the drugs to be referred to the panel and who, to the
extent feasible, possess skill and experience in the de-
velopment, manufacture, or utilization of such drugs;
‘‘(B) members with diverse expertise in such
fields as clinical and administrative medicine, phar-
macy, pharmacology, pharmacoeconomics, biological
and physical sciences, and other related professions;
‘‘(C) a representative of consumer interests and
a representative of interests of the drug manufactur-
ing industry not directly affected by the matter to be
brought before the panel; and
‘‘(D) 2 or more members who are specialists or
have other expertise in the particular disease or con-
dition for which the drug under review is proposed to
be indicated.
Scientific, trade, and consumer organizations shall be af-
forded an opportunity to nominate individuals for appoint-
ment to the panels. No individual who is in the regular
full-time employ of the United States and engaged in the
administration of this Act may be a voting member of any
panel. The Secretary shall designate one of the members of
each panel to serve as chairman thereof.
‘‘(4) Each member of a panel shall publicly disclose
all conflicts of interest that member may have with the work
to be undertaken by the panel. No member of a panel may
vote on any matter where the member or the immediate
family of such member could gain financially from the ad-
vice given to the Secretary. The Secretary may grant a
waiver of any conflict of interest upon public disclosure of
such conflict of interest if such waiver is necessary to afford
the panel essential expertise, except that the Secretary may
not grant a waiver for a member of a panel when the mem-
ber’s own scientific work is involved.
‘‘(5) The Secretary shall provide education and train-
ing to each new panel member before such member partici-
pates in a panel’s activities, including education regarding
requirements under this Act and related regulations of the
Secretary, and the administrative processes and procedures
related to panel meetings.
‘‘(6) Panel members (other than officers or employees
of the United States), while attending meetings or con-
ferences of a panel or otherwise engaged in its business,
shall be entitled to receive compensation for each day so
engaged, including traveltime, at rates to be fixed by the
Secretary, but not to exceed the daily equivalent of the rate
in effect for positions classified above grade GS–15 of the
General Schedule. While serving away from their homes or
regular places of business, panel members may be allowed
travel expenses (including per diem in lieu of subsistence)
as authorized by section 5703 of title 5, United States Code,
for persons in the Government service employed intermit-
tently.
‘‘(7) The Secretary shall ensure that scientific advisory
panels meet regularly and at appropriate intervals so that
any matter to be reviewed by such panel can be presented
to the panel not more than 60 days after the matter is ready
for such review. Meetings of the panel may be held using
electronic communication to convene the meeting.
‘‘(8) Within 60 days after a scientific advisory panel
makes recommendations on any matter under its review,
the Food and Drug Administration official responsible for
the matter shall review the conclusions and recommenda-
tions of the panel, and notify the affected persons of the
final decision on the matter, or of the reasons that no such
decision has been reached. Each such final decision shall
be documented including the rationale for the decision.
‘‘(9) A scientific advisory panel under this subsection
shall not be subject to the annual chartering and annual
report requirements of the Federal Advisory Committee
Act.’’.
SEC. 17. DISPUTE RESOLUTION.
Chapter V (21 U.S.C. 351 et seq.), as amended by sec-
tion 3, is amended by inserting after section 505A the fol-
lowing:
‘‘DISPUTE RESOLUTION
‘‘SEC. 506. If, regarding an obligation under this Act,
there is a scientific controversy between the Secretary and
a person who is a sponsor, applicant, or manufacturer and
no specific provision of this Act or regulation promulgated
under this Act provides a right of review of the matter in
controversy, the Secretary shall, by regulation, establish a
procedure under which such sponsor, applicant, or manu-
facturer may request a review of such controversy by an
appropriate scientific advisory panel under section 505(n).
Such review shall take place in a timely manner. The Sec-
retary shall promulgate such regulations within 180 days
of the date of the enactment of the Prescription Drug User
Fee Reauthorization and Medical Device Regulatory Mod-
ernization Act of 1997.’’.
SEC. 18. INFORMAL AGENCY STATEMENTS.
Section 701 (21 U.S.C. 371) is amended by adding
at the end the following:
‘‘(h)(1)(A) The Secretary shall develop guidance docu-
ments with public participation and ensure that the exist-
ence of such documents and the documents themselves are
made available to the public both in written form and
through electronic means. Such documents shall not create
or confer any rights for or on any person, although they
present the views of the Secretary on matters under the ju-
risdiction of the Food and Drug Administration.
‘‘(B) Although guidance documents shall not be bind-
ing on the Secretary, the Secretary shall ensure that em-
ployees of the Food and Drug Administration do not deviate
from such guidances without appropriate justification and
supervisory concurrence.
‘‘(C) For guidance documents that set forth initial in-
terpretations of statute or regulation, changes in interpreta-
tion or policy that are of more than a minor nature, com-
plex scientific issues, or highly controversial issues, the Sec-
retary shall ensure public participation prior to implemen-
tation of any guidance documents, unless the Secretary de-
termines that for reasons of the public health need, such
prior public participation is not feasible. In such cases, the
Secretary shall provide for public comment upon implemen-
tation, and take such comment into account.
‘‘(D) For guidance documents that set forth existing
practices or minor changes in policy, the Secretary shall
provide for public comment upon implementation.
‘‘(2) In developing guidance documents, the Secretary
shall ensure uniform nomenclature and uniform internal
procedures for approval of such documents. The Secretary
shall ensure that guidance documents and revisions of such
documents are properly dated and indicate the nonbinding
nature of the documents.
‘‘(3) The Secretary, through the Food and Drug Ad-
ministration, shall maintain electronically and publish pe-
riodically in the Federal Register a list of guidance docu-
ments. Such list shall be updated quarterly. All such docu-
ments shall be made available to the public.
‘‘(4) The Secretary shall report to the Committee on
Commerce of the House of Representatives and the Commit-
tee on Labor and Human Resources of the Senate no later
than July 1, 2000, on the implementation of these prac-
tices.’’.
SEC. 19. POSITRON EMISSION TOMOGRAPHY.
(a) REGULATION OF COMPOUNDED POSITRON EMIS-
SION TOMOGRAPHY DRUGS.—
(1) DEFINITION.—Section 201 (21 U.S.C. 321) is
amended by adding at the end the following:
‘‘(ii) The term ‘compounded positron emission tomog-
raphy drug’—
‘‘(1) means a drug that—
‘‘(A) exhibits spontaneous disintegration of
unstable nuclei by the emission of positrons and
is used for the purpose of providing dual photon
positron emission tomographic diagnostic im-
ages; and
‘‘(B) has been compounded by or on the
order of a practitioner who is licensed by a State
to compound or order compounding for a drug
described 
in 
subparagraph 
(A), 
and 
is
compounded in accordance with that State’s law,
for a patient or for research, teaching, or quality
control; and
‘‘(2) includes any nonradioactive reagent, rea-
gent kit, ingredient, nuclide generator, accelerator,
target material, electronic synthesizer, or other appa-
ratus or computer program to be used in the prepara-
tion of such a drug.’’.
(b) ADULTERATION.—
(1) IN GENERAL.—Section 501(a)(2) (21 U.S.C.
351(a)(2)) is amended by striking ‘‘; or (3)’’ and in-
serting the following: ‘‘; or (C) if it is a compounded
positron emission tomography drug and the methods
used in, or the facilities and controls used for, its
compounding, processing, packing, or holding do not
conform to or are not operated or administered in
conformity with the positron emission tomography
compounding standards and the official monographs
of the United States Pharmacopeia to assure that
such drug meets the requirements of this Act as to
safety and has the identity and strength, and meets
the quality and purity characteristics, that it
purports or is represented to possess; or (3)’’.
(2) SUNSET.—Section 501(a)(2)(C) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C.
351(a)(2)(C)) shall not apply 4 years after the date
of enactment of this Act or 2 years after the date on
which the Secretary of Health and Human Services
establishes the requirements described in subsection
(c)(1)(B), whichever is later.
(c) REQUIREMENTS FOR REVIEW OF APPROVAL PRO-
CEDURES AND CURRENT GOOD MANUFACTURING PRAC-
TICES FOR POSITRON EMISSION TOMOGRAPHY.—
(1) PROCEDURES AND REQUIREMENTS.—
(A) IN GENERAL.—In order to take account
of the special characteristics of compounded
positron emission tomography drugs and the spe-
cial techniques and processes required to produce
these drugs, not later than 2 years after the date
of enactment of this Act, the Secretary of Health
and Human Services shall establish—
(i) appropriate procedures for the ap-
proval of compounded positron emission to-
mography drugs pursuant to section 505 of
the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355); and
(ii) appropriate current good manufac-
turing practice requirements for such drugs.
(B) 
CONSIDERATIONS
AND
CONSULTA-
TION.—In establishing the procedures and re-
quirements required by subparagraph (A), the
Secretary of Health and Human Services shall
take due account of any relevant differences be-
tween not-for-profit institutions that compound
the drugs for their patients and commercial
manufacturers of the drugs. Prior to establishing
the procedures and requirements, the Secretary of
Health and Human Services shall consult with
patient advocacy groups, professional associa-
tions, manufacturers, and physicians and sci-
entists licensed to make or use compounded
positron emission tomography drugs.
(2) SUBMISSION
OF
NEW
DRUG
APPLICATIONS
AND ABBREVIATED NEW DRUG APPLICATIONS.—
(A) IN GENERAL.—Except as provided in
subparagraph (B), the Secretary of Health and
Human Services shall not require the submission
of new drug applications or abbreviated new
drug applications under subsection (b) or (j) of
section 505 (21 U.S.C. 355), for compounded
positron emission tomography drugs that are not
adulterated 
drugs 
described 
in 
section
501(a)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351(a)(2)(C)) (as
amended by subsection (b)), for a period of 4
years after the date of enactment of this Act, or
for 2 years after the date on which the Secretary
establishes procedures and requirements under
paragraph (1), whichever is later.
(B) EXCEPTION.—Nothing in this Act shall
prohibit the voluntary submission of such appli-
cations or the review of such applications by the
Secretary of Health and Human Services. Noth-
ing in this Act shall constitute an exemption for
a compounded positron emission tomography
drug from the requirements of regulations issued
under section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i)) for such
drugs.
(d) REVOCATION OF CERTAIN INCONSISTENT DOCU-
MENTS.—Within 30 days after the date of enactment of this
Act, the Secretary of Health and Human Services shall pub-
lish in the Federal Register a notice terminating the appli-
cation of the following notices and rule, to the extent the
notices and rule relate to compounded positron emission to-
mography drugs:
(1) A notice entitled ‘‘Regulation of Positron
Emission Tomographic Drug Products: Guidance;
Public Workshop’’, published in the Federal Register
on February 27, 1995.
(2) A notice entitled ‘‘Guidance for Industry:
Current Good Manufacturing Practices for Positron
Emission Tomographic (PET) Drug Products; Avail-
ability’’, published in the Federal Register on April
22, 1997.
(3) A final rule entitled ‘‘Current Good Manu-
facturing Practice for Finished Pharmaceuticals;
Positron Emission Tomography’’, published in the
Federal Register on April 22, 1997.
(e) DEFINITION.—As used in this section, the term
‘‘compounded positron emission tomography drug’’ has the
meaning given the term in section 201 of the Federal Food,
Drug and Cosmetic Act (21 U.S.C. 321).
SEC. 20. REQUIREMENTS FOR RADIOPHARMACEUTICALS.
(a) REQUIREMENTS.—
(1) REGULATIONS.—
(A) PROPOSED
REGULATIONS.—Not later
than 180 days after the date of enactment of this
Act, the Secretary of Health and Human Serv-
ices, after consultation with patient advocacy
groups, associations, physicians licensed to use
radiopharmaceuticals, and the regulated indus-
try, shall issue proposed regulations governing
the approval of radiopharmaceuticals designed
for diagnosis and monitoring of diseases and
conditions. The regulations shall provide that the
determination of the safety and effectiveness of
such a radiopharmaceutical under section 505 of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) or section 351 of the Public Health
Service Act (42 U.S.C. 262) shall include consid-
eration 
of 
the 
proposed 
use 
of 
the
radiopharmaceutical in the practice of medicine,
the pharmacological and toxicological activity of
the radiopharmaceutical (including any carrier
or 
ligand 
component 
of 
the
radiopharmaceutical), and the estimated ab-
sorbed 
radiation 
dose 
of 
the
radiopharmaceutical.
(B) FINAL REGULATIONS.—Not later than
18 months after the date of enactment of this
Act, the Secretary shall promulgate final regula-
tions 
governing 
the 
approval 
of 
the
radiopharmaceuticals.
(2) 
SPECIAL
RULE.—In 
the 
case 
of 
a
radiopharmaceutical intended to be used for diag-
nostic or monitoring purposes, the indications for
which such radiopharmaceutical is approved for mar-
keting may, in appropriate cases, refer to manifesta-
tions of disease (such as biochemical, physiological,
anatomic, or pathological processes) common to, or
present in, one or more disease states.
(b) 
DEFINITION.—In 
this 
section, 
the 
term
‘‘radiopharmaceutical’’ means—
(1) an article—
(A) that is intended for use in the diagnosis
or monitoring of a disease or a manifestation of
a disease in humans; and
(B) that exhibits spontaneous disintegration
of unstable nuclei with the emission of nuclear
particles or photons; or
(2) any nonradioactive reagent kit or nuclide
generator that is intended to be used in the prepara-
tion of any such article.
SEC. 21. MODERNIZATION OF REGULATION.
(a) LICENSES.—
(1) IN GENERAL.—Section 351(a) of the Public
Health Service (42 U.S.C. 262(a)) is amended to read
as follows:
‘‘(a)(1) No person shall introduce or deliver for intro-
duction into interstate commerce any biological product un-
less—
‘‘(A) a biologics license is in effect for the biologi-
cal product; and
‘‘(B) each package of the biological product is
plainly marked with—
‘‘(i) the proper name of the biological prod-
uct contained in the package;
‘‘(ii) the name, address, and applicable li-
cense number of the manufacturer of the biologi-
cal product; and
‘‘(iii) the expiration date of the biological
product.
‘‘(2)(A) The Secretary shall establish, by regulation,
requirements for the approval, suspension, and revocation
of biologics licenses.
‘‘(B) The Secretary shall approve a biologics license
application—
‘‘(i) on the basis of a demonstration that—
‘‘(I) the biological product that is the sub-
ject of the application is safe, pure, and potent;
and
‘‘(II) the facility in which the biological
product is manufactured, processed, packed, or
held meets standards designed to assure that the
biological product continues to be safe, pure, and
potent; and
‘‘(ii) if the applicant (or other appropriate per-
son) consents to the inspection of the facility that is
the subject of the application, in accordance with sub-
section (c).
‘‘(3) The Secretary shall prescribe requirements under
which a biological product undergoing investigation shall
be exempt from the requirements of paragraph (1).’’.
(2) ELIMINATION
OF
EXISTING
LICENSE
RE-
QUIREMENT.—Section 351(d) of the Public Health
Service Act (42 U.S.C. 262(d)) is amended—
(A) by striking ‘‘(d)(1)’’ and all that follows
through ‘‘of this section.’’;
(B) in paragraph (2)—
(i) by striking ‘‘(2)(A) Upon’’ and in-
serting ‘‘(d)(1) Upon’’ and
(ii) by redesignating subparagraph (B)
as paragraph (2); and
(C) in paragraph (2) (as so redesignated by
subparagraph (B)(ii))—
(i) by striking ‘‘subparagraph (A)’’
and inserting ‘‘paragraph (1)’’; and
(ii) by striking ‘‘this subparagraph’’
each place it appears and inserting ‘‘this
paragraph’’.
(b) LABELING.—Section 351(b) of the Public Health
Service Act (42 U.S.C. 262(b)) is amended to read as fol-
lows:
‘‘(b) No person shall falsely label or mark any package
or container of any biological product or alter any label
or mark on the package or container of the biological prod-
uct so as to falsify the label or mark.’’.
(c) INSPECTION.—Section 351(c) of the Public Health
Service Act (42 U.S.C. 262(c)) is amended by striking
‘‘virus, serum,’’ and all that follows and inserting ‘‘biologi-
cal product.’’.
(d) DEFINITION; APPLICATION.—Section 351 of the
Public Health Service Act (42 U.S.C. 262) is amended by
adding at the end the following:
‘‘(i) In this section, the term ‘biological product’ means
a virus, therapeutic serum, toxin, antitoxin, vaccine, blood,
blood component or derivative, allergenic product, or analo-
gous product, or arsphenamine or derivative of arsphen-
amine (or any other trivalent organic arsenic compound),
applicable to the prevention, treatment, or cure of a disease
or condition of human beings.’’.
(e) CONFORMING AMENDMENT.—Section 503(g)(4) (21
U.S.C. 353(g)(4)) is amended—
(1) in subparagraph (A)—
(A) by striking ‘‘section 351(a)’’ and insert-
ing ‘‘section 351(i)’’; and
(B) by striking ‘‘262(a)’’ and inserting
‘‘262(i)’’; and
(2) in subparagraph (B)(iii), by striking ‘‘prod-
uct or establishment license under subsection (a) or
(d)’’ and inserting ‘‘biologics license application
under subsection (a)’’.
(f) SPECIAL RULE.—The Secretary of Health and
Human Services shall take measures to minimize dif-
ferences in the review and approval of products required
to have approved biologics license applications under sec-
tion 351 of the Public Health Service Act (42 U.S.C. 262)
and products required to have approved new drug applica-
tions under section 505(b)(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(b)(1)).
(g) EXAMINATIONS
AND PROCEDURES.—Paragraph
(3) of section 353(d) of the Public Health Service Act (42
U.S.C. 263a(d)) is amended to read as follows:
‘‘(3) EXAMINATIONS AND PROCEDURES.—The ex-
aminations and procedures identified in paragraph
(2) are laboratory examinations and procedures
which have been approved by the Food and Drug Ad-
ministration for home use or which, as determined by
the Secretary, are simple laboratory examinations
and procedures which have an insignificant risk of an
erroneous result, including those which—
‘‘(A) employ methodologies that are so sim-
ple and accurate as to render the likelihood of er-
roneous results by the user negligible, or
‘‘(B) the Secretary has determined pose no
reasonable risk of harm to the patient if per-
formed incorrectly.’’.
SEC. 22. PILOT AND SMALL SCALE MANUFACTURE.
(a) HUMAN
DRUGS.—Section 505(c) (21 U.S.C.
355(c)) is amended by adding at the end thereof the follow-
ing:
‘‘(4) A drug manufactured in a pilot or other small
facility may be used to demonstrate the safety and effective-
ness of the drug and to obtain approval prior to scaling
up to a larger facility, unless the Secretary makes a deter-
mination that a full scale production facility is necessary
to ensure the safety or effectiveness of the drug.’’.
(b) ANIMAL
DRUGS.—Section 512(c) (21 U.S.C.
360b(c)) is amended by adding at the end the following:
‘‘(4) A drug manufactured in a pilot or other small
facility may be used to demonstrate the safety and effective-
100
ness of the drug and to obtain approval prior to scaling
up to a larger facility, unless the Secretary makes a deter-
mination that a full scale production facility is necessary
to ensure the safety or effectiveness of the drug.’’.
SEC. 23. INSULIN AND ANTIBIOTICS.
(a) CERTIFICATION
OF DRUGS CONTAINING INSU-
LIN.—
(1) AMENDMENT.—Section 506 (21 U.S.C. 356),
as in effect before the date of the enactment of this
Act, is repealed.
(2) CONFORMING AMENDMENTS.—
(A) Section 301(j) (21 U.S.C. 331(j)) is
amended by striking ‘‘506, 507,’’.
(B) Subsection (k) of section 502 (21 U.S.C.
352) is repealed.
(C) Sections 301(i)(1), 510(j)(1)(A), and
510(j)(1)(D) (21 U.S.C. 331(i)(1), 360(j)(1)(A),
360(j)(1)(D)) are each amended by striking ‘‘,
506, 507,’’.
(D) Section 801(d)(1) (21 U.S.C. 381(d)(1))
is amended by inserting after ‘‘503(b)’’ the fol-
lowing: ‘‘or composed wholly or partly of insu-
lin’’.
(E) Section 8126(h)(2) of title 38, United
States Code, is amended by inserting ‘‘or’’ at the
101
end of subparagraph (B), by striking ‘‘; or’’ at
the end of subparagraph (C) and inserting a pe-
riod, and by striking subparagraph (D).
(b) CERTIFICATION OF ANTIBIOTICS.—
(1) AMENDMENT.—Section 507 (21 U.S.C. 357)
is repealed.
(2) CONFORMING AMENDMENTS.—
(A) Section 201(aa) (21 U.S.C. 321(aa)) is
amended by striking out ‘‘or 507’’, section
201(dd) (21 U.S.C. 321(dd)) is amended by
striking ‘‘507,’’, and section 201(ff)(3)(A) (21
U.S.C. 321(ff)(3)(A)) is amended by striking ‘‘,
certified as an antibiotic under section 507,’’.
(B) Section 301(e) (21 U.S.C. 331(e)) is
amended by striking ‘‘507(d) or (g),’’.
(C) Section 306(d)(4)(B)(ii) (21 U.S.C.
335a(d)(4)(B)(ii)) is amended by striking ‘‘or
507’’.
(D) Section 502 (21 U.S.C. 352) is amend-
ed by striking subsection (l).
(E) Section 520(l) (21 U.S.C. 360j(l)) is
amended by striking paragraph (4) and by strik-
ing ‘‘or Antibiotic Drugs’’ in the subsection
heading.
102
(F) Section 525(a) (21 U.S.C. 360aa(a)) is
amended by inserting ‘‘or’’ at the end of para-
graph (1), by striking paragraph (2), and by re-
designating paragraph (3) as paragraph (2).
(G) Section 525(a) (21 U.S.C. 360aa(a)) is
amended by striking ‘‘, certification of such drug
for such disease or condition under section 507,’’.
(H) Section 526(a)(1) (21 U.S.C. 360bb) is
amended by striking ‘‘the submission of an ap-
plication for certification of the drug under sec-
tion 507,’’, by inserting ‘‘or’’ at the end of sub-
paragraph (A), by striking subparagraph (B),
and by redesignating subparagraph (C) as sub-
paragraph (B).
(I) Section 526(b) (21 U.S.C. 360bb(b)) is
amended—
(i) in paragraph (1), by striking ‘‘, a
certificate was issued for the drug under
section 507,’’; and
(ii) in paragraph (2) by striking ‘‘, a
certificate has not been issued for the drug
under section 507,’’ and by striking ‘‘, ap-
proval of an application for certification
under section 507,’’.
103
(J) Section 527(a) (21 U.S.C. 360cc(a)) is
amended by inserting ‘‘or’’ at the end of para-
graph (1), by striking paragraph (2), by redesig-
nating paragraph (3) as paragraph (2), and by
striking ‘‘, issue another certificate under section
507,’’.
(K) Section 527(b) (21 U.S.C. 360cc(b)) is
amended by striking ‘‘, if a certification is is-
sued under section 507 for such a drug, or’’, ‘‘of
the issuance of the certification under section
507,’’, and ‘‘issue another certification under sec-
tion 507, or’’.
(L) Section 704(a)(1) (21 U.S.C. 374(a)(1))
is amended by striking ‘‘, section 507 (d) or (g)’’.
(M) Section 735(1) (21 U.S.C. 379g(1)(C))
is amended by inserting ‘‘or’’ at the end of sub-
paragraph (B), by striking subparagraph (C),
and by redesignating subparagraph (D) as sub-
paragraph (C).
(N) Subparagraphs (A)(ii) and (B) of sec-
tions 5(b)(1) of the Orphan Drug Act (21 U.S.C.
360ee(b)(1)(A), 360ee(b)(1)(B)) are each amend-
ed by striking ‘‘or 507’’.
104
(O) Section 45C(b)(2)(A)(ii)(II) of the In-
ternal Revenue Code of 1986 is amended by
striking ‘‘or 507’’.
(P) Section 156(f)(4)(B) of title 35, United
States Code, is amended by striking ‘‘507,’’ each
place it occurs.
(c) EXPORTATION.—Section 802 (21 U.S.C. 382) is
amended by adding at the end thereof the following:
‘‘(i) Insulin and antibiotics may be exported without
regard to the requirements in this section if the insulin and
antibiotics meet the requirements of section 801(e)(1).’’.
(d) APPLICATION.—An antibiotic drug which was cer-
tified or exempted from certification under section 507 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357)
before the date of the enactment of this Act shall, after such
date, be considered to be a drug for which an application
was filed under section 505(b) of such Act (21 U.S.C.
355(b)), and approved for safety and effectiveness under sec-
tion 505(c) of such Act (21 U.S.C. 355(c)), except that if
such antibiotic drug was approved under an abbreviated
application under such section 507, such drug shall be con-
sidered to have been approved under section 505(j) of such
Act.
(e) EFFECT.—In the application of section 505 of the
Federal Food, Drug, and Cosmetic Act after the date of en-
105
actment of this Act to a drug that contains an active ingre-
dient (including any ester or salt of the active ingredient)
that was an antibiotic drug within the meaning of section
507 of such Act and was the subject of an approved or pend-
ing application for marketing approval (exemption from
certification) before the date of the enactment of such Act,
none of the patent or market exclusivity provisions of sec-
tion 505 shall apply to such a drug.
SEC. 24. FDA MISSION AND ANNUAL REPORT.
(a) MISSION.—Section 903 (21 U.S.C. 393) is amend-
ed by redesignating subsections (b) and (c) as subsections
(c) and (d), respectively, and by adding after subsection (a)
the following:
‘‘(b) MISSION.—The Food and Drug Administration
shall promote the public health by promptly and efficiently
reviewing clinical research and taking appropriate action
on the marketing of regulated products in a timely manner,
and with respect to such products shall protect the public
health by ensuring that—
‘‘(1) foods are safe, wholesome, sanitary, and
properly labeled;
‘‘(2) human and veterinary drugs are safe and
effective;
‘‘(3) there is reasonable assurance of safety and
effectiveness of devices intended for human use;
106
‘‘(4) cosmetics are safe and properly labeled; and
‘‘(5) public health and safety are protected from
electronic product radiation.
The Food and Drug Administration shall participate with
other countries to reduce the burden of regulation, har-
monize regulatory requirements, and achieve appropriate
reciprocal arrangements.’’.
(b) ANNUAL REPORT.—Section 903 (21 U.S.C. 393),
as amended by subsection (a), is amended by adding at the
end the following:
‘‘(e) ANNUAL REPORT.—The Secretary shall, simulta-
neously with the submission each year of the budget for the
Food and Drug Administration, submit to the Committee
on Commerce of the House of Representatives and the Com-
mittee on Labor and Human Resources of the Senate an
annual report which shall—
‘‘(1) review the performance of the Food and
Drug Administration in meeting its mission and the
development of Food and Drug Administration poli-
cies to implement such mission;
‘‘(2) review the performance of the Food and
Drug Administration in meeting its own performance
standards, including its own outcome measurements,
and statutory deadlines for the approval of products
or for other purposes contained in this Act;
107
‘‘(3) describe the staffing and resources of the
Food and Drug Administration; and
‘‘(4)(A) list each bilateral and multinational
meeting held by the Food and Drug Administration
to address methods and approaches to reduce the bur-
den of regulation, to harmonize regulation, and to
seek appropriate reciprocal arrangements, (B) de-
scribe the goals, activities, and accomplishments of the
Food and Drug Administration in such meetings, and
(C) list issues that the Food and Drug Administra-
tion is considering or has presented for each such
meeting.’’.
SEC. 25. INFORMATION SYSTEM.
Chapter IX is amended by adding at the end the fol-
lowing section:
‘‘SEC. 906. INFORMATION SYSTEM.
‘‘The Secretary shall establish and maintain an infor-
mation system to track the status and progress of each ap-
plication or submission (including a petition, notification,
or other similar form of request) submitted to the Food and
Drug Administration requesting agency action.’’.
SEC. 26. EDUCATION AND TRAINING.
Chapter IX, as amended by section 25, is amended by
adding at the end the following sections:
108
‘‘SEC. 907. EDUCATION.
‘‘The Secretary shall conduct training and education
programs for the employees of the Food and Drug Adminis-
tration relating to the regulatory responsibilities and poli-
cies established by this Act, including programs for sci-
entific training and training in administrative process and
procedure and integrity issues.’’.
SEC. 27. CENTERS FOR EDUCATION AND RESEARCH ON
DRUGS.
Chapter IX, as amended by section 26, is amended by
adding at the end the following section:
‘‘SEC. 908. DEMONSTRATION PROGRAM REGARDING CEN-
TERS FOR EDUCATION AND RESEARCH ON
DRUGS.
‘‘(a) IN GENERAL.—The Secretary, acting through the
Commissioner of Food and Drugs, shall establish a dem-
onstration program for the purpose of making one or more
grants for the establishment and operation of one or more
centers to carry out the activities specified in subsection (b).
‘‘(b) REQUIRED ACTIVITIES.—The activities referred to
in subsection (a) are the following:
‘‘(1) The conduct of state-of-the-art clinical and
laboratory research for the following purposes:
‘‘(A) To increase awareness of new uses of
drugs and the unforeseen risks of new uses of
drugs.
109
‘‘(B) To provide objective clinical informa-
tion to the following entities:
‘‘(i) Health care practitioners or other
providers of health care goods or services.
‘‘(ii) Pharmacy benefit managers.
‘‘(iii) Health maintenance organiza-
tions or other managed health care organi-
zations.
‘‘(iv) Health care insurers or govern-
mental agencies.
‘‘(C) To improve the quality of health care
while reducing the cost of health care through the
prevention of adverse effects of drugs and the
consequences of such effects, such as unnecessary
hospitalizations.
‘‘(2) The conduct of research on the comparative
effectiveness and safety of drugs.
‘‘(3) Such other activities as the Secretary deter-
mines to be appropriate, except that the grant may
not be expended to assist the Secretary in the review
of new drugs.
‘‘(c) APPLICATION FOR GRANT.—A grant under sub-
section (a) may be made only if an application for the
grant is submitted to the Secretary and the application is
in such form, is made in such manner, and contains such
110
agreements, assurances, and information as the Secretary
determines to be necessary to carry out this section.
‘‘(d) PEER REVIEW.—A grant under subsection (a)
may be made only if the application for the grant has un-
dergone appropriate technical and scientific peer review.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated $2,000,000 for fiscal year 1998, and
$3,000,000 for fiscal year 1999.’’.
SEC. 28. HARMONIZATION.
Section 803 (21 U.S.C. 383) is amended by adding
at the end the following:
‘‘(c) The Secretary shall participate in meetings with
representatives of other countries to discuss methods and
approaches to reduce the burden of regulation and har-
monize regulatory requirements if the Secretary determines
that such harmonization continues consumer protections
consistent with the purposes of this Act. The Secretary shall
report to the Committee on Commerce of the House of Rep-
resentatives and the Committee on Labor and Human Re-
sources of the Senate at least 60 days before executing any
bilateral or multilateral agreement under subsection (b).’’.
SEC. 29. ENVIRONMENTAL IMPACT REVIEW.
Chapter VII, as amended by section 12, is amended
by adding at the end the following:
111
‘‘SUBCHAPTER G—ENVIRONMENTAL IMPACT REVIEW
‘‘SEC. 761. ENVIRONMENTAL IMPACT REVIEW.
‘‘Notwithstanding any other provision of law, an envi-
ronmental impact statement prepared in accordance with
the regulations published at part 25 of 21 C.F.R. (as in
effect on August 31, 1997) in connection with an action
carried out under (or a recommendation or report relating
to) this Act, shall be considered to meet the requirements
for a detailed statement under section 102(2)(C) of the Na-
tional Environmental Policy Act.’’.
SEC. 30. NATIONAL UNIFORMITY.
(a) NONPRESCRIPTION
DRUGS.—Chapter VII (21
U.S.C. 371 et seq.), as amended by section 29, is further
amended by adding at the end the following:
‘‘SUBCHAPTER
H—NATIONAL
UNIFORMITY
FOR
NON-
PRESCRIPTION DRUGS FOR HUMAN USE AND PRE-
EMPTION FOR LABELING OR PACKAGING OF COSMET-
ICS
‘‘SEC. 771. NATIONAL UNIFORMITY FOR NONPRESCRIPTION
DRUGS FOR HUMAN USE.
‘‘(a) IN GENERAL.—Except as provided in subsection
(b), (c)(1), (d), (e), or (f), no State or political subdivision
of a State may establish or continue in effect any
requirement—
112
‘‘(1) that relates to the regulation of a drug in-
tended for human use that is not subject to the re-
quirements of section 503(b)(1); and
‘‘(2) that is different from or in addition to, or
that is otherwise not identical with, a requirement
under this Act, the Poison Prevention Packaging Act
of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packag-
ing and Labeling Act (15 U.S.C. 1451 et seq.).
‘‘(b) EXEMPTION.—Upon application of a State or po-
litical subdivision thereof, the Secretary may by regulation,
after notice and opportunity for written and oral presen-
tation of views, exempt from subsection (a), under such con-
ditions as may be prescribed in such regulation, a State
or political subdivision requirement that—
‘‘(1) protects an important public interest that
would otherwise be unprotected;
‘‘(2) would not cause any drug to be in violation
of any applicable requirement or prohibition under
Federal law; and
‘‘(3) would not unduly burden interstate com-
merce.
‘‘(c) SCOPE.—
‘‘(1) IN GENERAL.—This section shall not apply
to—
113
‘‘(A) any State or political subdivision re-
quirement that relates to the practice of phar-
macy; or
‘‘(B) any State or political subdivision re-
quirement that a drug be dispensed only upon
the prescription of a practitioner licensed by law
to administer such drug.
‘‘(2) SAFETY OR EFFECTIVENESS.—For purposes
of subsection (a), a requirement that relates to the
regulation of a drug shall be deemed to include any
requirement relating to public information or any
other form of public communication relating to a
warning of any kind for a drug.
‘‘(d) EXCEPTIONS.—
‘‘(1) IN GENERAL.—In the case of a drug de-
scribed in subsection (a)(1) that is not the subject of
an application approved under section 505 or 507 or
a final regulation promulgated by the Secretary es-
tablishing conditions under which the drug is gen-
erally recognized as safe and effective and not mis-
branded, subsection (a) shall apply only with respect
to a requirement of a State or political subdivision of
a State that relates to the same subject as, but is dif-
ferent from or in addition to, or that is otherwise not
identical with—
114
‘‘(A) a regulation in effect with respect to
the drug pursuant to a statute described in sub-
section (a)(2); or
‘‘(B) any other requirement in effect with
respect to the drug pursuant to an amendment
to such a statute made on or after the date of en-
actment of this section.
‘‘(2) STATE INITIATIVES.—This section shall not
apply to a State public initiative enacted prior to the
date of enactment of this section.
‘‘(e) NO EFFECT ON PRODUCT LIABILITY LAW.—Noth-
ing in this section shall be construed to modify or otherwise
affect any action or the liability of any person under the
product liability law of any State.
‘‘(f) STATE ENFORCEMENT AUTHORITY.—Nothing in
this section shall prevent a State or political subdivision
thereof from enforcing, under any relevant civil or other en-
forcement authority, a requirement that is identical to a
requirement of this Act.’’.
(b) INSPECTIONS.—Section 704(a)(1) (21 U.S.C.
374(a)(1)) is amended by striking ‘‘prescription drugs’’
each place it appears and inserting ‘‘prescription drugs,
nonprescription drugs intended for human use,’’.
(c) MISBRANDING.—Paragraph (1) of section 502(e)
(21 U.S.C. 352(e)(1)) is amended to read as follows:
115
‘‘(1)(A) If it is a drug, unless its label bears, to the
exclusion of any other nonproprietary name (except the ap-
plicable systematic chemical name or the chemical for-
mula)—
‘‘(i) the established name (as defined in subpara-
graph (3)) of the drug, if there is such a name;
‘‘(ii) the established name and quantity or, if
deemed appropriate by the Secretary, the proportion
of each active ingredient, including the quantity,
kind, and proportion of any alcohol, and also includ-
ing whether active or not the established name and
quantity or if deemed appropriate by the Secretary,
the proportion of any bromides, ether, chloroform, ac-
etanilide, acetophenetidin, amidopyrine, antipyrine,
atropine, hyoscine, hyoscyamine, arsenic, digitalis,
digitalis glucosides, mercury, ouabain, strophanthin,
strychnine, thyroid, or any derivative or preparation
of any such substances, contained therein, except that
the requirement for stating the quantity of the active
ingredients, other than the quantity of those specifi-
cally named in this subclause, shall not apply to non-
prescription drugs not intended for human use; and
‘‘(iii) the established name of each inactive in-
gredient listed in alphabetical order on the outside
container of the retail package and, if deemed appro-
116
priate by the Secretary, on the immediate container,
as prescribed in regulation promulgated by the Sec-
retary, but nothing in this clause shall be deemed to
require that any trade secret be divulged, except that
the requirements of this subclause with respect to al-
phabetical order shall apply only to nonprescription
drugs that are not also cosmetics and this subclause
shall not apply to nonprescription drugs not intended
for human use.
‘‘(B) For any prescription drug the established name
of such drug or ingredient, as the case may be, on such
label (and on any labeling on which a name for such drug
or ingredient is used) shall be printed prominently and in
type at least half as large as that used thereon for any pro-
prietary name or designation for such drug or ingredient,
except that to the extent that compliance with the require-
ments of clause (A)(ii) or (iii) or this subparagraph is im-
practicable, exemptions shall be established by regulations
promulgated by the Secretary.’’.
(d) COSMETICS.—Subchapter H of chapter VII, as
amended by subsection (a), is further amended by adding
at the end the following:
117
‘‘SEC. 772. PREEMPTION FOR LABELING OR PACKAGING OF
COSMETICS.
‘‘(a) IN GENERAL.—Except as provided in subsection
(b), (d), or (e), a State or political subdivision of a State
shall not impose or continue in effect any requirement for
labeling or packaging of a cosmetic that is different from
or in addition to, or that is otherwise not identical with
a requirement that is specifically applicable to a particular
cosmetic or class of cosmetics under this Act, the Poison
Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.),
or the Fair Packaging and Labeling Act (15 U.S.C. 1451
et seq.).
‘‘(b) EXEMPTION.—Upon application of a State or po-
litical subdivision thereof, the Secretary may by regulation
after notice and opportunity for written and oral presen-
tation of views, exempt from subsection (a), under such con-
ditions as may be prescribed in such regulation, a State
or political subdivision requirement for labeling and pack-
aging that—
‘‘(1) protects an important public interest that
would otherwise be unprotected;
‘‘(2) would not cause a cosmetic to be in viola-
tion of any applicable requirements or prohibition
under Federal law; and
‘‘(3) 
would 
not 
unduly 
burden 
interstate
commerce.
118
‘‘(c) SCOPE.—For purposes of subsection (a), a ref-
erence to a State requirement that relates to the packaging
or labeling of a cosmetic means any specific requirement
relating to the same aspect of such cosmetic as a require-
ment specifically applicable to that particular cosmetic or
class of cosmetics under this Act for packaging or labeling,
including any State requirement relating to public infor-
mation or any other form of public communication.
‘‘(d) NO EFFECT ON PRODUCT LIABILITY LAW.—Noth-
ing in this section shall be construed to modify or otherwise
affect any action or the liability of any person under the
product liability law of any State.
‘‘(e) STATE INITIATIVE.—This section shall not apply
to a State requirement adopted by a State public initiative
or referendum enacted prior to September 1, 1997.’’.
SEC. 31. FDA STUDY OF MERCURY COMPOUNDS IN DRUGS
AND FOOD.
(a) LIST AND ANALYSIS.—The Secretary of Health and
Human Services shall, through the Food and Drug Admin-
istration—
(1) compile a list of drugs and foods that contain
intentionally introduced mercury compounds, and
(2) provide a quantitative and qualitative anal-
ysis of the mercury compounds in the list under para-
graph (1).
120
exposure to, or ingestion or inhalation of, mer-
cury when so used.
In conducting such study, the Secretary shall consult
with the Administrator of the Environmental Protec-
tion Agency, the Chair of the Consumer Product Safe-
ty Commission, and the Administrator of the Agency
for Toxic Substances and Disease Registry, and, to
the extent the Secretary believes necessary or appro-
priate, with any other Federal or private entity.
(2) REGULATIONS.—If, in the opinion of the Sec-
retary, the use of elemental, organic or inorganic mer-
cury offered for sale as a drug or dietary supplement
poses a threat to human health, the Secretary shall
promulgate regulations restricting the sale of mercury
intended for such use. At a minimum, such regula-
tions shall be designed to protect the health of children
and other sensitive populations from adverse effects
resulting from exposure to, or ingestion or inhalation
of, mercury. Such regulations, to the extent feasible,
should not unnecessarily interfere with the availabil-
ity of mercury for use in religious ceremonies.
121
SEC. 32. NOTIFICATION OF DISCONTINUANCE OF A LIFE
SAVING PRODUCT.
Chapter VII (21 U.S.C. 371 et seq.), as amended by
section 30, is further amended by adding at the end the
following:
‘‘SUBCHAPTER I—NOTIFICATION OF THE
DISCONTINUANCE OF A LIFE SAVING PRODUCT
‘‘SEC. 781. DISCONTINUANCE OF A LIFE SAVING PRODUCT.
‘‘(a) IN GENERAL.—A manufacturer that is the sole
manufacturer of a drug or device—
‘‘(1) that is—
‘‘(A) life supporting;
‘‘(B) life sustaining; or
‘‘(C) intended for use in the prevention of a
debilitating disease or condition; and
‘‘(2) for which an application has been approved
under section 505(b), 505(j), or 515(d),
shall notify the Secretary of a discontinuance of the manu-
facture of the drug or device at least 6 months prior to
the date of the discontinuance.
‘‘(b) REDUCTION IN NOTIFICATION PERIOD.—On ap-
plication of a manufacturer, the Secretary may reduce the
notification period required under subsection (a) for the
manufacturer if good cause exists for the reduction, such
as a situation in which—
122
‘‘(1) a public health problem may result from
continuation of the manufacturing for the 6-month
period;
‘‘(2) a biomaterials shortage prevents the con-
tinuation of the manufacturing for the 6-month pe-
riod;
‘‘(3) a liability problem may exist for the manu-
facturer if the manufacturing is continued for the 6-
month period;
‘‘(4) continuation of the manufacturing for the
6-month period may cause substantial economic hard-
ship for the manufacturer;
‘‘(5) the manufacturer has filed for bankruptcy
under chapter 7 or 11 of title 11, United States Code;
or
‘‘(6) the Secretary determines that there would be
no adverse impact from the discontinuance of a drug
or device.
‘‘(c) DISTRIBUTION.—To the maximum extent prac-
ticable, the Secretary shall distribute information on the
discontinuation of the drugs and devices described in sub-
section (a) to appropriate physician and patient organiza-
tions.’’.