nostic and prevention modalities, disciplines and 
systems. 
‘‘(B) The Director maintains the informa-
tion received under subparagraph (A); makes 
such information available to health care practi-
tioners and the general public through estab-
lishing one or more Internet sites; and receives, 
maintains, and makes available through such 
site appropriate comments and information pro-
vided in response to such information. 
‘‘(C) The Director carries out subpara-
graph (B) in a manner reasonably calculated to 
provide a forum for obtaining and dissemi-
nating information, including clinical data, to-
ward the following goals: 
‘‘(i) Identifying alternative treatment, 
diagnostic and prevention systems, modali-
ties, and disciplines that should be inte-
grated with the practice of conventional 
medicine as a complement to such medi-
cine and integrated into health care deliv-
ery systems in the United States. 
‘‘(ii) Identifying any alternative med-
ical practices or procedures that constitute 
a threat to the public health. 
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‘‘(iii) Making available to the Commis-
sioner of Food and Drugs information for 
uses with respect to promoting innovations 
in evidence-based clinical practice and 
health care technologies under title IX of 
the Public Health Service Act. 
‘‘(2) DIETARY SUPPLEMENTS AND FOOD.—In 
consultation with the Commissioner of Food and 
Drugs, the Director of the Center shall carry out the 
following: 
‘‘(A) Activities under paragraph (1) shall 
include carrying out such paragraph with re-
spect to information that relates to the effects 
of dietary supplements and food on diseases 
and disorders and is obtained by the practi-
tioners in the course of their professional prac-
tices and submitted to the Director. 
‘‘(B) With respect to paragraph (1)(C) as 
applied for purposes of this paragraph, the 
goals shall be the following: 
‘‘(i) Identifying dietary supplements 
and food and uses of such supplements 
and food that are of clinical benefit in 
treating particular diseases or disorders. 
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‘‘(ii) As appropriate, providing for the 
publication of authoritative statements, 
within 
the 
meaning 
of 
section 
403(r)(3)(C)(i) of the Federal Food, Drug, 
and Cosmetic Act, about the relationship 
between a nutrient and a disease or health- 
related condition. 
‘‘(iii) 
Carrying 
out 
paragraph 
(1)(C)(iii) with respect to dietary supple-
ments. 
‘‘(3) VOLUNTARY
PARTICIPATION.—Paragraph 
(1) may not be construed as requiring that any 
health care practitioner or other person participate 
in the program under such paragraph. 
‘‘(4) CERTAIN AUTHORITIES.—The posting by 
the Director of the Center of information on the 
Internet site under paragraph (1) is subject to the 
following: 
‘‘(A) The Director may not post informa-
tion submitted by a health care practitioner un-
less the practitioner authorizes the Director to 
include in the posting the identity and the busi-
ness address of the practitioner. 
‘‘(B) The Director may impose reasonable 
restrictions on the format and volume of infor-
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mation to be posted and on the frequency of 
postings. 
‘‘(5) CRITERIA.—Not later than one year after 
the date of the enactment of the Medical Informa-
tion and Treatment Access Act, the Secretary shall 
by regulation issue criteria for carrying out this sub-
section. 
‘‘(6) DEFINITIONS.—For purposes of this sub-
section, the terms ‘dietary supplement’ and ‘food’ 
have the meaning given such terms in section 201 
of the Federal Food, Drug, and Cosmetic Act.’’. 
TITLE III—GENERAL 
PROVISIONS 
SEC. 301. DEFINITIONS. 
For purposes of this Act: 
(1) The terms ‘‘device’’, ‘‘labeling’’, and ‘‘new 
drug’’ have the meanings given such terms in section 
201 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301). 
(2) The term ‘‘off-label use’’, with respect to a 
new drug or a device, means a use not included in 
the labeling approved for the drug or device pursu-
ant to section 505, 510, or 515 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355, 360c, 
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360e) or section 351 of the Public Health Service 
Act (42 U.S.C. 262). 
(3) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services. 
SEC. 302. EFFECTIVE DATES. 
(a) IN GENERAL.—Subject to subsection (b)— 
(1) sections 201 and 202 take effect on the 
date on which a final rule takes effect pursuant to 
sections 201(d) and 202(d), respectively; and 
(2) the amendment made by section 203 takes 
effect on the date on which the final rule required 
under section 485D(i)(5) of the Public Health Serv-
ice Act (as added by such amendment) takes effect. 
(b) ISSUANCE OF CRITERIA.—Sections 201(d) and 
202(d) of this Act and section 485D(i)(5) of the Public 
Health Service Act (as added by section 203 of this Act) 
take effect on the date of the enactment of this Act. 
Æ 
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