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'

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

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

SEC. 501. Effective date

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.'

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.'

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.'

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;

'(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 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

'(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.

'(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.'

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.'

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.'

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.

(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.

(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)'.

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.

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.'

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.'

(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.

(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.

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).'

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,'

(c) MISBRANDING- Subparagraph (1) of section 502(e) (21 U.S.C

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.

(c) STUDY OF MERCURY SALES-

(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.

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.'

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.).'

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.'

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).'

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.'

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

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).

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.

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