‘‘(C) immediately undertakes all corrections
identified by the accredited person.
When such compliance is complete, the accredited person
shall provide the inspected person a certification of compli-
ance which includes the dates of inspections, a statement
that the inspected facility is in compliance with the re-
quirements of section 520(f), the date the compliance was
achieved at the facility, and the signature of the accredited
person attesting to the finding that the inspected facility
is in good manufacturing practices compliance as defined
by such section. When an accredited person has certified
compliance with good manufacturing practices require-
ments and provided the Secretary with a copy of the cer-
tification within 10 days of its being made, the Secretary
may not perform a good manufacturing practices inspec-
tion of the person subject to an inspection for a period
of 2 years after the date of the certification unless justified
by good cause.’’; and
(5) in subsection (c), by striking ‘‘or employee’’
and inserting ‘‘, employee, or accredited person’’;
(6) in subsection (e), by striking ‘‘or employee’’
each place it occurs and inserting ‘‘, employee, or ac-
credited person’’; and
(7) by adding at the end the following:
‘‘(f) Persons duly designated by the Secretary to con-
duct inspections under this section shall not request any
information not permitted under subsections (a) and (e)
unless such person states with specificity and in writing
the identification of the information subject to the request,
the reason for the request, and that the written request
seeks to obtain information not required to be produced
under this section. Such request shall not include informa-
tion related to sales (other than distribution), personnel,
or pricing data.’’.
SEC. 18. USE OF SCIENTIFIC AND MEDICAL INFORMATION.
Section 502(f) (21 U.S.C. 352(f)) is amended by add-
ing at the end the following: ‘‘The dissemination of medi-
cal texts, articles from peer-reviewed scientific publica-
tions, information from Federal Government agencies, and
presentations at medical and scientific meetings shall not
form a basis to require adequate directions for use under
clause (1) or information for use (or the equivalent there-
of) under any exemption to clause (1) and shall not form
a basis to require the filing of a report required under
section 510(k) or the filing of an application under section
505 or 515 unless such person, in addition to disseminat-
ing the above-referenced information, encourages the un-
approved use of a legally marketed device through label-
ing, advertising, or other means of promotion. Mere
knowledge that a legally available device is used by li-
censed practitioners for the treatment or diagnosis of dis-
eases or conditions in individual patients shall not form
a basis to require adequate directions for use under clause
(1), or information for use (or the equivalent thereof)
under any exemption to clause (1), and shall not form a
basis to require either the filing of a notification required
under section 510(k) or an application under section 515.
The Secretary shall not consider the dissemination of med-
ical texts, articles from peer review scientific publications,
information from Federal Government agencies, presen-
tations at medical and scientific meetings, and displays at
trade shows relating to a device which is investigational
within the meaning of section 520(g) to be activities pro-
hibited under published regulations of the Secretary unless
the sponsor of an investigation for the device, or an agent
of such sponsor, in addition to the aforementioned activi-
ties encourages the use of a device.’’.
SEC. 19. REPORTS.
(a) EXCLUSION OF REPORTS BY DISTRIBUTORS.—
Section 519 (21 U.S.C. 360i) is amended—
(1) in subsection (a), by striking ‘‘manufac-
turer, importer, or distributor’’ and inserting ‘‘man-
ufacturer or importer’’;
(2) in paragraph (4) of subsection (a), by strik-
ing ‘‘manufacturer, importer, or distributor’’ and in-
serting ‘‘manufacturer or importer’’;
(3) in paragraph (8) of subsection (a), by strik-
ing ‘‘manufacturer, importer, or distributor’’ each
place it occurs and inserting ‘‘manufacturer or im-
porter’’;
(4) in paragraph (8)(B)(i) of subsection (a), by
striking ‘‘manufacturer, importer, or distributor’’
and inserting ‘‘manufacturer or importer’’; and
(5) in subsection (a), by inserting ‘‘and’’ at the
end of paragraph (7), by striking ‘‘; and’’ at the end
of paragraph (8) and inserting a period, by striking
paragraph (9).
(b) LIMITATION ON MALFUNCTION REPORTING.—
Section 519(a)(1)(B) (21 U.S.C. 360i(a)(1)(B)) is amend-
ed by inserting before the semicolon the following: ‘‘, ex-
cept that information that a device failed to perform as
labeled or in an acceptable manner shall not constitute a
malfunction within the meaning of this subparagraph
when the available information clearly shows that the de-
vice failure was caused by improper servicing or mainte-
nance to the device as determined exclusively by the device
labeling which was provided to the user’’.
(c) REGULATIONS.—Within 120 days after the date
of enactment of this section, the Secretary of Health and
Human Services shall delete the regulations of the Sec-
retary appearing in part 800 of title 21 of the Code of
Federal Regulations, requiring distributors, other than
importers, to make reports of deaths, serious injuries or
illness, and malfunctions related to devices and shall
amend the regulations of the Secretary to conform to the
change in malfunction reporting in section 519(a)(1)(B)
of the Federal Food, Drug, and Cosmetic Act.
(d) USER REPORTS, CERTIFICATIONS, AND REPORTS
OF REMOVALS
AND CORRECTIONS.—Section 519 (21
U.S.C. 360i) is amended by repealing subsections (b), (d),
and (f).
SEC. 20. G.M.P. AND DEVICE REPORTS.
Section 303(c) is amended by inserting before the pe-
riod at the end the following: ‘‘; or (6) for having violated
subsection (a), (b), (c), or (k) of section 301 by failure
to comply with either section 502(t)(2) or 501(h), or for
having violated section 301(g)(1)(B) by failing to furnish
material or information required under section 519(a), if
such person acted in good faith, had no reason to believe
that the person’s acts violated the law, and had no prior
notice from the Secretary that the acts constituted viola-
tions of the Act’’.
SEC. 21. CIVIL PENALTIES.
Section 303 (21 U.S.C. 333) is amended—
(1) in subsection (g)(2)(C), by adding at the
end the following: ‘‘Additionally, the Secretary may
direct a person subject to a civil penalty under para-
graph (1) to apply the monetary amount of the pen-
alty to the correction of the violation that resulted
in the penalty assessment in lieu of paying such
moneys into the United States Treasury. Any person
who undertakes correction of violations under this
subparagraph must submit an independent audit of
the corrections to the Secretary within a time speci-
fied in the civil penalty order. A failure to submit
such independent audit in a timely manner shall be
deemed to be a violation of this Act.’’; and
(2) in subsection (f)(2), by adding at the end
‘‘The person accused of a violation under this sub-
section shall be entitled to reasonable discovery in
accordance with the Federal Rules of Civil Proce-
dure.’’.
SEC. 22. INFORMATION SYSTEM.
Chapter IX, as amended by section 9, is amended by
adding at the end the following:
‘‘SEC. 907. INFORMATION SYSTEM.
‘‘The Secretary shall establish and maintain an infor-
mation system to track the status and progress of each
application or submission (including a petition, notifica-
tion, or other similar form of request) submitted to the
Food and Drug Administration requesting agency action.
The system shall permit access by the applicant.’’.
SEC. 23. ENVIRONMENTAL IMPACT REVIEW.
Chapter VII, as amended by section 13, is amended
by adding at the end the following:
‘‘SUBCHAPTER E—ENVIRONMENTAL IMPACT REVIEW
‘‘SEC. 745. ENVIRONMENTAL IMPACT REVIEW.
‘‘No action by the Secretary pursuant to this Act
shall require, with respect to an action to be taken by the
Secretary, the preparation of an environmental impact
statement under the National Environmental Policy Act
of 1969 or an environmental assessment unless the Sec-
retary demonstrates that—
‘‘(1) because of extraordinary circumstances the
action will have a significant effect on the human
environment; and
‘‘(2) the consideration of such significant effect
on the human environment will directly affect the
Secretary’s decision on the action.’’
SEC. 24. INFORMAL AGENCY STATEMENTS.
Section 701 (21 U.S.C. 371) is amended by adding
at the end the following:
‘‘(h)(1) The Secretary shall not rely upon informal
agency statements, including guidance documents, policy
statements, points to consider documents, or any other
statements that have not been promulgated in accordance
with the rulemaking requirements of chapter V of title 5,
United States Code, to require any action be taken to sat-
isfy a requirement of this Act.
‘‘(2) The Secretary shall publish notice in the Federal
Register of the availability to the public of each type of
statement identified in paragraph (1). Additionally, the
Secretary shall undertake to make available all such state-
ments by electronic or other similar means.
SEC. 25. EDUCATION AND RESEARCH; PRACTICE OF MEDI-
CINE.
Chapter IX, as amended by section 23, is amended
by adding at the end the following:
‘‘SEC. 908. EDUCATION AND RESEARCH.
‘‘(a) EDUCATION.—The Secretary shall conduct
training and education programs for the employees of the
Food and Drug Administration relating to the regulatory
responsibilities and policies established by this Act, includ-
ing programs for scientific training, administrative process
and procedure, and integrity issues.
‘‘(b) RESEARCH.—The Secretary, acting through the
Food and Drug Administration, may conduct or contract
for scientific research only if it is directly related to the
implementation of this Act.
‘‘SEC. 909. PRACTICE OF MEDICINE.
‘‘Nothing in this Act shall be construed to limit or
interfere with the authority of a health care practitioner,
licensed by law to administer drugs and devices, to pre-
scribe or administer any legally marketed drug or device
to a patient for any condition or disease within a legiti-
mate health care practitioner-patient relationship.’’.
SEC. 26. PUBLICATION OF NOTICE OF DEVIATION.
Section 705 (21 U.S.C 375) is amended by adding
at the end the following:
‘‘(c) The Secretary may make public or communicate
to any person outside the Food and Drug Administration
any information regarding a notice which informs a regu-
lated person of a purported deviation from a requirement
of this Act only after the Secretary has completed the in-
vestigation of such deviation.’’.
Æ