Calendar No. 446

104TH CONGRESS

2D SESSION S. 1477

[Report No. 104–284]

A BILL

To amend the Federal Food, Drug, and Cosmetic

logical products, and for other purposes.the regulation of food, drugs, devices, and bioAct and the Public Health Service Act to improve

JUNE 20, 1996

Reported with an amendment
II

Calendar No. 446

104TH CONGRESS

2D SESSION S. 1477

[Report No. 104–284]

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 (for herself, Mr. INHOFE, and Mr. FRIST) introduced the

following bill; which was read twice and referred to the Committee on

Labor and Human Resources

JUNE 20, 1996

Reported by Mrs. KASSEBAUM, with an amendment

[Strike out all after the enacting clause and insert the part printed in italic]

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,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Food and Drug Ad3 ministration Performance and Accountability Act of

4 1995’’.

5 TITLE I—MISSION AND

6 ACCOUNTABILITY

7 SEC. 101. SHORT TITLE.

8 This title may be cited as the ‘‘Food and Drug Ad9 ministration Regulatory Reform Act of 1995’’.

10 SEC. 102. THE MISSION OF THE FOOD AND DRUG ADMINIS11 TRATION.

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

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

14 the Administration is to promote and protect the health

15 of the American people by—

16 ‘‘(1) facilitating the rapid and efficient develop17 ment and availability of products subject to its regu18 lation;

19 ‘‘(2) protecting the public from unsafe or inef20 fective products subject to its regulation; and

21 ‘‘(3) enforcing the applicable statutes and regu22 lations in a timely, fair, consistent, and decisive

23 manner.’’.

24 SEC. 103. PERFORMANCE STANDARDS AND REVIEW.

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

26 adding at the end thereof the following new paragraph:
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1 ‘‘(3) PERFORMANCE STANDARDS AND RE2 VIEW.—Within 180 days after the date of enactment

3 of this paragraph, the Commissioner, after consulta4 tion with representatives of patient advocacy groups,

5 health professionals, and the regulated industries,

6 shall publish in the Federal Register quantifiable

7 performance standards for action by the Administra8 tion on applications or submissions (including peti9 tions, notifications, or any other similar form of re10 quest) for the review of a product that is a new

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

12 food additive and that is subject to premarket review

13 or approval of any kind under this Act. The per14 formance standards shall be reviewed, and after con15 sultation with representatives of patient advocacy

16 groups, health professionals, and the regulated in17 dustries, may be revised, annually by the Commis18 sioner. The performance standards shall establish

19 objectives for the Administration that—

20 ‘‘(A) expedite action on applications for

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

22 and 515, and for biological products under sec23 tion 351(a) of the Public Health Service Act

24 (42 U.S.C. 262(a))—
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1 ‘‘(i) for a serious, life-threatening, or

2 seriously debilitating disease or condition;

3 or

4 ‘‘(ii) for any other condition if a new

5 drug, device, or biological product—

6 ‘‘(I) provides therapy not avail7 able from other approved therapy; or

8 ‘‘(II) offers significant improve9 ment over other approved therapy;

10 ‘‘(B) reduce backlogs on all applications

11 with the objective of eliminating all backlogs by

12 January 1, 2000; and

13 ‘‘(C) establish a schedule to bring the Ad14 ministration into full compliance by July 1,

15 1998, with the time periods specified in this Act

16 for action on all applications.

17 For applications for which there is no statutory time

18 period, the applicable time period for action shall be

19 180 days. The Commissioner shall prepare and pub20 lish in the Federal Register for public comment an

21 annual report comparing the performance of the Ad22 ministration with the applicable performance stand23 ards, analyzing any failure to achieve any of the

24 standards, and setting forth a plan to achieve com25 pliance with the standards that have not been met.’’.
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1 SEC. 104. INFORMATION SYSTEM.

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

3 adding at the end thereof the following new section:

4 ‘‘SEC. 906. INFORMATION SYSTEM.

5 ‘‘The Secretary shall establish and maintain an infor6 mation system to track the status and progress of each

7 application or submission (including a petition, notifica8 tion, or other similar form of request) submitted to the

9 Food and Drug Administration requesting agency action.

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

11 SEC. 105. POLICY STATEMENTS.

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

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

14 The’’; and

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

16 new paragraph:

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

18 governing the development and use of all policy statements

19 of general applicability (including any guideline, points-to20 consider, protocol, recommendation, or similar document

21 regardless of the form or designation) that are not pro22 mulgated as regulation. The procedure shall provide an

23 opportunity for affected persons to participate in the de24 velopment and continued use of the policy by sharing ex25 pertise, experience, or providing comment before the policy

26 is adopted and after the policy is implemented.
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1 ‘‘(B) The Secretary shall establish a procedure for

2 the formal publication and compilation of all policy state3 ments of general applicability (including any guideline,

4 points-to-consider, protocol, recommendation, or similar

5 document regardless of the form or designation) that are

6 not promulgated as regulations.’’.

7 SEC. 106. ADVISORY COMMITTEES.

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

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

10 GENERAL.—Without’’; and

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

12 new subsections:

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

14 The Commissioner may delegate the appointment and

15 oversight authority granted under subsection (a) to a cen16 ter director. The center director may not authorize any

17 office or division of the center to carry out the appoint18 ment and oversight authority granted under this sub19 section.

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

21 ‘‘(1) SCOPE.—A scientific review group may de22 termine the matters that the group will consider and

23 may establish an appropriate agenda with respect to

24 the determination of the matters.
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1 ‘‘(2) NONVOTING MEMBERS.—A scientific re2 view group shall include a nonvoting industry rep3 resentative and a nonvoting public representative.

4 ‘‘(3) NOTIFICATION OF SCOPE OF DISCUS5 SION.—To the extent feasible, the specific matters

6 and questions to be discussed at a meeting of a sci7 entific review group shall be publicly announced and

8 published in the Federal Register at least 30 days

9 prior to the date of the meeting.

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

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

12 be renewed for a second term. An individual may

13 serve on more than one scientific review group. The

14 chairperson of a scientific review group shall be a

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

16 of the chairperson may be renewed for not more

17 than 3 terms.

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

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

20 adequate education and training relating to the re21 sponsibilities of the member.

22 ‘‘(6) FREQUENCY OF MEETINGS.—The Sec23 retary shall take whatever action is necessary to en24 sure that regular meetings are held by scientific re25 view groups, at appropriate intervals and for a suffi-
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1 cient length of time, so that any matter to be re2 viewed by any scientific review group shall be pre3 sented to the group not more than 90 days after the

4 matter is ready for review by the group. The meet5 ings shall occur not less than 6 times each year un6 less there are compelling reasons for fewer meetings.

7 ‘‘(d) PERSONS INVOLVEMENT WITH REVIEW

8 GROUPS.—

9 ‘‘(1) IN GENERAL.—All persons, including em10 ployees of the Secretary, shall have the same rights

11 and responsibilities regarding—

12 ‘‘(A) the submission of data and informa13 tion to, and contact and discussion with, a sci14 entific review group;

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

16 meetings of the group; and

17 ‘‘(C) access to data and information sub18 mitted to a scientific review group (except for

19 data and information that are not available for

20 public disclosure under section 552 of title 5,

21 United States Code).

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

23 In a case in which a scientific review group reviews

24 an application (including a petition, notification, or

25 other similar request), all related data and informa-
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1 tion that are not available for public disclosure

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

3 shall be exchanged between the applicant and the

4 Food and Drug Administration at the time the data

5 and information are submitted to the scientific re6 view group but shall not otherwise be publicly dis7 closed.

8 ‘‘(3) PARTICIPATION IN MEETINGS.—Any meet9 ings of a scientific review group shall provide ade10 quate time for initial presentations and for response

11 to any differing views and shall encourage free and

12 open participation by all interested persons.

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

14 a scientific review group makes its conclusions and rec15 ommendations on any matter under review of the group,

16 the Food and Drug Administration official responsible for

17 the matter shall review the conclusions and recommenda18 tions of the group, shall make a final determination on

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

20 determination in writing and, if the determination differs

21 from the conclusions and recommendations of the group,

22 shall include the reasons for the difference.

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

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

25 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’’.
13

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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-
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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
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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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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-
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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
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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,
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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;
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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
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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
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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 reimporta13 tion of the exported drug or device would present an

14 imminent hazard to the public health and safety of

15 the United States and the only means of limiting the

16 hazard is to prohibit the export of the drug or de17 vice; 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.’’.

4 SECTION 1. SHORT TITLE.

5 This Act may be cited as the ‘‘Food and Drug Admin6 istration Performance and Accountability Act of 1996’’.

7 SEC. 2. TABLE OF CONTENTS.

8 The table of contents for this Act is as follows:

Sec. 1. Short title.

Sec. 2. Table of contents.

Sec. 3. References.

TITLE I—MISSION AND ACCOUNTABILITY

Sec. 101. Short title.

Sec. 102. The mission of the Food and Drug Administration.

Sec. 103. Performance standards and review.

Sec. 104. Interagency collaboration.

Sec. 105. Information system.

Sec. 106. Policy statements.

Sec. 107. Scientific review groups.

Sec. 108. Appeals within the Food and Drug Administration.

Sec. 109. Appointment and term of the Commissioner of Food and Drugs.

TITLE II—EXPEDITED ACCESS TO PRODUCTS FOR SERIOUSLY ILL

PATIENTS

Sec. 201. Short title.

Sec. 202. Access to unapproved therapies.

Sec. 203. Expanding humanitarian use of devices.

Sec. 204. Expediting approval of new drugs, biologics, and medical devices for serious conditions.

TITLE III—REVITALIZING THE INVESTIGATION OF NEW PRODUCTS

Sec. 301. Short title.

Sec. 302. Timely review and reasonable data requirements for clinical research on

drugs and biological products.

Sec. 303. Timely review and reasonable data requirements for clinical research on

devices.

Sec. 304. Sense of the committee concerning mutual recognition agreements.

Sec. 305. Collaborative research design.

TITLE IV—EFFICIENT, ACCOUNTABLE, AND FAIR PRODUCT REVIEW

Sec. 401. Short title.

Sec. 402. The content and review of an application.

Sec. 403. Contracts for expert review.
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Sec. 404. Prompt and efficient review.

Sec. 405. Good manufacturing practice inspection.

Sec. 406. Environmental impact review.

Sec. 407. Effectiveness, outcome, and cost-effectiveness standards.

Sec. 408. Definition of a day for purposes of product review.

Sec. 409. Approval of supplemental applications for approved products.

Sec. 410. Pediatric studies marketing exclusivity.

Sec. 411. Notifications for device market clearance.

TITLE V—DRUG AND BIOLOGICAL PRODUCTS REGULATORY

REFORM

Sec. 501. Short title.

Sec. 502. New drug approval standard.

Sec. 503. Pilot and small scale manufacture.

Sec. 504. Manufacturing changes.

Sec. 505. Insulin and antibiotics.

Sec. 506. Modernization of regulation of biological products.

Sec. 507. Effective medication guides.

Sec. 508. State and local requirements respecting nonprescription drugs intended

for human use.

Sec. 509. Requirement of radiopharmaceuticals.

TITLE VI—DEVICE REGULATORY REFORM

Sec. 601. Short title.

Sec. 602. Premarket notification.

Sec. 603. Medical device approval standards.

Sec. 604. Tracking.

Sec. 605. Postmarket surveillance.

Sec. 606. Device distributor reporting.

Sec. 607. Premarket approval.

Sec. 608. Device performance standards.

Sec. 609. Accredited-party participation.

TITLE VII—ANIMAL DRUG REGULATORY REFORM

Sec. 701. Short title.

Sec. 702. Evidence of effectiveness.

Sec. 703. Limitation of residues.

Sec. 704. Adulterated drugs.

Sec. 705. Veterinary feed directives.

Sec. 706. Timeframes for approval.

TITLE VIII—FOOD REGULATORY REFORM

Sec. 801. Short title.

Sec. 802. Indirect food additives.

Sec. 803. Health claims of food products.

TITLE IX—ESTABLISHMENT OF CENTERS FOR EDUCATION AND

RESEARCH ON DRUGS, DEVICES, AND BIOLOGICAL PRODUCTS

Sec. 901. Centers for Education and Research on Drugs, Devices, and Biological

Products.
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TITLE X—PROGRAM IN CLINICAL PHARMACOLOGY

Sec. 1001. Reauthorization of clinical pharmacology program.

1 SEC. 3. REFERENCES.

2 Except as otherwise expressly provided, whenever in

3 this Act an amendment or repeal is expressed in terms of

4 an amendment to, or repeal of, a section or other provision,

5 the reference shall be considered to be made to a section or

6 other provision of the Federal Food, Drug, and Cosmetic

7 Act (21 U.S.C. 321 et seq.).

8 TITLE I—MISSION AND

9 ACCOUNTABILITY

10 SEC. 101. SHORT TITLE.

11 This title may be cited as the ‘‘Food and Drug Admin12 istration Regulatory Reform Act of 1996’’.

13 SEC. 102. THE MISSION OF THE FOOD AND DRUG ADMINIS14 TRATION.

15 Section 903(a) (21 U.S.C. 393(a)) is amended by add16 ing at the end thereof the following: ‘‘The mission of the

17 Administration is to promote and protect the public health

18 by—

19 ‘‘(1) facilitating the rapid and efficient develop20 ment and availability of articles subject to the regula21 tion of the Administration;

22 ‘‘(2) protecting the public from unsafe or ineffec23 tive articles subject to the regulation of the Adminis24 tration; and
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1 ‘‘(3) enforcing the applicable statutes and regula2 tions in a timely, fair, consistent, and decisive man3 ner.’’.

4 SEC. 103. PERFORMANCE STANDARDS AND REVIEW.

5 Section 903(b) (21 U.S.C. 393(b)) is amended by add6 ing at the end thereof the following new paragraph:

7 ‘‘(3) PERFORMANCE STANDARDS AND REVIEW.—

8 ‘‘(A) IN GENERAL.—Not later than 180

9 days after the date of enactment of this para10 graph, the Secretary, after consultation with ex11 perts in the development, clinical investigation,

12 and regulation of drugs, biological products, new

13 animal drugs, devices, food additives, and color

14 additives and representatives of patient and

15 consumer advocacy groups, health and tech16 nology professionals, and the regulated indus17 tries, shall develop and publish in the Federal

18 Register quantifiable performance standards for

19 action by the Administration on—

20 ‘‘(i) applications or submissions (in21 cluding petitions, notifications, or any other

22 similar form of request) for review of a pro23 tocol, a product investigation, a product ap24 proval, a new use approval, a manufactur25 ing change, a change in labeling, or any
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1 other form of regulatory action relating to

2 the review of an article that is a new drug,

3 biological product, new animal drug, device,

4 food additive, or color additive and that is

5 subject to premarket review or approval

6 under this Act; and

7 ‘‘(ii) the scheduling of advisory com8 mittee meetings, and the action taken by the

9 Administration following an advisory com10 mittee recommendation, relating to the ap11 plications and submissions described in

12 clause (i).

13 ‘‘(B) REVIEW OF PERFORMANCE STAND14 ARDS.—The performance standards required by

15 subparagraph (A) shall be reviewed annually by

16 the Secretary, and after consultation with ex17 perts in the development, clinical investigation,

18 and regulation of drugs, biological products, new

19 animal drugs, devices, food additives, and color

20 additives, and representatives of patient and

21 consumer advocacy groups, health and tech22 nology professionals, and the regulated indus23 tries, may be revised, annually by the Secretary.

24 ‘‘(C) AGENCY OBJECTIVES.—The perform25 ance standards required by subparagraph (A)
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1 shall establish objectives for the Administration

2 that—

3 ‘‘(i) expedite the clinical investigation

4 of an article that is a new drug, device, or

5 biological product through closer collabora6 tion between the Administration and the

7 sponsor of the investigation;

8 ‘‘(ii) expedite the review of an applica9 tion for a new drug, device, or biological

10 product—

11 ‘‘(I) for an immediately life12 threatening disease or condition; or

13 ‘‘(II) for any other serious condi14 tion if the new drug, device, or biologi15 cal product provides therapy that is

16 not available from another approved

17 therapy or offers significant improve18 ment over another approved therapy or

19 diagnostic or monitoring agents;

20 ‘‘(iii) reduce backlogs in the review of

21 all applications with the objective of elimi22 nating all backlogs in the review of applica23 tions by January 1, 1998;

24 ‘‘(iv) establish a schedule to bring the

25 Administration into full compliance by
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1 July 1, 1998, with the time periods speci2 fied in this Act for the review of all applica3 tions; and

4 ‘‘(v) improve the consistency and fair5 ness of the regulatory process of the Admin6 istration.

7 The Secretary shall issue such other performance

8 standards that the Secretary determines will con9 tribute to the efficient, fair, and effective oper10 ation of the Administration.

11 ‘‘(D) ANNUAL REPORT.—The Secretary

12 shall prepare and publish in the Federal Register

13 for public comment an annual report that—

14 ‘‘(i) provides detailed data on the ac15 tual performance of the Administration re16 lating to the action taken by the Adminis17 tration with respect to the applications and

18 submissions described in subparagraph

19 (A)(i) and the activities relating to advisory

20 committees described in subparagraph

21 (A)(ii);

22 ‘‘(ii) compares the performance of the

23 Administration with each applicable per24 formance standard developed and published

25 under subparagraph (A);
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1 ‘‘(iii) describes—

2 ‘‘(I) any priorities established

3 with respect to action to be taken by

4 the Administration on matters relating

5 to the applications and submissions de6 scribed in subparagraph (A)(i) and the

7 activities relating to advisory commit8 tees described in subparagraph (A)(ii);

9 ‘‘(II) how such priorities are im10 plemented; and

11 ‘‘(III) the data on each priority

12 category;

13 ‘‘(iv) analyzes any failure to achieve

14 any of the performance standards;

15 ‘‘(v) identifies regulatory policies that

16 have a significant impact on compliance

17 with the performance standards and ana18 lyzes how such policies could be modified in

19 order to achieve compliance with the per20 formance standards; and

21 ‘‘(vi) sets forth a plan to achieve com22 pliance with the performance standards that

23 have not been met.

24 ‘‘(E) STATISTICAL INFORMATION.—The re25 port described in subparagraph (D) shall include
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1 a full statistical presentation relating to all ap2 plications, petitions, or notifications for a new

3 drug, device, biological product, new animal

4 drug, food additive, or color additive approved

5 by the Administration during the year, taking

6 into account the date of—

7 ‘‘(i) the submission of any investiga8 tional application;

9 ‘‘(ii) the application of any clinical

10 hold;

11 ‘‘(iii) the submission of any applica12 tion, petition, or notification for approval

13 or clearance;

14 ‘‘(iv) the acceptance for filing of any

15 application, petition, or notification for ap16 proval or clearance;

17 ‘‘(v) the occurrence of any

18 unapprovable action;

19 ‘‘(vi) the occurrence of any approvable

20 action; and

21 ‘‘(vii) the approval or clearance of any

22 application, petition, or notification.’’.
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1 SEC. 104. INTERAGENCY COLLABORATION.

2 Section 903(b) (21 U.S.C. 393(b)), as amended by sec3 tion 103, is further amended by adding at the end thereof

4 the following new paragraph:

5 ‘‘(4) INTERAGENCY COLLABORATION.—The Sec6 retary shall implement programs and policies that

7 will foster collaboration between the Administration,

8 the National Institutes of Health, and other Federal

9 science-based agencies, to enhance the scientific exper10 tise available to the Commissioner for the evaluation

11 of emerging medical therapies, including complemen12 tary therapies, and advances in nutrition and food

13 science.’’.

14 SEC. 105. INFORMATION SYSTEM.

15 Chapter IX (21 U.S.C. 391 et seq.) is amended by add16 ing at the end thereof the following new section:

17 ‘‘SEC. 906. INFORMATION SYSTEM.

18 ‘‘The Secretary shall establish and maintain an infor19 mation system to track the status and progress of each ap20 plication or submission (including a petition, notification,

21 or other similar form of request) for the approval or clear22 ance of a drug, biological product, new animal drug, device,

23 food additive, or color additive submitted to the Food and

24 Drug Administration. The system shall permit access by the

25 applicant, petitioner, or the person who submits a notifica26 tion.’’.
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1 SEC. 106. POLICY STATEMENTS.

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

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

4 The’’; and

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

6 new paragraph:

7 ‘‘(2)(A) Not later than 180 days after the date of enact8 ment of the Food and Drug Administration Performance

9 and Accountability Act of 1996, the Secretary shall estab10 lish a procedure governing the development and use of all

11 policy statements of general applicability that provide guid12 ance relating to the conduct of preclinical or clinical inves13 tigations or other testing to support an application or sub14 mission (including a petition, notification, or any other

15 similar form of request) under section 409, 505, 510(k), 512,

16 515, or 721 or that provide guidance on the submission of

17 an application or submission (including a petition, notifi18 cation, or any other similar form of request) under section

19 409, 505, 510(k), 512, 515, or 721 (including any guidance,

20 guideline, points-to-consider, protocol, recommendation, or

21 similar document regardless of the form or designation).

22 The procedure shall provide an opportunity for affected per23 sons to participate in the development and continued use

24 of a policy statement by sharing expertise or experience,

25 or providing comment, before the policy statement is adopt26 ed and after the policy statement is implemented, except
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1 that if the Secretary determines that there is a public health

2 need to issue the policy statement immediately, the Sec3 retary shall provide an opportunity for affected persons to

4 provide comment promptly after the policy statement is is5 sued.

6 ‘‘(B) The Secretary shall establish a procedure for the

7 periodic compilation and publication of all policy state8 ments of general applicability (including any guideline,

9 points-to-consider, protocol, recommendation, or similar

10 document regardless of the form or designation).’’.

11 SEC. 107. SCIENTIFIC REVIEW GROUPS.

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

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

14 GENERAL.—Without’’; and

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

16 new subsections:

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

18 The Commissioner may not delegate the appointment and

19 oversight authority granted under subsection (a).

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

21 ‘‘(1) SCOPE.—The Commissioner shall consult

22 with a scientific review group in determining the

23 matters that the group will consider at the meetings

24 of the scientific review group.
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1 ‘‘(2) NOTIFICATION OF SCOPE OF DISCUSSION.—

2 To the extent feasible, the specific matters (including

3 questions) to be discussed at a meeting of a scientific

4 review group shall be publicly announced and pub5 lished in the Federal Register at least 30 days prior

6 to the date of the meeting.

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

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

9 such membership renewed for not more than 1 addi10 tional term. An individual may serve on more than

11 one scientific review group. The chairperson of a sci12 entific review group shall be a member who has served

13 on the scientific group for at least 3 years. The term

14 of the chairperson may be renewed for not more than

15 3 terms.

16 ‘‘(4) TRAINING.—Prior to service on a scientific

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

18 adequate education and training relating to the re19 sponsibilities of the member.

20 ‘‘(5) FREQUENCY OF MEETINGS.—The Secretary

21 shall take whatever action is necessary to ensure that

22 regular meetings are held by scientific review groups,

23 at appropriate intervals and for a sufficient length of

24 time. The meetings shall occur not less than 3 times
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1 each year unless the Secretary determines that there

2 are sufficient reasons for fewer meetings.

3 ‘‘(d) ACCESS TO INFORMATION; PARTICIPATION BY IN4 TERESTED PERSONS IN MEETINGS.—

5 ‘‘(1) IN GENERAL.—When a scientific review

6 group reviews an application or submission (includ7 ing a petition, notification, or any other similar form

8 of request) for approval or clearance, or some part

9 thereof, submitted for an article under section 409,

10 505, 510(k), 513(f), 512, 515, or 721, the Secretary

11 shall provide the person who submitted the applica12 tion or submission with copies of all documents pro13 vided to the members of the scientific review group in

14 preparation for a meeting of the scientific review

15 group. The Secretary shall provide such documents to

16 the person at the same time such documents are pro17 vided to the members of the scientific review group.

18 Before the meeting, the person shall have an oppor19 tunity to submit documents to the members of the sci20 entific review group in response to the Secretary’s

21 documents. The person shall provide the documents to

22 the Secretary, who shall immediately provide copies

23 of the documents to the members of the scientific re24 view group.
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1 ‘‘(2) PARTICIPATION IN MEETINGS.—Any meet2 ing of a scientific review group shall include adequate

3 time for initial presentations and for response to any

4 differing views and the group shall encourage free and

5 open participation by all interested persons.

6 ‘‘(e) FDA ACTIONS.—Not later than 60 days after the

7 date a scientific review group makes its conclusions and

8 recommendations on any matter under review of the group,

9 the official of the Food and Drug Administration respon10 sible for the matter shall review the conclusions and rec11 ommendations of the group, make a final determination on

12 the matter, and notify the affected persons of the determina13 tion in writing and, if the determination differs from the

14 conclusions and recommendations of the group, include the

15 reasons for the difference.’’.

16 SEC. 108. APPEALS WITHIN THE FOOD AND DRUG ADMINIS17 TRATION.

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

19 section 105, is further amended by adding at the end thereof

20 the following new section:

21 ‘‘SEC. 907. APPEALS WITHIN THE FOOD AND DRUG ADMINIS22 TRATION.

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

24 regulation establish an internal appeal system within the

25 Food and Drug Administration for the appeal of any deci-
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1 sion made by an employee of the Food and Drug Adminis2 tration, except that this subsection shall not apply to deci3 sions involving formal administrative or judicial proceed4 ings. As the final stage in the internal appeal system, the

5 Secretary shall provide for the right to request an evalua6 tion by an appropriate scientific review group of a final

7 decision of the Secretary on an appeal involving a signifi8 cant scientific issue. Upon receipt of such a request, the Sec9 retary shall refer the request to the chairperson of the appro10 priate scientific review group, or a member designated by

11 the chairperson, who shall review the request and determine

12 whether the scientific review group should conduct an eval13 uation. The Secretary shall make publicly known the exist14 ence of the internal appeal system and the procedures for

15 an internal appeal.

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

17 ‘‘(1) IN GENERAL.—The sponsor of a preclinical

18 or clinical investigation, or the applicant for the ap19 proval or clearance of an application or submission

20 (including a petition, notification, or any other simi21 lar form of request), shall have the right to request an

22 evaluation by an appropriate scientific review group

23 established under section 904 of any significant sci24 entific issue pending before, or any significant sci25 entific decision made by, the Secretary under this
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1 Act. An appropriate scientific review group shall re2 view the request and determine whether to conduct an

3 evaluation within 30 days after the date the request

4 is received by the Secretary.

5 ‘‘(2) SCOPE.—The significant scientific issues

6 that a scientific review group may evaluate include

7 matters involving a decision by the Secretary not to

8 permit a clinical investigation to begin or to con9 tinue, a refusal by the Secretary to file an applica10 tion, a protocol design, and decisions relating to a

11 pending application or submission (including a peti12 tion, notification, or any other similar form of re13 quest). The significant scientific issues shall not have

14 been previously reviewed by a scientific review group.

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

16 group agrees to conduct an evaluation on an issue

17 under paragraph (1), the evaluation shall be sched18 uled for the next meeting of the group.

19 ‘‘(c) ADDITIONAL INFORMAL AND FORMAL PROCE20 DURES.—

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

22 conclusions and recommendations regarding the reso23 lution of any significant scientific dispute, the Sec24 retary is authorized to use such additional informal
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1 and formal procedures as may be considered useful.

2 The procedures may include the use of—

3 ‘‘(A) panels of qualified Food and Drug Ad4 ministration officials to make conclusions and

5 recommendations regarding the resolution of any

6 significant scientific dispute;

7 ‘‘(B) panels of qualified Federal Govern8 ment employees who are not employees of the

9 Food and Drug Administration to make conclu10 sions and recommendations regarding the resolu11 tion of any significant scientific dispute; and

12 ‘‘(C) outside mediators and arbitrators who

13 are not Federal Government employees to make

14 conclusions and recommendations regarding the

15 resolution of any significant scientific dispute.

16 ‘‘(2) APPLICATION OF FACA.—The Federal Advi17 sory Committee Act (5 U.S.C. App. 2) shall not apply

18 to a panel described in paragraph (1).

19 ‘‘(d) REVIEW OF RECOMMENDATIONS.—Not later than

20 60 days after the date on which a matter that is presented

21 for resolution under this section has been the subject of con22 clusions and recommendations, the official of the Food and

23 Drug Administration responsible for the matter shall review

24 the conclusions and recommendations, make a final deter25 mination on the matter, and notify the parties of the deter-
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1 mination in writing and if the determination differs from

2 the conclusions and recommendations, the reasons for the

3 difference.’’.

4 SEC. 109. APPOINTMENT AND TERM OF THE COMMISSIONER

5 OF FOOD AND DRUGS.

6 (a) PURPOSE.—It is the purpose of this section to pro7 mote increased accountability of the Commissioner of Food

8 and Drugs by providing for a limited term of appointment

9 for the Commissioner of Food and Drugs.

10 (b) LIMITATION.—Section 903(b)(1) (21 U.S.C.

11 393(b)(1)) is amended by striking ‘‘the Senate.’’ and insert12 ing ‘‘the Senate for a term of 5 years. The Commissioner

13 shall be appointed to serve 1 term. An individual serving

14 in the office of Commissioner may be removed from office

15 only pursuant to a finding by the President of neglect of

16 duty or malfeasance in office.’’.

17 (c) APPLICABILITY.—The amendment made by sub18 section (b) shall not apply to the tenure of the individual

19 who is serving as the Commissioner of Food and Drugs on

20 the date of enactment of this Act.
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1 TITLE II—EXPEDITED ACCESS

2 TO PRODUCTS FOR SERI3 OUSLY ILL PATIENTS

4 SEC. 201. SHORT TITLE.

5 This title may be cited as the ‘‘Patient Rights Regu6 latory Reform Act of 1996’’.

7 SEC. 202. ACCESS TO UNAPPROVED THERAPIES.

8 Chapter V (21 U.S.C. 351 et seq.) is amended by add9 ing at the end thereof the following new subchapter:

10 ‘‘Subchapter D—Unapproved Therapies and

11 Diagnostics and Collaborative Research

12 ‘‘SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES

13 AND DIAGNOSTICS.

14 ‘‘(a) IN GENERAL.—Any person, through a licensed

15 health care practitioner or licensed health care professional,

16 may request from a manufacturer or distributor, and any

17 manufacturer or distributor may provide to a person after

18 compliance with the provisions of this section, an investiga19 tional drug (including a biological product) or investiga20 tional device for the diagnosis, monitoring, or treatment of

21 a serious disease or condition, an immediately life-threaten22 ing or seriously debilitating disease or condition, or any

23 other disease or condition designated by the Secretary as

24 appropriate for expanded access under this section if—
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1 ‘‘(1) the person has no comparable or satisfac2 tory alternative therapy available to treat, diagnose,

3 or monitor the disease or condition;

4 ‘‘(2) the risk to the person from the investiga5 tional drug or device is not greater than the risk from

6 the disease or condition; and

7 ‘‘(3) an exemption for the investigational drug or

8 device is in effect under a regulation promulgated

9 pursuant to section 505(i) or 520(g) and the sponsor

10 and investigators comply with such regulation.

11 ‘‘(b) PROTOCOLS.—A manufacturer or distributor may

12 submit to the Secretary 1 or more expanded access protocols

13 covering expanded access use of a drug or device described

14 in subsection (a). The protocols shall be subject to the provi15 sions of section 505(i) for a drug and section 520(g) for

16 a device and may include any form of use of the drug or

17 device outside a clinical investigation, prior to approval of

18 the drug or device for marketing, including protocols for

19 treatment, use, parallel track, emergency use, uncontrolled

20 trials, and single patient protocols.

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

22 a fee for an investigational drug or device under an ex23 panded access protocol so long as the fee is not more than

24 that necessary to recover the costs of the manufacture and
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1 handling of the drug or device. The Secretary shall be noti2 fied in advance of the assessing of any such fees.

3 ‘‘(d) NOTIFICATION OF AVAILABILITY.—The Commis4 sioner shall inform national, State, and local medical asso5 ciations and societies, voluntary health associations, and

6 other appropriate persons about the availability of an in7 vestigational drug or device under expanded access protocols

8 under this section. Such notification shall identify—

9 ‘‘(1) the investigational drug or device;

10 ‘‘(2) the expanded access use of the investiga11 tional drug or device; and

12 ‘‘(3) the name and address of the manufacturer

13 or distributor that is providing the investigational

14 drug or device for expanded access use.’’.

15 SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES.

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

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

18 thereof the following flush sentences:

19 ‘‘The request shall be in the form of an application submit20 ted to the Secretary. Not later than 30 days after the date

21 of the receipt of the application, the Secretary shall issue

22 an order approving or denying the application.’’;

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

24 (3) by striking paragraph (6).
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1 SEC. 204. EXPEDITING APPROVAL OF NEW DRUGS, BIO2 LOGICS, AND MEDICAL DEVICES FOR SERI3 OUS CONDITIONS.

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

5 355(c)(1)) is amended by adding at the end thereof the fol6 lowing flush sentence:

7 ‘‘In a case in which an application is submitted under sub8 section (b)(1) for a new drug, or section 351(a) of the Public

9 Health Service Act for a biological product, that is intended

10 for use for an immediately life-threatening or serious dis11 ease or condition and that provides therapy or diagnosis

12 not available from another approved drug or biological

13 product or offers significant improvement over another ap14 proved drug or biological product, the Secretary shall ap15 prove or deny approval of the application within 180 days

16 after the receipt of the application.’’.

17 (b) PREMARKET APPROVAL.—

18 (1) AMENDMENT.—Section 515(d)(1)(A) (21

19 U.S.C. 360e(d)(1)(A)) is amended by adding at the

20 end thereof the following flush sentence:

21 ‘‘With respect to an application submitted under this sub22 section for a device for a life-threatening disease or condi23 tion, a seriously debilitating disease or condition, or for any

24 other serious disease or condition that provides therapy or

25 diagnosis not available from another approved device or of26 fers a significant improvement over another approved de-
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1 vice, the Secretary shall approve or deny the approval of

2 the application within 180 days after the receipt of the ap3 plication.’’.

4 (2) EFFECTIVE DATE.—The amendment made by

5 paragraph (1) shall take effect on July 1, 1998.

6 TITLE III—REVITALIZING THE

7 INVESTIGATION OF NEW

8 PRODUCTS

9 SEC. 301. SHORT TITLE.

10 This title may be cited as the ‘‘Investigational Prod11 ucts Regulatory Reform Act of 1996’’.

12 SEC. 302. TIMELY REVIEW AND REASONABLE DATA RE13 QUIREMENTS FOR CLINICAL RESEARCH ON

14 DRUGS AND BIOLOGICAL PRODUCTS.

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

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

17 The’’;

18 (2) by redesignating paragraphs (1), (2), and (3)

19 as subparagraphs (A), (B), and (C), respectively; and

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

21 new paragraphs:

22 ‘‘(2)(A) A clinical investigation of a new drug (includ23 ing a biological product) may begin 30 days after the date

24 on which the Secretary receives from the sponsor of the in25 vestigation a notification containing information about the
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1 drug and the clinical investigation unless, prior to the 30-

2 day period, the Secretary informs the sponsor in writing

3 that the investigation may not begin, and specifies the basis

4 for the decision and the information needed in order for

5 the clinical investigation to commence.

6 ‘‘(B) Not later than 1 year after the date of enactment

7 of the Food and Drug Administration Performance and Ac8 countability Act of 1996, the Secretary, after consultation

9 with experts in the development, clinical investigation, and

10 regulation of drugs, physicians and other health care prac11 titioners, and representatives of patient and consumer ad12 vocacy groups and the regulated industries, shall publish

13 in the Federal Register criteria for the type and amount

14 of information relating to the safety of an investigational

15 drug to be included in a notification described in subpara16 graph (A). In the establishment of the criteria, the Secretary

17 shall take into account the recommendations of the Inter18 national Conference on Harmonization of Technical Re19 quirements for Registration of Pharmaceuticals for Human

20 Use. The Secretary shall periodically review, and may re21 vise, the criteria.

22 ‘‘(C) The Secretary shall establish a mechanism to en23 sure the fair and consistent application of safety standards

24 for clinical investigations.
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1 ‘‘(3)(A) The Secretary may place a clinical hold on

2 any ongoing clinical investigation if the Secretary deter3 mines that such action is necessary for the protection of

4 human subjects.

5 ‘‘(B) If the Secretary places a clinical hold on a clini6 cal investigation, the Secretary shall immediately advise

7 the sponsor for the investigation in writing of such action,

8 and provide the sponsor an opportunity to meet with the

9 Secretary, not later than 10 business days after the receipt

10 of such a communication, to discuss the clinical hold. Not

11 later than 10 days after such a meeting, the Secretary shall

12 provide to the sponsor in writing the conditions for the

13 withdrawal of the clinical hold. Any written request re14 ceived by the Secretary from the sponsor requesting that a

15 clinical hold be removed shall receive a decision, in writing

16 and specifying the reasons therefor, not later than 20 days

17 after the receipt of the request.’’.

18 SEC. 303. TIMELY REVIEW AND REASONABLE DATA RE19 QUIREMENTS FOR CLINICAL RESEARCH ON

20 DEVICES.

21 Section 520(g) (21 U.S.C. 360j(g)) is amended by add22 ing at the end thereof the following new paragraphs:

23 ‘‘(6) The procedures and conditions prescribed pursu24 ant to paragraph (2)(A) shall be subject to subparagraphs

25 (B) and (C) of section 505(i)(2), except that the provision
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1 of subparagraph (B) of such section relating to the consider2 ation of the recommendations of the International Con3 ference on Harmonization of Technical Requirements for

4 Registration of Pharmaceuticals for Human Use shall not

5 apply to this paragraph.

6 ‘‘(7) The Secretary shall, not later than 120 days after

7 the date of enactment of this paragraph, by regulation

8 amend the content of parts 812 and 813 of title 21 of the

9 Code of Federal Regulations to update the procedures and

10 conditions under which devices intended for human use

11 may upon application be granted an exemption from cer12 tain requirements under this Act. The regulation shall—

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

14 including manufacturing changes, in response to in15 formation collected during an investigation without

16 requiring an additional approval of an application

17 for an investigational device exemption or the ap18 proval of a supplement to the application, if the spon19 sor of the investigation determines that, prior to mak20 ing any changes, the changes do not constitute a sig21 nificant change in design or a significant change in

22 basic principles of operation; and

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

24 to an application for an investigational device exemp25 tion, changes or modifications to clinical protocols
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1 that do not affect the validity of data or information

2 resulting from the completion of an approved protocol

3 so long as such changes do not affect any patient pro4 tection provisions of the protocol.’’.

5 SEC. 304. SENSE OF THE COMMITTEE CONCERNING MU6 TUAL RECOGNITION AGREEMENTS.

7 (a) FINDINGS.—The Committee on Labor and Human

8 Resources of the Senate finds that there have been lengthy

9 discussions between the members of the European Union

10 and the Commissioner of Food and Drugs on the issue of

11 mutual recognition agreements relating to the regulation of

12 drugs, biological products, devices, foods, food additives, and

13 color additives, and the regulation of good manufacturing

14 practices.

15 (b) SENSE OF THE COMMITTEE.—It is the sense of the

16 Committee on Labor and Human Resources of the Senate

17 that—

18 (1) the Secretary of Health and Human Serv19 ices, in consultation with the Secretary of Commerce,

20 should move toward the acceptance of mutual recogni21 tion agreements relating to the regulation of drugs,

22 biological products, devices, foods, food additives, and

23 color additives, and the regulation of good manufac24 turing practices, reached between the European

25 Union and the Commissioner of Food and Drugs;
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1 (2) the Secretary of Health and Human Services

2 should regularly participate in meetings with other

3 foreign governments to discuss and reach agreement

4 on methods and approaches to harmonize regulatory

5 requirements; and

6 (3) the Office of International Relations of the

7 Department of Health and Human Services (as estab8 lished under section 803 of the Federal Food, Drug,

9 and Cosmetic Act (21 U.S.C. 383)) should have the

10 responsibility of ensuring that the process of harmo11 nizing international regulatory requirements is con12 tinuous.

13 SEC. 305. COLLABORATIVE RESEARCH DESIGN.

14 Chapter V (21 U.S.C. 351 et seq.), as amended by sec15 tion 202, is further amended by adding at the end thereof

16 the following new section:

17 ‘‘SEC. 552. COLLABORATIVE RESEARCH DESIGN.

18 ‘‘(a) REVIEW OF DESIGN.—

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

20 sponsor a preclinical or clinical investigation of a

21 drug (including a biological product) or device may

22 request a meeting with the Secretary to review the de23 sign of 1 or more protocols for the preclinical or clini24 cal testing of the drug or device.
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1 ‘‘(2) FORM.—A request described in paragraph

2 (1) shall be in writing and shall include any protocol

3 for which the review is requested. A protocol shall be

4 designed so that the fewest number of patients and

5 procedures necessary to obtain data necessary for the

6 approval of a new drug, biological product, or device

7 is required, consistent with public health and safety.

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

9 meet with the person within 30 days after the request

10 and shall provide to the person a written review of

11 the protocol, including any deficiencies in the proto12 col. A written summary shall be made of the meeting.

13 The summary shall include the written review of the

14 protocol and, after agreement by the person and the

15 Secretary, shall be made part of the product review

16 file maintained by the Food and Drug Administra17 tion.

18 ‘‘(b) MODIFICATION OF AGREEMENTS.—Any agree19 ments reached through meetings with respect to the design

20 of any protocol under subsection (a) may be modified only

21 in accordance with the following provisions:

22 ‘‘(1) An agreement may be modified at any time

23 by mutual consent of the sponsor of a preclinical or

24 clinical investigation and the Secretary.
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1 ‘‘(2) An agreement may be modified by the spon2 sor unilaterally, if the change is to a protocol and the

3 change is one that would not require the approval of

4 the Secretary under the applicable regulations.

5 ‘‘(3) An agreement may be modified by the Sec6 retary unilaterally, if the change to the agreement

7 is—

8 ‘‘(A) made by the director of the office of the

9 Food and Drug Administration responsible for

10 regulating the drug or device that is the subject

11 of the agreement; and

12 ‘‘(B) set forth in writing, including an ex13 planation of the scientific or clinical need for the

14 change.

15 The director described in paragraph (3)(A) may not dele16 gate the regulatory responsibility described in such para17 graph.

18 ‘‘(c) APPEALS.—Any person requesting a meeting

19 under subsection (a) may appeal the decision of the Sec20 retary to disapprove or modify an agreement or protocol

21 under section 907.

22 ‘‘(d) GUIDELINES AND LIMITATION.—The Secretary

23 shall issue guidelines to implement this section. Such guide24 lines shall address the responsibilities of the person request25 ing the meeting, as well as the responsibilities of the Sec-
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1 retary. Repeated failure to follow the guidelines may be

2 grounds for a refusal by the Secretary to meet with a person

3 requesting a meeting under this section.’’.

4 TITLE IV—EFFICIENT, ACCOUNT5 ABLE, AND FAIR PRODUCT RE6 VIEW

7 SEC. 401. SHORT TITLE.

8 This title may be cited as the ‘‘Product Review Regu9 latory Reform Act of 1996’’.

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

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

12 adding at the end thereof the following new subchapter:

13 ‘‘Subchapter D—Review of Applications, In14 spections, Environmental Impact Reviews,

15 and Manufacturing Changes

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

17 ‘‘(a) IN GENERAL.—This section applies to an appli18 cation or submission (including a petition, notification, or

19 any other similar form of request) submitted for approval

20 or clearance of a new drug, device, biological product, new

21 animal drug, animal feed bearing or containing a new ani22 mal drug, color additive, or food additive.

23 ‘‘(b) FILING REQUIREMENTS.—Not later than 60 days

24 after the date of enactment of this section, the Commissioner

25 shall establish and publish in the Federal Register a mecha-
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1 nism to ensure the fair and consistent application of filing

2 requirements.

3 ‘‘(c) CLASSIFICATION OF A PRODUCT.—Not later than

4 60 days after the receipt of a written request of a person

5 who submits an application or submission (including a pe6 tition, notification, or any other similar form of request)

7 for information respecting the classification of an article

8 as a drug, biological product, or device or the component

9 of the Food and Drug Administration that will regulate the

10 article (including a request respecting a combination prod11 uct subject to section 503(g)), the Secretary shall provide

12 the person a written statement that identifies the classifica13 tion of the article or the component of the Food and Drug

14 Administration that will regulate the article. The Sec15 retary’s statement shall be binding and may not be modified

16 by the Secretary except with the written agreement of the

17 person who submitted the request. If the Secretary does not

18 provide the statement within the 60-day period, the classi19 fication and component designated by the person submit20 ting the request shall be final and binding and may not

21 be modified by the Secretary except with the written agree22 ment of the person.

23 ‘‘(d) REASONABLE DATA REQUIREMENTS.—Not later

24 than 1 year after the date of enactment of the Food and

25 Drug Administration Performance and Accountability Act
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1 of 1996, the Secretary, after consultation with experts in

2 the development and testing of articles that are new drugs,

3 biological products, devices, food additives, new animal

4 drugs, animal feed bearing or containing a new animal

5 drug, color additives, or food additives, experts in the regu6 lation of such articles, consumer and patient advocacy

7 groups, and the regulated industries, shall publish in the

8 Federal Register criteria for the type and amount of infor9 mation relating to safety or effectiveness to be included in

10 an application for the approval of an article that is a new

11 drug, biological product, device, food additive, new animal

12 drug, animal feed bearing or containing a new animal

13 drug, color additive, or food additive, or a new use of an

14 approved article that is a new drug, biological product, de15 vice, food additive, new animal drug, animal feed bearing

16 or containing a new animal drug, color additive, or food

17 additive. In establishing the criteria for drugs, the Sec18 retary shall consider any recommendations of the Inter19 national Conference on Harmonization of Technical Re20 quirements for Registration of Pharmaceuticals for Human

21 Use.’’.

22 SEC. 403. CONTRACTS FOR EXPERT REVIEW.

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

24 section 402, is further amended by adding at the end thereof

25 the following new section:
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1 ‘‘SEC. 742. CONTRACTS FOR EXPERT REVIEW.

2 ‘‘(a) IN GENERAL.—

3 ‘‘(1) AUTHORITY.—The Secretary may contract

4 with outside organizations and individuals, with ex5 pertise in relevant disciplines, to review, evaluate,

6 and make conclusions and recommendations to the

7 Secretary on parts or all of any application or sub8 mission (including a petition, notification, or any

9 other similar form of request). The Secretary shall re10 tain full authority to make determinations with re11 spect to the approval or disapproval of any article, or

12 the classification of a device under section 513(f)(1).

13 Any such contract shall be subject to the requirements

14 of section 708. Funds obtained under part 2 of sub15 chapter C may be used for external review of any

16 drug (including a biological product) for which a user

17 fee was paid.

18 ‘‘(2) INCREASED EFFICIENCY AND EXPERTISE

19 THROUGH CONTRACTS.—The Secretary shall use the

20 authority granted in paragraph (1)—

21 ‘‘(A) for the review of categories of indirect

22 food additive petitions and notifications for

23 clearance under section 510(k);

24 ‘‘(B) whenever contracts will improve the ef25 ficiency, timeliness, and quality of the review of

26 applications or submissions (including petitions,
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1 notifications, or any other similar form of re2 quests) for the approval or clearance of new

3 drugs, new animal drugs, biological products, de4 vices, and food additives; and

5 ‘‘(C) whenever contracts will increase the

6 scientific and technical expertise that is nec7 essary to keep informed of emerging new thera8 pies and technologies that pose significant new

9 scientific and technical issues.

10 The Secretary shall retain full authority to make de11 terminations with respect to the approval or dis12 approval of an article, or the classification of an arti13 cle as a device under section 513(f)(1).

14 ‘‘(b) ELIGIBILITY REQUIREMENTS.—Not later than 90

15 days after the date of enactment of this section, the Sec16 retary shall by regulation establish the requirements that

17 an organization or individual shall meet to be eligible to

18 conduct reviews under subsection (a). Such regulations shall

19 provide for the protection of confidential or proprietary in20 formation and shall provide for protection against conflicts

21 of interest.

22 ‘‘(c) REVIEW OF EXPERT’S EVALUATION.—

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

24 official of the Food and Drug Administration respon25 sible for any matter for which expert review is used
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1 pursuant to this section shall review the conclusions

2 and recommendations of the expert review organiza3 tion or individual and shall make a final decision re4 garding the matter under review within 60 days after

5 receiving the conclusions and recommendation.

6 ‘‘(2) LIMITATION.—A final decision under para7 graph (1) shall be made within the applicable pre8 scribed time period for review of an application as set

9 forth in this Act.

10 ‘‘(d) REPORT TO CONGRESS.—Not later than 2 years

11 after the date of enactment of this section, the Secretary

12 shall prepare and submit to Congress a report on the use

13 of the authority to contract with outside organizations and

14 individuals for expert reviews. Such report shall include an

15 evaluation of the extent to which such contracting improves

16 the efficiency of review and the expertise available to the

17 Food and Drug Administration.’’.

18 SEC. 404. PROMPT AND EFFICIENT REVIEW.

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

20 section 403, is further amended by adding at the end thereof

21 the following new section:

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

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

24 apply to any of the following applications, petitions, and

25 notifications:
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1 ‘‘(1) A petition for the issuance of a regulation

2 prescribing the safe use of a human food additive or

3 animal feed additive under section 409.

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

5 under section 505.

6 ‘‘(3) An application for approval of a new ani7 mal drug or an animal feed bearing or containing a

8 new animal drug under subsection (b) or (m) of sec9 tion 512, respectively.

10 ‘‘(4) A notification submitted under section

11 510(k) for classification of a device.

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

13 under section 515.

14 ‘‘(6) A petition for issuance of a regulation for

15 the listing of a color additive under section 721.

16 ‘‘(b) REVIEW PROCEDURES AND POLICIES.—The Sec17 retary shall establish procedures and policies to facilitate

18 a collaborative review process between the Commissioner

19 and the applicant, petitioner, or person who submits a noti20 fication with respect to an application, petition, or notifica21 tion described in subsection (a). As part of this collaborative

22 process—

23 ‘‘(1) open, informal, and prompt communica24 tions shall be encouraged;
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1 ‘‘(2) meetings (except that meetings shall not be

2 required with respect to matters relating to a notifica3 tion submitted under section 510(k)) shall be held be4 fore the expiration of one-half of the statutory time

5 period for review of the application or petition and

6 before the expiration of three-quarters of such period,

7 or within 15 days after a scientific review group has

8 convened and made recommendations on an applica9 tion or petition, unless the Commissioner and the ap10 plicant or petitioner determine that a meeting is un11 necessary;

12 ‘‘(3) by mutual consent, the Commissioner and

13 the applicant or petitioner may establish a different

14 schedule for meetings required under paragraph (2);

15 and

16 ‘‘(4) the Secretary shall, prior to the meetings

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

18 or petitioner in writing a description of any defi19 ciencies of the application or petition and the infor20 mation necessary to bring the application or petition

21 into a form that would require approval.

22 The Secretary and the applicant or petitioner may agree

23 to supersede any procedures and policies adopted under this

24 section and the requirements of paragraphs (2) and (3).
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1 Any such agreement shall be in writing, and shall specify

2 how any such agreement shall be modified or set aside.

3 ‘‘(c) APPROVAL, DISAPPROVAL, AND CLASSIFICA4 TION.—

5 ‘‘(1) CONSIDERATION OF INTERNATIONAL AP6 PROVALS.—Beginning July 1, 1998, if the Secretary

7 fails to meet a time period for action on an applica8 tion or notification for the approval or clearance of

9 an article that is a new drug, device, biological prod10 uct, or new animal drug that offers a significant im11 provement over an existing approved article or a peti12 tion for the approval of a direct food additive that

13 has the potential to make foods more wholesome and

14 contribute to a healthier diet, and such an article has

15 been approved for marketing in the European Union

16 or the United Kingdom, the Secretary shall, within

17 30 days after a request of a person who submits an

18 application, notification, or petition described in this

19 paragraph, either approve or disapprove the applica20 tion, notification, or petition and notify the person in

21 writing of that decision. In the case of a disapproval,

22 or a determination that a device is not substantially

23 equivalent, such notification shall set forth the reasons

24 for the disapproval or the determination.
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1 ‘‘(2) APPEAL.—A person whose application, no2 tification, or petition has been disapproved (including

3 a determination that a device does not meet the re4 quirements relating to substantial equivalence) under

5 paragraph (1) may obtain judicial review under—

6 ‘‘(A) section 505(h) for the disapproval of a

7 new drug under paragraph (1);

8 ‘‘(B) section 517 for the disapproval of a

9 device or a determination of not substantially

10 equivalent relating to a device under paragraph

11 (1);

12 ‘‘(C) chapter VII of title 5, United States

13 Code, for the disapproval of a license for a bio14 logical product under paragraph (1);

15 ‘‘(D) section 512(h) for the disapproval of a

16 new animal drug under paragraph (1); and

17 ‘‘(E) section 409(g) for the disapproval of a

18 direct food additive under paragraph (1).

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

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

21 the Secretary in any fiscal year fails to meet the stat22 utory time period for action on an application, noti23 fication, or petition for at least 95 percent of the ap24 plications, notifications, and petitions submitted in a

25 particular product category, the Secretary shall—
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1 ‘‘(A) in the following fiscal year, contract

2 with expert organizations and individuals under

3 section 742, to review applications, notifications,

4 and petitions of persons who submit the applica5 tions, notifications, and petitions in that follow6 ing fiscal year and who consent to the review;

7 and

8 ‘‘(B) in the following fiscal year and with

9 the consent of the persons described in this sub10 paragraph, contract with expert organizations

11 and individuals under section 742, to review ap12 plications, notifications, and petitions that were

13 submitted by persons in any preceding fiscal

14 year and that the Secretary has failed to review

15 within the statutory time period for action on

16 the applications, notifications, and petitions

17 with respect to the particular product category.

18 ‘‘(2) APPROVAL.—If an organization or individ19 ual selected to conduct a review under paragraph (1)

20 recommends the approval or clearance of an applica21 tion, notification, or petition described in paragraph

22 (1), the Secretary shall, within 60 days after receiv23 ing the determination of the organization or individ24 ual (but not later than the time period for review set

25 forth in this Act), either approve or disapprove the
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1 application, notification, or petition, and, in the case

2 of a disapproval, notify the person who submitted the

3 application, notification, or petition in writing of the

4 basis for the disapproval. The person may appeal an

5 adverse decision under subsection (c)(2).’’.

6 SEC. 405. GOOD MANUFACTURING PRACTICE INSPECTION.

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

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

9 thereof the following new section:

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

11 ‘‘(a) IN GENERAL.—In order to comply with the in12 spection requirements of this Act, the Secretary may ac13 credit organizations to conduct inspections under section

14 704 to evaluate compliance of a manufacturer with applica15 ble requirements for good manufacturing practice.

16 ‘‘(b) ELIGIBILITY REQUIREMENTS.—If the Secretary

17 elects to accredit organizations to conduct inspections under

18 section 704, the Secretary shall by regulation, within 90

19 days after the date of enactment of this section, establish

20 the requirements that an organization shall meet to be eligi21 ble to be accredited to participate as a qualified organiza22 tion to conduct inspections under subsection (a). Such regu23 lation shall provide for the protection of confidential or pro24 prietary information and shall provide for protection

25 against conflicts of interest.
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1 ‘‘(c) ACCREDITATION.—Not later than 90 days after

2 the date on which the Secretary receives an application for

3 accreditation under this section, the Secretary shall review

4 the application and determine whether an applicant is in

5 compliance with the requirements established under this sec6 tion. Within the 90-day period, the Secretary shall grant

7 accreditation or shall deny accreditation and specify in

8 writing the reasons for the denial and the requirements that

9 shall be met to obtain accreditation.

10 ‘‘(d) REVOCATION OF ACCREDITATION.—The Secretary

11 may at any time revoke accreditation granted under sub12 section (c) for failure to comply with the requirements es13 tablished under this section after specifying in writing the

14 reasons for the revocation and the requirements that shall

15 be met to retain accreditation and after an informal hear16 ing on the revocation.

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

18 under this section that conducts an inspection under this

19 section at the request of the Secretary shall—

20 ‘‘(1) apply all relevant principles of good manu21 facturing practice established in this Act and in regu22 lations promulgated by the Secretary;

23 ‘‘(2) provide to the Secretary and the manufac24 turer within 30 days after the completion of the in25 spection a report of the findings of the inspection; and
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1 ‘‘(3) immediately provide the Secretary with a

2 notice of any condition that could cause or contribute

3 to a significant threat to the public health.’’.

4 SEC. 406. ENVIRONMENTAL IMPACT REVIEW.

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

6 section 405, is further amended by adding at the end thereof

7 the following new section:

8 ‘‘SEC. 745. ENVIRONMENTAL IMPACT REVIEW.

9 ‘‘Notwithstanding any other provision of law, no ac10 tion by the Secretary pursuant to this Act shall be subject

11 to an environmental assessment, an environmental impact

12 statement, or other environmental consideration unless the

13 director of the office responsible for the action demonstrates,

14 in writing—

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

16 the environmental impact of the action is sufficiently

17 substantial and within the factors that the Secretary

18 is authorized to consider under this Act; and

19 ‘‘(2) that consideration of the environmental im20 pact will directly affect the decision on the action.’’.

21 SEC. 407. EFFECTIVENESS, OUTCOME, AND COST-EFFEC22 TIVENESS STANDARDS.

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

24 adding at the end thereof the following new subsection:
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1 ‘‘(e) LIMITATION ON DETERMINATION OF EFFECTIVE2 NESS.—In a review of an application for an article that

3 is a new drug, device, biological product, new animal drug,

4 or animal feed bearing or containing a new animal drug,

5 the determination of effectiveness shall not include the eval6 uation of—

7 ‘‘(1) any potential use not included in the label8 ing;

9 ‘‘(2) the cost-effectiveness of an article described

10 in this subsection, unless the proposed labeling explic11 itly includes a representation about cost-effectiveness;

12 and

13 ‘‘(3) the clinical outcome resulting from the use

14 of a diagnostic device, unless the labeling explicitly

15 includes a representation regarding clinical out16 come.’’.

17 SEC. 408. DEFINITION OF A DAY FOR PURPOSES OF PROD18 UCT REVIEW.

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

20 at the end thereof the following new paragraph:

21 ‘‘(gg) For purposes of reviewing any application or

22 submission (including a petition, notification, or any other

23 similar form of request), or any document, with respect to

24 an article that is a new drug, device, biological product,

25 new animal drug, an animal feed bearing or containing
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1 a new animal drug, color additive, or food additive, that

2 is submitted to the Secretary to obtain marketing approval,

3 to obtain classification of a device under section 513(f)(1),

4 or to establish or clarify the regulatory status of the article,

5 the term ‘day’ means a calendar day in which the Secretary

6 has responsibility to review such a submission (excluding

7 any calendar day between the date of receipt by the submit8 ter of a written communication from the Secretary setting

9 forth the action of the Secretary on a submission and the

10 date of receipt by the Secretary of the written response of

11 the submitter to the action).’’.

12 SEC. 409. APPROVAL OF SUPPLEMENTAL APPLICATIONS

13 FOR APPROVED PRODUCTS.

14 (a) PERFORMANCE STANDARDS.—Not later than 180

15 days after the date of enactment of this section, the Sec16 retary of Health and Human Services shall publish in the

17 Federal Register performance standards for the prompt re18 view of supplemental applications submitted for approved

19 articles under the Federal Food, Drug, and Cosmetic Act

20 (21 U.S.C. 321 et seq.).

21 (b) GUIDANCE TO INDUSTRY.—Not later than 180 days

22 after the date of enactment of this section, the Secretary

23 of Health and Human Services shall issue guidances to

24 clarify the requirements and facilitate the submission of

25 data to support the approval of supplemental applications
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1 for the approved articles described in subsection (a). The

2 guidances shall—

3 (1) clarify circumstances in which published

4 matter may be the basis for approval of a supple5 mental application;

6 (2) specify data requirements that will avoid du7 plication by recognizing the availability of data pre8 viously submitted in support of an original applica9 tion; and

10 (3) define supplemental applications that are eli11 gible for priority review.

12 (c) RESPONSIBILITIES OF CENTERS.—The Secretary of

13 Health and Human Services shall designate an individual

14 in each center within the Food and Drug Administration

15 (except the Center for Food Safety and Applied Nutrition)

16 to be responsible for—

17 (1) encouraging the prompt review of supple18 mental applications for approved products; and

19 (2) working with sponsors to facilitate the devel20 opment and submission of data to support supple21 mental applications.

22 (d) COLLABORATION.—The Secretary of Health and

23 Human Services shall implement programs and policies

24 that will foster collaboration between the Food and Drug

25 Administration, the National Institutes of Health, profes-
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1 sional medical and scientific societies, and others persons,

2 to identify published and unpublished studies that could

3 support a supplemental application, and to encourage

4 sponsors to make supplemental applications or conduct fur5 ther research in support of a supplemental application

6 based, in whole or in part, on such studies.

7 SEC. 410. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.

8 Chapter V of the Federal Food, Drug, and Cosmetic

9 Act (21 U.S.C. 351 et seq.) is amended by inserting after

10 section 505 the following new section:

11 ‘‘SEC. 505A. PEDIATRIC STUDIES FOR NEW DRUG APPLICA12 TIONS.

13 ‘‘(a) MARKET EXCLUSIVITY FOR APPROVED APPLICA14 TIONS WITH PEDIATRIC STUDIES SUBMITTED BY AN AP15 PLICANT.—If an application submitted under section

16 505(b)(1) is approved on or after the date of enactment of

17 this section, and such application includes reports of pedi18 atric studies described and requested in subsection (c), and

19 such studies are completed and the reports thereof submitted

20 in accordance with subsection (c)(2) or completed and the

21 reports thereof accepted in accordance with subsection

22 (c)(3), the Secretary may not make the approval of an ap23 plication submitted under section 505(b)(2) or 505(j) that

24 refers to the drug for which the section 505(b)(1) approval

25 is granted effective prior to the expiration of 6 months from
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1 the earliest date on which the approval of such application

2 for the drug under section 505(b)(2) or 505(j), respectively,

3 could otherwise be made effective under the applicable pro4 visions of this chapter.

5 ‘‘(b) MARKET EXCLUSIVITY FOR APPROVED APPLICA6 TIONS WITH PEDIATRIC STUDIES REQUESTED BY THE

7 SECRETARY.—If the Secretary makes a written request for

8 pediatric studies described in subsection (c) to the holder

9 of an approval under section 505(b)(1) for a drug, and such

10 studies are completed and the reports thereof submitted in

11 accordance with subsection (c)(2) or completed and the re12 ports thereof accepted in accordance with subsection (c)(3),

13 the Secretary may not make the approval of an application

14 submitted under section 505(b)(2) or 505(j) that refers to

15 the drug subject to the section 505(b)(1) approval effective

16 prior to the expiration of 6 months from the earliest date

17 on which an approval of such application under section

18 505(b)(2) or 505(j), respectively, could otherwise be made

19 effective under the applicable provisions of this chapter.

20 Nothing in this subsection shall affect the ability of the Sec21 retary to make effective a section 505(b)(2) or 505(j) ap22 proval for a subject drug if such approval is proper under

23 such section and is made effective prior to the submission

24 of the reports of pediatric studies described in subsection

25 (c).
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1 ‘‘(c) CONDUCT OF PEDIATRIC STUDIES.—

2 ‘‘(1) AGREEMENT FOR STUDIES.—The Secretary

3 may, pursuant to a written request for studies and

4 after consultation with the sponsor of an application

5 or holder of an approval for a drug under section

6 505(b)(1), agree with the sponsor or holder concerning

7 the conduct of pediatric studies for such drug.

8 ‘‘(2) WRITTEN PROTOCOLS TO MEET THE STUD9 IES REQUIREMENT.—If the sponsor or holder and the

10 Secretary agree upon written protocols for such stud11 ies, the studies requirement of subsection (a) or (b) is

12 satisfied upon the completion of the studies in accord13 ance with the protocols and the submission of the re14 ports thereof to the Secretary. Not later than 60 days

15 after the submission of the report of the studies, the

16 Secretary shall determine if such studies were or were

17 not conducted in accordance with the written proto18 cols and reported in accordance with the requirements

19 of the Secretary for filing and so notify the sponsor

20 or holder.

21 ‘‘(3) OTHER METHODS TO MEET THE STUDIES

22 REQUIREMENT.—If the sponsor or holder and the Sec23 retary have not agreed in writing on the protocols for

24 the studies, the studies requirement of subsection (a)

25 or (b) is satisfied when such studies have been com-
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1 pleted and the reports accepted by the Secretary. Not

2 later than 90 days after the submission of the reports

3 of the studies, the Secretary shall accept or reject such

4 reports and so notify the sponsor or holder. The Sec5 retary’s only responsibility in accepting or rejecting

6 the reports shall be to determine, within 90 days, that

7 the studies fairly respond to the written request, that

8 such studies have been conducted in accordance with

9 commonly accepted scientific principles and protocols,

10 and that such studies have been reported in accord11 ance with the requirements of the Secretary for filing.

12 ‘‘(d) DELAY OF EFFECTIVE DATE FOR CERTAIN APPLI13 CATIONS; PERIOD OF MARKET EXCLUSIVITY.—If the Sec14 retary determines that an approval of an application under

15 section 505(b)(2) or 505(j) for a drug may be made effective

16 after the submission of reports of pediatric studies under

17 this section but before the Secretary has determined whether

18 the requirements of subsection (c) have been satisfied, the

19 Secretary may delay the effective date of any approval

20 under section 505(b)(2) or 505(j), respectively, until the de21 termination under subsection (c) is made, but such delay

22 shall not exceed 90 days. In the event that the requirements

23 of this section are satisfied, the 6-month period referred to

24 in subsection (a) or (b) shall be deemed to have begun on

25 the date an approval of an application under section
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1 505(b)(2) or 505(j), respectively, would have been permitted

2 absent action under this subsection.

3 ‘‘(e) NOTICE OF DETERMINATIONS ON STUDIES RE4 QUIREMENT.—The Secretary shall publish notice of any de5 termination that the requirements of paragraph (2) or (3)

6 of subsection (c) have been met and that approvals under

7 section 505(b)(2) or 505(j) for a drug will be subject to de8 ferred effective dates under this section.

9 ‘‘(f) DEFINITIONS.—As used in this section, the term

10 ‘pediatric studies’ or ‘studies’ means at least 1 human clini11 cal investigation in a population of adolescent age or

12 younger. At the Secretary’s discretion, pharmacokinetic

13 studies may be considered as clinical investigations.’’.

14 SEC. 411. NOTIFICATIONS FOR DEVICE MARKET CLEAR15 ANCE.

16 Section 510(k) (21 U.S.C. 360(k)) is amended by strik17 ing ‘‘report to’’ and inserting ‘‘shall notify the Secretary

18 to report to’’.

19 TITLE V—DRUG AND BIOLOGI20 CAL PRODUCTS REGULATORY

21 REFORM

22 SEC. 501. SHORT TITLE.

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

24 Product Regulatory Reform Act of 1996’’.
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1 SEC. 502. NEW DRUG APPROVAL STANDARD.

2 Section 505(d) (21 U.S.C. 355(d)) is amended by add3 ing at the end thereof the following new sentence: ‘‘Substan4 tial evidence may consist of data from 1 well-controlled

5 clinical investigation and confirmatory evidence obtained

6 prior to, or after, such investigation.’’.

7 SEC. 503. PILOT AND SMALL SCALE MANUFACTURE.

8 Section 505(c) (21 U.S.C. 355(c)) is amended by add9 ing at the end thereof the following new paragraph:

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

11 in a pilot or other small facility may be used to demonstrate

12 the safety and effectiveness of the drug or product and to

13 obtain approval prior to scaling up to a larger facility, un14 less the Secretary demonstrates in writing and specifies in

15 detail the reasons, after an informal hearing, that a full

16 scale production facility is necessary to ensure the safety

17 or effectiveness of the drug or product.’’.

18 SEC. 504. MANUFACTURING CHANGES.

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

20 section 406, is further amended by adding at the end thereof

21 the following new section:

22 ‘‘SEC. 746. MANUFACTURING CHANGES.

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

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

25 be made in accordance with this section.
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1 ‘‘(b) DRUG AND BIOLOGICAL PRODUCT.—A change in

2 the manufacture of a new drug, a biological product that

3 is the subject of a monograph in an official compendium,

4 a biological product that can be adequately characterized

5 by chemical, physical, or biological means, or a new animal

6 drug—

7 ‘‘(1) shall require validation; and

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

9 qualitative and quantitative formulation relating to

10 the new drug, biological product, or new animal drug

11 or in the approved release specifications relating to

12 the new drug, biological product, or new animal drug,

13 or if there is a change in the approved qualitative or

14 quantitative formula or in the approved release speci15 fications of a type permitted by the Secretary by reg16 ulation, may be made at any time so long as the

17 change is reported annually to the Secretary; or

18 ‘‘(B) in the case of a change other than a change

19 described in subparagraph (A), shall require comple20 tion of an appropriate study demonstrating equiva21 lence according to criteria established by the Sec22 retary (unless such requirement is waived by the Sec23 retary), may be made at any time, and shall be re24 ported to the Secretary through a supplement or

25 amendment submitted at the time the change is made.
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1 ‘‘(c) BIOLOGICAL PRODUCT NOT SUBJECT TO A MONO2 GRAPH.—A change in the manufacture of a biological prod3 uct that is not the subject of a monograph in an official

4 compendium and cannot be adequately characterized by

5 chemical, physical, or biological means—

6 ‘‘(1) shall require validation; and

7 ‘‘(2)(A) if the change relates solely to a modifica8 tion of the manufacturing facility or change in per9 sonnel, with no change in the approved manufactur10 ing process or release specifications, may be made at

11 any time so long as the change is reported annually

12 to the Secretary; or

13 ‘‘(B) in the case of a change other than a change

14 described in subparagraph (A), shall require comple15 tion of a bioassay or other appropriate study dem16 onstrating equivalence according to criteria estab17 lished by the Secretary (unless such requirement is

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

19 and shall be reported to the Secretary through an

20 amendment submitted at the time the change is made.

21 ‘‘(d) SPECIAL DETERMINATION FOR A BIOLOGICAL

22 PRODUCT.—A determination shall be made, prior to the ap23 proval of a biological product under section 351(a) of the

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

25 product can be adequately characterized for purposes of this
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1 section. With respect to biological products approved prior

2 to the date of enactment of the Food and Drug Administra3 tion Performance and Accountability Act of 1996, the deter4 mination shall be made not later than 90 days after the

5 date of enactment of such Act. Any determination made

6 under this subsection is subject to change based upon new

7 scientific information.’’.

8 SEC. 505. INSULIN AND ANTIBIOTICS.

9 (a) CERTIFICATION OF DRUGS CONTAINING INSU10 LIN.—Section 506 (21 U.S.C. 356) is repealed.

11 (b) CERTIFICATION OF ANTIBIOTICS.—Section 507 (21

12 U.S.C. 357) is repealed.

13 (c) EXPORTATION.—Section 802 (21 U.S.C. 382) is

14 amended—

15 (1) by redesignating subsection (h) as subsection

16 (i); and

17 (2) by inserting after subsection (g) the following

18 new subsection:

19 ‘‘(h) EXPORTATION OF UNAPPROVED PRODUCTS.—In20 sulin and antibiotics may be exported without regard to

21 the requirements in this section if the insulin and anti22 biotics meet the requirements of section 801(e)(1).’’.
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1 SEC. 506. MODERNIZATION OF REGULATION OF BIOLOGI2 CAL PRODUCTS.

3 (a) IN GENERAL.—Section 351 of the Public Health

4 Service Act (42 U.S.C. 262) is amended by striking ‘‘SEC.

5 351. (a)’’ and all that follows through ‘‘barter, or exchange

6 the same.’’ and inserting the following:

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

8 (6), no person shall introduce or deliver for introduction

9 into interstate commerce any biological product unless—

10 ‘‘(A) a license is in effect for the biological prod11 uct; and

12 ‘‘(B) each package of the biological product is

13 plainly marked with the proper name of the biological

14 product contained therein, the name, address, and ap15 plicable license number of the manufacturer of the bi16 ological product, and the expiration date of the bio17 logical product.

18 ‘‘(2) The license required under paragraph (1)(A)

19 shall, as determined by the Secretary, cover the biological

20 product, any facility in which the biological product is

21 manufactured, processed, packed, or held, or both the prod22 uct and facility.

23 ‘‘(3)(A) The Secretary shall establish, by regulation,

24 requirements for license applications for biological prod25 ucts.
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1 ‘‘(B) Except as provided in subparagraph (D), a li2 cense application that covers a biological product shall be

3 approved based upon a demonstration that—

4 ‘‘(i) the product that is the subject of the applica5 tion is safe and effective in accordance with sections

6 505(c) and 505(d) of the Federal Food, Drug, and

7 Cosmetic Act (21 U.S.C. 355 (c) and (d)), or meets

8 standards designed to ensure that the product is safe,

9 pure, and where appropriate, potent; and

10 ‘‘(ii) the methods used in, and the facilities and

11 control used for, the manufacture, processing, pack12 ing, and holding of such product meet standards de13 signed to ensure that the product meets the require14 ments of clause (i).

15 ‘‘(C) A license application that covers a facility shall

16 ensure that the product and the facility meet standards de17 signed to ensure that the product meets applicable require18 ments of subparagraph (B).

19 ‘‘(D) A license application for blood or a blood compo20 nent (including plasma) shall be approved based on a dem21 onstration that the product is safe, pure, and where appro22 priate, potent, and that the facility in which the product

23 is manufactured, processed, packed, or held meets standards

24 designed to ensure that such product is safe, pure, and

25 where appropriate, potent.
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1 ‘‘(4)(A) Requirements prescribed under paragraph (3)

2 shall include a requirement for preapproval inspection

3 under subsection (c).

4 ‘‘(B) A license shall be approved only on condition that

5 the licensee agrees to permit inspection of the facility of the

6 licensee in accordance with subsection (c).

7 ‘‘(5)(A) Except as provided in subparagraph (C), an

8 approved license for a biological product may be revoked

9 if the Secretary determines, on the record after providing

10 an opportunity for a hearing in accordance with section

11 554 of title 5, United States Code, that the requirements

12 for approval as specified in paragraph (3) are no longer

13 met with respect to such product, or that other public health

14 reasons, prescribed by regulation, exist. No action to revoke

15 a license based on the findings of an inspection shall be

16 initiated prior to the submission and review by the Sec17 retary of a written response submitted by the licensee to

18 a notice of inspectional findings so long as such written

19 response is received within 30 days after the date of receipt

20 by the licensee of the findings. The revocation of any prod21 uct license shall not prevent the continued use of any li22 censed biological product that has been sold and delivered

23 by the licensee unless the biological product is subject to

24 recall under subsection (d).
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1 ‘‘(B) If at any time before the Secretary has taken

2 final action to revoke a license, the licensee requests an in3 spection by the Secretary to determine whether the licensee

4 is in compliance with applicable standards, the Secretary

5 shall conduct an inspection within 30 days after the date

6 of the request. If the inspection confirms that the licensee

7 is not in compliance with applicable standards, the 30-day

8 requirement for inspection shall not apply to any subse9 quent request by the licensee under this subparagraph for

10 inspection. If the inspection confirms that the licensee is

11 in compliance with all applicable requirements, the Sec12 retary shall withdraw any proposed action within 30 days

13 after the inspection.

14 ‘‘(C) If the Secretary determines that conditions exist

15 that constitute a danger to health, the Secretary shall sus16 pend the license, notify the licensee that the licensee’s license

17 is suspended, and require notification of the suspension to

18 any consignee. Within 30 days thereafter, the Secretary

19 shall initiate the hearing process under subparagraph (A).

20 ‘‘(6) The requirements of paragraph (1) do not apply

21 to a biological product for which there is in effect an inves22 tigational new drug application under section 505(i) of the

23 Federal Food, Drug, and Cosmetic Act.’’.
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1 (b) DELETION OF ELA REQUIREMENT.—Section

2 351(d) of the Public Health Service Act (42 U.S.C. 262(d))

3 is amended—

4 (1) by striking ‘‘(d)(1)’’ and all that follows

5 through ‘‘of this section.’’;

6 (2) by redesignating paragraph (2)(A) as sub7 section (d)(1);

8 (3) by redesignating subparagraph (B) as para9 graph (2); and

10 (4) in paragraph (2) (as so redesignated), by

11 striking ‘‘subparagraph (A)’’ and inserting ‘‘para12 graph (1)’’.

13 (c) LABELING.—Section 351(b) of the Public Health

14 Service Act (42 U.S.C. 262(b)) is amended to read as fol15 lows:

16 ‘‘(b) No person shall falsely label or mark any package

17 or container of any biological product or alter any label

18 or mark on the package so as to falsify the label or mark.’’.

19 (d) INSPECTION.—Section 351(c) of the Public Health

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

21 ‘‘virus, serum,’’ and all that follows through ‘‘other product

22 aforesaid’’ and inserting ‘‘biological product’’.

23 (e) DEFINITION; APPLICATION.—Section 351 of the

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

25 adding at the end thereof the following new subsections:
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1 ‘‘(i) For purposes of this section, the term ‘biological

2 product’ means a virus, therapeutic serum, toxin, antitoxin,

3 vaccine, blood, blood component or derivative, allergenic

4 biologic product, or arsphenamine or its derivative (or any

5 other analogous biological product) applicable to the pre6 vention, treatment, or cure of diseases or conditions of

7 human beings.

8 ‘‘(j)(1) Sections 505(i), 903, and 904 of the Federal

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

10 products, and references in such sections to new drug appli11 cations shall be deemed to include product license applica12 tions for biological products.

13 ‘‘(2) Requirements involving labeling or advertising

14 for biological products shall be established in accordance

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

16 and Cosmetic Act.’’.

17 SEC. 507. EFFECTIVE MEDICATION GUIDES.

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

19 section 108, is further amended by adding at the end thereof

20 the following new section:

21 ‘‘SEC. 908. EFFECTIVE MEDICATION GUIDES.

22 ‘‘(a) IN GENERAL.—Not later than 30 days after the

23 date of enactment of this section, the Secretary shall request

24 that national organizations representing health care profes25 sionals, consumer organizations, voluntary health agencies,
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1 the pharmaceutical industry, drug wholesalers, patient

2 drug information database companies, and other relevant

3 parties collaborate to develop a long-range comprehensive

4 action plan to achieve goals consistent with the goals of the

5 proposed rule of the Food and Drug Administration on

6 ‘Prescription Drug Product Labeling: Medication Guide

7 Requirements (60 Fed. Reg. 44182; relating to the provision

8 of oral and written prescription information to consumers).

9 ‘‘(b) PLAN.—The plan described in subsection (a)

10 shall—

11 ‘‘(1) identify the plan goals;

12 ‘‘(2) assess the effectiveness of the current pri13 vate-sector approaches used to provide oral and writ14 ten prescription information to consumers;

15 ‘‘(3) develop guidelines for providing effective

16 oral and written prescription information consistent

17 with the findings of any such assessment;

18 ‘‘(4) develop a mechanism to assess periodically

19 the quality of the oral and written prescription infor20 mation and the frequency with which the information

21 is provided to consumers; and

22 ‘‘(5) provide for compliance with relevant State

23 board regulations.

24 ‘‘(c) LIMITATION ON THE AUTHORITY OF THE SEC25 RETARY.—The Secretary shall have no authority to imple-
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1 ment the proposed rule described in subsection (a), or to

2 develop any similar regulation, policy statement, or other

3 guideline specifying a uniform content or format for writ4 ten information voluntarily provided to consumers about

5 prescription drugs if, not later than 120 days after the date

6 of enactment of this section, the national organizations de7 scribed in subsection (a) develop and begin to implement

8 a comprehensive, long-range action plan (as described in

9 subsection (a)) regarding the provision of oral and written

10 prescription information.

11 ‘‘(d) SECRETARY REVIEW.—Not later than January 1,

12 2001, the Secretary shall review the status of private-sector

13 initiatives designed to achieve the goals of the plan de14 scribed in subsection (a), and if such goals are not achieved,

15 the limitation in subsection (c) shall not apply, and the

16 Secretary shall seek public comment on other initiatives

17 that may be carried out to meet such goals. The Secretary

18 shall not delegate such review authority to the Commis19 sioner.’’.

20 SEC. 508. STATE AND LOCAL REQUIREMENTS RESPECTING

21 NONPRESCRIPTION DRUGS INTENDED FOR

22 HUMAN USE.

23 Subchapter A of chapter V (21 U.S.C. 351 et seq.) is

24 amended by inserting after section 522 the following new

25 section:
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1 ‘‘SEC. 523. STATE AND LOCAL REQUIREMENTS RESPECTING

2 NONPRESCRIPTION DRUGS INTENDED FOR

3 HUMAN USE.

4 ‘‘(a) LIMITATION.—

5 ‘‘(1) IN GENERAL.—Except as provided in sub6 section (b), no State or political subdivision thereof

7 may establish or continue in effect any requirement—

8 ‘‘(A) that relates to the regulation of a drug

9 intended for human use that is not subject to the

10 requirements of section 503(b)(1); and

11 ‘‘(B) that is different from or in addition

12 to, or that is otherwise not identical with, a re13 quirement of this Act or the Fair Packaging and

14 Labeling Act (15 U.S.C. 1451 et seq.), and the

15 administrative implementation of such Act.

16 ‘‘(2) SPECIAL RULE.—For purposes of this sec17 tion, a requirement relating to the regulation of a

18 drug described in paragraph (1) shall be deemed to

19 include any requirement relating to the subject matter

20 in any provision of this Act, the Fair Packaging and

21 Labeling Act (15 U.S.C. 1451 et seq.), and any re22 quirement relating to the dissemination of informa23 tion in any manner about such drug, but shall not

24 include any requirement relating to the dispensing of

25 a drug only upon prescription of a practitioner li26 censed by law to administer such drug.
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1 ‘‘(b) EXEMPTION.—Upon application of a State, the

2 Secretary may by regulation, after providing notice and an

3 opportunity for written and oral presentation of views, ex4 empt from the provisions of subsection (a), under such con5 ditions as the Secretary may impose, a proposed require6 ment relating to the regulation of a drug intended for

7 human use—

8 ‘‘(1) that is justified by compelling local condi9 tions or protects an important public interest that

10 would otherwise be unprotected;

11 ‘‘(2) that would not cause any drug intended for

12 human use that is not subject to the requirements of

13 section 503(b)(1) to be in violation of any applicable

14 requirement or prohibition under Federal law; and

15 ‘‘(3) that would not unduly burden interstate

16 commerce.’’.

17 SEC. 509. REQUIREMENT OF RADIOPHARMACEUTICALS.

18 (a) REQUIREMENTS.—

19 (1) REGULATIONS.—Not later than 180 days

20 after the date of enactment of this Act, the Secretary

21 of Health and Human Services, after consultation

22 with patient advocacy groups, associations, physi23 cians licensed to use radiopharmaceuticals, and the

24 regulated industry, shall establish proposed regula25 tions governing the approval of a
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1 radiopharmaceutical designed for diagnosis and mon2 itoring that shall assess the safety and effectiveness of

3 the radiopharmaceutical taking into account the ap4 propriate use of the radiopharmaceutical in the prac5 tice of medicine, the pharmacological and toxi6 cological activity of the radiopharmaceutical, and the

7 estimated absorbed radiation dose of the

8 radiopharmaceutical. Not later than 1 year after the

9 date of enactment of this Act, the Secretary shall issue

10 final regulations.

11 (2) SPECIAL RULE.—In the case of a

12 radiopharmaceutical intended to be used for diag13 nostic purposes, the indications for which such

14 radiopharmaceutical is approved under this section

15 may refer to manifestations of disease (such as bio16 chemical, physiological, anatomic, or pathological

17 processes) common to or present in 1 or more disease

18 states, or may refer to a diagnostic procedure used in

19 the diagnosis of 1 or more diseases or conditions.

20 (b) APPROVAL.—All applications or petitions request21 ing approval of a radiopharmaceutical and all other mat22 ters relating to such radiopharmaceutical shall be reviewed

23 and acted upon by a single office in the Center for Drug

24 Evaluation and Research, and that office shall report di25 rectly to the director of the Center for Drug Evaluation and
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1 Research. A single scientific review group may provide con2 clusions and recommendations regarding any such matter

3 relating to the approval of a radiopharmaceutical. Such

4 group shall be appointed and administered pursuant to sec5 tion 904 of the Federal Food, Drug, and Cosmetic Act (21

6 U.S.C. 394), as amended by section 107.

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

8 ‘‘radiopharmaceutical’’ means—

9 (1) an article that is intended for use in vivo in

10 the diagnosis, cure, mitigation, treatment, or preven11 tion of a disease or a manifestation of disease in

12 man, and that exerts its primary effect by the sponta13 neous disintegration of unstable nuclei with the emis14 sion of ionizing radiation; or

15 (2) a reagent kit or nuclide generator that is in16 tended to be used in the preparation of any such arti17 cle.

18 (d) APPROVAL ASSESSED UNDER PERFORMANCE

19 STANDARDS.—The approval of radiopharmaceuticals shall

20 be assessed under quantifiable performance standards estab21 lished by the Secretary under section 903(b)(3) of the Fed22 eral Food, Drug, and Cosmetic Act, as added by section 103.
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1 TITLE VI—DEVICE REGULATORY

2 REFORM

3 SEC. 601. SHORT TITLE.

4 This title may be cited as the ‘‘Medical Device Reform

5 Act of 1996’’.

6 SEC. 602. PREMARKET NOTIFICATION.

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

8 (21 U.S.C. 360) is amended—

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

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

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

12 section 513 or 520 and is not identified in a list

13 under subsection (n), or a device that is classified into

14 class II under section 513 or 520 and is exempt from

15 the requirements of this subsection under subsection

16 (l))’’;

17 (2) by adding at the end of subsection (k) the fol18 lowing flush sentence:

19 ‘‘The Secretary shall review the notification required by this

20 subsection and make a determination under section

21 513(f)(1)(A) within 90 days of receiving the notification.’’;

22 and

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

24 new subsections:
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1 ‘‘(l) Not later than 30 days after the date of enactment

2 of this subsection, the Secretary shall publish in the Federal

3 Register a list of each type of class II device that does not

4 require a notification under subsection (k) to provide rea5 sonable assurance of safety and effectiveness. Each type of

6 class II device so identified by the Secretary not to require

7 the notification shall be exempt from the requirement to

8 provide notification under subsection (k) as of the date of

9 the publication of the list in the Federal Register. Begin10 ning on the date that is 1 day after the date of the publica11 tion of a list under this subsection, any person may petition

12 the Secretary to exempt a type of class II device from the

13 notification requirement of subsection (k). The Secretary

14 shall respond to the petition within 120 days of the receipt

15 of the petition and determine whether or not to grant the

16 petition in whole or in part.

17 ‘‘(m) The Secretary may not withhold a determination

18 of the initial classification of a device under section

19 513(f)(1) because of a failure to comply with any provision

20 of this Act unrelated to a substantial equivalence decision,

21 including a failure to comply with good manufacturing

22 practices under section 520(f).

23 ‘‘(n) Not later than 15 days after the date of enactment

24 of this subsection, the Secretary shall publish in the Federal

25 Register a list of each type of class I device that shall not
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1 be considered exempt from the notification requirement of

2 section 510(k) because such notification is necessary to pro3 tect the public health. If the Secretary fails to publish the

4 list within 15 days after the date of enactment of this sub5 section, all types of class I devices shall be exempt from the

6 requirement to provide notification under section 510(k).’’.

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

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

9 striking the period at the end thereof and inserting the fol10 lowing: ‘‘, unless within 30 days of receiving an order

11 classifying the device into class III, the individual who sub12 mits a notification under section 510(k) requests an advi13 sory committee review and recommendation with respect to

14 the classification of the device and a final order of classi15 fication from the Secretary. After the request, a device clas16 sified into class III under this paragraph shall not be

17 deemed to be finally classified until an advisory committee

18 established under subsection (b) reviews the request with re19 spect to the classification of the device and, within 60 days

20 of the date of receiving the request, recommends to the Sec21 retary a classification for the device based on the classifica22 tion criteria set forth in subparagraphs (A) through (C) of

23 subsection(a)(1). Thereafter, the Secretary shall have 10

24 days after the date of receiving the recommendation of the

25 advisory committee to determine by order the final classi-
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1 fication of the device by applying the classification criteria

2 set forth in subparagraphs (A) through (C) of

3 subsection(a)(1).’’.

4 (c) SUBSTANTIAL EQUIVALENCE.—Section

5 513(i)(1)(A) (21 U.S.C. 360c(i)(1)(A)) is amended by in6 serting after ‘‘intended use’’ the following: ‘‘, which, as de7 termined by the Secretary, shall include each use reasonably

8 included within a general use,’’.

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

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

11 the following new paragraph:

12 ‘‘(4)(A) Any change or modification to a device ini13 tially classified under section 513(f), other than a major

14 change (including any major modification) in the intended

15 use or a change or modification in design that is significant

16 and significantly affects safety or effectiveness, shall not re17 quire an additional notification under section 510(k) if,

18 prior to the commercial distribution of the device—

19 ‘‘(i) the change or modification is supported by

20 appropriate data or information, (including data or

21 information demonstrating compliance with good

22 manufacturing practice regulations promulgated

23 under section 520(f)); and
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1 ‘‘(ii) the change or modification is shown by

2 such data or information to not adversely affect the

3 safety or effectiveness of the device.

4 ‘‘(B) All data or information relied upon to document

5 that a change to (including any modification of) the device

6 does not require an additional notification under section

7 510(k) shall be made available to the Secretary upon request

8 and shall be maintained, at least for a period of time equal

9 to the expected life of the device or 2 years after the date

10 of commercial distribution of the device by the manufac11 turer, whichever is greater.’’.

12 SEC. 603. MEDICAL DEVICE APPROVAL STANDARDS.

13 (a) DEVICE CLASSES.—Section 513(a)(3)(A) (21

14 U.S.C. 360c(a)(3)(A)) is amended—

15 (1) by striking ‘‘well-controlled’’ and inserting

16 ‘‘one or more well-controlled’’; and

17 (2) by striking ‘‘clinical investigations’’ and in18 serting ‘‘one or more clinical investigations’’.

19 (b) SUPPLEMENT TO APPLICATION.—Section 513(a)(3)

20 (21 U.S.C. 360c(a)(3)) is amended by adding at the end

21 thereof the following new subparagraphs:

22 ‘‘(C) The Secretary shall accept, for the purpose of fa23 cilitating a review of a premarket application, a supple24 ment to a premarket application, or a premarket notifica25 tion of a device, retrospective or historical clinical data as
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1 a control, or for use, in determining whether there is a rea2 sonable assurance of effectiveness of a device if sufficient

3 valid data are available and the effects of the device on the

4 cure, mitigation, treatment, or prevention of a disease are

5 clearly defined and well understood.

6 ‘‘(D) The Secretary may not require a person intend7 ing to conduct clinical trials to conduct clinical trials using

8 prospective concurrent controls in determining whether

9 there is a reasonable assurance of effectiveness for a device

10 or whether a device is substantially equivalent to a predi11 cate device unless—

12 ‘‘(i) the effects of the device on the cure, mitiga13 tion, treatment, or prevention of a disease or condi14 tion are not clearly defined and well understood as

15 determined by the Secretary;

16 ‘‘(ii) retrospective or historical data are not

17 available that meet the standards of the Secretary for

18 quality and completeness; or

19 ‘‘(iii) there is a compelling public health reason

20 to not rely on retrospective or historical data as a

21 control.’’.

22 SEC. 604. TRACKING.

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

24 as follows:
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1 ‘‘Device Tracking

2 ‘‘(e) The Secretary may by regulation require a manu3 facturer to adopt a method of tracking a class II or class

4 III device—

5 ‘‘(1) the failure of which would be reasonably

6 likely to be life-threatening or have serious adverse

7 health consequences; and

8 ‘‘(2) which is—

9 ‘‘(A) permanently implantable; or

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

11 used outside a device user facility.

12 Any patient receiving a device subject to tracking under

13 this section may refuse to release, or refuse permission to

14 release, the patient’s name, address, social security number,

15 or other identifying information for the purpose of track16 ing.’’.

17 SEC. 605. POSTMARKET SURVEILLANCE.

18 Section 522 (21 U.S.C. 360l) is amended to read as

19 follows:

20 ‘‘SEC. 522. POSTMARKET SURVEILLANCE.

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

22 manufacturer to conduct postmarket surveillance for any

23 device of the manufacturer that—
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1 ‘‘(1) is a permanent implant the failure of which

2 may cause serious, adverse health consequences or

3 death;

4 ‘‘(2) is intended for a use in supporting or sus5 taining human life; or

6 ‘‘(3) potentially presents a serious risk to human

7 health or creates public health concerns that justify

8 surveillance under this section.

9 ‘‘(b) SURVEILLANCE APPROVAL.—Each manufacturer

10 required to conduct a surveillance of a device under sub11 section (a) shall, within 30 days of receiving notice from

12 the Secretary that the manufacturer is required under this

13 section to conduct the surveillance, submit for the approval

14 of the Secretary, a protocol for the required surveillance.

15 The Secretary, within 60 days of the date of the receipt

16 of the protocol, shall determine if the principal investigator

17 proposed to be used in the surveillance has sufficient quali18 fications and experience to conduct the surveillance and if

19 the protocol will result in collection of useful data or other

20 information necessary to protect the public health and to

21 provide safety and effectiveness information for the device.

22 The Secretary may not approve the protocol until the proto23 col has been reviewed by a qualified scientific and technical

24 review committee established by the Secretary.’’.
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1 SEC. 606. DEVICE DISTRIBUTOR REPORTING.

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

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

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

5 (2) in subsection (a)—

6 (A) in paragraph (7), by striking the semi7 colon at the end thereof and inserting ‘‘; and’’;

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

9 and inserting a period; and

10 (C) by striking paragraph (9); and

11 (3) in subsection (d), by striking ‘‘, importer,

12 and distributor’’ and inserting ‘‘and importer’’.

13 SEC. 607. PREMARKET APPROVAL.

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

15 U.S.C. 360e(d)) is amended—

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

17 (2) of this subsection’’ each place it appears and in18 serting ‘‘paragraph (4)’’;

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

20 thereof the following new clause:

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

22 any other information from investigations conducted under

23 the authority of regulations required by section 520(g) to

24 make a determination of whether there is a reasonable as25 surance of safety and effectiveness of a device subject to a

26 pending application under this section if—
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1 ‘‘(I) the data or information is derived from in2 vestigations of an earlier version of the device, the de3 vice has been modified during or after the investiga4 tions, and the modification of the device does not con5 stitute a significant change in the design or in the

6 basic principles of operation of the device that would

7 invalidate the data or information; or

8 ‘‘(II) the data or information on a device ap9 proved under this section is available for use under

10 this Act and is relevant to the design and intended

11 use of the device subject to the pending application.’’;

12 (3) by redesignating paragraphs (2) and (3) as

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

14 (4) by inserting after paragraph (1) the follow15 ing new paragraphs:

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

17 shall be reviewed in the following manner to achieve final

18 action on the application within 180 days of the receipt

19 of the application:

20 ‘‘(A) The Secretary shall meet with an applicant

21 within 90 days of the receipt of the application to

22 discuss the review status of the application. If the ap23 plication does not appear in a form that would re24 quire an approval under this subsection, the Sec25 retary shall in writing, and prior to the meeting,
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1 present to the applicant a description of any defi2 ciencies in the application and what information is

3 required to bring the application into a form that

4 would require an approval.

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

6 a panel established under section 513 for review and

7 an approval recommendation (unless a panel is not

8 required under subsection (c)(2)) within 30 days of

9 the date of the meeting referred to in subparagraph

10 (A) or at the next scheduled panel meeting following

11 the meeting referred to in subparagraph (A), which12 ever occurs first.

13 ‘‘(C) The Secretary shall meet with the applicant

14 within 15 days of the date of the panel review to dis15 cuss the status of the application, including a discus16 sion on what action is necessary to bring the applica17 tion into a form that would require approval under

18 this subsection. Prior to the meeting, the Secretary

19 shall in writing, set forth an agenda for the meeting

20 (including a complete description of the subject mat21 ter to be discussed at the meeting), and a full descrip22 tion of the additional information required to bring

23 the application into a form that would require an ap24 proval under this subsection. Participation of the ap-
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1 plicant at such a meeting shall be at the discretion

2 of the applicant.

3 ‘‘(D) The Secretary shall meet with the applicant

4 not later than 135 days after the receipt of an appli5 cation under subsection (c), if an advisory panel is

6 not required under subsection (c)(2), and inform the

7 applicant whether or not the application is in a form

8 that would require approval under this subsection. If

9 the application is in such form, the Secretary shall,

10 at or prior to the meeting, present in writing to the

11 applicant a description of all additional information

12 necessary to require an approval of the application

13 under this subsection. If the application is not in

14 such form, the Secretary shall deny approval of the

15 application and prior to the meeting, present in writ16 ing to the applicant each basis for denying approval

17 of the application and the additional information re18 quired to bring the application into a form that

19 would require approval.

20 ‘‘(E) The Secretary shall issue an order approv21 ing or denying an application within 180 days of the

22 receipt of the application under subsection (c).

23 ‘‘(3) The time for the review of an application by the

24 Secretary under this subsection shall not take more than
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1 180 days and such time may not be extended if the applica2 tion is amended.’’.

3 (b) REVISIONS OF REGULATIONS.—

4 (1) PREMARKET APPROVAL OF APPLICATIONS.—

5 The Secretary of Health and Human Services shall

6 revise, through notice and comment procedures, the

7 regulations set forth in part 814 of title 21 of the

8 Code of Federal Regulations, to conform to the

9 amendment made by subsection (a).

10 (2) PREMARKET APPROVAL OF SUPPLEMENTS.—

11 The Secretary of Health and Human Services shall

12 revise regulations relating to premarket approval of

13 devices to eliminate premarket approval of supple14 ments that relate to manufacturing or product

15 changes (excluding changes in intended use) of a de16 vice that have been demonstrated through appropriate

17 data or information to not adversely affect safety or

18 effectiveness. The Secretary of Health and Human

19 Services shall require the manufacturer of a device to

20 notify the Secretary of Health and Human Services

21 of significant manufacturing changes or other changes

22 not subject to a supplement under section 515 within

23 10 days of implementing such changes. All informa24 tion relied upon in making such changes shall be

25 made a part of the device master record. The informa-
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1 tion shall be maintained for a period of time equal

2 to the period of time for the design and expected life

3 of the device, but not less than 2 years after the date

4 of release of the device for commercial distribution by

5 the manufacturer.

6 SEC. 608. DEVICE PERFORMANCE STANDARDS.

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

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

9 following new subsection:

10 ‘‘Performance Standards of Standard-Setting

11 Organizations

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

13 device under section 510(k), 513(f), 515, or 520, the Sec14 retary shall recognize appropriate device performance

15 standards developed by any standard-setting organization

16 accredited by the American National Standards Institute

17 (ANSI), the International Standards Organization (ISO),

18 or the International Electrotechnical Commission (IEC).

19 ‘‘(2)(A) For any standard-setting organization not

20 identified in paragraph (1), and for the purpose of facilitat21 ing a review of devices under section 510(k), 513(f), 515,

22 or 520, the Secretary shall establish a procedure governing

23 the certification by the Food and Drug Administration of

24 the competence of such an organization to develop standards

25 for devices.
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1 ‘‘(B) A certification of a standard-setting organization

2 not identified in paragraph (1) shall be based on formal,

3 written criteria that include requirements with respect to

4 the role of the organization in the scientific community, sci5 entific or medical expertise, standard-writing experience,

6 conflict of interest considerations, and the openness of the

7 standard-setting process of the organization.

8 ‘‘(C) The Secretary may impose a reasonable one-time

9 fee on the standard-setting organization for certification

10 pursuant to this paragraph.

11 ‘‘(3)(A) Upon being notified by a standard-setting or12 ganization described in paragraph (1) that a standard has

13 been adopted by the organization, the Secretary shall recog14 nize the standard by publishing a notice in the Federal Reg15 ister listing the name of the standard.

16 ‘‘(B) Upon being notified by a standard-setting orga17 nization certified under paragraph (2) that a standard has

18 been adopted by the organization, the Secretary shall review

19 and may recognize the standard by publishing a notice in

20 the Federal Register listing the name of the standard.

21 ‘‘(4) The Secretary may withdraw recognition of a

22 performance standard adopted by a standard-setting orga23 nization described in paragraph (1) or a standard-setting

24 organization certified under paragraph (2) if the Secretary

25 determines that the standard is insufficient to facilitate a
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1 review of a device. The Secretary shall notify the standard2 setting organization and specify the basis for the with3 drawal.

4 ‘‘(5) The Secretary shall promulgate regulations under

5 which the Secretary may withdraw the certification of a

6 standard-setting organization described in paragraph (2),

7 or may no longer rely upon standards adopted by a stand8 ard-setting organization described in paragraph (1), if the

9 Secretary determines that such organization no longer pos10 sesses the appropriate scientific or medical expertise, con11 flict of interest practices, standard-writing experience, or

12 any other qualification necessary to the development of de13 vice standards.

14 ‘‘(6) As provided for in this section, the Secretary may

15 promulgate performance standards for a device that differs

16 from or is not established by, an organization described in

17 paragraph (1) or an organization certified under para18 graph (2).

19 ‘‘(7) The Secretary shall not require, as a condition

20 for approving an application under section 515 or 520 or

21 classifying a device under sections 510(k) and 513(f), con22 formity with a device standard recognized under this sub23 section if the person requesting such approval or classifica24 tion submits evidence to demonstrate a reasonable assur25 ance that the device is substantially equivalent to a legally
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1 marketed predicate device or provides reasonable assurance

2 that the device is safe and effective.

3 ‘‘(8) A performance standard recognized pursuant to

4 this subsection for a device—

5 ‘‘(A) shall include provisions to provide reason6 able assurance of the safe and effective performance of

7 the device;

8 ‘‘(B) shall, where necessary to provide reasonable

9 assurances of the safe and effective performance of the

10 device, include—

11 ‘‘(i) provisions with respect to the construc12 tion, components, ingredients, and properties of

13 the device and the compatibility of the device

14 with power systems and connections to the sys15 tems;

16 ‘‘(ii) provisions for the testing (on a sample

17 basis or, if necessary, on an individual basis) of

18 the device or, if it is determined that no other

19 more practicable means are available to the Sec20 retary to assure the conformity of a device to the

21 standard, provisions for the testing (on a sample

22 basis or, if necessary, on an individual basis) of

23 the device by the Secretary or by another person

24 at the direction of the Secretary;
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1 ‘‘(iii) provisions for the measurement of the

2 performance characteristics of the device; and

3 ‘‘(iv) provisions requiring that the results of

4 each or certain of the tests of the device required

5 to be made under clause (ii) demonstrate that the

6 device is in conformity with those portions of the

7 standard for which the test or tests were re8 quired; and

9 ‘‘(C) shall, where appropriate, require the proce10 dures, for the proper installation, maintenance, oper11 ation, and use of the device.

12 ‘‘(9) The Secretary shall accept a certification by a

13 person who has made a submission pursuant to section

14 510(k), 515, or 520 that the device conforms with each

15 standard identified in the certification. The Secretary may,

16 where appropriate, require data demonstrating conformity

17 with a standard recognized under this subsection.

18 ‘‘(10) The Secretary shall require a person who makes

19 a certification under paragraph (9) that a device conforms

20 to an applicable performance standard recognized under

21 this subsection or who makes a certification that a device

22 conforms to a standard established under subsection (a) or

23 (b) to maintain data demonstrating conformity of the de24 vice to the standard for a period of time equal to the period

25 of time for the design and expected life of the device. Such
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1 data shall be made available to the Secretary upon re2 quest.’’.

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

4 U.S.C. 351(e)) is amended—

5 (1) by striking ‘‘(e)’’ and inserting ‘‘(e)(1)’’;

6 (2) by striking ‘‘section 514’’ and inserting ‘‘sec7 tion 514(b)’’; and

8 (3) by inserting at the end thereof the following:

9 ‘‘(2) If it is, or purports to be or is represented as,

10 a device which is certified to be in compliance with any

11 voluntary standard recognized under section 514(c), unless

12 such a device is in all respects in conformity with such a

13 standard.’’.

14 SEC. 609. ACCREDITED-PARTY PARTICIPATION.

15 Subchapter A of chapter V (21 U.S.C. 351 et seq.), as

16 amended by section 508, is further amended by adding at

17 the end the following new section:

18 ‘‘SEC. 523A. ACCREDITED-PARTY PARTICIPATION.

19 ‘‘(a) IN GENERAL.—Not later than 1 year after the

20 date of enactment of this section, the Secretary shall ac21 credit persons, including any entity or any individual who

22 is not an employee of the Department to review and ini23 tially classify devices under section 513(f)(1) that are sub24 ject to a report under section 510(k) and to review and rec-
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1 ommend to the Secretary approval or denial of applications

2 submitted under section 515(c)(1).

3 ‘‘(b) ACCREDITATION.—Not later than 6 months after

4 the date of enactment of this section, the Secretary shall

5 establish and publish in the Federal Register requirements

6 to accredit or deny accreditation to a person who makes

7 a request for accreditation to carry out the activities de8 scribed in subsection (a). The requirements shall, at a mini9 mum, advise such person how to become accredited, and set

10 forth criteria for accreditation including criteria to avoid

11 conflicts of interest and to ensure that persons to be accred12 ited are capable of maintaining the confidentiality of sub13 missions consistent with section 552 of title 5, United States

14 Code, and the regulations of the Food and Drug Adminis15 tration. The Secretary shall respond to a request for accred16 itation not later than 60 days after the receipt of the re17 quest. The accreditation of a person shall specify the activi18 ties under subsection (a) which such person is authorized

19 to carry out in the place of the Secretary.

20 ‘‘(c) WITHDRAWAL OF ACCREDITATION.—The Sec21 retary may suspend or withdraw the accreditation of any

22 person accredited under this section, after providing notice

23 and an opportunity for an informal hearing, if such person

24 acts in a manner that is substantially inconsistent with the

25 purposes of this section, including the failure to avoid con-
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1 flicts of interest, the failure to protect confidentiality of in2 formation, or the failure to competently review premarket

3 submissions for devices.

4 ‘‘(d) SELECTION AND COMPENSATION.—A person who

5 submits a premarket submission for a device to the Sec6 retary for review and classification, or approval of a device,

7 shall have the option to select an accredited person to review

8 such submission. The Secretary shall identify for the person

9 no less than 2 accredited persons from whom the selection

10 may be made. Compensation for an accredited person shall

11 be determined by agreement between the accredited person

12 and the person who engages the services of the accredited

13 person.

14 ‘‘(e) REVIEW BY SECRETARY.—

15 ‘‘(1) IN GENERAL.—If a person exercises the op16 tion to obtain review of a premarket submission that

17 is an application or a notification by an accredited

18 person, the Secretary shall complete a filing review

19 for a premarket approval application under section

20 515(c)(1) not later than 30 days after the receipt of

21 such application, or shall ensure the completeness of

22 a premarket notification submission under section

23 510(k) not later than 15 days after the receipt of such

24 submission, prior to referring the premarket submis-
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1 sion for review by the accredited person selected by

2 the person submitting the premarket submission.

3 ‘‘(2) REPORT ON CLASSIFICATION, APPROVAL, OR

4 DENIAL.—The Secretary shall require an accredited

5 person, upon recommending a classification of a de6 vice or approval or disapproval of an application for

7 a device, to report to the Secretary the reasons of the

8 accredited person for such classification or approval

9 or disapproval. For devices reviewed and initially

10 classified under section 513(f)(1) and subject to a re11 port under section 510(k), the Secretary shall have

12 not more than 15 days to review the submission. For

13 applications submitted under section 515(c)(1), the

14 Secretary shall have not more than 45 days to review

15 the application. The Secretary may change the classi16 fication under section 513(f)(1), or the approval or

17 disapproval of the application under section 515(d),

18 that is recommended by the accredited person, and in

19 such case shall notify the person making the submis20 sion of the detailed reasons for the change.

21 ‘‘(f) DURATION.—This section shall remain in force for

22 a period of 3 years from the date on which the Secretary

23 accredits the first person to conduct initial classifications

24 under section 513(f)(1) and to conduct premarket approval

25 reviews under section 515.
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1 ‘‘(g) REPORTS.—

2 ‘‘(1) IMPLEMENTATION OF ACCREDITATION PROC3 ESS.—Not later than 1 year after the date of enact4 ment of this section, the Secretary shall prepare and

5 submit to the committees of Congress with oversight

6 authority over the Food and Drug Administration a

7 report concerning each action the Secretary has taken

8 to implement the accreditation of persons to under9 take the activities described in subsection (a).

10 ‘‘(2) EXAMINATION OF THE USE OF ACCREDITED

11 PERSONS.—

12 ‘‘(A) IN GENERAL.—Not later than 2 years

13 after the date on which the Secretary accredits

14 the first person to conduct initial classifications

15 under section 513(f)(1) and to conduct pre16 market approval reviews under section 515, the

17 Secretary shall contract with an independent re18 search organization to prepare and submit to the

19 Secretary a written report examining the use of

20 accredited persons under this section. The Sec21 retary shall submit the report to the committees

22 described in paragraph (1) not later than 30

23 months after the date on which the Secretary ac24 credits the first person to conduct initial classi-
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1 fications under section 513(f)(1) and to conduct

2 premarket approval reviews under section 515.

3 ‘‘(B) CONTENTS.—The report by the inde4 pendent research organization described in sub5 paragraph (A) shall identify the benefits or det6 riments to public and patient health of using ac7 credited persons to conduct such reviews, and

8 shall summarize all relevant data, including

9 data on the review of accredited persons (includ10 ing review times, recommendations, and com11 pensation), and data on the review of the Sec12 retary (including review times, changes, and rea13 sons for changes).’’.

14 TITLE VII—ANIMAL DRUG

15 REGULATORY REFORM

16 SEC. 701. SHORT TITLE.

17 This title may be cited as the ‘‘Animal Drug Regu18 latory Reform Act of 1996’’.

19 SEC. 702. EVIDENCE OF EFFECTIVENESS.

20 (a) SUBSTANTIAL EVIDENCE.—Section 512(d) (21

21 U.S.C. 360b(d)) is amended—

22 (1) by striking paragraph (3); and

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

24 new paragraph:
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1 ‘‘(4)(A) As used in this subsection and subsections

2 (c)(2)(F)(iii) and (e)(1)(C), the term ‘substantial evidence’

3 means evidence from 1 or more scientifically sound studies,

4 including as appropriate in vitro studies, studies in labora5 tory animals (including a target species), bioequivalence

6 studies, and any studies voluntarily undertaken by or for

7 the applicant, that taken together provide reasonable assur8 ance that the drug will have the claimed or intended effect

9 of the drug.

10 ‘‘(B) For purposes of subparagraph (A), a study shall

11 be considered to be scientifically sound if the study is de12 signed and conducted in a manner that is consistent with

13 generally recognized scientific procedures and principles.’’.

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

15 U.S.C. 360b(d)) is amended by inserting before paragraph

16 (4) (as added by subsection (a)) the following new para17 graph:

18 ‘‘(3) In a case in which a new animal drug contains

19 more than 1 active ingredient, or the labeling of the drug

20 prescribes, recommends, or suggests use of the drug in com21 bination with another animal drug, and the active ingredi22 ents or drugs in the combination have been separately ap23 proved for particular uses and species prior to the approval

24 of the application for the same uses and species in combina25 tion (or, in the absence of such approvals, after evaluating
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1 the safety and efficacy of the combination itself), the Sec2 retary may only consider with respect to the combination

3 whether any of the active ingredients or any of the drugs

4 in the combination, respectively, at the longest withdrawal

5 time of any of the active ingredients or drugs in the com6 bination, respectively—

7 ‘‘(A) is above its safe concentration (such as ex8 ceeding its established tolerance, as measured by its

9 marker residue); or

10 ‘‘(B) interferes with the methods of analysis for

11 another of the active ingredients or drugs in the com12 bination, respectively.’’.

13 (c) SUPPLEMENTAL APPLICATIONS.—Section

14 512(c)(2)(F)(iii) (21 U.S.C. 360b(c)(2)(F)(iii)) is amend15 ed—

16 (1) by striking ‘‘reports of new clinical or field

17 investigations (other than bioequivalence or residue

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

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

20 of animal safety, or’’; and

21 (2) by striking ‘‘essential to’’ and inserting ‘‘, re22 quired for’’.

23 (d) MINOR SPECIES AND USES.—Section 512(d)(1)

24 (21 U.S.C. 360b(d)(1)) is amended by adding at the end

25 the following new sentence: ‘‘Subparagraph (E) shall not
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1 apply to a claim for use of the drug described in subpara2 graph (E) in a minor species, or for a minor use of the

3 drug, as the terms ‘minor species’ and ‘minor use’ are de4 fined in regulations issued by the Secretary, if there is an

5 application filed under subsection (b) for the drug, and the

6 application is approved, prior to the submission of the

7 claim.’’.

8 (e) WITHDRAWAL OF APPROVAL.—Section

9 512(e)(1)(C) (21 U.S.C. 360b(e)(1)(C)) is amended by in10 serting after ‘‘substantial evidence’’ the following: ‘‘(as de11 fined in subsection (d)(4))’’.

12 (f) IMPLEMENTATION.—

13 (1) IN GENERAL.—Not later than 6 months after

14 the date of enactment of this Act, the Secretary shall

15 issue proposed regulations implementing the amend16 ments made by this section. Not later than 18 months

17 after the date of enactment of this Act, the Secretary

18 shall issue final regulations implementing the amend19 ments.

20 (2) CONTENTS.—In issuing regulations imple21 menting the amendments made by this section, and in

22 taking an action to review an application for ap23 proval of a new animal drug under section 512 of the

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

25 360b), or a request for an investigational exemption
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1 for a new animal drug under subsection (j) of such

2 section, that is pending or has been submitted prior

3 to the effective date of the regulations, the Secretary

4 shall—

5 (A) further define the term ‘‘substantial evi6 dence’’, as defined in subsection (d)(4) of such

7 section, in a manner that encourages the submis8 sion of applications for production drugs that

9 conserve food resources, of applications for veteri10 nary prescription drugs whose use is designed to

11 rely on the experience and training of practi12 tioners in establishing effective doses for such

13 drugs, and of supplemental applications, includ14 ing applications seeking approval for uses of

15 animal drugs in minor species, for minor uses of

16 such drugs, and for permitted unlabeled uses of

17 such drugs;

18 (B) take into account the proposals con19 tained in the citizen petition (FDA Docket No.

20 91P–0434/CP) jointly submitted by the Amer21 ican Veterinary Medical Association and the

22 Animal Health Institute, dated October 21, 1991;

23 and

24 (C)(i) provide for the opportunity for a con25 ference prior to the submission of an application
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1 for approval of a new animal drug under such

2 section, and prior to the submission of a request

3 for an investigational exemption under sub4 section (j) of such section, to make a decision es5 tablishing any submission or investigational re6 quirement relating to the application or request

7 (which decision shall bind the Secretary and the

8 applicant or requester unless the Secretary by

9 order determines that a documented scientific

10 issue that occurred subsequent to the conference

11 requires the decision to be modified in order to

12 ensure that an appropriate determination can be

13 made with respect to the safety or effectiveness of

14 the animal drug involved); and

15 (ii) not later than 10 days after each such

16 conference, by written order, provide a scientific

17 justification specific to the animal drug and in18 tended uses under consideration for requiring

19 studies of types other than the types of studies

20 specified in subsection (d)(4) of such section, as

21 being essential to provide substantial evidence of

22 effectiveness for the intended uses of the drug.

23 SEC. 703. LIMITATION OF RESIDUES.

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

25 amended to read as follows:
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1 ‘‘(F) on the basis of information submitted to the

2 Secretary as part of the application or any other in3 formation before the Secretary with respect to such

4 drug, any use prescribed, recommended, or suggested

5 in labeling proposed for such drug will result in a

6 residue of such drug in excess of a tolerance found by

7 the Secretary to be safe for such drug;’’.

8 SEC. 704. ADULTERATED DRUGS.

9 Section 501(a)(2) (21 U.S.C. 351(a)(2)) is amended—

10 (1) in subparagraph (A), by striking ‘‘health; or’’

11 and inserting ‘‘health;’’; and

12 (2) in subparagraph (B), by striking ‘‘possess;’’

13 and inserting the following: ‘‘possess; or (C) if it is

14 a drug intended for use by animals other than man

15 and the methods used in, or the facilities or controls

16 used for, its manufacture, processing, packing, or

17 holding do not conform to or are not operated or ad18 ministered in conformity with current good manufac19 turing practice requirements (appropriate for animal

20 drugs) adopted pursuant to regulations issued by the

21 Secretary to ensure that such drug meets the require22 ments of this Act as to safety and has the identity

23 and strength, and meets the quality and purity char24 acteristics, which it purports or is represented to pos25 sess for use in animals other than man;’’.
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1 SEC. 705. VETERINARY FEED DIRECTIVES.

2 (a) WRITTEN OR ORAL ORDERS.—Section

3 503(f)(1)(A) (21 U.S.C. 353(f)(1)(A)) is amended by strik4 ing ‘‘other than man’’ and inserting the following: ‘‘other

5 than man, other than a veterinary feed directive drug in6 tended for use in animal feed or an animal feed bearing

7 or containing a veterinary feed directive drug,’’.

8 (b) GENERAL REQUIREMENTS.—Chapter V (21 U.S.C.

9 351 et seq.) is amended by inserting after section 503 the

10 following new section:

11 ‘‘VETERINARY FEED DIRECTIVES DRUGS

12 ‘‘SEC. 504. (a)(1) A drug intended for use in or on

13 animal feed that is limited by an approved application

14 filed pursuant to section 512(b) to use under the profes15 sional supervision of a licensed veterinarian is a veterinary

16 feed directive drug. Any animal feed bearing or containing

17 a veterinary feed directive drug shall be fed to animals only

18 by or upon the lawful veterinary feed directive issued by

19 a licensed veterinarian in the course of the professional

20 practice of the veterinarian. When labeled, distributed, held,

21 and used in accordance with this section, a veterinary feed

22 directive drug and any animal feed bearing or containing

23 a veterinary feed directive drug shall be exempt from section

24 502(f).

25 ‘‘(2) A veterinary feed directive is lawful if it—
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1 ‘‘(A) contains such information as the Secretary

2 may, by general regulation or by order, require; and

3 ‘‘(B) is in compliance with the conditions and

4 indications for use of the drug set forth in the notice

5 published pursuant to section 512(i).

6 ‘‘(3)(A) Any persons involved in the distribution or use

7 of animal feed bearing or containing a veterinary feed di8 rective drug, and the licensed veterinarian issuing the vet9 erinary feed directive, shall maintain a copy of the veteri10 nary feed directive applicable to each such feed, except in

11 the case of a person distributing such feed to another person

12 for further distribution, such person distributing the feed

13 shall maintain a written acknowledgment from the person

14 to whom the feed is shipped stating that that person shall

15 not ship or move such feed to an animal production facility

16 without a veterinary feed directive or ship such feed to an17 other person for further distribution unless that person has

18 provided the same written acknowledgment to the imme19 diate supplier of that person.

20 ‘‘(B) Every person required under subparagraph (A)

21 to maintain records, and every person in charge or custody

22 thereof, shall, upon request of an officer or employee des23 ignated by the Secretary, permit such officer or employee

24 at all reasonable times to have access to and copy and verify

25 such records.
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1 ‘‘(C) Any person who distributes animal feed bearing

2 or containing a veterinary feed directive drug shall upon

3 first engaging in such distribution notify the Secretary of

4 the name and place of business of that person. The failure

5 to provide such notification shall be deemed to be an act

6 which results in the drug being misbranded.

7 ‘‘(b) A veterinary feed directive drug and any feed

8 bearing or containing a veterinary feed directive drug shall

9 be deemed to be misbranded if the drug and feed labeling

10 fails to bear such cautionary statement and such other in11 formation as the Secretary may, by general regulation or

12 by order, prescribe, or the drug and feed advertising fails

13 to conform to the conditions and indications for use pub14 lished pursuant to section 512(i) or fails to contain the gen15 eral cautionary statement prescribed by the Secretary.

16 ‘‘(c) Neither a drug subject to this section, nor animal

17 feed bearing or containing such a drug, shall be deemed to

18 be a prescription article under any Federal or State law.’’.

19 (c) CONFORMING AMENDMENTS.—Section 512 (21

20 U.S.C. 360b) is amended—

21 (1) in subsection (a)(2)(C), by striking ‘‘its label22 ing’’ and inserting ‘‘its labeling, its distribution, its

23 holding,’’;

24 (2) in subsection (i), by striking ‘‘requirements)’’

25 and inserting ‘‘requirements and any requirement
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1 that an animal feed bearing or containing the new

2 animal drug be limited to use under the professional

3 supervision of a licensed veterinarian)’’; and

4 (3) in subsection (m)(4)(B)(i)—

5 (A) by striking ‘‘paragraph (5)(A) of this

6 subsection’’ and inserting ‘‘paragraph (5)(A) or

7 under section 504(a)(3)(A)’’; and

8 (B) by striking ‘‘subparagraph (B) of such

9 paragraph’’ and inserting ‘‘paragraph (5)(B) or

10 section 504(a)(3)(B)’’.

11 (d) PROHIBITED ACTS.—Section 301(e) (21 U.S.C.

12 331(e)) is amended—

13 (1) by striking ‘‘section 412’’ and inserting ‘‘sec14 tion 412, 504,’’; and

15 (2) by striking ‘‘under section 412,’’ and insert16 ing ‘‘under section 412, 504,’’.

17 SEC. 706. TIMEFRAMES FOR APPROVAL.

18 The first sentence of section 512(c)(1) (21 U.S.C.

19 360b(c)(1)) is amended by striking ‘‘one hundred and

20 eighty’’ and inserting ‘‘90’’.

21 TITLE VIII—FOOD REGULATORY

22 REFORM

23 SEC. 801. SHORT TITLE.

24 This title may be cited as the ‘‘Food Regulatory Re25 form Act of 1996’’.
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1 SEC. 802. INDIRECT FOOD ADDITIVES.

2 (a) APPROVAL.—Section 409 (21 U.S.C. 348) is

3 amended by adding at the end thereof the following new

4 subsection:

5 ‘‘Alternative Approval Procedure

6 ‘‘(j)(1) As an alternative to the approval procedure es7 tablished under subsection (b), any person may submit a

8 notification for an indirect food additive under this sub9 section.

10 ‘‘(2) Any person who proposes to begin the introduc11 tion or delivery for introduction into interstate commerce

12 of an article intended for use as an indirect food additive

13 may submit to the Secretary, at least 90 days prior to mak14 ing such introduction or delivery, a notification containing

15 information demonstrating that the labeled use of the article

16 is safe.

17 ‘‘(3) Within 90 days after the receipt of the notification

18 by the Secretary, the Secretary shall—

19 ‘‘(A) either—

20 ‘‘(i) approve the notification if the article is

21 safe for its intended use; or

22 ‘‘(ii) disapprove the notification if the arti23 cle has not been shown to be safe for its intended

24 use; and

25 ‘‘(B) publish a notice of this determination in

26 the Federal Register and, if the notification is ap-
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1 proved, promulgate an appropriate regulation pursu2 ant to subsection (c).’’.

3 (b) DEFINITION.—Section 201 (21 U.S.C. 321), as

4 amended by section 408, is further amended by adding at

5 the end thereof the following new paragraph:

6 ‘‘(hh) The term ‘indirect food additive’ means a food

7 additive that is intended to contact food but that is not

8 intended for consumption as a food ingredient.’’.

9 SEC. 803. HEALTH CLAIMS OF FOOD PRODUCTS.

10 Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by

11 adding at the end thereof the following new subparagraph:

12 ‘‘(C) Notwithstanding the provisions of subparagraphs

13 (A)(i) and (B), a claim of the type described in paragraph

14 (1)(B) which is not authorized by the Secretary in a regula15 tion promulgated in accordance with subparagraph (B)

16 shall be authorized and may be made if—

17 ‘‘(i) an authoritative scientific body of the

18 United States Government with official responsibility

19 for public health protection or research directly relat20 ing to human nutrition (such as the National Insti21 tutes of Health or the Centers for Disease Control and

22 Prevention), the National Academy of Sciences, or

23 subdivisions of the scientific body or the National

24 Academy of Sciences, has published statements, con25 clusions, or recommendations in effect recognizing
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1 that the relationship between the nutrient and disease

2 or health-related condition to which the claim refers

3 is supported by pertinent scientific evidence; and

4 ‘‘(ii) the manufacturer or distributor of the food

5 for which such claim is made has submitted to the

6 Secretary at least 90 days before the first introduction

7 of such food into interstate commerce a notice of

8 claim, including a concise description of the basis

9 upon which such manufacturer or distributor relied

10 for determining that the requirements of clause (i)

11 have been satisfied.’’.

12 TITLE IX—ESTABLISHMENT OF

13 CENTERS FOR EDUCATION

14 AND RESEARCH ON DRUGS,

15 DEVICES, AND BIOLOGICAL

16 PRODUCTS

17 SEC. 901. CENTERS FOR EDUCATION AND RESEARCH ON

18 DRUGS, DEVICES, AND BIOLOGICAL PROD19 UCTS.

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

21 section 507, is further amended by adding at the end thereof

22 the following new section:
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1 ‘‘SEC. 909. CENTERS FOR EDUCATION AND RESEARCH ON

2 DRUGS, DEVICES, AND BIOLOGICAL PROD3 UCTS.

4 ‘‘(a) IN GENERAL.—The Secretary, acting through the

5 Commissioner, shall establish a consortium of 3 or more

6 centers for research and education on drugs, devices, and

7 biological products in accordance with subsection (b).

8 ‘‘(b) GRANT AUTHORITY.—The Secretary, acting

9 through the Commissioner, shall make grants to 3 or more

10 private entities to assist each of the entities in the establish11 ment and operation of a center for research and education

12 on drugs, devices, and biological products. In awarding a

13 grant under this subsection, the Secretary shall use a peer14 review selection procedure.

15 ‘‘(c) AUTHORIZED GRANT ACTIVITIES.—

16 ‘‘(1) REQUIRED ACTIVITIES.—A grant awarded

17 under subsection (b) shall be used to—

18 ‘‘(A) conduct state-of-the-art clinical and

19 laboratory research that—

20 ‘‘(i) increases awareness of new uses of

21 drugs, devices, or biological products and

22 the unforeseen risks of new uses of drugs,

23 devices, or biological products;

24 ‘‘(ii) provides objective clinical infor25 mation to—
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1 ‘‘(I) health care practitioners or

2 other providers of health care goods or

3 services;

4 ‘‘(II) pharmacy benefit managers;

5 ‘‘(III) health maintenance organi6 zations or other managed health care

7 organizations; and

8 ‘‘(IV) health care insurers or gov9 ernmental agencies; and

10 ‘‘(iii) improves the quality of health

11 care while reducing the cost of health care

12 through the prevention of adverse effects of

13 drugs, devices, or biological products and

14 the consequences of such effects, such as un15 necessary hospitalizations; and

16 ‘‘(B) conduct research on the comparative

17 effectiveness and safety of drugs, devices, or bio18 logical products.

19 ‘‘(2) DISCRETIONARY ACTIVITIES.—A grant

20 awarded under subsection (b) may be used to con21 duct—

22 ‘‘(A) surveillance of the adverse effects of

23 drugs, devices, or biological products;
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1 ‘‘(B) a study of new or unapproved uses for

2 marketed drugs, devices, or biological products;

3 or

4 ‘‘(C) a study of the therapeutic characteris5 tics of clinically special populations, such as

6 children, women, and elderly individuals.

7 ‘‘(3) LIMITATION.—A grant awarded under sub8 section (b) may not be used to assist the Secretary in

9 the review of new drugs.

10 ‘‘(d) APPLICATION.—An entity that desires to receive

11 a grant under this section shall submit to the Secretary an

12 application at such time, in such manner, and accom13 panied by such information as the Secretary may require.

14 ‘‘(e) ESTABLISHMENT OF AN OVERSIGHT COMMIT15 TEE.—The Secretary shall establish within the Food and

16 Drug Administration a committee to provide oversight of

17 the research and educational activities of the consortium of

18 centers described in subsection (a). The committee shall be

19 composed of—

20 ‘‘(1) a representative from each of the centers;

21 ‘‘(2) a representative from the Food and Drug

22 Administration;

23 ‘‘(3) a representative from consumer advocacy

24 groups; and
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1 ‘‘(4) a representative from the pharmaceutical,

2 device, or biological products industry.

3 ‘‘(f) REPORT.—Not later than September 30, 1999, the

4 Secretary shall prepare and submit to the Chairmen and

5 Ranking Members of the Committee on Labor and Human

6 Resources of the Senate and the Committee on Commerce

7 of the House of Representatives a report on the activities

8 of the consortium of centers established pursuant to this sec9 tion. The report shall include an analysis on the impact

10 of the centers on the safe use of drugs, devices, and biological

11 products and recommendations on whether the funding for

12 the centers should be extended and increased.

13 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There

14 are authorized to be appropriated to carry out this section

15 $9,000,000 for fiscal year 1997, $12,000,000 for fiscal year

16 1998, $15,000,000 for fiscal year 1999, and $15,000,000 for

17 fiscal year 2000.’’.

18 TITLE X—PROGRAM IN CLINICAL

19 PHARMACOLOGY

20 SEC. 1001. REAUTHORIZATION OF CLINICAL PHARMACOL21 OGY PROGRAM.

22 Section 2(b) of Public Law 102–222 (105 Stat. 1677)

23 is amended by striking ‘‘to carry out this section’’ and in24 serting ‘‘, and fiscal years 1997 and 1998, $1,900,000 for

25 each fiscal year, to carry out this section’’.