FDA3 — Health Hippo

fda3

FILE s830.
enr –S.830–S.830

An Act To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes.

This Act may be cited as the ‘Food and Drug Administration Modernization Act of 1997’

TITLE III–IMPROVING
REGULATION OF FOOD

SEC. 301. Flexibility for regulations
regarding claims

SEC. 302. Petitions for claims

SEC. 303. Health claims for food products

SEC. 304. Nutrient content claims

SEC. 305. Referral statements

SEC. 306. Disclosure of irradiation

SEC. 307. Irradiation petition

SEC. 308. Glass and ceramic ware

SEC. 309. Food contact substances

TITLE
IV–GENERAL PROVISIONS

SEC. 401. Dissemination of information on new
uses

SEC. 402. Expanded access to investigational
therapies and diagnostics

SEC. 403. Approval of supplemental
applications for approved products

SEC. 404. Dispute resolution

SEC. 405. Informal agency statements

SEC. 406. Food and Drug Administration
mission and annual report

SEC. 407. Information system

SEC. 408. Education and training

SEC. 409. Centers for education and research
on therapeutics

SEC. 410. Mutual recognition agreements and
global harmonization

SEC. 411. Environmental impact review

SEC. 412. National uniformity for
nonprescription drugs and cosmetics

SEC. 413. Food and Drug Administration study
of mercury compounds in drugs and food

SEC. 414. Interagency collaboration

SEC. 415. Contracts for expert review

SEC. 416. Product classification

SEC. 417. Registration of foreign
establishments

SEC. 418. Clarification of seizure authority

SEC. 419. Interstate commerce

SEC. 420. Safety report disclaimers

SEC. 421. Labeling and advertising regarding
compliance with statutory requirements

SEC. 422. Rule of construction

TITLE
V–EFFECTIVE DATE

SEC. 501. Effective
date

TITLE III–IMPROVING REGULATION OF FOOD

SEC. 301. FLEXIBILITY FOR REGULATIONS REGARDING CLAIMS

Section 403(r) (21 U.S.C. 343(r)) is amended by adding at the
end the following: ‘(7) The Secretary may make proposed regulations
issued under this paragraph effective upon publication pending
consideration of public comment and publication of a final regulation
if the Secretary determines that such action is necessary–

‘(A) to enable the Secretary to review and act promptly on
petitions the Secretary determines provide for information necessary
to– ‘(i) enable consumers to develop and maintain healthy dietary
practices; ‘(ii) enable consumers to be informed promptly and
effectively of important new knowledge regarding nutritional and
health benefits of food; or ‘(iii) ensure that scientifically sound
nutritional and health information is provided to consumers as soon
as possible; or

‘(B) to enable the Secretary to act promptly to ban or modify a
claim under this paragraph.

Such proposed regulations shall be deemed final agency action for
purposes of judicial review.’

SEC. 302. PETITIONS FOR CLAIMS

Section 403(r)(4)(A)(i) (21 U.S.C. 343(r)(4)(A)(i)) is amended–

(1) by adding after the second sentence the following: ‘If the
Secretary does not act within such 100 days, the petition shall be
deemed to be denied unless an extension is mutually agreed upon by
the Secretary and the petitioner.’;

(2) in the fourth sentence (as amended by paragraph (1)) by
inserting immediately before the comma the following: ‘or the
petition is deemed to be denied’; and

(3) by adding at the end the following: ‘If the Secretary does
not act within such 90 days, the petition shall be deemed to be
denied unless an extension is mutually agreed upon by the Secretary
and the petitioner. If the Secretary issues a proposed regulation,
the rulemaking shall be completed within 540 days of the date the
petition is received by the Secretary.

If the Secretary does not issue a regulation within such 540
days, the Secretary shall provide the Committee on Commerce of the
House of Representatives and the Committee on Labor and Human
Resources of the Senate the reasons action on the regulation did not
occur within such 540 days.’

SEC. 303. HEALTH CLAIMS FOR FOOD PRODUCTS

Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by adding at
the end thereof the following: ‘(C) Notwithstanding the provisions of
clauses (A)(i) and (B), a claim of the type described in subparagraph
(1)(B) which is not authorized by the Secretary in a regulation
promulgated in accordance with clause (B) shall be authorized and may
be made with respect to a food if–

‘(i) a scientific body of the United States Government with
official responsibility for public health protection or research
directly relating to human nutrition (such as the National Institutes
of Health or the Centers for Disease Control and Prevention) or the
National Academy of Sciences or any of its subdivisions has published
an authoritative statement, which is currently in effect, about the
relationship between a nutrient and a disease or health-related
condition to which the claim refers;

‘(ii) a person has submitted to the Secretary, at least 120 days
(during which the Secretary may notify any person who is making a
claim as authorized by clause (C) that such person has not submitted
all the information required by such clause) before the first
introduction into interstate commerce of the food with a label
containing the claim, (I) a notice of the claim, which shall include
the exact words used in the claim and shall include a concise
description of the basis upon which such person relied for
determining that the requirements of subclause (i) have been
satisfied, (II) a copy of the statement referred to in subclause (i)
upon which such person relied in making the claim, and (III) a
balanced representation of the scientific literature relating to the
relationship between a nutrient and a disease or health-related
condition to which the claim refers;

‘(iii) the claim and the food for which the claim is made are in
compliance with clause (A)(ii) and are otherwise in compliance with
paragraph (a) and section 201(n); and

‘(iv) the claim is stated in a manner so that the claim is an
accurate representation of the authoritative statement referred to in
subclause (i) and so that the claim enables the public to comprehend
the information provided in the claim and to understand the relative
significance of such information in the context of a total daily
diet.

For purposes of this clause, a statement shall be regarded as an
authoritative statement of a scientific body described in subclause
(i) only if the statement is published by the scientific body and
shall not include a statement of an employee of the scientific body
made in the individual capacity of the employee.

‘(D) A claim submitted under the requirements of clause (C) may
be made until–

‘(i) such time as the Secretary issues a regulation under the
standard in clause (B)(i)– ‘(I) prohibiting or modifying the claim
and the regulation has become effective, or ‘(II) finding that the
requirements of clause (C) have not been met, including finding that
the petitioner has not submitted all the information required by such
clause; or

‘(ii) a district court of the United States in an enforcement
proceeding under chapter III has determined that the requirements of
clause (C) have not been met.’

SEC. 304. NUTRIENT CONTENT CLAIMS

Section 403(r)(2) (21 U.S.C. 343(r)(2)) is amended by adding at
the end the following: ‘(G) A claim of the type described in
subparagraph (1)(A) for a nutrient, for which the Secretary has not
promulgated a regulation under clause (A)(i), shall be authorized and
may be made with respect to a food if–

‘(i) a scientific body of the United States Government with
official responsibility for public health protection or research
directly relating to human nutrition (such as the National Institutes
of Health or the Centers for Disease Control and Prevention) or the
National Academy of Sciences or any of its subdivisions has published
an authoritative statement, which is currently in effect, which
identifies the nutrient level to which the claim refers;

‘(iii) the claim and the food for which the claim is made are in
compliance with clauses (A) and (B), and are otherwise in compliance
with paragraph (a) and section 201(n); and

‘(H) A claim submitted under the requirements of clause (G) may
be made until–

‘(i) such time as the Secretary issues a regulation– ‘(I)
prohibiting or modifying the claim and the regulation has become
effective, or ‘(II) finding that the requirements of clause (G) have
not been met, including finding that the petitioner had not submitted
all the information required by such clause; or

‘(ii) a district court of the United States in an enforcement
proceeding under chapter III has determined that the requirements of
clause (G) have not been met.’

SEC. 305. REFERRAL STATEMENTS

Section 403(r)(2)(B) (21 U.S.C. 343(r)(2)(B)) is amended to read
as follows: ‘(B) If a claim described in subparagraph (1)(A) is made
with respect to a nutrient in a food and the Secretary makes a
determination that the food contains a nutrient at a level that
increases to persons in the general population the risk of a disease
or health-related condition that is diet related, the label or
labeling of such food shall contain, prominently and in immediate
proximity to such claim, the following statement: ‘See nutrition
information for [Bold->] XX [<-Bold] content.’ The blank
shall identify the nutrient associated with the increased disease or
health-related condition risk. In making the determination described
in this clause, the Secretary shall take into account the
significance of the food in the total daily diet.’

SEC. 306. DISCLOSURE OF IRRADIATION

Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting after
section 403B the following: ‘DISCLOSURE ‘SEC. 403C. (a) No provision
of section 201(n), 403(a), or 409 shall be construed to require on
the label or labeling of a food a separate radiation disclosure
statement that is more prominent than the declaration of ingredients
required by section 403(i)(2).

‘(b) In this section, the term ‘radiation disclosure statement’
means a written statement that discloses that a food has been
intentionally subject to radiation.’

SEC. 307. IRRADIATION PETITION

Not later than 60 days following the date of the enactment of
this Act, the Secretary of Health and Human Services shall make a
final determination on any petition pending with the Food and Drug
Administration that would permit the irradiation of red meat under
section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act. If the
Secretary does not make such determination, the Secretary shall, not
later than 60 days following the date of the enactment of this Act,
provide the Committee on Commerce of the House of Representatives and
the Committee on Labor and Human Resources of the Senate an
explanation of the process followed by the Food and Drug
Administration in reviewing the petition referred to in paragraph (1)
and the reasons action on the petition was delayed.

SEC. 308. GLASS AND CERAMIC WARE

(a) IN GENERAL- The Secretary may not implement any requirement
which would ban, as an unapproved food additive, lead and cadmium
based enamel in the lip and rim area of glass and ceramic ware before
the expiration of one year after the date such requirement is
published.

(b) LEAD AND CADMIUM BASED ENAMEL- Unless the Secretary
determines, based on available data, that lead and cadmium based
enamel on glass and ceramic ware–

(1) which has less than 60 millimeters of decorating area below
the external rim, and

(2) which is not, by design, representation, or custom of usage
intended for use by children, is unsafe, the Secretary shall not take
any action before January 1, 2003, to ban lead and cadmium based
enamel on such glass and ceramic ware. Any action taken after January
1, 2003, to ban such enamel on such glass and ceramic ware as an
unapproved food additive shall be taken by regulation and such
regulation shall provide that such products shall not be removed from
the market before 1 year after publication of the final regulation.

SEC. 309. FOOD CONTACT SUBSTANCES

(a) FOOD CONTACT SUBSTANCES- Section 409(a) (21 U.S.C. 348(a))
is amended–

(1) in paragraph (1)– (A) by striking ‘subsection (i)’ and
inserting ‘subsection (j)’; and (B) by striking at the end ‘or’;

(2) by striking the period at the end of paragraph (2) and
inserting ‘; or’;

(3) by inserting after paragraph (2) the following:

‘(3) in the case of a food additive as defined in this Act that is
a food contact substance, there is– ‘(A) in effect, and such
substance and the use of such substance are in conformity with, a
regulation issued under this section prescribing the conditions under
which such additive may be safely used; or ‘(B) a notification
submitted under subsection (h) that is effective.’; and

(4) by striking the matter following paragraph (3) (as added by
paragraph (3)) and inserting the following flush sentence: ‘While
such a regulation relating to a food additive, or such a notification
under subsection (h)(1) relating to a food additive that is a food
contact substance, is in effect, and has not been revoked pursuant to
subsection (i), a food shall not, by reason of bearing or containing
such a food additive in accordance with the regulation or
notification, be considered adulterated under section 402(a)(1).’

(b) NOTIFICATION FOR FOOD CONTACT SUBSTANCES- Section 409 (21
U.S.C. 348), as amended by subsection (a), is further amended–

(1) by redesignating subsections (h) and (i), as subsections (i)
and (j), respectively;

(2) by inserting after subsection (g) the following: ‘NOTIFICATION
RELATING TO A FOOD CONTACT SUBSTANCE ‘(h)(1) Subject to such
regulations as may be promulgated under paragraph (3), a manufacturer
or supplier of a food contact substance may, at least 120 days prior
to the introduction or delivery for introduction into interstate
commerce of the food contact substance, notify the Secretary of the
identity and intended use of the food contact substance, and of the
determination of the manufacturer or supplier that the intended use
of such food contact substance is safe under the standard described
in subsection (c)(3)(A). The notification shall contain the
information that forms the basis of the determination and all
information required to be submitted by regulations promulgated by
the Secretary.

‘(2)(A) A notification submitted under paragraph (1) shall
become effective 120 days after the date of receipt by the Secretary
and the food contact substance may be introduced or delivered for
introduction into interstate commerce, unless the Secretary makes a
determination within the 120-day period that, based on the data and
information before the Secretary, such use of the food contact
substance has not been shown to be safe under the standard described
in subsection (c)(3)(A), and informs the manufacturer or supplier of
such determination.

‘(B) A decision by the Secretary to object to a notification
shall constitute final agency action subject to judicial review.

‘(C) In this paragraph, the term ‘food contact substance’ means
the substance that is the subject of a notification submitted under
paragraph (1), and does not include a similar or identical substance
manufactured or prepared by a person other than the manufacturer
identified in the notification.

‘(3)(A) The process in this subsection shall be utilized for
authorizing the marketing of a food contact substance except where
the Secretary determines that submission and review of a petition
under subsection (b) is necessary to provide adequate assurance of
safety, or where the Secretary and any manufacturer or supplier agree
that such manufacturer or supplier may submit a petition under
subsection (b).

‘(B) The Secretary is authorized to promulgate regulations to
identify the circumstances in which a petition shall be filed under
subsection (b), and shall consider criteria such as the probable
consumption of such food contact substance and potential toxicity of
the food contact substance in determining the circumstances in which
a petition shall be filed under subsection (b).

‘(4) The Secretary shall keep confidential any information
provided in a notification under paragraph (1) for 120 days after
receipt by the Secretary of the notification. After the expiration of
such 120 days, the information shall be available to any interested
party except for any matter in the notification that is a trade
secret or confidential commercial information.

‘(5)(A)(i) Except as provided in clause (ii), the notification
program established under this subsection shall not operate in any
fiscal year unless–

‘(I) an appropriation equal to or exceeding the applicable amount
under clause (iv) is made for such fiscal year for carrying out such
program in such fiscal year; and

‘(II) the Secretary certifies that the amount appropriated for
such fiscal year for the Center for Food Safety and Applied Nutrition
of the Food and Drug Administration (exclusive of the appropriation
referred to in subclause (I)) equals or exceeds the amount
appropriated for the Center for fiscal year 1997, excluding any
amount appropriated for new programs.

‘(ii) The Secretary shall, not later than April 1, 1999, begin
accepting and reviewing notifications submitted under the
notification program established under this subsection if–

‘(I) an appropriation equal to or exceeding the applicable amount
under clause (iii) is made for the last six months of fiscal year
1999 for carrying out such program during such period; and

‘(II) the Secretary certifies that the amount appropriated for
such period for the Center for Food Safety and Applied Nutrition of
the Food and Drug Administration (exclusive of the appropriation
referred to in subclause (I)) equals or exceeds an amount equivalent
to one-half the amount appropriated for the Center for fiscal year
1997, excluding any amount appropriated for new programs.

‘(iii) For the last six months of fiscal year 1999, the
applicable amount under this clause is $1,500,000, or the amount
specified in the budget request of the President for the six-month
period involved for carrying out the notification program in fiscal
year 1999, whichever is less.

‘(iv) For fiscal year 2000 and subsequent fiscal years, the
applicable amount under this clause is $3,000,000, or the amount
specified in the budget request of the President for the fiscal year
involved for carrying out the notification program under this
subsection, whichever is less.

‘(B) For purposes of carrying out the notification program under
this subsection, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 1999 through fiscal
year 2003, except that such authorization of appropriations is not
effective for a fiscal year for any amount that is less than the
applicable amount under clause (iii) or (iv) of subparagraph (A),
whichever is applicable.

‘(C) Not later than April 1 of fiscal year 1998 and February 1
of each subsequent fiscal year, the Secretary shall submit a report
to the Committees on Appropriations of the House of Representatives
and the Senate, the Committee on Commerce of the House of
Representatives, and the Committee on Labor and Human Resources of
the Senate that provides an estimate of the Secretary of the costs of
carrying out the notification program established under this
subsection for the next fiscal year.

‘(6) In this section, the term ‘food contact substance’ means
any substance intended for use as a component of materials used in
manufacturing, packing, packaging, transporting, or holding food if
such use is not intended to have any technical effect in such food.’;

(3) in subsection (i), as so redesignated by paragraph (1), by
adding at the end the following: ‘The Secretary shall by regulation
prescribe the procedure by which the Secretary may deem a
notification under subsection (h) to no longer be effective.’; and

(4) in subsection (j), as so redesignated by paragraph (1), by
striking ‘subsections (b) to (h)’ and inserting ‘subsections (b) to
(i)’.

TITLE IV–GENERAL PROVISIONS

SEC. 401. DISSEMINATION OF INFORMATION ON NEW USES

(a) IN GENERAL- Chapter V (21 U.S.C. 351 et seq.) is amended by
inserting after subchapter C the following: ‘SUBCHAPTER
D–DISSEMINATION OF TREATMENT INFORMATION

‘SEC. 551. REQUIREMENTS FOR DISSEMINATION OF TREATMENT INFORMATION
ON DRUGS OR DEVICES

‘(a) IN GENERAL- Notwithstanding sections 301(d), 502(f), and
505, and section 351 of the Public Health Service Act (42 U.S.C

262), a manufacturer may disseminate to–

‘(1) a health care practitioner;

‘(2) a pharmacy benefit manager;

‘(3) a health insurance issuer;

‘(4) a group health plan; or

‘(5) a Federal or State governmental agency; written information
concerning the safety, effectiveness, or benefit of a use not
described in the approved labeling of a drug or device if the
manufacturer meets the requirements of subsection (b).

‘(b) SPECIFIC REQUIREMENTS- A manufacturer may disseminate
information under subsection (a) on a new use only if–

‘(1)(A) in the case of a drug, there is in effect for the drug an
application filed under subsection (b) or (j) of section 505 or a
biologics license issued under section 351 of the Public Health
Service Act; or

‘(B) in the case of a device, the device is being commercially
distributed in accordance with a regulation under subsection (d) or
(e) of section 513, an order under subsection (f) of such section, or
the approval of an application under section 515;

‘(2) the information meets the requirements of section 552;

‘(3) the information to be disseminated is not derived from
clinical research conducted by another manufacturer or if it was
derived from research conducted by another manufacturer, the
manufacturer disseminating the information has the permission of such
other manufacturer to make the dissemination;

‘(4) the manufacturer has, 60 days before such dissemination,
submitted to the Secretary– ‘(A) a copy of the information to be
disseminated; and ‘(B) any clinical trial information the
manufacturer has relating to the safety or effectiveness of the new
use, any reports of clinical experience pertinent to the safety of
the new use, and a summary of such information;

‘(5) the manufacturer has complied with the requirements of
section 554 (relating to a supplemental application for such use);

‘(6) the manufacturer includes along with the information to be
disseminated under this subsection– ‘(A) a prominently displayed
statement that discloses– ‘(i) that the information concerns a use
of a drug or device that has not been approved or cleared by the
Food and Drug Administration; ‘(ii) if applicable, that the
information is being disseminated at the expense of the manufacturer;
‘(iii) if applicable, the name of any authors of the information who
are employees of, consultants to, or have received compensation from,
the manufacturer, or who have a significant financial interest in the
manufacturer; ‘(iv) the official labeling for the drug or device and
all updates with respect to the labeling; ‘(v) if applicable, a
statement that there are products or treatments that have been
approved or cleared for the use that is the subject of the
information being disseminated pursuant to subsection (a)(1); and
‘(vi) the identification of any person that has provided funding for
the conduct of a study relating to the new use of a drug or device
for which such information is being disseminated; and ‘(B) a
bibliography of other articles from a scientific reference
publication or scientific or medical journal that have been
previously published about the use of the drug or device covered by
the information disseminated (unless the information already includes
such bibliography).

‘(c) ADDITIONAL INFORMATION- If the Secretary determines, after
providing notice of such determination and an opportunity for a
meeting with respect to such determination, that the information
submitted by a manufacturer under subsection (b)(3)(B), with respect
to the use of a drug or device for which the manufacturer intends to
disseminate information, fails to provide data, analyses, or other
written matter that is objective and balanced, the Secretary may
require the manufacturer to disseminate–

‘(1) additional objective and scientifically sound information
that pertains to the safety or effectiveness of the use and is
necessary to provide objectivity and balance, including any
information that the manufacturer has submitted to the Secretary or,
where appropriate, a summary of such information or any other
information that the Secretary has authority to make available to the
public; and

‘(2) an objective statement of the Secretary, based on data or
other scientifically sound information available to the Secretary,
that bears on the safety or effectiveness of the new use of the drug
or device.

‘SEC. 552. INFORMATION AUTHORIZED TO BE DISSEMINATED

‘(a) AUTHORIZED INFORMATION- A manufacturer may disseminate
information under section 551 on a new use only if the information–

‘(1) is in the form of an unabridged– ‘(A) reprint or copy of an
article, peer-reviewed by experts qualified by scientific training or
experience to evaluate the safety or effectiveness of the drug or
device involved, which was published in a scientific or medical
journal (as defined in section 556(5)), which is about a clinical
investigation with respect to the drug or device, and which would be
considered to be scientifically sound by such experts; or ‘(B)
reference publication, described in subsection (b), that includes
information about a clinical investigation with respect to the drug
or device that would be considered to be scientifically sound by
experts qualified by scientific training or experience to evaluate
the safety or effectiveness of the drug or device that is the subject
of such a clinical investigation; and

‘(2) is not false or misleading and would not pose a significant
risk to the public health.

‘(b) REFERENCE PUBLICATION- A reference publication referred to
in subsection (a)(1)(B) is a publication that–

‘(1) has not been written, edited, excerpted, or published
specifically for, or at the request of, a manufacturer of a drug or
device;

‘(2) has not been edited or significantly influenced by such a
manufacturer;

‘(3) is not solely distributed through such a manufacturer but is
generally available in bookstores or other distribution channels
where medical textbooks are sold;

‘(4) does not focus on any particular drug or device of a
manufacturer that disseminates information under section 551 and
does not have a primary focus on new uses of drugs or devices that
are marketed or under investigation by a manufacturer supporting the
dissemination of information; and

‘(5) presents materials that are not false or misleading.

‘SEC. 553. ESTABLISHMENT OF LIST OF ARTICLES AND PUBLICATIONS
DISSEMINATED AND LIST OF PROVIDERS THAT RECEIVED ARTICLES AND
REFERENCE PUBLICATIONS

‘(a) IN GENERAL- A manufacturer may disseminate information
under section 551 on a new use only if the manufacturer prepares and
submits to the Secretary biannually–

‘(1) a list containing the titles of the articles and reference
publications relating to the new use of drugs or devices that were
disseminated by the manufacturer to a person described in section
551(a) for the 6-month period preceding the date on which the
manufacturer submits the list to the Secretary; and

‘(2) a list that identifies the categories of providers (as
described in section 551(a)) that received the articles and reference
publications for the 6-month period described in paragraph (1).

‘(b) RECORDS- A manufacturer that disseminates information under
section 551 shall keep records that may be used by the manufacturer
when, pursuant to section 555, such manufacturer is required to take
corrective action and shall be made available to the Secretary, upon
request, for purposes of ensuring or taking corrective action
pursuant to such section. Such records, at the Secretary’s
discretion, may identify the recipient of information provided
pursuant to section 551 or the categories of such recipients.

‘SEC. 554. REQUIREMENT REGARDING SUBMISSION OF SUPPLEMENTAL
APPLICATION FOR NEW USE; EXEMPTION FROM REQUIREMENT

‘(a) IN GENERAL- A manufacturer may disseminate information
under section 551 on a new use only if–

‘(1)(A) the manufacturer has submitted to the Secretary a
supplemental application for such use; or

‘(B) the manufacturer meets the condition described in subsection
(b) or (c) (relating to a certification that the manufacturer will
submit such an application); or

‘(2) there is in effect for the manufacturer an exemption under
subsection (d) from the requirement of paragraph (1).

‘(b) CERTIFICATION ON SUPPLEMENTAL APPLICATION; CONDITION IN
CASE OF COMPLETED STUDIES- For purposes of subsection (a)(1)(B), a
manufacturer may disseminate information on a new use if the
manufacturer has submitted to the Secretary an application containing
a certification that–

‘(1) the studies needed for the submission of a supplemental
application for the new use have been completed; and

‘(2) the supplemental application will be submitted to the
Secretary not later than 6 months after the date of the initial
dissemination of information under section 551.

‘(c) CERTIFICATION ON SUPPLEMENTAL APPLICATION; CONDITION IN
CASE OF PLANNED STUDIES-

‘(1) IN GENERAL- For purposes of subsection (a)(1)(B), a
manufacturer may disseminate information on a new use if– ‘(A) the
manufacturer has submitted to the Secretary an application
containing– ‘(i) a proposed protocol and schedule for conducting the
studies needed for the submission of a supplemental application for
the new use; and ‘(ii) a certification that the supplemental
application will be submitted to the Secretary not later than 36
months after the date of the initial dissemination of information
under section 551 (or, as applicable, not later than such date as the
Secretary may specify pursuant to an extension under paragraph (3));
and ‘(B) the Secretary has determined that the proposed protocol is
adequate and that the schedule for completing such studies is
reasonable.

‘(2) PROGRESS REPORTS ON STUDIES- A manufacturer that submits to
the Secretary an application under paragraph (1) shall submit to the
Secretary periodic reports describing the status of the studies
involved.

‘(3) EXTENSION OF TIME REGARDING PLANNED STUDIES- The period of
36 months authorized in paragraph (1)(A)(ii) for the completion of
studies may be extended by the Secretary if– ‘(A) the Secretary
determines that the studies needed to submit such an application
cannot be completed and submitted within 36 months; or ‘(B) the
manufacturer involved submits to the Secretary a written request for
the extension and the Secretary determines that the manufacturer has
acted with due diligence to conduct the studies in a timely manner,
except that an extension under this subparagraph may not be provided
for more than 24 additional months.

‘(d) EXEMPTION FROM REQUIREMENT OF SUPPLEMENTAL APPLICATION-

‘(1) IN GENERAL- For purposes of subsection (a)(2), a manufacturer
may disseminate information on a new use if– ‘(A) the manufacturer
has submitted to the Secretary an application for an exemption from
meeting the requirement of subsection (a)(1); and ‘(B)(i) the
Secretary has approved the application in accordance with paragraph
(2); or ‘(ii) the application is deemed under paragraph (3)(A) to
have been approved (unless such approval is terminated pursuant to
paragraph (3)(B)).

‘(2) CONDITIONS FOR APPROVAL- The Secretary may approve an
application under paragraph (1) for an exemption if the Secretary
makes a determination described in subparagraph (A) or (B), as
follows: ‘(A) The Secretary makes a determination that, for reasons
defined by the Secretary, it would be economically prohibitive with
respect to such drug or device for the manufacturer to incur the
costs necessary for the submission of a supplemental application. In
making such determination, the Secretary shall consider (in addition
to any other considerations the Secretary finds appropriate)– ‘(i)
the lack of the availability under law of any period during which the
manufacturer would have exclusive marketing rights with respect to
the new use involved; and ‘(ii) the size of the population expected
to benefit from approval of the supplemental application.

‘(B) The Secretary makes a determination that, for reasons
defined by the Secretary, it would be unethical to conduct the
studies necessary for the supplemental application. In making such
determination, the Secretary shall consider (in addition to any other
considerations the Secretary finds appropriate) whether the new use
involved is the standard of medical care for a health condition.

‘(3) TIME FOR CONSIDERATION OF APPLICATION; DEEMED APPROVAL- ‘(A)
IN GENERAL- The Secretary shall approve or deny an application under
paragraph (1) for an exemption not later than 60 days after the
receipt of the application. If the Secretary does not comply with the
preceding sentence, the application is deemed to be approved.

‘(B) TERMINATION OF DEEMED APPROVAL- If pursuant to a deemed
approval under subparagraph (A) a manufacturer disseminates written
information under section 551 on a new use, the Secretary may at any
time terminate such approval and under section 555(b)(3) order the
manufacturer to cease disseminating the information.

‘(e) REQUIREMENTS REGARDING APPLICATIONS- Applications under
this section shall be submitted in the form and manner prescribed by
the Secretary.

‘SEC. 555. CORRECTIVE ACTIONS; CESSATION OF DISSEMINATION

‘(a) POSTDISSEMINATION DATA REGARDING SAFETY AND EFFECTIVENESS-

‘(1) CORRECTIVE ACTIONS- With respect to data received by the
Secretary after the dissemination of information under section 551 by
a manufacturer has begun (whether received pursuant to paragraph (2)
or otherwise), if the Secretary determines that the data indicate
that the new use involved may not be effective or may present a
significant risk to public health, the Secretary shall, after
consultation with the manufacturer, take such action regarding the
dissemination of the information as the Secretary determines to be
appropriate for the protection of the public health, which may
include ordering that the manufacturer cease the dissemination of
the information.

‘(2) RESPONSIBILITIES OF MANUFACTURERS TO SUBMIT DATA- After a
manufacturer disseminates information under section 551, the
manufacturer shall submit to the Secretary a notification of any
additional knowledge of the manufacturer on clinical research or
other data that relate to the safety or effectiveness of the new use
involved. If the manufacturer is in possession of the data, the
notification shall include the data. The Secretary shall by
regulation establish the scope of the responsibilities of
manufacturers under this paragraph, including such limits on the
responsibilities as the Secretary determines to be appropriate.

‘(b) CESSATION OF DISSEMINATION-

‘(1) FAILURE OF MANUFACTURER TO COMPLY WITH REQUIREMENTS- The
Secretary may order a manufacturer to cease the dissemination of
information pursuant to section 551 if the Secretary determines that
the information being disseminated does not comply with the
requirements established in this subchapter.

Such an order may be issued only after the Secretary has
provided notice to the manufacturer of the intent of the Secretary to
issue the order and (unless paragraph (2)(B) applies) has provided an
opportunity for a meeting with respect to such intent. If the failure
of the manufacturer constitutes a minor violation of this
subchapter, the Secretary shall delay issuing the order and provide
to the manufacturer an opportunity to correct the violation.

‘(2) SUPPLEMENTAL APPLICATIONS- The Secretary may order a
manufacturer to cease the dissemination of information pursuant to
section 551 if– ‘(A) in the case of a manufacturer that has
submitted a supplemental application for a new use pursuant to
section 554(a)(1), the Secretary determines that the supplemental
application does not contain adequate information for approval of the
new use for which the application was submitted; ‘(B) in the case of
a manufacturer that has submitted a certification under section
554(b), the manufacturer has not, within the 6-month period involved,
submitted the supplemental application referred to in the
certification; or ‘(C) in the case of a manufacturer that has
submitted a certification under section 554(c) but has not yet
submitted the supplemental application referred to in the
certification, the Secretary determines, after an informal hearing,
that the manufacturer is not acting with due diligence to complete
the studies involved.

‘(3) TERMINATION OF DEEMED APPROVAL OF EXEMPTION REGARDING
SUPPLEMENTAL APPLICATIONS- If under section 554(d)(3) the Secretary
terminates a deemed approval of an exemption, the Secretary may order
the manufacturer involved to cease disseminating the information. A
manufacturer shall comply with an order under the preceding sentence
not later than 60 days after the receipt of the order.

‘(c) CORRECTIVE ACTIONS BY MANUFACTURERS-

‘(1) IN GENERAL- In any case in which under this section the
Secretary orders a manufacturer to cease disseminating information,
the Secretary may order the manufacturer to take action to correct
the information that has been disseminated, except as provided in
paragraph (2).

‘(2) TERMINATION OF DEEMED APPROVAL OF EXEMPTION REGARDING
SUPPLEMENTAL APPLICATIONS- In the case of an order under subsection
(b)(3) to cease disseminating information, the Secretary may not
order the manufacturer involved to take action to correct the
information that has been disseminated unless the Secretary
determines that the new use described in the information would pose a
significant risk to the public health.

‘SEC. 556. DEFINITIONS

‘For purposes of this subchapter:

‘(1) The term ‘health care practitioner’ means a physician, or
other individual who is a provider of health care, who is licensed
under the law of a State to prescribe drugs or devices.

‘(2) The terms ‘health insurance issuer’ and ‘group health plan’
have the meaning given such terms under section 2791 of the Public
Health Service Act.

‘(3) The term ‘manufacturer’ means a person who manufactures a
drug or device, or who is licensed by such person to distribute or
market the drug or device.

‘(4) The term ‘new use’– ‘(A) with respect to a drug, means a
use that is not included in the labeling of the approved drug; and
‘(B) with respect to a device, means a use that is not included in
the labeling for the approved or cleared device.

‘(5) The term ‘scientific or medical journal’ means a scientific
or medical publication– ‘(A) that is published by an organization–
‘(i) that has an editorial board; ‘(ii) that utilizes experts, who
have demonstrated expertise in the subject of an article under review
by the organization and who are independent of the organization, to
review and objectively select, reject, or provide comments about
proposed articles; and ‘(iii) that has a publicly stated policy, to
which the organization adheres, of full disclosure of any conflict
of interest or biases for all authors or contributors involved with
the journal or organization; ‘(B) whose articles are peer-reviewed
and published in accordance with the regular peer-review procedures
of the organization; ‘(C) that is generally recognized to be of
national scope and reputation; ‘(D) that is indexed in the Index
Medicus of the National Library of Medicine of the National
Institutes of Health; and ‘(E) that is not in the form of a special
supplement that has been funded in whole or in part by one or more
manufacturers.

‘SEC. 557. RULES OF CONSTRUCTION

‘(a) UNSOLICITED REQUEST- Nothing in section 551 shall be
construed as prohibiting a manufacturer from disseminating
information in response to an unsolicited request from a health care
practitioner.

‘(b) DISSEMINATION OF INFORMATION ON DRUGS OR DEVICES NOT
EVIDENCE OF INTENDED USE- Notwithstanding subsection (a), (f), or (o)
of section 502, or any other provision of law, the dissemination of
information relating to a new use of a drug or device, in accordance
with section 551, shall not be construed by the Secretary as evidence
of a new intended use of the drug or device that is different from
the intended use of the drug or device set forth in the official
labeling of the drug or device.

Such dissemination shall not be considered by the Secretary as
labeling, adulteration, or misbranding of the drug or device.

‘(c) PATENT PROTECTION- Nothing in section 551 shall affect
patent rights in any manner.

‘(d) AUTHORIZATION FOR DISSEMINATION OF ARTICLES AND FEES FOR
REPRINTS OF ARTICLES- Nothing in section 551 shall be construed as
prohibiting an entity that publishes a scientific journal (as defined
in section 556(5)) from requiring authorization from the entity to
disseminate an article published by such entity or charging fees for
the purchase of reprints of published articles from such entity.’

(b) PROHIBITED ACT- Section 301 (21 U.S.C. 331), as amended by
section 210, is amended by adding at the end the following: ‘(z) The
dissemination of information in violation of section 551.’

(c) REGULATIONS- Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services
shall promulgate regulations to implement the amendments made by this
section.

(d) EFFECTIVE DATE- The amendments made by this section shall
take effect 1 year after the date of enactment of this Act, or upon
the Secretary’s issuance of final regulations pursuant to subsection
(c), whichever is sooner.

(e) SUNSET- The amendments made by this section cease to be
effective September 30, 2006, or 7 years after the date on which the
Secretary promulgates the regulations described in subsection (c),
whichever is later.

(f) STUDIES AND REPORTS-

(1) GENERAL ACCOUNTING OFFICE- (A) IN GENERAL- The Comptroller
General of the United States shall conduct a study to determine the
impact of subchapter D of chapter V of the Federal Food, Drug, and
Cosmetic Act, as added by this section, on the resources of the
Department of Health and Human Services.

(B) REPORT- Not later than January 1, 2002, the Comptroller
General of the United States shall prepare and submit to the
Committee on Labor and Human Resources of the Senate and the
Committee on Commerce of the House of Representatives a report of the
results of the study.

(2) DEPARTMENT OF HEALTH AND HUMAN SERVICES- (A) IN GENERAL- In
order to assist Congress in determining whether the provisions of
such subchapter should be extended beyond the termination date
specified in subsection (e), the Secretary of Health and Human
Services shall, in accordance with subparagraph (B), arrange for the
conduct of a study of the scientific issues raised as a result of the
enactment of such subchapter including issues relating to– (i) the
effectiveness of such subchapter with respect to the provision of
useful scientific information to health care practitioners; (ii) the
quality of the information being disseminated pursuant to the
provisions of such subchapter; (iii) the quality and usefulness of
the information provided, in accordance with such subchapter, by the
Secretary or by the manufacturer at the request of the Secretary; and
(iv) the impact of such subchapter on research in the area of new
uses, indications, or dosages, particularly the impact on pediatric
indications and rare diseases.

(3) PROCEDURE FOR STUDY- (A) IN GENERAL- The Secretary shall
request the Institute of Medicine of the National Academy of Sciences
to conduct the study required by paragraph (2), and to prepare and
submit the report required by subparagraph (B), under an arrangement
by which the actual expenses incurred by the Institute of Medicine in
conducting the study and preparing the report will be paid by the
Secretary. If the Institute of Medicine is unwilling to conduct the
study under such an arrangement, the Comptroller General of the
United States shall conduct such study.

(B) REPORT- Not later than September 30, 2005, the Institute of
Medicine or the Comptroller General of the United States, as
appropriate, shall prepare and submit to the Committee on Labor and
Human Resources of the Senate, the Committee on Commerce of the House
of Representatives, and the Secretary a report of the results of the
study required by paragraph (2). The Secretary, after the receipt of
the report, shall make the report available to the public.

Chapter V (21 U.S.C. 351 et seq.), as amended in
section 401, is further amended by adding at the end the following:

‘SUBCHAPTER E–GENERAL PROVISIONS RELATING TO DRUGS AND DEVICES

‘SEC. 561. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS

‘(a) EMERGENCY SITUATIONS- The Secretary may, under appropriate
conditions determined by the Secretary, authorize the shipment of
investigational drugs or investigational devices for the diagnosis,
monitoring, or treatment of a serious disease or condition in
emergency situations.

‘(b) INDIVIDUAL PATIENT ACCESS TO INVESTIGATIONAL PRODUCTS
INTENDED FOR SERIOUS DISEASES- Any person, acting through a physician
licensed in accordance with State law, may request from a
manufacturer or distributor, and any manufacturer or distributor may,
after complying with the provisions of this subsection, provide to
such physician an investigational drug or investigational device for
the diagnosis, monitoring, or treatment of a serious disease or
condition if–

‘(1) the licensed physician determines that the person has no
comparable or satisfactory alternative therapy available to diagnose,
monitor, or treat the disease or condition involved, and that the
probable risk to the person from the investigational drug or
investigational device is not greater than the probable risk from the
disease or condition;

‘(2) the Secretary determines that there is sufficient evidence of
safety and effectiveness to support the use of the investigational
drug or investigational device in the case described in paragraph
(1);

‘(3) the Secretary determines that provision of the
investigational drug or investigational device will not interfere
with the initiation, conduct, or completion of clinical
investigations to support marketing approval; and

‘(4) the sponsor, or clinical investigator, of the investigational
drug or investigational device submits to the Secretary a clinical
protocol consistent with the provisions of section 505(i) or 520(g),
including any regulations promulgated under section 505(i) or 520(g),
describing the use of the investigational drug or investigational
device in a single patient or a small group of patients.

‘(c) TREATMENT INVESTIGATIONAL NEW DRUG
APPLICATIONS AND TREATMENT INVESTIGATIONAL DEVICE EXEMPTIONS- Upon
submission by a sponsor or a physician of a protocol intended to
provide widespread access to an investigational drug or
investigational device for eligible patients (referred to in this
subsection as an ‘expanded access protocol’), the Secretary shall
permit such investigational drug or investigational device to be made
available for expanded access under a treatment investigational new
drug application or treatment investigational device exemption if the
Secretary determines that–

‘(1) under the treatment investigational new drug application or
treatment investigational device exemption, the investigational drug
or investigational device is intended for use in the diagnosis,
monitoring, or treatment of a serious or immediately life-threatening
disease or condition;

‘(2) there is no comparable or satisfactory alternative therapy
available to diagnose, monitor, or treat that stage of disease or
condition in the population of patients to which the investigational
drug or investigational device is intended to be administered;

‘(3)(A) the investigational drug or investigational device is
under investigation in a controlled clinical trial for the use
described in paragraph (1) under an investigational drug application
in effect under section 505(i) or investigational device exemption in
effect under section 520(g); or

‘(B) all clinical trials necessary for approval of that use of
the investigational drug or investigational device have been
completed;

‘(4) the sponsor of the controlled clinical trials is actively
pursuing marketing approval of the investigational drug or
investigational device for the use described in paragraph (1) with
due diligence;

‘(5) in the case of an investigational drug or investigational
device described in paragraph (3)(A), the provision of the
investigational drug or investigational device will not interfere
with the enrollment of patients in ongoing clinical investigations
under section 505(i) or 520(g);

‘(6) in the case of serious diseases, there is sufficient evidence
of safety and effectiveness to support the use described in paragraph
(1); and

‘(7) in the case of immediately life-threatening diseases, the
available scientific evidence, taken as a whole, provides a
reasonable basis to conclude that the investigational drug or
investigational device may be effective for its intended use and
would not expose patients to an unreasonable and significant risk of
illness or injury.

A protocol submitted under this subsection shall be subject to the
provisions of section 505(i) or 520(g), including regulations
promulgated under section 505(i) or 520(g). The Secretary may inform
national, State, and local medical associations and societies,
voluntary health associations, and other appropriate persons about
the availability of an investigational drug or investigational device
under expanded access protocols submitted under this subsection. The
information provided by the Secretary, in accordance with the
preceding sentence, shall be the same type of information that is
required by section 402(j)(3) of the Public Health Service Act.

‘(d) TERMINATION- The Secretary may, at any time, with respect
to a sponsor, physician, manufacturer, or distributor described in
this section, terminate expanded access provided under this section
for an investigational drug or investigational device if the
requirements under this section are no longer met.

‘(e) DEFINITIONS- In this section, the terms ‘investigational
drug’, ‘investigational device’, ‘treatment investigational new drug
application’, and ‘treatment investigational device exemption’ shall
have the meanings given the terms in regulations prescribed by the
Secretary.’

(a) STANDARDS- Not later than 180 days after the date of
enactment of this Act, the Secretary of Health and Human Services
shall publish in the Federal Register standards for the prompt review
of supplemental applications submitted for approved articles under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or
section 351 of the Public Health Service Act (42 U.S.C. 262).

(b) GUIDANCE TO INDUSTRY- Not later than 180 days after the date
of enactment of this Act, the Secretary shall issue final guidances
to clarify the requirements for, and facilitate the submission of
data to support, the approval of supplemental applications for the
approved articles described in subsection (a). The guidances shall–

(1) clarify circumstances in which published matter may be the
basis for approval of a supplemental application;

(2) specify data requirements that will avoid duplication of
previously submitted data by recognizing the availability of data
previously submitted in support of an original application; and

(3) define supplemental applications that are eligible for
priority review.

(c) RESPONSIBILITIES OF CENTERS- The Secretary shall designate
an individual in each center within the Food and Drug Administration
(except the Center for Food Safety and Applied Nutrition) to be
responsible for–

(1) encouraging the prompt review of supplemental applications
for approved articles; and

(2) working with sponsors to facilitate the development and
submission of data to support supplemental applications.

(d) COLLABORATION- The Secretary shall implement programs and
policies that will foster collaboration between the Food and Drug
Administration, the National Institutes of Health, professional
medical and scientific societies, and other persons, to identify
published and unpublished studies that may support a supplemental
application, and to encourage sponsors to make supplemental
applications or conduct further research in support of a supplemental
application based, in whole or in part, on such studies.

SEC. 404. DISPUTE RESOLUTION

Subchapter E of chapter V, as added by section 402, is amended
by adding at the end the following: ‘SEC. 562. DISPUTE RESOLUTION

‘If, regarding an obligation concerning drugs or devices under
this Act or section 351 of the Public Health Service Act, there is a
scientific controversy between the Secretary and a person who is a
sponsor, applicant, or manufacturer and no specific provision of the
Act involved, including a regulation promulgated under such 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 manufacturer may request a review of such
controversy, including a review by an appropriate scientific advisory
panel described in section 505(n) or an advisory committee described
in section 515(g)(2)(B). Any such review shall take place in a timely
manner. The Secretary shall promulgate such regulations within 1 year
after the date of the enactment of the Food and Drug Administration
Modernization Act of 1997.’

SEC. 405. 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 documents
with public participation and ensure that information identifying the
existence of such documents and the documents themselves are made
available to the public both in written form and, as feasible,
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 jurisdiction of the Food and Drug
Administration.

‘(B) Although guidance documents shall not be binding on the
Secretary, the Secretary shall ensure that employees of the Food and
Drug Administration do not deviate from such guidances without
appropriate justification and supervisory concurrence. The Secretary
shall provide training to employees in how to develop and use
guidance documents and shall monitor the development and issuance of
such documents.

‘(C) For guidance documents that set forth initial
interpretations of a statute or regulation, changes in interpretation
or policy that are of more than a minor nature, complex scientific
issues, or highly controversial issues, the Secretary shall ensure
public participation prior to implementation of guidance documents,
unless the Secretary determines that such prior public participation
is not feasible or appropriate. In such cases, the Secretary shall
provide for public comment upon implementation 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 for such documents 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.

The Secretary shall periodically review all guidance documents
and, where appropriate, revise such documents.

‘(3) The Secretary, acting through the Commissioner, shall
maintain electronically and update and publish periodically in the
Federal Register a list of guidance documents. All such documents
shall be made available to the public.

‘(4) The Secretary shall ensure that an effective appeals
mechanism is in place to address complaints that the Food and Drug
Administration is not developing and using guidance documents in
accordance with this subsection.

‘(5) Not later than July 1, 2000, the Secretary after evaluating
the effectiveness of the Good Guidance Practices document, published
in the Federal Register at 62 Fed. Reg. 8961, shall promulgate a
regulation consistent with this subsection specifying the policies
and procedures of the Food and Drug Administration for the
development, issuance, and use of guidance documents.’

(a) MISSION- Section 903 (21 U.S.C. 393) is
amended–

(1) by redesignating subsections (b) and (c) as subsections (d)
and (e), respectively; and

(2) by inserting after subsection (a) the following: ‘(b) MISSION-
The Administration shall–

‘(1) 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;

‘(2) with respect to such products, protect the public health by
ensuring that– ‘(A) foods are safe, wholesome, sanitary, and
properly labeled; ‘(B) human and veterinary drugs are safe and
effective; ‘(C) there is reasonable assurance of the safety and
effectiveness of devices intended for human use; ‘(D) cosmetics are
safe and properly labeled; and ‘(E) public health and safety are
protected from electronic product radiation;

‘(3) participate through appropriate processes with
representatives of other countries to reduce the burden of
regulation, harmonize regulatory requirements, and achieve
appropriate reciprocal arrangements; and

‘(4) as determined to be appropriate by the Secretary, carry out
paragraphs (1) through (3) in consultation with experts in science,
medicine, and public health, and in cooperation with consumers,
users, manufacturers, importers, packers, distributors, and retailers
of regulated products.’

(b) ANNUAL REPORT- Section 903 (21 U.S.C. 393), as amended by
subsection (a), is further amended by adding at the end the
following:

‘(f) AGENCY PLAN FOR STATUTORY COMPLIANCE-

‘(1) IN GENERAL- Not later than 1 year after the date of enactment
of the Food and Drug Administration Modernization Act of 1997, the
Secretary, after consultation with appropriate scientific and
academic experts, health care professionals, representatives of
patient and consumer advocacy groups, and the regulated industry,
shall develop and publish in the Federal Register a plan bringing
the Secretary into compliance with each of the obligations of the
Secretary under this Act

The Secretary shall review the plan biannually and shall
revise the plan as necessary, in consultation with such persons.

‘(2) OBJECTIVES OF AGENCY PLAN- The plan required by paragraph
(1) shall establish objectives and mechanisms to achieve such
objectives, including objectives related to– ‘(A) maximizing the
availability and clarity of information about the process for review
of applications and submissions (including petitions, notifications,
and any other similar forms of request) made under this Act; ‘(B)
maximizing the availability and clarity of information for consumers
and patients concerning new products; ‘(C) implementing inspection
and postmarket monitoring provisions of this Act; ‘(D) ensuring
access to the scientific and technical expertise needed by the
Secretary to meet obligations described in paragraph (1); ‘(E)
establishing mechanisms, by July 1, 1999, for meeting the time
periods specified in this Act for the review of all applications and
submissions described in subparagraph (A) and submitted after the
date of enactment of the Food and Drug Administration Modernization
Act of 1997; and ‘(F) eliminating backlogs in the review of
applications and submissions described in subparagraph (A), by
January 1, 2000.

‘(g) ANNUAL REPORT- The Secretary shall annually prepare and
publish in the Federal Register and solicit public comment on a
report that–

‘(1) provides detailed statistical information on the performance
of the Secretary under the plan described in subsection (f);

‘(2) compares such performance of the Secretary with the
objectives of the plan and with the statutory obligations of the
Secretary; and

‘(3) identifies any regulatory policy that has a significant
negative impact on compliance with any objective of the plan or any
statutory obligation and sets forth any proposed revision to any
such regulatory policy.’

SEC. 407. INFORMATION SYSTEM

(a) AMENDMENT- Chapter VII (21 U.S.C. 371 et seq.) is amended by
adding at the end the following:

‘SUBCHAPTER D–INFORMATION AND EDUCATION

‘SEC. 741. INFORMATION SYSTEM

‘The Secretary shall establish and maintain an information
system to track the status and progress of each application or
submission (including a petition, notification, or other similar form
of request) submitted to the Food and Drug Administration requesting
agency action.’

(b) REPORT- Not later than 1 year after the date of enactment of
this Act, the Secretary of Health and Human Services shall submit a
report to the Committee on Labor and Human Resources of the Senate
and the Committee on Commerce of the House of Representatives on the
status of the system to be established under the amendment made by
subsection (a), including the projected costs of the system and
concerns about confidentiality.

SEC. 408. EDUCATION AND TRAINING

(a) FOOD AND DRUG ADMINISTRATION- Chapter VII (21 U.S.C. 371 et
seq.), as amended by section 407, is further amended by adding at the
end the following section:

‘SEC. 742. EDUCATION

‘(a) IN GENERAL- 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, including programs for–

‘(1) scientific training;

‘(2) training to improve the skill of officers and employees
authorized to conduct inspections under section 704;

‘(3) training to achieve product specialization in such
inspections; and

‘(4) training in administrative process and procedure and
integrity issues.

‘(b) INTRAMURAL FELLOWSHIPS AND OTHER TRAINING PROGRAMS- The
Secretary, acting through the Commissioner, may, through fellowships
and other training programs, conduct and support intramural research
training for predoctoral and postdoctoral scientists and physicians.’

(b) CENTERS FOR DISEASE CONTROL AND PREVENTION-

(1) IN GENERAL- Part B of title III of the Public Health Service
Act is amended by inserting after section 317F (42 U.S.C. 247b-7) the
following:

‘SEC. 317G. FELLOWSHIP AND TRAINING PROGRAMS

‘The Secretary, acting through the Director of the Centers for
Disease Control and Prevention, shall establish fellowship and
training programs to be conducted by such Centers to train
individuals to develop skills in epidemiology, surveillance,
laboratory analysis, and other disease detection and prevention
methods. Such programs shall be designed to enable health
professionals and health personnel trained under such programs to
work, after receiving such training, in local, State, national, and
international efforts toward the prevention and control of diseases,
injuries, and disabilities. Such fellowships and training may be
administered through the use of either appointment or nonappointment
procedures.’

(2) EFFECTIVE DATE- The amendment made by this subsection is
deemed to have taken effect July 1, 1995.

SEC. 409. CENTERS FOR EDUCATION AND RESEARCH ON THERAPEUTICS

Title IX of the Public Health Service Act (42 U.S.C. 299 et
seq.) is amended by adding at the end of part A the following new
section:

‘SEC. 905. DEMONSTRATION PROGRAM REGARDING CENTERS FOR EDUCATION
AND RESEARCH ON THERAPEUTICS

‘(a) IN GENERAL- The Secretary, acting through the Administrator
and in consultation with the Commissioner of Food and Drugs, shall
establish a demonstration 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–
‘(i) new uses of drugs, biological products, and devices; ‘(ii) ways
to improve the effective use of drugs, biological products, and
devices; and ‘(iii) risks of new uses and risks of combinations of
drugs and biological products.

‘(B) To provide objective clinical information to the following
individuals and entities:

‘(i) Health care practitioners or other providers of health
care goods or services

‘(ii) Pharmacy benefit managers

‘(iii) Health maintenance organizations or other managed
health care organizations

‘(iv) Health care insurers or governmental agencies

‘(v) Consumers

‘(C) To improve the quality of health care while reducing the cost
of health care through– ‘(i) the appropriate use of drugs,
biological products, or devices; and ‘(ii) the prevention of adverse
effects of drugs, biological products, and devices and the
consequences of such effects, such as unnecessary hospitalizations.

‘(2) The conduct of research on the comparative effectiveness and
safety of drugs, biological products, and devices.

‘(3) Such other activities as the Secretary determines 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 subsection (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 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 undergone 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 each of fiscal
years 1999 through 2002.’

(a) GOOD MANUFACTURING PRACTICE REQUIREMENTS-
Section 520(f)(1)(B) (21 U.S.C. 360j(f)(1)(B)) is amended–

(1) in clause (i), by striking ‘, and’ at the end and inserting a
semicolon;

(2) in clause (ii), by striking the period and inserting ‘; and’;
and

(3) by inserting after clause (ii) the following:

‘(iii) ensure that such regulation conforms, to the extent
practicable, with internationally recognized standards defining
quality systems, or parts of the standards, for medical devices.’

(b) HARMONIZATION EFFORTS- Section 803 (21 U.S.C. 383) is
amended by adding at the end the following: ‘(c)(1) The Secretary
shall support the Office of the United States Trade Representative,
in consultation with the Secretary of Commerce, in meetings with
representatives of other countries to discuss methods and approaches
to reduce the burden of regulation and harmonize regulatory
requirements if the Secretary determines that such harmonization
continues consumer protections consistent with the purposes of this
Act.

‘(2) The Secretary shall support the Office of the United States
Trade Representative, in consultation with the Secretary of Commerce,
in efforts to move toward the acceptance of mutual recognition
agreements relating to the regulation of drugs, biological products,
devices, foods, food additives, and color additives, and the
regulation of good manufacturing practices, between the European
Union and the United States.

‘(3) The Secretary shall regularly participate in meetings with
representatives of other foreign governments to discuss and reach
agreement on methods and approaches to harmonize regulatory
requirements.

‘(4) The Secretary shall, not later than 180 days after the date
of enactment of the Food and Drug Administration Modernization Act of
1997, make public a plan that establishes a framework for achieving
mutual recognition of good manufacturing practices inspections.

‘(5) Paragraphs (1) through (4) shall not apply with respect to
products defined in section 201(ff).’

SEC. 411. ENVIRONMENTAL IMPACT REVIEW

Chapter VII (21 U.S.C. 371 et seq.), as amended by section 407,
is further amended by adding at the end the following:

‘SUBCHAPTER E–ENVIRONMENTAL IMPACT REVIEW ‘SEC. 746.
ENVIRONMENTAL IMPACT

‘Notwithstanding any other provision of law, an environmental
impact statement prepared in accordance with the regulations
published in part 25 of title 21, Code of Federal Regulations (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 National Environmental Policy Act of 1969
(42 U.S.C. 4332(2)(C)).’

(a) NONPRESCRIPTION DRUGS- Chapter VII (21
U.S.C. 371 et seq.), as amended by section 411, is further amended by
adding at the end the following: ‘SUBCHAPTER F–NATIONAL UNIFORMITY
FOR NONPRESCRIPTION DRUGS AND PREEMPTION FOR LABELING OR PACKAGING OF
COSMETICS ‘SEC. 751. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS

‘(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–

‘(1) that relates to the regulation of a drug that is not subject
to the requirements of section 503(b)(1) or 503(f)(1)(A); 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 Packaging and Labeling Act (15 U.S.C. 1451 et seq.).

‘(b) EXEMPTION-

‘(1) IN GENERAL- Upon application of a State or political
subdivision thereof, the Secretary may by regulation, after notice
and opportunity for written and oral presentation of views, exempt
from subsection (a), under such conditions as may be prescribed in
such regulation, a State or political subdivision requirement that–
‘(A) protects an important public interest that would otherwise be
unprotected, including the health and safety of children; ‘(B) would
not cause any drug to be in violation of any applicable requirement
or prohibition under Federal law; and ‘(C) would not unduly burden
interstate commerce.

‘(2) TIMELY ACTION- The Secretary shall make a decision on the
exemption of a State or political subdivision requirement under
paragraph (1) not later than 120 days after receiving the application
of the State or political subdivision under paragraph (1).

‘(c) SCOPE-

‘(1) IN GENERAL- This section shall not apply to– ‘(A) any State
or political subdivision requirement that relates to the practice of
pharmacy; or ‘(B) any State or political subdivision requirement 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 described in subsection
(a)(1) that is not the subject of an application approved under
section 505 or section 507 (as in effect on the day before the date
of enactment of the Food and Drug Administration Modernization Act of
1997) or a final regulation promulgated by the Secretary establishing
conditions under which the drug is generally recognized as safe and
effective and not misbranded, 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 different from or
in addition to, or that is otherwise not identical with– ‘(A) a
regulation in effect with respect to the drug pursuant to a statute
described in subsection (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 enactment of the Food and Drug
Administration Modernization Act of 1997.

‘(2) STATE INITIATIVES- This section shall not apply to a State
requirement adopted by a State public initiative or referendum
enacted prior to September 1, 1997.

‘(e) NO EFFECT ON PRODUCT LIABILITY LAW- Nothing 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 enforcement 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,’

352(e)(1)) is amended to read as follows: ‘(1)(A) If it is a drug,
unless its label bears, to the exclusion of any other nonproprietary
name (except the applicable systematic chemical name or the chemical
formula)–

‘(i) the established name (as defined in subparagraph (3)) of the
drug, if there is such a name;

‘(ii) the established name and quantity or, if determined to be
appropriate by the Secretary, the proportion of each active
ingredient, including the quantity, kind, and proportion of any
alcohol, and also including whether active or not the established
name and quantity or if determined to be appropriate by the
Secretary, the proportion of any bromides, ether, chloroform,
acetanilide, 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 specifically named in
this subclause, shall not apply to nonprescription drugs not intended
for human use; and

‘(iii) the established name of each inactive ingredient listed in
alphabetical order on the outside container of the retail package
and, if determined to be appropriate by the Secretary, on the
immediate container, as prescribed in regulation promulgated by the
Secretary, except that nothing in this subclause shall be deemed to
require that any trade secret be divulged, and except that the
requirements of this subclause with respect to alphabetical order
shall apply only to nonprescription drugs that are not also cosmetics
and that 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 proprietary name or designation for such drug or ingredient,
except that to the extent that compliance with the requirements of
subclause (ii) or (iii) of clause (A) or this clause is
impracticable, exemptions shall be established by regulations
promulgated by the Secretary.’

(d) COSMETICS- Subchapter F of chapter VII, as amended by
subsection (a), is further amended by adding at the end the
following:

‘SEC. 752. PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS

‘(a) IN GENERAL- Except as provided in subsection (b), (d), or
(e), no State or political subdivision of a State may establish 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 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 political
subdivision thereof, the Secretary may by regulation, after notice
and opportunity for written and oral presentation of views, exempt
from subsection (a), under such conditions as may be prescribed in
such regulation, a State or political subdivision requirement for
labeling or packaging that–

‘(1) protects an important public interest that would otherwise be
unprotected;

‘(2) would not cause a cosmetic to be in violation of any
applicable requirement or prohibition under Federal law; and

‘(3) would not unduly burden interstate commerce.

‘(c) SCOPE- For purposes of subsection (a), a reference 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 requirement specifically applicable to that
particular cosmetic or class of cosmetics under this Act for
packaging or labeling, including any State requirement relating to
public information or any other form of public communication.

‘(d) NO EFFECT ON PRODUCT LIABILITY LAW- Nothing 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.’

(a) LIST AND ANALYSIS- The Secretary of Health
and Human Services shall, acting through the Food and Drug
Administration–

(1) compile a list of drugs and foods that contain intentionally
introduced mercury compounds, and

(2) provide a quantitative and qualitative analysis of the mercury
compounds in the list under paragraph (1).

The Secretary shall compile the list required by paragraph (1)
within 2 years after the date of enactment of the Food and Drug
Administration Modernization Act of 1997 and shall provide the
analysis required by paragraph (2) within 2 years after such date of
enactment.

(b) STUDY- The Secretary of Health and Human Services, acting
through the Food and Drug Administration, shall conduct a study of
the effect on humans of the use of mercury compounds in nasal sprays.
Such study shall include data from other studies that have been made
of such use.

(1) STUDY- The Secretary of Health and Human Services, acting
through the Food and Drug Administration and subject to
appropriations, shall conduct, or shall contract with the Institute
of Medicine of the National Academy of Sciences to conduct, a study
of the effect on humans of the use of elemental, organic, or
inorganic mercury when offered for sale as a drug or dietary
supplement. Such study shall, among other things, evaluate– (A) the
scope of mercury use as a drug or dietary supplement; and (B) the
adverse effects on health of children and other sensitive populations
resulting from exposure to, or ingestion or inhalation of, mercury
when so used.

In conducting such study, the Secretary shall consult with the
Administrator of the Environmental Protection Agency, the Chair of
the Consumer Product Safety Commission, and the Administrator of the
Agency for Toxic Substances and Disease Registry, and, to the extent
the Secretary believes necessary or appropriate, with any other
Federal or private entity.

(2) REGULATIONS- If, in the opinion of the Secretary, the use of
elemental, organic, or inorganic mercury 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 regulations 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 availability of mercury
for use in religious ceremonies.

SEC. 414. INTERAGENCY COLLABORATION

Section 903 (21 U.S.C. 393), as amended by section 406, is
further amended by inserting after subsection (b) the following: ‘(c)
INTERAGENCY COLLABORATION- The Secretary shall implement programs and
policies that will foster collaboration between the Administration,
the National Institutes of Health, and other science-based Federal
agencies, to enhance the scientific and technical expertise available
to the Secretary in the conduct of the duties of the Secretary with
respect to the development, clinical investigation, evaluation, and
postmarket monitoring of emerging medical therapies, including
complementary therapies, and advances in nutrition and food science.’

SEC. 415. CONTRACTS FOR EXPERT REVIEW

Chapter IX (21 U.S.C. 391 et seq.), as amended by section 214,
is further amended by adding at the end the following: ‘SEC. 907.
CONTRACTS FOR EXPERT REVIEW

‘(a) IN GENERAL-

‘(1) AUTHORITY- The Secretary may enter into a contract with any
organization or any individual (who is not an employee of the
Department) with relevant expertise, to review and evaluate, for the
purpose of making recommendations to the Secretary on, part or all of
any application or submission (including a petition, notification,
and any other similar form of request) made under this Act for the
approval or classification of an article or made under section 351(a)
of the Public Health Service Act (42 U.S.C. 262(a)) with respect to
a biological product. Any such contract shall be subject to the
requirements of section 708 relating to the confidentiality of
information

‘(2) INCREASED EFFICIENCY AND EXPERTISE THROUGH CONTRACTS- The
Secretary may use the authority granted in paragraph (1) whenever the
Secretary determines that use of a contract described in paragraph
(1) will improve the timeliness of the review of an application or
submission described in paragraph (1), unless using such authority
would reduce the quality, or unduly increase the cost, of such
review. The Secretary may use such authority whenever the Secretary
determines that use of such a contract will improve the quality of
the review of an application or submission described in paragraph
(1), unless using such authority would unduly increase the cost of
such review. Such improvement in timeliness or quality may include
providing the Secretary increased scientific or technical expertise
that is necessary to review or evaluate new therapies and
technologies

‘(b) REVIEW OF EXPERT REVIEW-

‘(1) IN GENERAL- Subject to paragraph (2), the official of the
Food and Drug Administration responsible for any matter for which
expert review is used pursuant to subsection (a) shall review the
recommendations of the organization or individual who conducted the
expert review and shall make a final decision regarding the matter in
a timely manner

‘(2) LIMITATION- A final decision by the Secretary on any such
application or submission shall be made within the applicable
prescribed time period for review of the matter as set forth in this
Act or in the Public Health Service Act (42 U.S.C. 201 et seq.).’

SEC. 416. PRODUCT CLASSIFICATION

Subchapter E of chapter V, as amended by section 404, is further
amended by adding at the end the following:

‘SEC. 563. CLASSIFICATION OF PRODUCTS

‘(a) REQUEST- A person who submits an application or submission
(including a petition, notification, and any other similar form of
request) under this Act for a product, may submit a request to the
Secretary respecting the classification of the product as a drug,
biological product, device, or a combination product subject to
section 503(g) or respecting the component of the Food and Drug
Administration that will regulate the product. In submitting the
request, the person shall recommend a classification for the product,
or a component to regulate the product, as appropriate

‘(b) STATEMENT- Not later than 60 days after the receipt of the
request described in subsection (a), the Secretary shall determine
the classification of the product under subsection (a), or the
component of the Food and Drug Administration that will regulate the
product, and shall provide to the person a written statement that
identifies such classification or such component, and the reasons for
such determination. The Secretary may not modify such statement
except with the written consent of the person, or for public health
reasons based on scientific evidence

‘(c) INACTION OF SECRETARY- If the Secretary does not provide
the statement within the 60-day period described in subsection (b),
the recommendation made by the person under subsection (a) shall be
considered to be a final determination by the Secretary of such
classification of the product, or the component of the Food and Drug
Administration that will regulate the product, as applicable, and may
not be modified by the Secretary except with the written consent of
the person, or for public health reasons based on scientific
evidence.’

SEC. 417. REGISTRATION OF FOREIGN ESTABLISHMENTS

Section 510(i) (21 U.S.C. 360(i)) is amended to read as follows:
‘(i)(1) Any establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or processing of
a drug or a device that is imported or offered for import into the
United States shall register with the Secretary the name and place of
business of the establishment and the name of the United States agent
for the establishment

‘(2) The establishment shall also provide the information
required by subsection (j)

‘(3) The Secretary is authorized to enter into cooperative
arrangements with officials of foreign countries to ensure that
adequate and effective means are available for purposes of
determining, from time to time, whether drugs or devices
manufactured, prepared, propagated, compounded, or processed by an
establishment described in paragraph (1), if imported or offered for
import into the United States, shall be refused admission on any of
the grounds set forth in section 801(a).’

SEC. 418. CLARIFICATION OF SEIZURE AUTHORITY

Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended–

(1) in the fifth sentence, by striking ‘paragraphs (1) and (2) of
section 801(e)’ and inserting ‘subparagraphs (A) and (B) of section
801(e)(1)’; and

(2) by inserting after the fifth sentence the following: ‘Any
person seeking to export an imported article pursuant to any of the
provisions of this subsection shall establish that the article was
intended for export at the time the article entered commerce.’

SEC. 419. INTERSTATE COMMERCE

Section 709 (21 U.S.C. 379a) is amended by striking ‘a device’
and inserting ‘a device, food, drug, or cosmetic’.

SEC. 420. SAFETY REPORT DISCLAIMERS

Chapter VII (21 U.S.C. 371 et seq.), as amended by section 412,
is further amended by adding at the end the following:

‘SUBCHAPTER G–SAFETY REPORTS

‘SEC. 756. SAFETY REPORT DISCLAIMERS

‘With respect to any entity that submits or is required to
submit a safety report or other information in connection with the
safety of a product (including a product that is a food, drug,
device, dietary supplement, or cosmetic) under this Act (and any
release by the Secretary of that report or information), such report
or information shall not be construed to reflect necessarily a
conclusion by the entity or the Secretary that the report or
information constitutes an admission that the product involved
malfunctioned, caused or contributed to an adverse experience, or
otherwise caused or contributed to a death, serious injury, or
serious illness. Such an entity need not admit, and may deny, that
the report or information submitted by the entity constitutes an
admission that the product involved malfunctioned, caused or
contributed to an adverse experience, or caused or contributed to a
death, serious injury, or serious illness.’

Section 301 (21 U.S.C. 331) is amended by
striking paragraph (l).

SEC. 422. RULE OF CONSTRUCTION

Nothing in this Act or the amendments made by this Act shall be
construed to affect the question of whether the Secretary of Health
and Human Services has any authority to regulate any tobacco product,
tobacco ingredient, or tobacco additive. Such authority, if any,
shall be exercised under the Federal Food, Drug, and Cosmetic Act as
in effect on the day before the date of the enactment of this Act.

TITLE V–EFFECTIVE DATE

SEC. 501. EFFECTIVE DATE

Except as otherwise provided in this Act, this Act and the
amendments made by this Act, other than the provisions of and the
amendments made by sections 111, 121, 125, and 307, shall take effect
90 days after the date of enactment of this Act.

Speaker of the House of Representatives

Vice President of the United States and President of the Senate