
the participants are—
‘‘(I) an appropriate number and variety of
adoption organizations that, as a group, have
expertise in all models of adoption practice and
that represent all members of the adoption triad
(birth mother, infant, and adoptive parent); and