‘‘(9) The Commission shall not disclose any informa-
tion reported to or otherwise obtained by the Commission
which is exempt from disclosure under subsection (a) of
section 552 of title 5, United States Code, by reasons of
paragraphs (4) and (6) of subsection (b) of such section.
‘‘(10) The Administrator of General Services shall
provide to the Commission on a reimbursable basis such
administrative support services as the Commission may re-
quest.
‘‘(e) MEETINGS.—Meetings of the Commission shall
be held up to 12 times a year at the call of the Chair-
person. Meetings of the subcommittee(s) shall be convened
as necessary. A Federal Government official shall be
present at all meetings. Meetings shall be open to the pub-
lic except as determined otherwise by the President. Ad-
vance notice of all meetings shall be given to the public.
Meetings shall be conducted, and records of proceedings
kept, as required by applicable laws and Federal regula-
tions.
‘‘(f) 
COMPENSATION.—Members 
may 
be 
com-
pensated at a rate not to exceed the maximum pay author-
ized by section 3109 of title 5, United States Code, plus
per diem and travel expenses as in accordance with stand-
ard government travel regulations.
‘‘(g) REPORTS.—(1) Reports by the Commission on
specific issues shall be submitted to the President, the
Congress, appropriate Federal agencies, and other appro-
priate entities. Within 60 days of the date a Federal agen-
cy receives a recommendation from the Commission that
the agency take any action with respect to its rules, poli-
cies, guidelines, or regulations, the agency shall publish
such recommendation in the Federal Register and shall
provide opportunity for interested persons to submit writ-
ten data, views, and arguments with respect to adoption
of the recommendation. Within the 180-day period begin-
ning on the date of such publication, the agency shall de-
termine whether the action proposed by such recommenda-
tion is appropriate, and to the extent that it determines
that—
‘‘(A) such action is not appropriate, the agency
shall, within such time period, provide the Commis-
sion with, and publish in the Federal Register, a no-
tice of such determination (including an adequate
statement of the reasons for the determination); or
‘‘(B) such action is appropriate, the agency
shall undertake such action as expeditiously as fea-
sible and shall notify the Commission of the deter-
mination and the action undertaken.
Executive summaries of each report of the Commission
shall be published in the Federal Register or on the World
Wide Web. Such summaries shall specifically list the agen-
cy to which any recommendations are directed and the
date by which such responses are required.
‘‘(2) An annual report shall be submitted to the
President, the Congress, and appropriate Federal agen-
cies. It shall contain, at a minimum—
‘‘(A) the Commission’s function;
‘‘(B) a list of members and their business ad-
dresses;
‘‘(C) the dates and places of meetings;
‘‘(D) a summary of the Commission’s activities
during the year;
‘‘(E) a summary of the Commission’s rec-
ommendations made during the year; and
‘‘(F) a summary of responses made by Federal
agencies to the Commission’s recommendations dur-
ing the year.
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the
purposes of carrying out this section, there are authorized
to be appropriated $5,000,000 for fiscal year 2001, and
such sums as may be necessary for fiscal year 2002 and
each subsequent fiscal year.’’.
(b) STUDY ON RESEARCH INVOLVING CHILDREN.—
The National Bioethics Advisory Commission under sec-
tion 1801 of the Public Health Service Act shall conduct
a thorough review and report on the research involving—
(1) the process of obtaining informed consent
from parents and children, including (A) the defini-
tions of ‘informed consent’ and ‘assent’, and (B)
substitute decisionmaking, including who can serve
as a legally authorized representative (as defined in
subpart A of part 46 of title 45, Code of Federal
Regulations);
(2) the requirements for what elements of infor-
mation should be disclosed to parents and children
(such as risks and benefits of, and alternatives to
participation in, the research project, and data of
prior adverse events);
(3) determining comprehension by parents and
children of the informed consent document, includ-
ing the distinction between research and therapeutic
treatment;
(4) the requirements of what additional meas-
ures should be undertaken with respect to protecting
children from undue risk;
(5) the appropriateness of the regulations for
children of different ages, from infants to adoles-
cents and emancipated minors;
(6) payment (financial and other) for research
participation; and
(7) the unique roles and responsibilities of
IRBs in reviewing research involving children, in-
cluding membership composition.
Æ