II

104TH CONGRESS

1ST SESSION S. 1477

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.

IN THE SENATE OF THE UNITED STATES

DECEMBER 13, 1995

Mrs. KASSEBAUM introduced the following bill; which was read twice and

referred to the Committee on Labor and Human Resources

A BILL

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Food and Drug Ad5 ministration Performance and Accountability Act of

6 1995’’.
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1 TITLE I—MISSION AND

2 ACCOUNTABILITY

3 SEC. 101. SHORT TITLE.

4 This title may be cited as the ‘‘Food and Drug Ad5 ministration Regulatory Reform Act of 1995’’.

6 SEC. 102. THE MISSION OF THE FOOD AND DRUG ADMINIS7 TRATION.

8 Section 903(a) (21 U.S.C. 393(a)) is amended by

9 adding at the end thereof the following: ‘‘The mission of

10 the Administration is to promote and protect the health

11 of the American people by—

12 ‘‘(1) facilitating the rapid and efficient develop13 ment and availability of products subject to its regu14 lation;

15 ‘‘(2) protecting the public from unsafe or inef16 fective products subject to its regulation; and

17 ‘‘(3) enforcing the applicable statutes and regu18 lations in a timely, fair, consistent, and decisive

19 manner.’’.

20 SEC. 103. PERFORMANCE STANDARDS AND REVIEW.

21 Section 903(b) (21 U.S.C. 393(b)) is amended by

22 adding at the end thereof the following new paragraph:

23 ‘‘(3) PERFORMANCE STANDARDS AND RE24 VIEW.—Within 180 days after the date of enactment

25 of this paragraph, the Commissioner, after consulta-
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1 tion with representatives of patient advocacy groups,

2 health professionals, and the regulated industries,

3 shall publish in the Federal Register quantifiable

4 performance standards for action by the Administra5 tion on applications or submissions (including peti6 tions, notifications, or any other similar form of re7 quest) for the review of a product that is a new

8 drug, biological product, new animal drug, device, or

9 food additive and that is subject to premarket review

10 or approval of any kind under this Act. The per11 formance standards shall be reviewed, and after con12 sultation with representatives of patient advocacy

13 groups, health professionals, and the regulated in14 dustries, may be revised, annually by the Commis15 sioner. The performance standards shall establish

16 objectives for the Administration that—

17 ‘‘(A) expedite action on applications for

18 new drugs and devices under sections 505(b)(1)

19 and 515, and for biological products under sec20 tion 351(a) of the Public Health Service Act

21 (42 U.S.C. 262(a))—

22 ‘‘(i) for a serious, life-threatening, or

23 seriously debilitating disease or condition;

24 or
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1 ‘‘(ii) for any other condition if a new

2 drug, device, or biological product—

3 ‘‘(I) provides therapy not avail4 able from other approved therapy; or

5 ‘‘(II) offers significant improve6 ment over other approved therapy;

7 ‘‘(B) reduce backlogs on all applications

8 with the objective of eliminating all backlogs by

9 January 1, 2000; and

10 ‘‘(C) establish a schedule to bring the Ad11 ministration into full compliance by July 1,

12 1998, with the time periods specified in this Act

13 for action on all applications.

14 For applications for which there is no statutory time

15 period, the applicable time period for action shall be

16 180 days. The Commissioner shall prepare and pub17 lish in the Federal Register for public comment an

18 annual report comparing the performance of the Ad19 ministration with the applicable performance stand20 ards, analyzing any failure to achieve any of the

21 standards, and setting forth a plan to achieve com22 pliance with the standards that have not been met.’’.

23 SEC. 104. INFORMATION SYSTEM.

24 Chapter IX (21 U.S.C. 391 et seq.) is amended by

25 adding at the end thereof the following new section:
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1 ‘‘SEC. 906. INFORMATION SYSTEM.

2 ‘‘The Secretary shall establish and maintain an infor3 mation system to track the status and progress of each

4 application or submission (including a petition, notifica5 tion, or other similar form of request) submitted to the

6 Food and Drug Administration requesting agency action.

7 The system shall permit access by the applicant.’’.

8 SEC. 105. POLICY STATEMENTS.

9 Section 701(a) (21 U.S.C. 371(a)) is amended—

10 (1) by striking ‘‘(a) The’’ and inserting ‘‘(a)(1)

11 The’’; and

12 (2) by adding at the end thereof the following

13 new paragraph:

14 ‘‘(2)(A) The Secretary shall establish a procedure

15 governing the development and use of all policy statements

16 of general applicability (including any guideline, points-to17 consider, protocol, recommendation, or similar document

18 regardless of the form or designation) that are not pro19 mulgated as regulation. The procedure shall provide an

20 opportunity for affected persons to participate in the de21 velopment and continued use of the policy by sharing ex22 pertise, experience, or providing comment before the policy

23 is adopted and after the policy is implemented.

24 ‘‘(B) The Secretary shall establish a procedure for

25 the formal publication and compilation of all policy state26 ments of general applicability (including any guideline,
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1 points-to-consider, protocol, recommendation, or similar

2 document regardless of the form or designation) that are

3 not promulgated as regulations.’’.

4 SEC. 106. ADVISORY COMMITTEES.

5 Section 904 (21 U.S.C. 394) is amended—

6 (1) by striking ‘‘Without’’ and inserting ‘‘(a) IN

7 GENERAL.—Without’’; and

8 (2) by adding at the end thereof the following

9 new subsections:

10 ‘‘(b) DELEGATION OF APPOINTMENT AUTHORITY.—

11 The Commissioner may delegate the appointment and

12 oversight authority granted under subsection (a) to a cen13 ter director. The center director may not authorize any

14 office or division of the center to carry out the appoint15 ment and oversight authority granted under this sub16 section.

17 ‘‘(c) MEMBERSHIP AND MEETING REQUIREMENTS.—

18 ‘‘(1) SCOPE.—A scientific review group may de19 termine the matters that the group will consider and

20 may establish an appropriate agenda with respect to

21 the determination of the matters.

22 ‘‘(2) NONVOTING MEMBERS.—A scientific re23 view group shall include a nonvoting industry rep24 resentative and a nonvoting public representative.
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1 ‘‘(3) NOTIFICATION OF SCOPE OF DISCUS2 SION.—To the extent feasible, the specific matters

3 and questions to be discussed at a meeting of a sci4 entific review group shall be publicly announced and

5 published in the Federal Register at least 30 days

6 prior to the date of the meeting.

7 ‘‘(4) TERMS.—A member of a scientific review

8 group shall serve for a term of 3 years, which may

9 be renewed for a second term. An individual may

10 serve on more than one scientific review group. The

11 chairperson of a scientific review group shall be a

12 member who has served at least 3 years. The term

13 of the chairperson may be renewed for not more

14 than 3 terms.

15 ‘‘(5) TRAINING.—Prior to service on a scientific

16 review group, a member of the group shall be given

17 adequate education and training relating to the re18 sponsibilities of the member.

19 ‘‘(6) FREQUENCY OF MEETINGS.—The Sec20 retary shall take whatever action is necessary to en21 sure that regular meetings are held by scientific re22 view groups, at appropriate intervals and for a suffi23 cient length of time, so that any matter to be re24 viewed by any scientific review group shall be pre25 sented to the group not more than 90 days after the
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1 matter is ready for review by the group. The meet2 ings shall occur not less than 6 times each year un3 less there are compelling reasons for fewer meetings.

4 ‘‘(d) PERSONS INVOLVEMENT WITH REVIEW

5 GROUPS.—

6 ‘‘(1) IN GENERAL.—All persons, including em7 ployees of the Secretary, shall have the same rights

8 and responsibilities regarding—

9 ‘‘(A) the submission of data and informa10 tion to, and contact and discussion with, a sci11 entific review group;

12 ‘‘(B) the participation of the persons at

13 meetings of the group; and

14 ‘‘(C) access to data and information sub15 mitted to a scientific review group (except for

16 data and information that are not available for

17 public disclosure under section 552 of title 5,

18 United States Code).

19 ‘‘(2) SUBMISSION OF INFORMATION TO FDA.—

20 In a case in which a scientific review group reviews

21 an application (including a petition, notification, or

22 other similar request), all related data and informa23 tion that are not available for public disclosure

24 under section 552 of title 5, United States Code,

25 shall be exchanged between the applicant and the
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1 Food and Drug Administration at the time the data

2 and information are submitted to the scientific re3 view group but shall not otherwise be publicly dis4 closed.

5 ‘‘(3) PARTICIPATION IN MEETINGS.—Any meet6 ings of a scientific review group shall provide ade7 quate time for initial presentations and for response

8 to any differing views and shall encourage free and

9 open participation by all interested persons.

10 ‘‘(e) FDA ACTIONS.—Within 60 days after the date

11 a scientific review group makes its conclusions and rec12 ommendations on any matter under review of the group,

13 the Food and Drug Administration official responsible for

14 the matter shall review the conclusions and recommenda15 tions of the group, shall make a final determination on

16 the matter, and shall notify the affected persons of the

17 determination in writing and, if the determination differs

18 from the conclusions and recommendations of the group,

19 shall include the reasons for the difference.

20 ‘‘(f) DEFINITION.—For purposes of this section, the

21 term ‘center director’ means a director of a center within

22 the Food and Drug Administration.’’.
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1 SEC. 107. APPEALS WITHIN THE FOOD AND DRUG ADMINIS2 TRATION.

3 Chapter IX (21 U.S.C. 391 et seq.), as amended by

4 section 104, is further amended by adding at the end

5 thereof the following new section:

6 ‘‘SEC. 907. APPEALS WITHIN THE FOOD AND DRUG ADMIN7 ISTRATION.

8 ‘‘(a) EMPLOYEE DECISIONS.—The Secretary shall by

9 regulation establish a system for the appeal within the

10 Food and Drug Administration of any decision by an em11 ployee of the Food and Drug Administration, except that

12 this subsection shall not apply to decisions involving for13 mal administrative or judicial proceedings. The Secretary

14 shall make publicly known the existence of the internal

15 appeal system and the procedures for an internal appeal.

16 ‘‘(b) REVIEW BY SCIENTIFIC REVIEW GROUP.—

17 ‘‘(1) IN GENERAL.—Any person shall have the

18 right to request an evaluation by an appropriate sci19 entific review group established under section 904 of

20 any significant scientific issue pending before, or sig21 nificant scientific decision made by, the Secretary

22 under this Act. An appropriate scientific review

23 group shall review the request and determine wheth24 er to conduct an evaluation within 30 days after the

25 date the request is received by the Secretary.
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1 ‘‘(2) SCOPE.—The issues a scientific review

2 group shall evaluate shall include, but not be limited

3 to, matters involving a decision by the Secretary not

4 to permit a clinical investigation to begin or to con5 tinue, a refusal by the Secretary to file an applica6 tion, a protocol design, and decisions relating to a

7 pending application (including a petition, notifica8 tion, or other similar request), where the same issue

9 has not previously been reviewed by a scientific re10 view group.

11 ‘‘(3) TIME LIMITATION.—If a scientific review

12 group agrees to conduct an evaluation on an issue

13 under paragraph (1), the evaluation shall be sched14 uled for the next meeting of the group.

15 ‘‘(c) ADDITIONAL INFORMAL AND FORMAL PROCE16 DURES.—

17 ‘‘(1) IN GENERAL.—For purposes of obtaining

18 conclusions and recommendations regarding the res19 olution of any dispute, the Secretary is authorized to

20 use such additional informal and formal procedures

21 as may be considered useful. The procedures may in22 clude, but not be limited to, the use of—

23 ‘‘(A) panels of qualified Food and Drug

24 Administration officials;
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1 ‘‘(B) panels of qualified government em2 ployees who are not employees of the Food and

3 Drug Administration; and

4 ‘‘(C) outside mediators and arbitrators

5 who are not government employees.

6 ‘‘(2) APPLICATION OF FACA.—The Federal Ad7 visory Committee Act (5 U.S.C. App) shall not apply

8 to a panel described in paragraph (1).

9 ‘‘(d) REVIEW OF RECOMMENDATIONS.—Within 60

10 days after any matter that is presented for resolution pur11 suant to this section has been the subject of conclusions

12 and recommendations, the Food and Drug Administration

13 official responsible for the matter shall personally review

14 the conclusions and recommendations, make a final deter15 mination on the matter, and notify the parties of the de16 termination in writing and if the determination differs

17 from the conclusions and recommendations, the reasons

18 for the difference.’’.

19 TITLE II—EXPEDITED ACCESS

20 TO PRODUCTS FOR SERI21 OUSLY ILL PATIENTS

22 SEC. 201. SHORT TITLE.

23 This title may be cited as the ‘‘Patient Rights Regu24 latory Reform Act of 1995’’.
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1 SEC. 202. ACCESS TO UNAPPROVED THERAPIES.

2 Chapter V (21 U.S.C. 351 et seq.) is amended by

3 adding at the end thereof the following new section:

4 ‘‘SEC. 543. EXPANDED ACCESS TO UNAPPROVED THERA5 PIES AND DIAGNOSTICS.

6 ‘‘(a) IN GENERAL.—Any person may request from a

7 manufacturer or distributor, and any manufacturer or dis8 tributor may provide to a person after compliance with

9 the provisions of this section, an investigational drug (in10 cluding a biological product) or device for the diagnosis,

11 monitoring, or treatment of a serious disease or condition,

12 life-threatening or seriously debilitating disease or condi13 tion, and any other disease or condition designated by the

14 Secretary as appropriate for expanded access under this

15 section by the person if—

16 ‘‘(1) the person has no comparable or satisfac17 tory alternative therapy available to treat, diagnose,

18 or monitor the disease or condition; or

19 ‘‘(2) the risk to the person from the investiga20 tional drug or device is not greater than the risk

21 from the disease or condition.

22 ‘‘(b) PROTOCOLS.—A manufacturer or distributor

23 may submit to the Secretary one or more expanded access

24 protocols covering expanded access use of a drug or device

25 described in subsection (a). The protocols shall be subject

26 to the provisions of section 505(i) for a drug and section
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1 520 (g) and (m) for a device and may include any form

2 of use of the drug or device outside a clinical investigation,

3 prior to approval of the drug or device for marketing, in4 cluding but not limited to protocols for treatment, use,

5 parallel track, single patient protocols, emergency use, and

6 uncontrolled trials.

7 ‘‘(c) FEES.—A manufacturer or distributor may

8 charge for an investigational drug or device under an ex9 panded access protocol, but the price of the drug or device

10 may not be more than that necessary to recover the costs

11 of manufacture, research, development, and handling for

12 the drug or device.

13 ‘‘(d) NOTIFICATION OF AVAILABILITY.—The manu14 facturer or distributor may inform national, State, and

15 local medical associations and societies, and voluntary

16 health associations, about the availability of an investiga17 tional drug or device for expanded access use pursuant

18 to this section but—

19 ‘‘(1) shall state that the drug or device is inves20 tigational;

21 ‘‘(2) shall not represent that the drug or device

22 is safe or effective for any use; and

23 ‘‘(3) shall not otherwise promote or advertise

24 the availability of the product for expanded access

25 use.
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1 SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES.

2 Section 520(m) (21 U.S.C. 360j(m)) is amended—

3 (1) in paragraph (2), by inserting at the end

4 thereof the following flush sentences:

5 ‘‘The request shall be in the form of an application to the

6 Secretary. Within 30 days of the date of the receipt of

7 the application, the Secretary shall issue an order approv8 ing or denying the application.’’;

9 (2) by striking paragraph (5); and

10 (3) by striking paragraph (6).

11 SEC. 204. EXPEDITING APPROVAL OF NEW DRUGS, BIO12 LOGICS, AND MEDICAL DEVICES FOR SERI13 OUS CONDITIONS.

14 (a) NEW DRUGS.—Section 505(c)(1) (21 U.S.C.

15 355(c)(1)) is amended by adding at the end thereof the

16 following flush sentence:

17 ‘‘In a case in which an application submitted under section

18 505(b)(1) for a new drug, or section 351(a) of the Public

19 Health Service Act a biological product, for a life-threaten20 ing disease or condition, a seriously debilitating disease

21 or condition, or for any other serious disease or condition

22 that provides therapy or diagnosis not available from an23 other approved drug or biological product or offers signifi24 cant improvement over another approved drug or biologi25 cal product, the Secretary shall approve or deny approval
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1 of the application within 120 days after the receipt of the

2 application.’’.

3 TITLE III—REVITALIZING THE

4 INVESTIGATION OF NEW

5 PRODUCTS

6 SEC. 301. SHORT TITLE.

7 This title may be cited as the ‘‘Investigational Prod8 ucts Regulatory Reform Act of 1995’’.

9 SEC. 302. TIMELY REVIEW AND REASONABLE DATA RE10 QUIREMENTS FOR CLINICAL RESEARCH ON

11 DRUGS AND BIOLOGICAL PRODUCTS.

12 Section 505(i) (21 U.S.C. 355(i)) is amended—

13 (1) by striking ‘‘(i) The’’ and inserting ‘‘(i)(1)

14 The’’;

15 (2) by redesignating paragraphs (1), (2), and

16 (3) as subparagraphs (A), (B), and (C), respectively;

17 and

18 (3) by adding at the end thereof the following

19 new paragraph:

20 ‘‘(2)(A) A clinical investigation of a new drug (includ21 ing a biological product) may begin 30 days after the date

22 the Secretary receives from the sponsor a notification con23 taining information about the drug and the clinical inves24 tigation unless, prior to the 30-day period, the Secretary

25 informs the sponsor in writing that the investigation may
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1 not begin, and specifies the basis for the decision and the

2 information needed in order for the clinical investigation

3 to commence.

4 ‘‘(B) Within 1 year after the date of enactment of

5 the Food and Drug Administration Performance and Ac6 countability Act of 1995, the Secretary, after consultation

7 with representatives of patient advocacy groups and the

8 regulated industries, shall publish in the Federal Register

9 criteria for the type and amount of information relating

10 to the safety of an investigational drug to be included in

11 a notification described in subparagraph (A), taking into

12 account the recommendations of the International Con13 ference on Harmonization of Technical Requirements for

14 Registration of Pharmaceuticals for Human Use. The Sec15 retary shall periodically review, and may revise, the cri16 teria.

17 ‘‘(C) The Commissioner shall establish a mechanism

18 to ensure the fair and consistent application of safety

19 standards for clinical investigations.’’.

20 SEC. 303. TIMELY REVIEW AND REASONABLE DATA RE21 QUIREMENTS FOR CLINICAL RESEARCH ON

22 DEVICES.

23 Section 520(g) (21 U.S.C. 360j(g)) is amended by

24 adding at the end thereof the following new paragraphs:
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1 ‘‘(6) The procedures and conditions prescribed pursu2 ant to paragraph (2)(A) shall be subject to subparagraphs

3 (B) and (C) of section 505(i)(2).

4 ‘‘(7) The Secretary shall, within 120 days of the date

5 of enactment of this paragraph, by regulation amend the

6 content of parts 812 and 813 of title 21 of the Code of

7 Federal Regulations to update the procedures and condi8 tions under which devices intended for human use may

9 upon application be granted an exemption from certain re10 quirements under this Act. The regulation shall—

11 ‘‘(A) permit developmental changes in devices,

12 including manufacturing changes, in response to in13 formation collected during an investigation without

14 requiring an additional approval of an application

15 for an investigational device exemption or the ap16 proval of a supplement to the application, if the

17 changes do not constitute a significant change in de18 sign or a significant change in basic principles of op19 eration; and

20 ‘‘(B) permit, without approval of a supplement

21 to an application for an investigational device ex22 emption, changes or modifications to clinical proto23 cols that do not affect the validity of data or infor24 mation resulting from the completion of an approved

25 protocol.’’.
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1 SEC. 304. COLLABORATIVE RESEARCH DESIGN.

2 Chapter V (21 U.S.C. 351 et seq.), as amended by

3 section 202, is further amended by adding at the end

4 thereof the following new section:

5 ‘‘SEC. 544. COLLABORATIVE RESEARCH DESIGN.

6 ‘‘(a) REVIEW OF DESIGN.—

7 ‘‘(1) REQUEST.—Any person who intends to

8 sponsor a preclinical or clinical investigation of a

9 drug (including a biological product) or device may

10 request a meeting with the Secretary to review the

11 design of one or more protocols or part or all of a

12 development plan for the drug or device.

13 ‘‘(2) FORM.—A request described in paragraph

14 (1) shall be in writing and shall include a proposal

15 for which the review is requested.

16 ‘‘(3) WRITTEN REVIEW.—The Secretary shall

17 meet with the person within 30 days of the request

18 and shall provide to the person a written review of

19 the proposal, including any deficiencies in the pro20 posal. A written summary shall be made of the

21 meeting. The summary shall include the written re22 view of the proposal and, after agreement by the in23 dividuals who attended the meeting, shall be made

24 part of the product review file maintained by the

25 Food and Drug Administration.
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1 ‘‘(b) MODIFICATION OF AGREEMENTS.—Agreements

2 reached through meetings under subsection (a) may be

3 changed in writing by mutual consent of the sponsor and

4 the Secretary at any time.

5 ‘‘(c) MODIFICATION OF AGREEMENTS BY THE

6 FDA.—Agreements reached through meetings under sub7 section (a) may be changed unilaterally only—

8 ‘‘(1) by the director of the office of the Food

9 and Drug Administration responsible for regulating

10 a drug or device subject to review under this section,

11 who may not delegate such responsibility; and

12 ‘‘(2) in writing and specifying the basis therefor

13 and demonstrating the substantial public health rea14 sons that require the change.

15 ‘‘(d) PANEL REVIEW.—

16 ‘‘(1) IN GENERAL.—Any person requesting a

17 meeting under subsection (a) may obtain review

18 from a panel established under subsection 513(b) of

19 a determination of the Secretary to disapprove a

20 protocol or product development plan.

21 ‘‘(2) AGREEMENT MODIFICATIONS.—Any per22 son who has reached an agreement with the Sec23 retary under subsection (b) may obtain review from

24 a panel described in paragraph (1) of a modification

25 of the agreement under subsection (c).’’.
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1 TITLE IV—EFFICIENT, ACCOUNT2 ABLE, AND FAIR PRODUCT

3 REVIEW

4 SEC. 401. REFERENCE.

5 This title may be cited as the ‘‘Product Review Regu6 latory Reform Act of 1995’’.

7 SEC. 402. THE CONTENT AND REVIEW OF AN APPLICATION.

8 Chapter VII (21 U.S.C. 371 et seq.) is amended by

9 adding at the end thereof the following new subchapter:

10 ‘‘SUBCHAPTER D—REVIEW OF APPLICATIONS

11 ‘‘SEC. 741. CONTENT AND REVIEW OF AN APPLICATION.

12 ‘‘(a) IN GENERAL.—This section applies to any appli13 cation (including a petition, notification, or other similar

14 request) submitted for a food additive, new drug, biologi15 cal product, new animal drug, animal feed bearing or con16 taining a new animal drug, device, or color additive.

17 ‘‘(b) FILING REQUIREMENTS.—The Commissioner

18 shall establish a mechanism to ensure the fair and consist19 ent application of filing requirements.

20 ‘‘(c) CLASSIFICATION OF A PRODUCT.—Within 60

21 days of the receipt of a written request of any person for

22 information respecting the classification of a product as

23 a drug, biological product, or device or the component of

24 the Food and Drug Administration that will regulate the

25 product (including a request respecting a combination
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1 product subject to section 503(g)) the Secretary shall pro2 vide the person a written statement of the classification

3 of the product or the component of the Food and Drug

4 Administration that will regulate the product. The Sec5 retary’s statement shall be binding and may not be

6 changed by the Secretary except with the written agree7 ment of the person who submitted the request. If the Sec8 retary does not provide the statement within the 60-day

9 period, the classification and component designated by the

10 person submitting the request shall be final and binding

11 and may not be changed by the Secretary except with the

12 written agreement of the person. All radiopharmaceutical

13 products shall be regulated in a separate division under

14 the Center for Devices and Radiological Health.

15 ‘‘(d) REASONABLE DATA REQUIREMENTS.—Within 1

16 year after the date of enactment of the Food and Drug

17 Administration Performance and Accountability Act of

18 1995, the Secretary, after consultation with patient advo19 cacy groups and the regulated industries, shall publish in

20 the Federal Register criteria for the type and amount of

21 information relating to safety and effectiveness to be in22 cluded in an application for the approval of a product, or

23 a new use of an approved product, described in subsection

24 (c). In developing the criteria, the Secretary shall consider

25 any recommendations of the International Conference on
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1 Harmonization of Technical Requirements for Registra2 tion of Pharmaceuticals for Human Use.’’.

3 SEC. 403. CONTRACTS FOR EXPERT REVIEW.

4 Chapter VII (21 U.S.C. 371 et seq.), as amended by

5 section 402, is further amended by adding at the end

6 thereof the following new section:

7 ‘‘SEC. 742. CONTRACTS FOR EXPERT REVIEW.

8 ‘‘(a) IN GENERAL.—The Secretary may contract with

9 outside organizations and individuals, with expertise in

10 relevant disciplines, to review, evaluate, and make conclu11 sions and recommendations to the Secretary on parts or

12 all of any application (including a petition, notification,

13 or other similar request for Food and Drug Administra14 tion action). Any such contract shall be subject to the re15 quirements of section 708. Funds obtained under part 2

16 of subchapter C may be used for external review of any

17 drug (including a biological product) for which a user fee

18 was paid.

19 ‘‘(b) REVIEW OF EXPERT’S EVALUATION.—

20 ‘‘(1) IN GENERAL.—Subject to paragraph (2),

21 the Food and Drug Administration official respon22 sible for any matter for which expert review is used

23 pursuant to this section shall personally review the

24 conclusions and recommendations of the expert re25 view organization or individual and shall make a
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1 final decision regarding the matter under review

2 within 60 days after receiving the conclusions and

3 recommendation.

4 ‘‘(2) LIMITATION.—A final decision under para5 graph (1) shall be made within the applicable pre6 scribed time period for review of an application as

7 set forth in this Act.’’.

8 SEC. 404. PROMPT AND EFFICIENT REVIEW.

9 Chapter VII (21 U.S.C. 371 et seq.), as amended by

10 section 403, is further amended by adding at the end

11 thereof the following new section:

12 ‘‘SEC. 743. PROMPT AND EFFICIENT REVIEW.

13 ‘‘(a) IN GENERAL.—The provisions of this section

14 shall apply to any of the following applications (including

15 a petition, notification, or other similar request):

16 ‘‘(1) An application for approval of a human

17 food additive or animal feed additive under section

18 409.

19 ‘‘(2) An application for approval of a new drug

20 under section 505(b)(1).

21 ‘‘(3) An application for approval of a new ani22 mal drug or an animal feed bearing or containing a

23 new animal drug under subsection (b)(1) or (m) of

24 section 512, respectively.
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1 ‘‘(4) A submission for a determination that a

2 device is substantially equivalent to a predicate de3 vice under sections 513(f)(1) and 513(i).

4 ‘‘(5) An application for approval of a device

5 under section 515.

6 ‘‘(6) An application for the listing of a color ad7 ditive under section 721.

8 ‘‘(b) REVIEW PROCEDURES AND POLICIES.—The

9 Secretary shall establish procedures and policies to facili10 tate a collaborative review process between the Food and

11 Drug Administration and the applicant with respect to an

12 application or submission described in subsection (a). As

13 part of this collaborative process—

14 ‘‘(1) open, informal, and prompt communica15 tions shall be encouraged;

16 ‘‘(2) meetings (except meetings with respect to

17 submissions to determine substantial equivalence of

18 a device to a predicate device) shall be held after the

19 expiration of one-half of the statutory time period

20 for review of the application and after the expiration

21 of three-quarters of such period, or within 15 days

22 after a scientific review group has convened and

23 made recommendations on an application, unless the

24 Food and Drug Administration and the applicant

25 determine that a meeting is unnecessary; and
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1 ‘‘(3) the Secretary shall, prior to the meetings

2 described in paragraph (2), present to the applicant

3 in writing a description of any deficiencies of the ap4 plication and the information necessary to bring the

5 application into a form that would require approval.

6 ‘‘(c) APPROVAL, DISAPPROVAL, AND CLASSIFICA7 TION.—

8 ‘‘(1) APPROVAL BASED ON FAILURE TO ACT.—

9 Beginning 1 year after the date of publication of an

10 applicable performance standard under section

11 903(b), or 18 months after the date of enactment of

12 the Food and Drug Administration Performance and

13 Accountability Act of 1995, whichever occurs first, if

14 the Secretary fails to meet a time period for action

15 on an application established in the standard and

16 the product that is a new drug, biological product,

17 new animal drug, device, or food additive that is the

18 subject of the application has met the marketing re19 quirements of the European Union or the United

20 Kingdom, at the request of the applicant the appli21 cation shall be deemed to be approved unless, within

22 30 days after the expiration of the time period es23 tablished in the standard, the Secretary notifies the

24 applicant in writing that the application is dis25 approved, setting forth the reasons for disapproval,
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1 and, with the consent of the applicant, publishes a

2 notice, within 30 days of notifying the applicant, in

3 the Federal Register disapproving the application

4 under paragraph (2) and setting forth the reasons

5 for the disapproval.

6 ‘‘(2) APPEAL.—A person whose application has

7 been disapproved under this subsection may appeal

8 using one of the following procedures:

9 ‘‘(A) PROCEDURES UNDER THE ACT.—The

10 procedures established for the product under

11 other provisions of this Act.

12 ‘‘(B) APPEAL.—An appeal to a United

13 States District Court to determine whether the

14 Secretary’s decision is supported by substantial

15 evidence in the administrative record.

16 ‘‘(d) CONTRACTS FOR EXPERT REVIEW.—

17 ‘‘(1) IN GENERAL.—Beginning July 1, 1998, if

18 the Secretary in any fiscal year fails to meet the

19 statutory time period for action on an application

20 for at least 95 percent of the applications in a par21 ticular category, the Secretary shall in the following

22 fiscal year, with the consent of the applicant, con23 tract with expert individuals and organizations

24 under section 742 to review new applications and

25 applications for which the Secretary has failed to
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1 meet the statutory time period for action for the

2 particular product category.

3 ‘‘(2) APPROVAL.—If an individual or organiza4 tion selected to conduct a review under paragraph

5 (1) determines that an application described in para6 graph (1) should be approved, the application shall

7 be considered to be approved unless, within 30 days

8 after the date the Secretary receives the determina9 tion of the individual or organization, the Secretary

10 publishes a notice in the Federal Register disapprov11 ing the application and setting forth the reasons for

12 disapproval. An applicant may appeal the dis13 approval under subsection (c)(2).’’.

14 SEC. 405. GOOD MANUFACTURING PRACTICE INSPECTION.

15 Chapter VII is (21 U.S.C. 371 et seq.), as amended

16 by section 404, is further amended by adding at the end

17 thereof the following new section:

18 ‘‘SEC. 744. GOOD MANUFACTURING PRACTICE INSPECTION.

19 ‘‘(a) IN GENERAL.—In order to comply with inspec20 tion requirements of this Act, the Secretary may accredit

21 organizations to conduct inspections under section 704 to

22 evaluate compliance of a manufacturer with applicable re23 quirements for good manufacturing practice.

24 ‘‘(b) ELIGIBILITY REQUIREMENTS.—The Secretary

25 shall by regulation establish the requirements that an or-
29

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1 ganization shall meet to be eligible to be accredited to par2 ticipate as a qualified organization to conduct inspections

3 under subsection (a).

4 ‘‘(c) ACCREDITATION.—Within 90 days after the date

5 the Secretary receives an application for accreditation

6 under this section, the Secretary shall review the applica7 tion and determine whether an applicant is in compliance

8 with the requirements established under this section.

9 Within the 90-day period, the Secretary shall grant ac10 creditation or shall deny accreditation and specify in writ11 ing the reasons for the denial and the requirements that

12 shall be met to obtain accreditation.

13 ‘‘(d) REVOCATION OF ACCREDITATION.—The Sec14 retary may at any time revoke accreditation granted under

15 subsection (c) for failure to comply with the requirements

16 established under this section after specifying in writing

17 the reasons for the revocation and the requirements that

18 shall be met to retain accreditation and after an informal

19 hearing on the revocation.

20 ‘‘(e) INSPECTIONS.—Any organization accredited

21 under this subsection that conducts an inspection under

22 this subsection at the request of the Secretary shall—

23 ‘‘(1) apply all relevant principles of good manu24 facturing practice established in this Act and in reg25 ulations promulgated by the Secretary; and
30

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1 ‘‘(2) provide to the Secretary and the manufac2 turer within 30 days after the completion of the in3 spection an adequate report of the findings of the in4 spection.

5 ‘‘(f) LIMITATION.—When an accredited organization

6 has conducted a good manufacturing practice inspection

7 under section 704, the Secretary may not perform such

8 an inspection for a period of 2 years after the date of the

9 receipt of the report required under subsection (e)(2), un10 less justified by good cause.’’.

11 SEC. 406. ENVIRONMENTAL IMPACT REVIEW.

12 Chapter VII (21 U.S.C. 371 et seq.), as amended by

13 section 405, is further amended by adding at the end

14 thereof the following new section:

15 ‘‘SEC. 745. ENVIRONMENTAL IMPACT REVIEW.

16 ‘‘Notwithstanding any provision of other law, no ac17 tion by the Secretary pursuant to this Act shall be subject

18 to an environmental assessment, an environmental impact

19 statement, or other environmental consideration unless the

20 director of the office responsible for the action dem21 onstrates, in writing and specifying the basis therefor—

22 ‘‘(1) that there is a reasonable probability that

23 the environmental impact of the action is sufficiently

24 substantial and within the factors that the Secretary

25 is authorized to consider under this Act; and
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1 ‘‘(2) that consideration of the environmental

2 impact will directly affect the decision on the ac3 tion.’’.

4 SEC. 407. INFORMATION EXCHANGE.

5 Chapter VII (21 U.S.C. 371 et seq.), as amended by

6 section 406, is further amended by adding at the end

7 thereof the following new sections:

8 ‘‘SEC. 746. DISSEMINATION OF INFORMATION ON DRUGS.

9 ‘‘(a) DISSEMINATION.—

10 ‘‘(1) IN GENERAL.—Notwithstanding sections

11 301(d) and 502(f), and subject to the requirements

12 of paragraph (2) and subsection (b), a person may

13 disseminate to any person that is a health care prac14 titioner or other provider of health care goods or

15 services, a pharmacy benefit manager, a health

16 maintenance organization or other managed health

17 care organization, or a health care insurer or gov18 ernmental agency, written information, or an oral or

19 written summary of the written information, con20 cerning—

21 ‘‘(A) a treatment use for an investigational

22 new drug (including a biological product) ap23 proved by the Secretary for such treatment use;

24 or
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1 ‘‘(B) a use (whether or not such use is

2 contained in the official labeling) of a new drug

3 for which an approval of an application filed

4 under section 505(b) is in effect.

5 ‘‘(2) REQUIREMENTS.—A person may dissemi6 nate information under paragraph (1)(B) only if—

7 ‘‘(A) the information is an unabridged—

8 ‘‘(i) reprint or copy of a peer-reviewed

9 article from a scientific or medical journal

10 that is published by an organization that is

11 independent of the pharmaceutical indus12 try; or

13 ‘‘(ii) chapter, authored by an expert

14 or experts in the disease to which the use

15 relates, from a recognized reference text16 book that is published by an organization

17 that is independent of the pharmaceutical

18 industry;

19 ‘‘(B) the text of the information has been

20 approved by a continuing medical education ac21 crediting agency that is independent of the

22 pharmaceutical industry as part of a scientific

23 or medical educational program approved by the

24 agency;
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1 ‘‘(C) the information relates to a use that

2 is recognized under Federal law for purposes of

3 third-party coverage or reimbursement, and—

4 ‘‘(i) the text of the information has

5 been approved by an organization referred

6 to in such Federal law; and

7 ‘‘(ii) the information is part of a dis8 ease management program or treatment

9 guideline with respect to the use; or

10 ‘‘(D) the information is an accurate and

11 truthful summary of the information described

12 in subparagraph (A), (B), or (C).

13 ‘‘(b) DISCLOSURE STATEMENT.—In order to afford

14 a full and fair evaluation of the information described in

15 subsection (a), a person disseminating the information

16 shall include a statement that discloses—

17 ‘‘(1) if applicable, that the use of a new drug

18 described in subparagraph (A) or (B) of subsection

19 (a)(1) and the information with respect to the use

20 have not been approved by the Food and Drug Ad21 ministration;

22 ‘‘(2) if applicable, that the information is being

23 disseminated at the expense of the sponsor of the

24 new drug;
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•S 1477 IS

1 ‘‘(3) if applicable, that one or more authors of

2 the information being disseminated are employees of

3 or consultants to the sponsor of the new drug; and

4 ‘‘(4) the official labeling for the drug and bio5 logical product, or in the case of a treatment use of

6 an investigational new drug, the investigator bro7 chure and all updates thereof.

8 ‘‘(c) DEFINITION.—As used in this section, the term

9 ‘expense’ includes financial, in-kind, and other contribu10 tions provided for the purpose of disseminating the infor11 mation described in subsection (a).

12 ‘‘(d) SPECIAL RULE.—In the case of a professional

13 disagreement between the Secretary and other qualified

14 experts with respect to the application of section 502(a),

15 the Secretary may not use section 502 to prohibit the dis16 semination of information in the types of circumstances

17 and under the conditions set forth in subsections (a) and

18 (b).

19 ‘‘SEC. 747. DISSEMINATION OF INFORMATION ON DEVICES.

20 ‘‘(a) IN GENERAL.—Notwithstanding sections 301,

21 501(f), 501(i), 502(a), 502(f), and 502(o), or any other

22 provision of law, and subject to subsections (b) and (c),

23 a person may disseminate to any person that is a health

24 care practitioner or other provider of health care goods

25 or services, a pharmacy benefit manager, a health mainte-
35

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1 nance organization or other managed health care organi2 zation, or a health care insurer or governmental agency,

3 written or oral information (including information ex4 changed at scientific and educational meetings, work5 shops, or demonstrations) relating to a use, whether or

6 not the use is described in the official labeling, of a device

7 produced by a manufacturer registered pursuant to sec8 tion 510.

9 ‘‘(b) DISCLOSURE STATEMENTS AND REQUIRE10 MENTS.—

11 ‘‘(1) DISCLOSURE STATEMENTS.—To the extent

12 practicable, the requirement with respect to a state13 ment of disclosure under subsection (b) of section

14 746 shall apply to the dissemination of written and

15 oral information under this section, except that this

16 paragraph shall not apply to the dissemination of

17 written or oral information with respect to the in18 tended use described in the labeling of a device.

19 ‘‘(2) ADDITIONAL REQUIREMENTS.—A person

20 may disseminate information under subsection (a)

21 only if—

22 ‘‘(A) the information is an unabridged—

23 ‘‘(i) reprint or copy of a peer-reviewed

24 article from a scientific or medical journal

25 that is published by an organization that is
36

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1 independent of the medical device industry;

2 or

3 ‘‘(ii) chapter, authored by an expert

4 or experts in the medical specialty to which

5 the use relates, from a recognized ref6 erence textbook that is published by an or7 ganization that is independent of the medi8 cal device industry;

9 ‘‘(B) the information has been approved by

10 a continuing medical education accrediting

11 agency that is independent of the medical de12 vice industry as part of a scientific or medical

13 educational program approved by the agency;

14 ‘‘(C) the information relates to a use that

15 is recognized under Federal law for purposes of

16 third-party reimbursement, and—

17 ‘‘(i) the text of the information has

18 been approved by an organization referred

19 to in such Federal law; and

20 ‘‘(ii) the information is part of a dis21 ease management program or treatment

22 guideline with respect to such use; or

23 ‘‘(D) the oral or written information is—

24 ‘‘(i) part of an exchange of informa25 tion solely among health care practitioners,
37

•S 1477 IS

1 health care reimbursement officials, and

2 the industry;

3 ‘‘(ii) exchanged for educational or sci4 entific purposes; or

5 ‘‘(iii) presented at continuing medical

6 education programs, seminars, workshops,

7 or demonstrations.

8 ‘‘(3) APPLICABILITY.—The requirements under

9 subsection (a)(1)(A) and (B) of section 746 shall not

10 apply with respect to devices.

11 ‘‘SEC. 748. POLICY ON INFORMATION DISSEMINATION.

12 ‘‘(a) CONSTRUCTION.—Notwithstanding section 502

13 (a), (f), and (o), or any other provision of law, the written

14 or oral dissemination of information relating to a new use

15 of a new drug or device, in accordance with sections 746

16 and 747, shall not be construed as evidence of a new in17 tended use of the new drug or device that is different from

18 the intended use of the new drug or device set forth in

19 the official labeling. The dissemination shall not be consid20 ered as labeling, adulteration, or misbranding of the new

21 drug or device.

22 ‘‘(b) RESPOND TO UNSOLICITED QUESTIONS.—Noth23 ing in this Act shall affect the ability of manufacturers

24 to respond fully to unsolicited questions from health care
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1 practitioners and other persons about drugs (including bi2 ological products) or devices.

3 ‘‘SEC. 749. APPROVAL OF NEW USES.

4 ‘‘(a) IN GENERAL.—As an alternative to the proce5 dures established in section 505(c)(1) for a new drug (in6 cluding a biological product) and section 515(d)(1)(A) for

7 a device, the Secretary shall approve an application under

8 this section for a new use of a previously approved new

9 drug or device if experts qualified by scientific training

10 and experience to evaluate the safety and effectiveness of

11 drugs or devices conclude that a new use that has not been

12 reviewed or approved by the Secretary represents sound

13 medical practice based upon reliable clinical experience

14 and other confirmatory information, unless the Secretary

15 demonstrates that there are other compelling public health

16 reasons related to the safety or effectiveness of the drug

17 or device why approval would harm the health of individ18 ual patients.

19 ‘‘(b) PETITION.—The holder of an approved applica20 tion may submit a petition to the Secretary presenting in21 formation that new use of a previously approved new drug

22 or device meets the criteria for approval established in this

23 subsection. The petition shall include data and informa24 tion relating to the new use and shall demonstrate that

25 the new use—
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1 ‘‘(1) has existed in clinical practice for at least

2 five years;

3 ‘‘(2) is common among clinicians experienced in

4 the field; and

5 ‘‘(3) represents reasonable medical practice

6 based upon reliable clinical experience and other

7 confirmatory information.

8 ‘‘(c) ACTION ON PETITION.—Upon receipt of the pe9 tition, the Secretary shall obtain the conclusions and rec10 ommendations of a scientific review group established

11 under section 904 and grant or deny the petition within

12 180 days of the receipt of the petition.’’.

13 SEC. 408. EFFECTIVENESS, OUTCOME, AND COST-EFFEC14 TIVENESS STANDARDS.

15 Section 741, as added by section 402, is amended by

16 adding at the end thereof the following new subsection:

17 ‘‘(e) In reviewing an application for a product that

18 is a new drug, biological product, new animal drug, animal

19 feed bearing or containing a new animal drug, or device

20 the determination of effectiveness shall not include the

21 evaluation of—

22 ‘‘(1) relative effectiveness, unless the effective23 ness of the product is explicitly compared to the ef24 fectiveness of another product in the labeling;
40

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1 ‘‘(2) any potential use not explicitly included in

2 the labeling;

3 ‘‘(3) the cost-effectiveness of the product de4 scribed in this subsection as compared to the cost5 effectiveness of a similar product, unless the labeling

6 explicitly includes a representation about cost-effec7 tiveness; and

8 ‘‘(4) the clinical outcome resulting from use of

9 a device, unless the labeling explicitly includes a rep10 resentation regarding clinical outcome.’’.

11 SEC. 409. DEFINITION OF A DAY FOR PURPOSES OF PROD12 UCT REVIEW.

13 Section 201 (21 U.S.C. 321) is amended by adding

14 at the end thereof the following:

15 ‘‘(gg) For purposes of reviewing any application, noti16 fication or petition, or any document, with respect to a

17 product that is a new drug, biological product, new animal

18 drug, device, or food additive that is submitted to the Sec19 retary to obtain approval of marketing, or to establish or

20 clarify the regulatory status of the product, the term ‘day’

21 means a calendar day (excluding any calendar day be22 tween the date of receipt by the submitter of a written

23 communication from the Secretary setting forth the action

24 of the Secretary on a submission and the date of receipt

25 by the Secretary of the written response of the submitter
41

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1 to the action) in which the Secretary has responsibility to

2 review such a submission.’’.

3 TITLE V—DRUG, BIOLOGICAL

4 PRODUCTS, DEVICES EXPORT

5 REFORM

6 SEC. 501. SHORT TITLE.

7 This title may be cited as the ‘‘Drug, Biological Prod8 ucts, Devices Export Reform Act of 1995’’.

9 SEC. 502. EXPORT OF DRUGS AND DEVICES.

10 (a) EXPORTS AND IMPORTS.—Section 801 (21

11 U.S.C. 381) is amended—

12 (1) in subsection (d), by adding at the end

13 thereof the following new paragraph:

14 ‘‘(3) No component, part or accessory of a drug, bio15 logical product, or device, including a drug in bulk form,

16 shall be excluded from importation into the United States

17 under paragraph (a), if the component, part, or accessory

18 will be incorporated into a device, drug, or biological prod19 uct that will be exported from the United States in accord20 ance with subsection (e) of section 802 or section 351(h)

21 of the Public Health Service Act.’’;

22 (2) in subsection (e)(1), by striking the second

23 sentence; and
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1 (3) in subsection (e)(2), by inserting before the

2 period at the end thereof the following: ‘‘or that the

3 device is eligible for export under section 802’’.

4 (b) EXPORT OF CERTAIN UNAPPROVED DRUGS AND

5 DEVICES.—Section 802 (21 U.S.C. 382) is amended to

6 read as follows:

7 ‘‘SEC. 802. EXPORTS OF CERTAIN UNAPPROVED PRODUCTS.

8 ‘‘(a) IN GENERAL.—A drug (including a biological

9 product) intended for human or animal use or a device

10 for human use—

11 ‘‘(1)(A) which, in the case of a drug—

12 ‘‘(i) requires approval by the Secretary

13 under section 505 or section 512; or

14 ‘‘(ii) requires licensing by the Secretary

15 under section 351 of the Public Health Service

16 Act or by the Secretary of Agriculture under

17 the Act of March 4, 1913 (known as the Virus18 Serum Toxin Act),

19 before the drug may be introduced or delivered for

20 introduction into interstate commerce to a country;

21 and

22 ‘‘(B) which—

23 ‘‘(i) does not have such approval or license;

24 ‘‘(ii) is not exempt from such sections or

25 Act; and
43

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1 ‘‘(iii) is introduced or delivered for intro2 duction into interstate commerce to a country;

3 or

4 ‘‘(2) which, in the case of a device—

5 ‘‘(A) does not comply with an applicable

6 requirement under section 514 or 515;

7 ‘‘(B) is exempt under section 520(g) from

8 section 514 or 515; or

9 ‘‘(C) is a banned device under section 516,

10 is adulterated, misbranded, and in violation of such sec11 tions or Act unless the export of the drug or device is au12 thorized under subsection (b), (c), (e), or (f) or under sec13 tion 801(e)(2).

14 ‘‘(b) EXPORTATION TO ANY COUNTRY OR A SPECIFIC

15 COUNTRY.—

16 ‘‘(1) EXPORTATIONS TO ANY COUNTRY.—Ex17 cept as otherwise provided in this section, a drug

18 (including a biological product) or device may be ex19 ported to any country, if the drug or device complies

20 with the laws of that country and has valid market21 ing authorization by the appropriate approval au22 thority—

23 ‘‘(A) in Australia, Canada, Israel, Japan,

24 New Zealand, or Switzerland; or
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1 ‘‘(B) in the European Union or a country

2 in the European Economic Area (the countries

3 in the European Union and the European Free

4 Trade Association) if the drug or device is mar5 keted in that country or the drug or device is

6 authorized for general marketing in the Euro7 pean Economic Area.

8 ‘‘(2) EXPORTATION TO A CERTAIN COUNTRY.—

9 A drug or device may be exported to the countries

10 described in paragraph (1) if the drug or device

11 complies with the laws of any such country and has

12 a valid marketing authorization by the appropriate

13 approval authority in that country.

14 ‘‘(c) EXPORTATION TO A COUNTRY WITH A REGU15 LATORY SYSTEM.—

16 ‘‘(1) IN GENERAL.—A drug or device may be

17 exported under this section to any other country

18 that has an adequate regulatory system to protect

19 the health of the citizens of such a country. The

20 Comptroller General, in consultation with the Sec21 retary and other appropriate parties, shall develop a

22 list of countries to which a drug or device may be

23 exported under this paragraph and a list of rec24 ommended criteria for additions or deletions of coun25 tries to the list of countries.
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1 ‘‘(2) REQUEST DESIGNATION.—An appropriate

2 country official, manufacturer, or exporter, may re3 quest the Secretary to designate a country to receive

4 drugs or devices exported under this section that

5 meets the requirements of paragraph (1) by submit6 ting documentation in support of such designation to

7 the Secretary. Any person other than an appropriate

8 country official requesting such designation shall

9 provide a letter from the country indicating the de10 sire of the country to be designated.

11 ‘‘(3) TIME LIMITATION FOR DESIGNATION.—If

12 the Secretary fails to, within 90 days of the date of

13 the receipt of a request under paragraph (2), re14 spond to the request with a denial of the requested

15 designation, the request shall be considered granted

16 and the country that is the subject of the request

17 shall be designated as eligible to receive drugs or de18 vices exported under this subsection.

19 ‘‘(4) WITHDRAWAL OF DESIGNATION.—If infor20 mation is provided to the Secretary that indicates

21 that, due to a public health emergency or systematic

22 patterns of abuse of the regulatory system in a

23 country designated under paragraph (3), the country

24 is no longer able to carry out the functions described

25 in paragraph (1), or if the country no longer meets
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1 the requirements for designation under this sub2 section, the Secretary may withdraw the designation

3 of the country.

4 ‘‘(d) LIMITATIONS.—A drug or device may not be ex5 ported under this section if—

6 ‘‘(1) the drug or device is not manufactured,

7 processed, packaged, and held in conformity with

8 current good manufacturing practice or is adulter9 ated under paragraph (1), (2)(A), or (3) of section

10 501(a) or subsection (c) or (d) of section 501;

11 ‘‘(2) the drug or device is not labeled and ad12 vertised in accordance with the requirements and

13 conditions for use of any country in which the drug

14 or device is approved, either in English or the pre15 dominant language of the country to which the drug

16 or device is being exported, except that with respect

17 to advertising alternative methods of communication

18 that are consistent with the requirements of the ap19 proving country shall be allowed if authorized by the

20 receiving country;

21 ‘‘(3) the requirements of subparagraphs (A)

22 through (D) of section 801(e)(1) have not been met;

23 ‘‘(4) the drug or device has been the subject of

24 a finding by the Secretary under section 505, 512

25 or 515 or under section 351 of the Public Health
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1 Service Act (42 U.S.C. 262), or by the Secretary of

2 Agriculture under the Act of March 4, 1913 (37

3 Stat. 832–833) (commonly known as the ‘Virus

4 Serum Toxin Act’) that the drug or device has not

5 been shown to be safe or effective for labeled indica6 tion of the drug or device;

7 ‘‘(5) the Secretary finds that the drug or device

8 poses an unreasonable and substantial risk to public

9 health in the receiving country;

10 ‘‘(6) the drug or device is the subject of a no11 tice by the Secretary or the Secretary of Agriculture

12 of a determination that the possibility of

13 reimportation of the exported drug or device would

14 present an imminent hazard to the public health and

15 safety of the United States and the only means of

16 limiting the hazard is to prohibit the export of the

17 drug or device; or

18 ‘‘(7) the drug or device will be re-exported or

19 transshipped to a country not authorized to receive

20 an exported drug or device under this section.

21 In making a finding under paragraph (5), the Secretary,

22 to the maximum extent possible, shall consult with the af23 fected country.

24 ‘‘(e) EXPORTATION OF DRUG FOR INVESTIGATIONAL

25 USE.—A drug intended for investigational use in any
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1 country described in subsection (b) or designated under

2 subsection (c) may be exported in accordance with the

3 laws of that country and still be exempt from regulation

4 under section 505(i) or section 512(j).

5 ‘‘(f) EXPORTATION OF A DRUG FOR TROPICAL DIS6 EASE.—

7 ‘‘(1) IN GENERAL.—A drug (including a biologi8 cal product) that is to be used in the prevention or

9 treatment of a tropical disease may, upon approval

10 of an application submitted under paragraph (2), be

11 exported if—

12 ‘‘(A) the Secretary finds, based on credible

13 scientific evidence, including clinical investiga14 tions, that the drug is safe and effective in the

15 country to which the drug is to be exported in

16 the prevention or treatment of a tropical dis17 ease in such country;

18 ‘‘(B) the drug is manufactured, processed,

19 packaged, and held in conformity with current

20 good manufacturing practice and is not adulter21 ated under paragraphs (1), (2)(A), and (3) of

22 subsection (a), and subsection (c) or (d), of sec23 tion 501;

24 ‘‘(C) the outside of the shipping package is

25 labeled with the following statement: ‘This drug
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1 may be sold or offered for sale only in the fol2 lowing countries:’, the blank space being filled

3 with a list of the countries to which export of

4 the drug is authorized under this subsection;

5 ‘‘(D) the drug is not the subject of a notice

6 by the Secretary or the Secretary of Agriculture

7 of a determination that the manufacture of the

8 drug in the United States for export to a coun9 try is contrary to the public health and safety

10 of the United States; and

11 ‘‘(E) the requirements of subparagraphs

12 (A) through (D) of section 801(d)(1) have been

13 met.

14 ‘‘(2) APPLICATION.—Any person may apply to

15 have a drug exported under paragraph (1). The ap16 plication shall—

17 ‘‘(A) describe the drug to be exported;

18 ‘‘(B) list each country to which the drug is

19 to be exported;

20 ‘‘(C) contain a certification by the appli21 cant that the drug will not be exported to a

22 country for which the Secretary cannot make a

23 finding described in paragraph (1)(A);

24 ‘‘(D) identify the establishments in which

25 the drug is manufactured; and
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1 ‘‘(E) demonstrate to the Secretary that the

2 drug meets the requirements of paragraph (1).

3 ‘‘(3) REQUIRED REPORTING.—The holder of an

4 approved application for the export of a drug under

5 this subsection shall report to the Secretary—

6 ‘‘(A) the receipt of any information indi7 cating that the drug is being or may have been

8 exported from a country for which the Sec9 retary made a finding under paragraph (1)(A)

10 to a country for which the Secretary cannot

11 make such a finding; and

12 ‘‘(B) the receipt of any information indi13 cating any adverse reactions to such drug.

14 ‘‘(4) ADDITIONAL LIMITATIONS.—

15 ‘‘(A) FAILURE TO MEET CERTAIN RE16 QUIREMENTS.—If the Secretary determines

17 that—

18 ‘‘(i) a drug for which an application is

19 approved under paragraph (2) does not

20 continue to meet the requirements of para21 graph (1);

22 ‘‘(ii) the holder of the application has

23 not made the report required by paragraph

24 (3); or
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1 ‘‘(iii) the manufacture of the drug in

2 the United States for export is contrary to

3 the public health and safety of the United

4 States and an application for the export of

5 the drug has been approved under para6 graph (2),

7 then before taking action against the holder of an

8 application for which a determination was made

9 under clause (i), (ii), or (iii), the Secretary shall no10 tify the holder in writing of the determination and

11 provide the holder 30 days to take such corrective

12 actions as may be required by the Secretary to pre13 vent the Secretary from taking action against the

14 holder. If the Secretary takes action against the

15 holder because of the determination, the Secretary

16 shall provide the holder a written statement specify17 ing the reasons for the determination and provide

18 the holder, on request, an opportunity for an infor19 mal hearing with respect to the determination.

20 ‘‘(B) LIMITATION ON THE EXPORTATION

21 OF A HAZARDOUS DRUG BY AN IMPORTER.—If

22 at any time the Secretary, or in the absence of

23 the Secretary, the official designated to act on

24 behalf of the Secretary determines that—
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1 ‘‘(i) the holder of an approved applica2 tion under paragraph (2) is exporting a

3 drug from the United States to an im4 porter;

5 ‘‘(ii) the importer is exporting the

6 drug to a country for which the Secretary

7 cannot make a finding under paragraph

8 (1)(A); and

9 ‘‘(iii) the export presents an imminent

10 hazard to the public health in the country,

11 the Secretary shall immediately prohibit the ex12 port of the drug to the importer, provide the

13 person exporting the drug from the United

14 States prompt notice of the determination, and

15 afford the person an opportunity for an expe16 dited hearing. A determination by the Secretary

17 under this subparagraph may not be stayed

18 pending final action by a reviewing court. The

19 authority conferred by this subparagraph may

20 not be delegated by the Secretary.

21 ‘‘(C) LIMITATION ON THE EXPORTATION

22 OF A HAZARD DRUG BY A HOLDER.—If the Sec23 retary, or in the absence of the Secretary, the

24 official designated to act on behalf of the Sec25 retary determines that the holder of an ap-
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1 proved application under paragraph (2) is ex2 porting a drug to a country for which the Sec3 retary cannot make a finding under paragraph

4 (1)(A), and that the export of the drug presents

5 an imminent hazard, the Secretary shall imme6 diately prohibit the export of the drug to such

7 country, provide the holder prompt notice of the

8 determination, and afford the holder an oppor9 tunity for an expedited hearing. A determina10 tion by the Secretary under this subparagraph

11 may not be stayed pending final action by a re12 viewing court. The authority conferred by this

13 subparagraph shall not be delegated by the Sec14 retary.

15 ‘‘(D) LIMITATION ON THE EXPORTATION

16 OF OTHER DRUGS BY A HOLDER.—If the Sec17 retary receives credible evidence that the holder

18 of an application approved under paragraph (2)

19 is exporting a drug to a country for which the

20 Secretary cannot make a finding under para21 graph (1)(A), the Secretary shall give the hold22 er 60 days to provide information to the Sec23 retary respecting such evidence and shall pro24 vide the holder an opportunity for an informal

25 hearing on such evidence. Upon the expiration
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1 of such 60 days, the Secretary shall prohibit the

2 export of such drug to such country if the Sec3 retary determines the holder is exporting the

4 drug to a country for which the Secretary can5 not make a finding under paragraph (1)(A).

6 ‘‘(E) LIMITATION OF THE EXPORTATION

7 OF OTHER DRUGS BY AN IMPORTER.—If the

8 Secretary receives credible evidence that an im9 porter is exporting a drug to a country for

10 which the Secretary cannot make a finding

11 under paragraph (1)(A), the Secretary shall no12 tify the holder of the application authorizing

13 the export of such drug of such evidence and

14 shall require the holder to investigate the export

15 by such importer and to report to the Secretary

16 within 14 days of the receipt of such notice the

17 findings of the holder. If the Secretary deter18 mines that the importer has exported a drug to

19 such a country, the Secretary shall prohibit

20 such holder from exporting such drug to the

21 importer unless the Secretary determines that

22 the export by the importer was unintentional.’’.

23 SEC. 503. PARTIALLY PROCESSED BIOLOGICAL PRODUCTS.

24 Subsection (h) of section 351 of the Public Health

25 Service Act (42 U.S.C. 262) is amended to read as follows:
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1 ‘‘(h) A partially processed biological product that—

2 ‘‘(1) is not in a form applicable to the preven3 tion, treatment, or cure of diseases or injuries of

4 man;

5 ‘‘(2) is not intended for sale in the United

6 States; and

7 ‘‘(3) is intended for further manufacture into

8 final dosage form outside the United States,

9 shall be subject to no restriction on the export of the prod10 uct under this Act or the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 321 et seq.) if the product is manu12 factured, processed, packaged, and held in conformity with

13 current good manufacturing practice and meets the re14 quirements of section 801(e)(1) of the Federal Food,

15 Drug, and Cosmetic Act (21 U.S.C. 381(e)(1)).’’.

16 TITLE VI—DRUG AND BIOLOGI17 CAL PRODUCTS REGULATORY

18 REFORM

19 SEC. 601. SHORT TITLE.

20 This title may be cited as the ‘‘Drug and Biological

21 Product Regulatory Reform Act of 1995’’.

22 SEC. 602. NEW DRUG APPROVAL STANDARD.

23 Section 505(d) (21 U.S.C. 355(d)) is amended by

24 adding at the end thereof the following new sentence:

25 ‘‘Substantial evidence may consist of data from one well-
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1 controlled clinical investigation (which may be waived by

2 the Secretary) and confirmatory evidence (obtained either

3 before or after such investigation).’’.

4 SEC. 603. PILOT AND SMALL SCALE MANUFACTURE.

5 Section 505(c) (21 U.S.C. 355(c)) is amended by

6 adding at the end thereof the following new paragraph:

7 ‘‘(4) A new drug or biological product manufactured

8 in a pilot or other small facility may be used to dem9 onstrate the safety and effectiveness of the drug or prod10 uct and to obtain approval prior to scaling up to a larger

11 facility, unless the Secretary demonstrates in writing and

12 specifying in detail the reasons, after an informal hearing,

13 that a full scale production facility is necessary to ensure

14 the safety or effectiveness of the drug or product.’’.

15 SEC. 604. MANUFACTURING CHANGES.

16 Chapter VII (21 U.S.C. 371 et seq.), as amended by

17 section 407, is further amended by adding at the end

18 thereof the following new section:

19 ‘‘SEC. 750. MANUFACTURING CHANGES.

20 ‘‘(a) IN GENERAL.—A change in the manufacture of

21 a new drug, biological product, or new animal drug, may

22 be made in accordance with this section.

23 ‘‘(b) DRUG AND BIOLOGICAL PRODUCT.—A change

24 in the manufacture of a new drug, a biological product

25 that is the subject of a monograph in an official compen-
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1 dium, a biological product that can be adequately charac2 terized by chemical, physical, or biological means, or a new

3 animal drug shall require—

4 ‘‘(1) validation; and

5 ‘‘(2)(A) if there is no change in the approved

6 qualitative and quantitative formulation or in the

7 approved release specifications, or if there is a

8 change in the approved qualitative or quantitative

9 formula or in the approved release specifications of

10 a type permitted by the Secretary by regulation, may

11 be made at any time and shall be reported annually

12 to the Secretary; and

13 ‘‘(B) for any other change, shall require com14 pletion of an appropriate study demonstrating

15 equivalence according to criteria established by the

16 Secretary (unless such requirement is waived by the

17 Secretary), may be made at any time, and shall be

18 reported to the Secretary through a supplement or

19 amendment submitted at the time the change is

20 made.

21 ‘‘(c) BIOLOGICAL PRODUCT NOT SUBJECT TO A

22 MONOGRAPH.—A change in the manufacture of a biologi23 cal product that is not the subject of a monograph in an

24 official compendium and cannot be adequately character-
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1 ized by chemical, physical, or biological means shall re2 quire validation and—

3 ‘‘(1) if the change relates solely to a modifica4 tion of the manufacturing facility or change in per5 sonnel, with no change in the approved manufactur6 ing process or release specifications, may be made at

7 any time and shall be reported annually to the Sec8 retary; and

9 ‘‘(2) for any other change, shall require comple10 tion of a bioassay or other appropriate study dem11 onstrating equivalence according to criteria estab12 lished by the Secretary (unless such requirement is

13 waived by the Secretary), may be made at any time,

14 and shall be reported to the Secretary through an

15 amendment submitted at the time the change is

16 made.

17 ‘‘(d) SPECIAL DETERMINATION FOR A BIOLOGICAL

18 PRODUCT.—A determination shall be made prior to ap19 proval of a biological product under section 351(a) of the

20 Public Health Service Act (42 U.S.C. 262(a)) whether the

21 product can be adequately characterized for purposes of

22 this subsection. With respect to biological products ap23 proved prior to the date of enactment of the Food and

24 Drug Administration Performance and Accountability Act

25 of 1995, the determination shall be made within 90 days
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1 after the date of enactment of such Act. Any determina2 tion under this subsection is subject to change based upon

3 new scientific information.’’.

4 SEC. 605. INSULIN AND ANTIBIOTICS.

5 (a) CERTIFICATION OF DRUGS CONTAINING INSU6 LIN.—Section 506 (21 U.S.C. 356) is repealed.

7 (b) CERTIFICATION OF ANTIBIOTICS.—Section 507

8 (21 U.S.C. 357) is repealed.

9 (c) EXPORTATION.—Section 802 (21 U.S.C. 382), as

10 amended by section 502(b), is further amended by adding

11 at the end thereof the following new subsection:

12 ‘‘(g) EXPORTATION OF UNAPPROVED PRODUCTS.—

13 Insulin and antibiotics may be exported without regard to

14 the requirements in this section if the insulin and anti15 biotics meet the requirements in subsection (e)(1).’’.

16 SEC. 606. BIOLOGICAL PRODUCTS.

17 (a) MODERNIZATION OF REGULATION OF BIOLOGI18 CAL PRODUCTS.—

19 (1) IN GENERAL.—Section 351 of the Public

20 Health Service Act (42 U.S.C. 262) is amended by

21 striking ‘‘SEC. 351. (a)’’ and all that follows through

22 ‘‘exchange the same.’’ and inserting the following:

23 ‘‘SEC. 351. (a)(1) Except as provided in paragraph

24 (4), no person shall introduce or deliver for introduction

25 into interstate commerce any biological product unless—
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1 ‘‘(A) a product license has been issued for the

2 biological product;

3 ‘‘(B) the biological product has been propa4 gated, manufactured, or prepared in accordance with

5 good manufacturing practices established by the Sec6 retary under section 501(a) of the Federal Food,

7 Drug, and Cosmetic Act (21 U.S.C. 351(a)); and

8 ‘‘(C) each package of the biological product is

9 plainly marked with the proper name of the biologi10 cal product contained therein, the name, address

11 and license number of the manufacturer of the bio12 logical product, and the expiration date of the bio13 logical product.

14 ‘‘(2) The Secretary shall establish, by regulation, re15 quirements for product license applications for biological

16 products. A product license application for a biological

17 product, other than blood, blood components, and blood

18 products, shall be approved based upon a demonstration

19 that the product that is the subject of the application is

20 safe and effective in accordance with section 505(d) of the

21 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

22 355(d)). A license application for blood, a blood compo23 nent, or a blood product shall be approved based upon a

24 demonstration that the product that is the subject of the

25 application is safe, pure, and, where appropriate, potent.
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1 ‘‘(3)(A) If the Secretary determines that grounds for

2 a suspension or revocation of a license for a biological

3 product exist that constitute a danger to health, the Sec4 retary shall suspend the license, notify the licensee of the

5 suspension, and require notification of the suspension to

6 any consignee. Within 30 days after the date of the receipt

7 by the licensee of a notification of suspension, the Sec8 retary shall afford the licensee an opportunity for a hear9 ing in accordance with section 554 of title 5, United States

10 Code.

11 ‘‘(B) If at any time before the Secretary has taken

12 final action to suspend or revoke a license the licensee re13 quests an inspection by the Secretary to determine wheth14 er the licensee is in compliance with applicable standards,

15 the Secretary shall conduct an inspection within 30 days

16 of the date of the request. If the Secretary fails to conduct

17 the inspection within the 30 days, the action to suspend

18 or revoke the license shall become null and void. If the

19 inspection confirms that the licensee is in compliance with

20 all applicable requirements, the Secretary shall withdraw

21 any proposed action within 30 days of the inspection.

22 ‘‘(4) The requirements of paragraph (1) do not apply

23 to a biological product for which there is in effect an inves24 tigational new drug application under section 505(i) of the

25 Federal Food, Drug, and Cosmetic Act.’’.
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1 (2) LABELING.—Section 351(b) of the Public

2 Health Service Act (42 U.S.C. 262(b)) is amended

3 to read as follows:

4 ‘‘(b) No person shall falsely label or mark any pack5 age or container of any biological product or alter any

6 label or mark on the package so as to falsify the label

7 or mark.’’.

8 (3) INSPECTION.—Section 351(c) of the Public

9 Health Service Act (42 U.S.C. 262(c)) is amended

10 by striking ‘‘virus, serum, toxin, antitoxin, vaccine,

11 blood, blood component, or blood product, or deriva12 tive allergenic product or other product aforesaid’’

13 and inserting ‘‘biological product’’.

14 (4) DEFINITION; APPLICATION.—Part F of title

15 III of the Public Health Service Act (42 U.S.C. 262

16 et seq.) is amended by adding at the end thereof the

17 following new subsections:

18 ‘‘(i) For purposes of this section, the term ‘biological

19 product’ means a virus, therapeutic serum, toxin, anti20 toxin, vaccine, blood, blood component or derivative, aller21 genic biologic product, or arsphenamine or its derivative

22 (or any other analogous biological product) applicable to

23 the prevention, treatment, or cure of diseases or conditions

24 of human beings.
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1 ‘‘(j)(1) Sections 505(i), 903, and 904 of the Federal

2 Food, Drug, and Cosmetic Act shall apply to all biological

3 products and references in those sections to new drug ap4 plications shall be deemed to include product license appli5 cations.

6 ‘‘(2) Requirements involving labeling or advertising

7 for biological products shall be established in accordance

8 with sections 201(m) and 502(n) of the Federal Food,

9 Drug, and Cosmetic Act.

10 (b) HARMONIZATION OF REGULATION OF BIOLOGI11 CAL PRODUCTS AND NEW DRUGS.—Not later than 2

12 years after the date of enactment of this section, the Sec13 retary of Health and Human Services shall harmonize reg14 ulations governing product license applications required

15 under section 351 of the Public Health Service Act (42

16 U.S.C. 262) with the regulations governing new drug ap17 plications required under section 505 of the Federal Food,

18 Drug, and Cosmetic Act (21 U.S.C. 355).

19 SEC. 607. REQUIREMENTS FOR EMERGING BIO20 TECHNOLOGY PRODUCTS.

21 Not later than 180 days after the date of enactment

22 of this Act, the Secretary of Health and Human Services

23 shall establish proposed regulations governing products of

24 human tissue and cell therapy that shall—
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1 (1) ensure the safety and effectiveness of the

2 products under section 351 of the Public Health

3 Service Act (42 U.S.C. 262 et seq.); and

4 (2) take in account whether regulation of facili5 ties in which the products are manufactured or proc6 essed is sufficient to ensure safety and effectiveness

7 of the products.

8 TITLE VII—DEVICE

9 REGULATORY REFORM

10 SEC. 701. SHORT TITLE.

11 This title may be cited as the ‘‘Medical Device Re12 form Act of 1995’’.

13 SEC. 702. PREMARKET NOTIFICATION.

14 (a) EXEMPTION OF CERTAIN DEVICES.—Section 510

15 (21 U.S.C. 360) is amended—

16 (1) in subsection (k), by striking ‘‘intended for

17 human use’’ and inserting ‘‘ intended for human use

18 (except a device that is classified into class I under

19 section 513 or 520 or a device that is classified into

20 class II under section 513 or 520, and is exempt

21 from the requirements of this subsection under sub22 section (l))’’;

23 (2) by adding at the end of subsection (k) (as

24 amended by paragraph (1)) the following:
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1 ‘‘The Secretary shall review the notification required by

2 this subsection and make a determination under section

3 513(f)(1)(A) within 90 days of receiving the notification.’’;

4 and

5 (3) by adding at the end thereof the following

6 new subsections:

7 ‘‘(l) Within 30 days of the date of enactment of this

8 subsection, the Secretary shall publish in the Federal Reg9 ister a list of each type of class II device that does not

10 require a report under subsection (k) to provide reasonable

11 assurance of safety and effectiveness. Each type of class

12 II device so identified by the Secretary not to require the

13 report shall be exempt from the requirement to file a re14 port under subsection (k) as of the date of the publication

15 of the list in the Federal Register. Beginning on the date

16 that is 1 day after the date of the publication of a list

17 under this subsection, any person may petition the Sec18 retary to exempt a type of class II device from subsection

19 (k). The Secretary shall respond to the petition within 120

20 days of the receipt of the petition and determine whether

21 or not to grant the petition in whole or in part.

22 ‘‘(m) The Secretary may not withhold a determina23 tion of the initial classification of a device under sub24 section 513(f)(1) because of a failure to comply with any

25 provision of this Act unrelated to a substantial equivalence
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1 decision, including a finding that the facility in which a

2 device is manufactured is not in compliance with good

3 manufacturing practice requirements as set forth in regu4 lations promulgated under the authority of subsection

5 520(f).’’.

6 (b) INITIAL CLASSIFICATION.—Section 513(f)(1) (21

7 U.S.C. 360c(f)(1)) is amended in the second sentence, by

8 striking the period at the end thereof and inserting the

9 following: ‘‘, unless within 30 days of receiving an order

10 classifying the device into class III, the individual who

11 submits a notification under section 510(k) requests an

12 advisory committee review and recommendation with re13 spect to the classification of the device and a final order

14 of classification from the Secretary. After the request, a

15 device classified into class III under this paragraph shall

16 not be deemed to be finally classified until an advisory

17 committee established under subsection (b) reviews the re18 quest with respect to the classification of the device and,

19 within 60 days of the date of receiving the request, rec20 ommends to the Secretary a classification for the device

21 based on the classification criteria set forth in subpara22 graphs (A) through (C) of subsection(a)(1). Thereafter,

23 the Secretary shall have 10 days to determine by order

24 the final classification of the device by applying the classi-
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1 fication criteria set forth in subparagraphs (A) through

2 (C) of subsection(a)(1).

3 (c) SUBSTANTIAL EQUIVALENCE.—Section 513(i)(1)

4 (21 U.S.C. 360c(i)(1)) is amended by adding at the end

5 thereof the following new subparagraph:

6 ‘‘(C) For the purpose of determining the intended use

7 of a predicate device under paragraph (A), each use in8 cluded within a general use for the predicate device shall

9 be deemed a legally marketed use of the predicate device

10 for purposes of premarket notifications required under

11 subsection 510(k).’’.

12 (d) DEVICE MODIFICATION.—Section 513(i) (21

13 U.S.C. 360c(i)) is amended by adding at the end thereof

14 the following new paragraph:

15 ‘‘(4) Any change or modification to a device initially

16 classified under section 513(f), other than a major change

17 (including any major modification) in the intended use,

18 shall not require an additional submission under section

19 510(k) if such change or modification is supported by ap20 propriate data or information, and the change or modifica21 tion can be shown to not adversely affect the safety or

22 effectiveness of the device. All data or information relied

23 upon to document that a change to (including any modi24 fication of) the device does not require an additional notifi25 cation under section 510(k) shall be made available to the
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1 Secretary upon request and shall be maintained, at least

2 for a period of time equal to the commercial life of the

3 device.’’.

4 SEC. 703. MEDICAL DEVICE APPROVAL STANDARDS.

5 Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is

6 amended—

7 (1) by striking ‘‘well-controlled investigations’’

8 and inserting ‘‘a scientific investigation’’;

9 (2) by striking ‘‘clinical investigations’’ and in10 serting ‘‘a clinical investigation’’;

11 (3) by striking ‘‘investigations it’’ and inserting

12 ‘‘investigation it’’; and

13 (4) by adding the following to the end thereof

14 the following new sentence: ‘‘The Secretary may re15 quire a well-controlled clinical investigation to dem16 onstrate effectiveness if the director of the Office of

17 Device Evaluation explains in writing the basis

18 therefor.’’.

19 SEC. 704. TRACKING.

20 Section 519(e) (21 U.S.C. 360i(e)) is amended to

21 read as follows:

22 ‘‘DEVICE TRACKING

23 ‘‘(e) The Secretary may by regulation require a man24 ufacturer to adopt a method of tracking a class II or class

25 III device—
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1 ‘‘(1) the failure of which would be life-threaten2 ing or have permanently debilitating effects; and

3 ‘‘(2) which is—

4 ‘‘(A) permanently implanted; or

5 ‘‘(B) life sustaining or life supporting and

6 used outside a device user facility.’’.

7 SEC. 705. POSTMARKET SURVEILLANCE.

8 Section 522(1) (21 U.S.C. 360l) is amended to read

9 as follows:

10 ‘‘SEC. 522. POSTMARKET SURVEILLANCE.

11 ‘‘(a) IN GENERAL.—The Secretary may require a

12 manufacturer to conduct postmarket surveillance for any

13 device of the manufacturer first introduced or delivered

14 for introduction into interstate commerce after January

15 1, 1991, that—

16 ‘‘(1) is a permanent implant the failure of

17 which may cause serious, adverse health con18 sequences or death;

19 ‘‘(2) is intended for a use in supporting or sus20 taining human life; or

21 ‘‘(3) potentially presents a serious risk to

22 human health.

23 ‘‘(b) SURVEILLANCE APPROVAL.—Each manufac24 turer required to conduct a surveillance of a device under

25 subsection (a) shall, within 30 days of receiving notice
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1 from the Secretary that the manufacturer is required

2 under this section to conduct the surveillance, submit for

3 the approval of the Secretary, a protocol for the required

4 surveillance. The Secretary, within 60 days of the date of

5 the receipt of the protocol, shall determine if the principal

6 investigator proposed to be used in the surveillance has

7 sufficient qualifications and experience to conduct the sur8 veillance and if the protocol will result in collection of use9 ful data or other information necessary to protect the pub10 lic health and to provide safety and effectiveness informa11 tion for the device. The Secretary may not approve the

12 protocol until the protocol has been reviewed by a qualified

13 scientific and technical review committee established by

14 the Secretary.’’.

15 SEC. 706. DEVICE DISTRIBUTOR REPORTING.

16 Section 519 (21 U.S.C. 360i) is amended—

17 (1) by striking ‘‘, importer, or distributor’’ each

18 place it appears and inserting ‘‘or importer’’;

19 (2) in subsection (a)—

20 (A) in paragraph (8), by striking ‘‘; and’’

21 and inserting a period; and

22 (B) by striking paragraph (9); and

23 (3) by striking subsection (f).
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1 SEC. 707. PREMARKET APPROVAL.

2 (a) ACTION ON APPLICATION.—Section 515(d) (21

3 U.S.C. 360e(d)) is amended—

4 (1) in paragraph (1)(A), by striking ‘‘paragraph

5 (2) of this subsection’’ each place it appears and in6 serting ‘‘paragraph (4)’’;

7 (2) in paragraph (1)(B), by adding at the end

8 thereof the following new clause:

9 ‘‘(iii) The Secretary shall accept and review data and

10 any other information from investigations conducted

11 under the authority of regulations required by section

12 520(g) to make a determination of whether there is a rea13 sonable assurance of safety and effectiveness of a device

14 subject to a pending application under this section if—

15 ‘‘(I) the data or information is derived from in16 vestigations of an earlier version of the device, the

17 device has been modified during or after the inves18 tigations, and the modification of the device does not

19 constitute a significant change in the design or in

20 the basic principles of operation of the device that

21 would invalidate the data or information; or

22 ‘‘(II) the data or information on a device ap23 proved under this section is available for use under

24 this Act and is relevant to the design and intended

25 use of the device subject to the pending applica26 tion.’’;
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1 (3) by redesignating paragraphs (2) and (3) as

2 paragraphs (4) and (5), respectively; and

3 (4) by inserting after paragraph (1) the follow4 ing new paragraph:

5 ‘‘(2) Each application received under section 515(c)

6 shall be reviewed in the following manner to achieve final

7 action on the application within 180 days of the receipt

8 of the application:

9 ‘‘(A) The Secretary shall meet with an appli10 cant within 90 days of the receipt of the application

11 to discuss the review status of the application. If the

12 application does not appear in a form that would re13 quire an approval under subsection (d), the Sec14 retary shall in writing, and prior to the meeting,

15 present to the applicant a description of any defi16 ciencies in the application and what information is

17 required to bring the application into a form that

18 would require an approval.

19 ‘‘(B) The Secretary shall refer an application to

20 a panel established under section 513 for review and

21 an approval recommendation, unless a panel is not

22 required under subsection (c)(2), within 30 days of

23 the date of the meeting referred to in subparagraph

24 (A) or at the next scheduled panel meeting following
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1 the meeting referred to in subparagraph (A), which2 ever occurs later.

3 ‘‘(C) The Secretary shall meet with the appli4 cant within 15 days of the date of the panel review

5 to discuss the status of the application, including a

6 discussion on what action is necessary to bring the

7 application into a form that would require approval

8 under this subsection. Prior to the meeting, the Sec9 retary shall in writing shall set forth an agenda for

10 the meeting (including a complete description of the

11 subject matter to the discussed at the meeting), and

12 a full description of the additional information nec13 essary to bring the application into a form that

14 would require an approval under subsection (d). Par15 ticipation of the applicant at such a meeting shall be

16 at the discretion of the applicant.

17 ‘‘(D) The Secretary shall meet with the appli18 cant not later than 135 days after the receipt of an

19 application under subsection (c), if an advisory panel

20 is not required under subsection (c)(2), and inform

21 the applicant whether or not the application is in a

22 form that would require approval under subsection

23 (d). If the application is in such form, the Secretary

24 shall, at or prior to the meeting, present in writing

25 to the applicant a description of all additional infor-
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1 mation necessary to require an approval of the appli2 cation under subsection (d). If the application is not

3 in such form, the Secretary shall deny approval of

4 the application and prior to the meeting, present in

5 writing to the applicant each basis for denying ap6 proval of the application and the additional informa7 tion required to bring the application into a form

8 that would require approval.

9 ‘‘(E) The Secretary shall issue an order approv10 ing or denying an application within 180 days of the

11 receipt of the application under subsection (c).

12 ‘‘(3)(A) Except as provided in subparagraph (B), the

13 time for the review of an application by the Secretary

14 under this subsection shall take not more than 180 days

15 and may not be extended if the application is amended.

16 ‘‘(B) The Secretary may not take more than 120 days

17 for the review of an application subject to an expedited

18 review under paragraph (1)(A) and may not extend the

19 120-day period if the application is amended.’’.

20 (b) REGULATIONS.—The Secretary shall revise

21 through notice and comment procedures the regulations

22 set forth in part 814 of title 21 of the Code of Federal

23 Regulations, to conform to the amendment made by para24 graph (1) and to eliminate premarket approval of supple-
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1 ments that relate to manufacturing changes and other

2 changes that do not affect device safety or effectiveness.

3 SEC. 708. DEVICE PERFORMANCE STANDARDS.

4 (a) ALTERNATIVE PROCEDURE.—Section 514 (21

5 U.S.C. 360d) is amended by adding at the end thereof

6 the following new subsection:

7 ‘‘PRODUCT REVIEW

8 ‘‘(c)(1) For the purpose of facilitating a review of a

9 device under sections 510(k), 515, and 520, any person

10 may submit a petition under this subsection for the rec11 ognition by the Secretary of an existing performance

12 standard for a device.

13 ‘‘(2) A petition under this subsection shall be made

14 following the adoption of a voluntary performance stand15 ard by any qualified governmental or nongovernmental or16 ganization established to develop performance standards.

17 ‘‘(3) The petition shall identify the specific standard,

18 the organization that adopted the standard, and the date

19 on which the standard was adopted by the organization.

20 ‘‘(4) Upon the receipt of a petition under this sub21 section, the Secretary shall place the petition on public dis22 play and within 30 days after the date of the receipt of

23 the petition, the Secretary shall publish a notice in the

24 Federal Register setting forth the proposed standard, stat25 ing that the entire application is publicly available for re26 view, and providing 60 days for public comment.
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1 ‘‘(5) Within 150 days after the receipt by the Sec2 retary of the application, the Secretary shall—

3 ‘‘(A)(i) grant the petition in whole or in part;

4 or

5 ‘‘(ii) deny the petition in whole or in part if the

6 Secretary demonstrates that the standard does not

7 establish an adequate performance standard for the

8 functions of a device for which the standard is rep9 resented to apply; and

10 ‘‘(B) publish a notice of the determination in

11 the Federal Register.

12 ‘‘(6) Upon the approval of the petition, the Secretary

13 shall publish in the Federal Register the order listing the

14 name of the recognized standard and shall provide any

15 person who requests the recognized standard a copy of the

16 standard.

17 ‘‘(7) Following the publication of a final regulation

18 listing a recognized standard, any premarket notification

19 for a device submitted under sections 510(k), 513(f)(1),

20 and 513(i) and any premarket approval application sub21 mitted under section 515 may include a certification of

22 compliance with the standard, which shall constitute full

23 and complete satisfaction of the requirements for safety

24 and effectiveness for the functions of the device for which

25 the standard is represented to apply.
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1 ‘‘(8) Any modification of a recognized standard shall

2 be subject to review under the procedure established in

3 this subsection for the modified standard to become a rec4 ognized standard.’’.

5 (b) ADULTERATED DEVICE.—Section 501(e) (21

6 U.S.C. 351(e)) is amended by striking ‘‘section 514’’ and

7 inserting ‘‘section 514(b)’’.

8 TITLE VIII—ANIMAL DRUG

9 REGULATORY REFORM

10 SEC. 801. SHORT TITLE.

11 This title may be cited as the ‘‘Animal Drug Regu12 latory Reform Act of 1995’’.

13 SEC. 802. NEW ANIMAL DRUG APPROVAL STANDARDS.

14 (a) SUBSTANTIAL EVIDENCE.—Section 512(d)(3)

15 (21 U.S.C. 360b(d)(3)) is amended by adding at the end

16 thereof the following new sentences: ‘‘Substantial evidence

17 shall consist of at least data from one scientifically sound

18 study (designed and conducted in a manner that is con19 sistent with generally recognized scientific procedures and

20 principles), which may be waived by the Secretary, and

21 confirmatory evidence obtained before or after the study.

22 The Director of the Center for Veterinary Medicine may

23 require a field trial as part of substantial evidence if the

24 Director of the Center for Veterinary Medicine dem25 onstrates, in writing and specifying the basis therefor, that
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1 no other form of scientifically sound study is adequate to

2 show the effectiveness of the drug.’’.

3 (b) COMBINATION OF DRUGS.—Section 512(d) (21

4 U.S.C. 360b(d)) is amended by adding at the end thereof

5 the following new paragraph:

6 ‘‘(4) If a new animal drug contains more than one

7 active ingredient or the labeling provides for the drug’s

8 use in combination with one or more other animal drugs,

9 in evaluating such combination the Secretary shall con10 sider whether—

11 ‘‘(A) the combination affects the safety of any

12 active ingredient;

13 ‘‘(B) the combination interferes with a method

14 of analysis for any active ingredient;

15 ‘‘(C) if the active ingredients have the same in16 tended effect, each of the active ingredients makes

17 a significant contribution to the labeled effectiveness;

18 and

19 ‘‘(D) if the active ingredients do not have the

20 same intended effect, the active ingredients provide

21 appropriate concurrent therapy for a labeled target

22 population.’’.

23 (c) APPROVAL.—Section 512(c)(2)(F)(iii) (21 U.S.C.

24 360b(c)(2)(F)(iii)) is amended—
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1 (1) by striking ‘‘reports of new clinical or field

2 investigations (other than bioequivalence or residue

3 studies) and’’ and inserting ‘‘substantial evidence of

4 effectiveness as defined in subsection (d)(4), any

5 study of animal safety, or’’; and

6 (2) by striking ‘‘essential to’’ and inserting ‘‘,

7 required for’’.

8 SEC. 803. RESIDUE LIMITATION.

9 Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is

10 amended to read as follows:

11 ‘‘(F) on the basis of information in the applica12 tion or otherwise available to the Secretary, any la13 beled use of the drug will result in an unsafe residue

14 of the drug;’’.

15 SEC. 804. ADULTERATED DRUGS.

16 Section 501(a)(2) (21 U.S.C. 351(a)(2)) is

17 amended—

18 (1) in subparagraph (A), by striking ‘‘health;

19 or’’ and inserting ‘‘health’’; and

20 (2) in subparagraph (B), by striking ‘‘possess;’’

21 and inserting the following: ‘‘possess; or (C) if it is

22 a drug intended for use by animals other than man

23 and the methods used in, or the facilities or controls

24 used for, its manufacture, processing, packing, or

25 holding do not conform to or are not operated or ad-
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1 ministered in conformity with current good manufac2 turing practice requirements (appropriate for animal

3 drugs) adopted pursuant to regulations issued by the

4 Secretary to ensure that such drug meets the re5 quirements of this Act as to safety and has the iden6 tity and strength, and meets the quality and purity

7 characteristics, which it purports or is represented

8 to possess for use in animals other than man;’’.

9 TITLE IX—FOOD REGULATORY

10 REFORM

11 SEC. 901. SHORT TITLE.

12 This title may be cited as the ‘‘Food Regulatory Re13 form Act of 1995’’.

14 SEC. 902. INDIRECT FOOD ADDITIVES.

15 (a) APPROVAL.—Section 409 (21 U.S.C. 348) is

16 amended by adding at the end thereof the following new

17 subsection:

18 ‘‘ALTERNATIVE APPROVAL PROCEDURE

19 ‘‘(j)(1) As an alternative to the approval procedure

20 established under subsection (b), any person may submit

21 a notification for an indirect food additive under this sub22 section.

23 ‘‘(2) Any person who proposes to begin the introduc24 tion or delivery for introduction into interstate commerce

25 of a product intended for use as an indirect food additive

26 may submit to the Secretary, at least 90 days prior to
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1 making such introduction or delivery, a notification con2 taining information demonstrating that the labeled use of

3 the product is safe.

4 ‘‘(3)(A) Within 90 days after the receipt of the notifi5 cation by the Secretary, the Secretary shall either—

6 ‘‘(A)(i) approve the notification if the product is

7 safe for its intended use; or

8 ‘‘(ii) disapprove the notification if there is a

9 reasonable possibility that the article is not safe for

10 its intended use; and

11 ‘‘(B) publish a notice of this determination in

12 the Federal Register and, if the notification is ap13 proved, promulgate an appropriate regulation pursu14 ant to subsection (c).

15 If the Secretary does not publish such a notice in the Fed16 eral Register within the 90-day period, the notification

17 shall be deemed to be approved and the Secretary shall

18 immediately approve the notification and promulgate an

19 appropriate regulation in the Federal Register pursuant

20 to subsection (c).’’.

21 (b) DEFINITION.—Section 201 (21 U.S.C. 321), as

22 amended by section 606(c), is further amended by adding

23 at the end thereof the following new subsection:
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1 ‘‘(ii) The term ‘indirect food additive’ means a food

2 additive that is intended to contact food but that is not

3 intended for consumption as a food ingredient.’’.

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