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[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 1477 Reported in Senate (RS)]

                                                       Calendar No. 446

104th CONGRESS

  2d Session

                                S. 1477

                          [Report No. 104-284]

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                             June 20, 1996

                       Reported with an amendment

                                                       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.

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

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Food and Drug 
Administration Performance and Accountability Act of 1995''.</DELETED>

         <DELETED>TITLE I--MISSION AND ACCOUNTABILITY</DELETED>

<DELETED>SEC. 101. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Food and Drug 
Administration Regulatory Reform Act of 1995''.</DELETED>

<DELETED>SEC. 102. THE MISSION OF THE FOOD AND DRUG 
              ADMINISTRATION.</DELETED>

<DELETED>    Section 903(a) (21 U.S.C. 393(a)) is amended by adding at 
the end thereof the following: ``The mission of the Administration is 
to promote and protect the health of the American people by--</DELETED>
        <DELETED>    ``(1) facilitating the rapid and efficient 
        development and availability of products subject to its 
        regulation;</DELETED>
        <DELETED>    ``(2) protecting the public from unsafe or 
        ineffective products subject to its regulation; and</DELETED>
        <DELETED>    ``(3) enforcing the applicable statutes and 
        regulations in a timely, fair, consistent, and decisive 
        manner.''.</DELETED>

<DELETED>SEC. 103. PERFORMANCE STANDARDS AND REVIEW.</DELETED>

<DELETED>    Section 903(b) (21 U.S.C. 393(b)) is amended by adding at 
the end thereof the following new paragraph:</DELETED>
        <DELETED>    ``(3) Performance standards and review.--Within 
        180 days after the date of enactment of this paragraph, the 
        Commissioner, after consultation with representatives of 
        patient advocacy groups, health professionals, and the 
        regulated industries, shall publish in the Federal Register 
        quantifiable performance standards for action by the 
        Administration on applications or submissions (including 
        petitions, notifications, or any other similar form of request) 
        for the review of a product that is a new drug, biological 
        product, new animal drug, device, or food additive and that is 
        subject to premarket review or approval of any kind under this 
        Act. The performance standards shall be reviewed, and after 
        consultation with representatives of patient advocacy groups, 
        health professionals, and the regulated industries, may be 
        revised, annually by the Commissioner. The performance 
        standards shall establish objectives for the Administration 
        that--</DELETED>
                <DELETED>    ``(A) expedite action on applications for 
                new drugs and devices under sections 505(b)(1) and 515, 
                and for biological products under section 351(a) of the 
                Public Health Service Act (42 U.S.C. 262(a))--
                </DELETED>
                        <DELETED>    ``(i) for a serious, life-
                        threatening, or seriously debilitating disease 
                        or condition; or</DELETED>
                        <DELETED>    ``(ii) for any other condition if 
                        a new drug, device, or biological product--
                        </DELETED>
                                <DELETED>    ``(I) provides therapy not 
                                available from other approved therapy; 
                                or</DELETED>
                                <DELETED>    ``(II) offers significant 
                                improvement over other approved 
                                therapy;</DELETED>
                <DELETED>    ``(B) reduce backlogs on all applications 
                with the objective of eliminating all backlogs by 
                January 1, 2000; and</DELETED>
                <DELETED>    ``(C) establish a schedule to bring the 
                Administration into full compliance by July 1, 1998, 
                with the time periods specified in this Act for action 
                on all applications.</DELETED>
        <DELETED>For applications for which there is no statutory time 
        period, the applicable time period for action shall be 180 
        days. The Commissioner shall prepare and publish in the Federal 
        Register for public comment an annual report comparing the 
        performance of the Administration with the applicable 
        performance standards, analyzing any failure to achieve any of 
        the standards, and setting forth a plan to achieve compliance 
        with the standards that have not been met.''.</DELETED>

<DELETED>SEC. 104. INFORMATION SYSTEM.</DELETED>

<DELETED>    Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at 
the end thereof the following new section:</DELETED>

<DELETED>``SEC. 906. INFORMATION SYSTEM.</DELETED>

<DELETED>    ``The Secretary shall establish and maintain an 
information system to track the status and progress of each application 
or submission (including a petition, notification, or other similar 
form of request) submitted to the Food and Drug Administration 
requesting agency action. The system shall permit access by the 
applicant.''.</DELETED>

<DELETED>SEC. 105. POLICY STATEMENTS.</DELETED>

<DELETED>    Section 701(a) (21 U.S.C. 371(a)) is amended--</DELETED>
        <DELETED>    (1) by striking ``(a) The'' and inserting ``(a)(1) 
        The''; and</DELETED>
        <DELETED>    (2) by adding at the end thereof the following new 
        paragraph:</DELETED>
<DELETED>    ``(2)(A) The Secretary shall establish a procedure 
governing the development and use of all policy statements of general 
applicability (including any guideline, points-to-consider, protocol, 
recommendation, or similar document regardless of the form or 
designation) that are not promulgated as regulation. The procedure 
shall provide an opportunity for affected persons to participate in the 
development and continued use of the policy by sharing expertise, 
experience, or providing comment before the policy is adopted and after 
the policy is implemented.</DELETED>
<DELETED>    ``(B) The Secretary shall establish a procedure for the 
formal publication and compilation of all policy statements of general 
applicability (including any guideline, points-to-consider, protocol, 
recommendation, or similar document regardless of the form or 
designation) that are not promulgated as regulations.''.</DELETED>

<DELETED>SEC. 106. ADVISORY COMMITTEES.</DELETED>

<DELETED>    Section 904 (21 U.S.C. 394) is amended--</DELETED>
        <DELETED>    (1) by striking ``Without'' and inserting ``(a) In 
        General.--Without''; and</DELETED>
        <DELETED>    (2) by adding at the end thereof the following new 
        subsections:</DELETED>
<DELETED>    ``(b) Delegation of Appointment Authority.--The 
Commissioner may delegate the appointment and oversight authority 
granted under subsection (a) to a center director. The center director 
may not authorize any office or division of the center to carry out the 
appointment and oversight authority granted under this 
subsection.</DELETED>
<DELETED>    ``(c) Membership and Meeting Requirements.--</DELETED>
        <DELETED>    ``(1) Scope.--A scientific review group may 
        determine the matters that the group will consider and may 
        establish an appropriate agenda with respect to the 
        determination of the matters.</DELETED>
        <DELETED>    ``(2) Nonvoting members.--A scientific review 
        group shall include a nonvoting industry representative and a 
        nonvoting public representative.</DELETED>
        <DELETED>    ``(3) Notification of scope of discussion.--To the 
        extent feasible, the specific matters and questions to be 
        discussed at a meeting of a scientific review group shall be 
        publicly announced and published in the Federal Register at 
        least 30 days prior to the date of the meeting.</DELETED>
        <DELETED>    ``(4) Terms.--A member of a scientific review 
        group shall serve for a term of 3 years, which may be renewed 
        for a second term. An individual may serve on more than one 
        scientific review group. The chairperson of a scientific review 
        group shall be a member who has served at least 3 years. The 
        term of the chairperson may be renewed for not more than 3 
        terms.</DELETED>
        <DELETED>    ``(5) Training.--Prior to service on a scientific 
        review group, a member of the group shall be given adequate 
        education and training relating to the responsibilities of the 
        member.</DELETED>
        <DELETED>    ``(6) Frequency of meetings.--The Secretary shall 
        take whatever action is necessary to ensure that regular 
        meetings are held by scientific review groups, at appropriate 
        intervals and for a sufficient length of time, so that any 
        matter to be reviewed by any scientific review group shall be 
        presented to the group not more than 90 days after the matter 
        is ready for review by the group. The meetings shall occur not 
        less than 6 times each year unless there are compelling reasons 
        for fewer meetings.</DELETED>
<DELETED>    ``(d) Persons Involvement With Review Groups.--</DELETED>
        <DELETED>    ``(1) In general.--All persons, including 
        employees of the Secretary, shall have the same rights and 
        responsibilities regarding--</DELETED>
                <DELETED>    ``(A) the submission of data and 
                information to, and contact and discussion with, a 
                scientific review group;</DELETED>
                <DELETED>    ``(B) the participation of the persons at 
                meetings of the group; and</DELETED>
                <DELETED>    ``(C) access to data and information 
                submitted to a scientific review group (except for data 
                and information that are not available for public 
                disclosure under section 552 of title 5, United States 
                Code).</DELETED>
        <DELETED>    ``(2) Submission of information to fda.--In a case 
        in which a scientific review group reviews an application 
        (including a petition, notification, or other similar request), 
        all related data and information that are not available for 
        public disclosure under section 552 of title 5, United States 
        Code, shall be exchanged between the applicant and the Food and 
        Drug Administration at the time the data and information are 
        submitted to the scientific review group but shall not 
        otherwise be publicly disclosed.</DELETED>
        <DELETED>    ``(3) Participation in meetings.--Any meetings of 
        a scientific review group shall provide adequate time for 
        initial presentations and for response to any differing views 
        and shall encourage free and open participation by all 
        interested persons.</DELETED>
<DELETED>    ``(e) FDA Actions.--Within 60 days after the date a 
scientific review group makes its conclusions and recommendations on 
any matter under review of the group, the Food and Drug Administration 
official responsible for the matter shall review the conclusions and 
recommendations of the group, shall make a final determination on the 
matter, and shall notify the affected persons of the determination in 
writing and, if the determination differs from the conclusions and 
recommendations of the group, shall include the reasons for the 
difference.</DELETED>
<DELETED>    ``(f) Definition.--For purposes of this section, the term 
`center director' means a director of a center within the Food and Drug 
Administration.''.</DELETED>

<DELETED>SEC. 107. APPEALS WITHIN THE FOOD AND DRUG 
              ADMINISTRATION.</DELETED>

<DELETED>    Chapter IX (21 U.S.C. 391 et seq.), as amended by section 
104, is further amended by adding at the end thereof the following new 
section:</DELETED>

<DELETED>``SEC. 907. APPEALS WITHIN THE FOOD AND DRUG 
              ADMINISTRATION.</DELETED>

<DELETED>    ``(a) Employee Decisions.--The Secretary shall by 
regulation establish a system for the appeal within the Food and Drug 
Administration of any decision by an employee of the Food and Drug 
Administration, except that this subsection shall not apply to 
decisions involving formal administrative or judicial proceedings. The 
Secretary shall make publicly known the existence of the internal 
appeal system and the procedures for an internal appeal.</DELETED>
<DELETED>    ``(b) Review by Scientific Review Group.--</DELETED>
        <DELETED>    ``(1) In general.--Any person shall have the right 
        to request an evaluation by an appropriate scientific review 
        group established under section 904 of any significant 
        scientific issue pending before, or significant scientific 
        decision made by, the Secretary under this Act. An appropriate 
        scientific review group shall review the request and determine 
        whether to conduct an evaluation within 30 days after the date 
        the request is received by the Secretary.</DELETED>
        <DELETED>    ``(2) Scope.--The issues a scientific review group 
        shall evaluate shall include, but not be limited to, matters 
        involving a decision by the Secretary not to permit a clinical 
        investigation to begin or to continue, a refusal by the 
        Secretary to file an application, a protocol design, and 
        decisions relating to a pending application (including a 
        petition, notification, or other similar request), where the 
        same issue has not previously been reviewed by a scientific 
        review group.</DELETED>
        <DELETED>    ``(3) Time limitation.--If a scientific review 
        group agrees to conduct an evaluation on an issue under 
        paragraph (1), the evaluation shall be scheduled for the next 
        meeting of the group.</DELETED>
<DELETED>    ``(c) Additional Informal and Formal Procedures.--
</DELETED>
        <DELETED>    ``(1) In general.--For purposes of obtaining 
        conclusions and recommendations regarding the resolution of any 
        dispute, the Secretary is authorized to use such additional 
        informal and formal procedures as may be considered useful. The 
        procedures may include, but not be limited to, the use of--
        </DELETED>
                <DELETED>    ``(A) panels of qualified Food and Drug 
                Administration officials;</DELETED>
                <DELETED>    ``(B) panels of qualified government 
                employees who are not employees of the Food and Drug 
                Administration; and</DELETED>
                <DELETED>    ``(C) outside mediators and arbitrators 
                who are not government employees.</DELETED>
        <DELETED>    ``(2) Application of faca.--The Federal Advisory 
        Committee Act (5 U.S.C. App) shall not apply to a panel 
        described in paragraph (1).</DELETED>
<DELETED>    ``(d) Review of Recommendations.--Within 60 days after any 
matter that is presented for resolution pursuant to this section has 
been the subject of conclusions and recommendations, the Food and Drug 
Administration official responsible for the matter shall personally 
review the conclusions and recommendations, make a final determination 
on the matter, and notify the parties of the determination in writing 
and if the determination differs from the conclusions and 
recommendations, the reasons for the difference.''.</DELETED>

   <DELETED>TITLE II--EXPEDITED ACCESS TO PRODUCTS FOR SERIOUSLY ILL 
                           PATIENTS</DELETED>

<DELETED>SEC. 201. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Patient Rights Regulatory 
Reform Act of 1995''.</DELETED>

<DELETED>SEC. 202. ACCESS TO UNAPPROVED THERAPIES.</DELETED>

<DELETED>    Chapter V (21 U.S.C. 351 et seq.) is amended by adding at 
the end thereof the following new section:</DELETED>

<DELETED>``SEC. 543. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND 
              DIAGNOSTICS.</DELETED>

<DELETED>    ``(a) In General.--Any person may request from a 
manufacturer or distributor, and any manufacturer or distributor may 
provide to a person after compliance with the provisions of this 
section, an investigational drug (including a biological product) or 
device for the diagnosis, monitoring, or treatment of a serious disease 
or condition, life-threatening or seriously debilitating disease or 
condition, and any other disease or condition designated by the 
Secretary as appropriate for expanded access under this section by the 
person if--</DELETED>
        <DELETED>    ``(1) the person has no comparable or satisfactory 
        alternative therapy available to treat, diagnose, or monitor 
        the disease or condition; or</DELETED>
        <DELETED>    ``(2) the risk to the person from the 
        investigational drug or device is not greater than the risk 
        from the disease or condition.</DELETED>
<DELETED>    ``(b) Protocols.--A manufacturer or distributor may submit 
to the Secretary one or more expanded access protocols covering 
expanded access use of a drug or device described in subsection (a). 
The protocols shall be subject to the provisions of section 505(i) for 
a drug and section 520 (g) and (m) for a device and may include any 
form of use of the drug or device outside a clinical investigation, 
prior to approval of the drug or device for marketing, including but 
not limited to protocols for treatment, use, parallel track, single 
patient protocols, emergency use, and uncontrolled trials.</DELETED>
<DELETED>    ``(c) Fees.--A manufacturer or distributor may charge for 
an investigational drug or device under an expanded access protocol, 
but the price of the drug or device may not be more than that necessary 
to recover the costs of manufacture, research, development, and 
handling for the drug or device.</DELETED>
<DELETED>    ``(d) Notification of Availability.--The manufacturer or 
distributor may inform national, State, and local medical associations 
and societies, and voluntary health associations, about the 
availability of an investigational drug or device for expanded access 
use pursuant to this section but--</DELETED>
        <DELETED>    ``(1) shall state that the drug or device is 
        investigational;</DELETED>
        <DELETED>    ``(2) shall not represent that the drug or device 
        is safe or effective for any use; and</DELETED>
        <DELETED>    ``(3) shall not otherwise promote or advertise the 
        availability of the product for expanded access use.</DELETED>

<DELETED>SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES.</DELETED>

<DELETED>    Section 520(m) (21 U.S.C. 360j(m)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (2), by inserting at the end 
        thereof the following flush sentences:</DELETED>
<DELETED>``The request shall be in the form of an application to the 
Secretary. Within 30 days of the date of the receipt of the 
application, the Secretary shall issue an order approving or denying 
the application.'';</DELETED>
        <DELETED>    (2) by striking paragraph (5); and</DELETED>
        <DELETED>    (3) by striking paragraph (6).</DELETED>

<DELETED>SEC. 204. EXPEDITING APPROVAL OF NEW DRUGS, BIOLOGICS, AND 
              MEDICAL DEVICES FOR SERIOUS CONDITIONS.</DELETED>

<DELETED>    (a) New Drugs.--Section 505(c)(1) (21 U.S.C. 355(c)(1)) is 
amended by adding at the end thereof the following flush 
sentence:</DELETED>
<DELETED>``In a case in which an application submitted under section 
505(b)(1) for a new drug, or section 351(a) of the Public Health 
Service Act a biological product, for a life-threatening disease or 
condition, a seriously debilitating disease or condition, or for any 
other serious disease or condition that provides therapy or diagnosis 
not available from another approved drug or biological product or 
offers significant improvement over another approved drug or biological 
product, the Secretary shall approve or deny approval of the 
application within 120 days after the receipt of the 
application.''.</DELETED>

       <DELETED>TITLE III--REVITALIZING THE INVESTIGATION OF NEW 
                           PRODUCTS</DELETED>

<DELETED>SEC. 301. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Investigational Products 
Regulatory Reform Act of 1995''.</DELETED>

<DELETED>SEC. 302. TIMELY REVIEW AND REASONABLE DATA REQUIREMENTS FOR 
              CLINICAL RESEARCH ON DRUGS AND BIOLOGICAL 
              PRODUCTS.</DELETED>

<DELETED>    Section 505(i) (21 U.S.C. 355(i)) is amended--</DELETED>
        <DELETED>    (1) by striking ``(i) The'' and inserting ``(i)(1) 
        The'';</DELETED>
        <DELETED>    (2) by redesignating paragraphs (1), (2), and (3) 
        as subparagraphs (A), (B), and (C), respectively; and</DELETED>
        <DELETED>    (3) by adding at the end thereof the following new 
        paragraph:</DELETED>
<DELETED>    ``(2)(A) A clinical investigation of a new drug (including 
a biological product) may begin 30 days after the date the Secretary 
receives from the sponsor a notification containing information about 
the drug and the clinical investigation unless, prior to the 30-day 
period, the Secretary informs the sponsor in writing that the 
investigation may not begin, and specifies the basis for the decision 
and the information needed in order for the clinical investigation to 
commence.</DELETED>
<DELETED>    ``(B) Within 1 year after the date of enactment of the 
Food and Drug Administration Performance and Accountability Act of 
1995, the Secretary, after consultation with representatives of patient 
advocacy groups and the regulated industries, shall publish in the 
Federal Register criteria for the type and amount of information 
relating to the safety of an investigational drug to be included in a 
notification described in subparagraph (A), taking into account the 
recommendations of the International Conference on Harmonization of 
Technical Requirements for Registration of Pharmaceuticals for Human 
Use. The Secretary shall periodically review, and may revise, the 
criteria.</DELETED>
<DELETED>    ``(C) The Commissioner shall establish a mechanism to 
ensure the fair and consistent application of safety standards for 
clinical investigations.''.</DELETED>

<DELETED>SEC. 303. TIMELY REVIEW AND REASONABLE DATA REQUIREMENTS FOR 
              CLINICAL RESEARCH ON DEVICES.</DELETED>

<DELETED>    Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at 
the end thereof the following new paragraphs:</DELETED>
<DELETED>    ``(6) The procedures and conditions prescribed pursuant to 
paragraph (2)(A) shall be subject to subparagraphs (B) and (C) of 
section 505(i)(2).</DELETED>
<DELETED>    ``(7) The Secretary shall, within 120 days of the date of 
enactment of this paragraph, by regulation amend the content of parts 
812 and 813 of title 21 of the Code of Federal Regulations to update 
the procedures and conditions under which devices intended for human 
use may upon application be granted an exemption from certain 
requirements under this Act. The regulation shall--</DELETED>
        <DELETED>    ``(A) permit developmental changes in devices, 
        including manufacturing changes, in response to information 
        collected during an investigation without requiring an 
        additional approval of an application for an investigational 
        device exemption or the approval of a supplement to the 
        application, if the changes do not constitute a significant 
        change in design or a significant change in basic principles of 
        operation; and</DELETED>
        <DELETED>    ``(B) permit, without approval of a supplement to 
        an application for an investigational device exemption, changes 
        or modifications to clinical protocols that do not affect the 
        validity of data or information resulting from the completion 
        of an approved protocol.''.</DELETED>

<DELETED>SEC. 304. COLLABORATIVE RESEARCH DESIGN.</DELETED>

<DELETED>    Chapter V (21 U.S.C. 351 et seq.), as amended by section 
202, is further amended by adding at the end thereof the following new 
section:</DELETED>

<DELETED>``SEC. 544. COLLABORATIVE RESEARCH DESIGN.</DELETED>

<DELETED>    ``(a) Review of Design.--</DELETED>
        <DELETED>    ``(1) Request.--Any person who intends to sponsor 
        a preclinical or clinical investigation of a drug (including a 
        biological product) or device may request a meeting with the 
        Secretary to review the design of one or more protocols or part 
        or all of a development plan for the drug or device.</DELETED>
        <DELETED>    ``(2) Form.--A request described in paragraph (1) 
        shall be in writing and shall include a proposal for which the 
        review is requested.</DELETED>
        <DELETED>    ``(3) Written review.--The Secretary shall meet 
        with the person within 30 days of the request and shall provide 
        to the person a written review of the proposal, including any 
        deficiencies in the proposal. A written summary shall be made 
        of the meeting. The summary shall include the written review of 
        the proposal and, after agreement by the individuals who 
        attended the meeting, shall be made part of the product review 
        file maintained by the Food and Drug Administration.</DELETED>
<DELETED>    ``(b) Modification of Agreements.--Agreements reached 
through meetings under subsection (a) may be changed in writing by 
mutual consent of the sponsor and the Secretary at any time.</DELETED>
<DELETED>    ``(c) Modification of Agreements by the FDA.--Agreements 
reached through meetings under subsection (a) may be changed 
unilaterally only--</DELETED>
        <DELETED>    ``(1) by the director of the office of the Food 
        and Drug Administration responsible for regulating a drug or 
        device subject to review under this section, who may not 
        delegate such responsibility; and</DELETED>
        <DELETED>    ``(2) in writing and specifying the basis therefor 
        and demonstrating the substantial public health reasons that 
        require the change.</DELETED>
<DELETED>    ``(d) Panel Review.--</DELETED>
        <DELETED>    ``(1) In general.--Any person requesting a meeting 
        under subsection (a) may obtain review from a panel established 
        under subsection 513(b) of a determination of the Secretary to 
        disapprove a protocol or product development plan.</DELETED>
        <DELETED>    ``(2) Agreement modifications.--Any person who has 
        reached an agreement with the Secretary under subsection (b) 
        may obtain review from a panel described in paragraph (1) of a 
        modification of the agreement under subsection 
        (c).''.</DELETED>

      <DELETED>TITLE IV--EFFICIENT, ACCOUNTABLE, AND FAIR PRODUCT 
                            REVIEW</DELETED>

<DELETED>SEC. 401. REFERENCE.</DELETED>

<DELETED>    This title may be cited as the ``Product Review Regulatory 
Reform Act of 1995''.</DELETED>

<DELETED>SEC. 402. THE CONTENT AND REVIEW OF AN APPLICATION.</DELETED>

<DELETED>    Chapter VII (21 U.S.C. 371 et seq.) is amended by adding 
at the end thereof the following new subchapter:</DELETED>

       <DELETED>``SUBCHAPTER D--REVIEW OF APPLICATIONS</DELETED>

<DELETED>``SEC. 741. CONTENT AND REVIEW OF AN APPLICATION.</DELETED>

<DELETED>    ``(a) In General.--This section applies to any application 
(including a petition, notification, or other similar request) 
submitted for a food additive, new drug, biological product, new animal 
drug, animal feed bearing or containing a new animal drug, device, or 
color additive.</DELETED>
<DELETED>    ``(b) Filing Requirements.--The Commissioner shall 
establish a mechanism to ensure the fair and consistent application of 
filing requirements.</DELETED>
<DELETED>    ``(c) Classification of a Product.--Within 60 days of the 
receipt of a written request of any person for information respecting 
the classification of a product as a drug, biological product, or 
device or the component of the Food and Drug Administration that will 
regulate the product (including a request respecting a combination 
product subject to section 503(g)) the Secretary shall provide the 
person a written statement of the classification of the product or the 
component of the Food and Drug Administration that will regulate the 
product. The Secretary's statement shall be binding and may not be 
changed by the Secretary except with the written agreement of the 
person who submitted the request. If the Secretary does not provide the 
statement within the 60-day period, the classification and component 
designated by the person submitting the request shall be final and 
binding and may not be changed by the Secretary except with the written 
agreement of the person. All radiopharmaceutical products shall be 
regulated in a separate division under the Center for Devices and 
Radiological Health.</DELETED>
<DELETED>    ``(d) Reasonable Data Requirements.--Within 1 year after 
the date of enactment of the Food and Drug Administration Performance 
and Accountability Act of 1995, the Secretary, after consultation with 
patient advocacy groups and the regulated industries, shall publish in 
the Federal Register criteria for the type and amount of information 
relating to safety and effectiveness to be included in an application 
for the approval of a product, or a new use of an approved product, 
described in subsection (c). In developing the criteria, the Secretary 
shall consider any recommendations of the International Conference on 
Harmonization of Technical Requirements for Registration of 
Pharmaceuticals for Human Use.''.</DELETED>

<DELETED>SEC. 403. CONTRACTS FOR EXPERT REVIEW.</DELETED>

<DELETED>    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
402, is further amended by adding at the end thereof the following new 
section:</DELETED>

<DELETED>``SEC. 742. CONTRACTS FOR EXPERT REVIEW.</DELETED>

<DELETED>    ``(a) In General.--The Secretary may contract with outside 
organizations and individuals, with expertise in relevant disciplines, 
to review, evaluate, and make conclusions and recommendations to the 
Secretary on parts or all of any application (including a petition, 
notification, or other similar request for Food and Drug Administration 
action). Any such contract shall be subject to the requirements of 
section 708. Funds obtained under part 2 of subchapter C may be used 
for external review of any drug (including a biological product) for 
which a user fee was paid.</DELETED>
<DELETED>    ``(b) Review of Expert's Evaluation.--</DELETED>
        <DELETED>    ``(1) In general.--Subject to paragraph (2), the 
        Food and Drug Administration official responsible for any 
        matter for which expert review is used pursuant to this section 
        shall personally review the conclusions and recommendations of 
        the expert review organization or individual and shall make a 
        final decision regarding the matter under review within 60 days 
        after receiving the conclusions and recommendation.</DELETED>
        <DELETED>    ``(2) Limitation.--A final decision under 
        paragraph (1) shall be made within the applicable prescribed 
        time period for review of an application as set forth in this 
        Act.''.</DELETED>

<DELETED>SEC. 404. PROMPT AND EFFICIENT REVIEW.</DELETED>

<DELETED>    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
403, is further amended by adding at the end thereof the following new 
section:</DELETED>

<DELETED>``SEC. 743. PROMPT AND EFFICIENT REVIEW.</DELETED>

<DELETED>    ``(a) In General.--The provisions of this section shall 
apply to any of the following applications (including a petition, 
notification, or other similar request):</DELETED>
        <DELETED>    ``(1) An application for approval of a human food 
        additive or animal feed additive under section 409.</DELETED>
        <DELETED>    ``(2) An application for approval of a new drug 
        under section 505(b)(1).</DELETED>
        <DELETED>    ``(3) An application for approval of a new animal 
        drug or an animal feed bearing or containing a new animal drug 
        under subsection (b)(1) or (m) of section 512, 
        respectively.</DELETED>
        <DELETED>    ``(4) A submission for a determination that a 
        device is substantially equivalent to a predicate device under 
        sections 513(f)(1) and 513(i).</DELETED>
        <DELETED>    ``(5) An application for approval of a device 
        under section 515.</DELETED>
        <DELETED>    ``(6) An application for the listing of a color 
        additive under section 721.</DELETED>
<DELETED>    ``(b) Review Procedures and Policies.--The Secretary shall 
establish procedures and policies to facilitate a collaborative review 
process between the Food and Drug Administration and the applicant with 
respect to an application or submission described in subsection (a). As 
part of this collaborative process--</DELETED>
        <DELETED>    ``(1) open, informal, and prompt communications 
        shall be encouraged;</DELETED>
        <DELETED>    ``(2) meetings (except meetings with respect to 
        submissions to determine substantial equivalence of a device to 
        a predicate device) shall be held after the expiration of one-
        half of the statutory time period for review of the application 
        and after the expiration of three-quarters of such period, or 
        within 15 days after a scientific review group has convened and 
        made recommendations on an application, unless the Food and 
        Drug Administration and the applicant determine that a meeting 
        is unnecessary; and</DELETED>
        <DELETED>    ``(3) the Secretary shall, prior to the meetings 
        described in paragraph (2), present to the applicant in writing 
        a description of any deficiencies of the application and the 
        information necessary to bring the application into a form that 
        would require approval.</DELETED>
<DELETED>    ``(c) Approval, Disapproval, and Classification.--
</DELETED>
        <DELETED>    ``(1) Approval based on failure to act.--Beginning 
        1 year after the date of publication of an applicable 
        performance standard under section 903(b), or 18 months after 
        the date of enactment of the Food and Drug Administration 
        Performance and Accountability Act of 1995, whichever occurs 
        first, if the Secretary fails to meet a time period for action 
        on an application established in the standard and the product 
        that is a new drug, biological product, new animal drug, 
        device, or food additive that is the subject of the application 
        has met the marketing requirements of the European Union or the 
        United Kingdom, at the request of the applicant the application 
        shall be deemed to be approved unless, within 30 days after the 
        expiration of the time period established in the standard, the 
        Secretary notifies the applicant in writing that the 
        application is disapproved, setting forth the reasons for 
        disapproval, and, with the consent of the applicant, publishes 
        a notice, within 30 days of notifying the applicant, in the 
        Federal Register disapproving the application under paragraph 
        (2) and setting forth the reasons for the 
        disapproval.</DELETED>
        <DELETED>    ``(2) Appeal.--A person whose application has been 
        disapproved under this subsection may appeal using one of the 
        following procedures:</DELETED>
                <DELETED>    ``(A) Procedures under the act.--The 
                procedures established for the product under other 
                provisions of this Act.</DELETED>
                <DELETED>    ``(B) Appeal.--An appeal to a United 
                States District Court to determine whether the 
                Secretary's decision is supported by substantial 
                evidence in the administrative record.</DELETED>
<DELETED>    ``(d) Contracts for Expert Review.--</DELETED>
        <DELETED>    ``(1) In general.--Beginning July 1, 1998, if the 
        Secretary in any fiscal year fails to meet the statutory time 
        period for action on an application for at least 95 percent of 
        the applications in a particular category, the Secretary shall 
        in the following fiscal year, with the consent of the 
        applicant, contract with expert individuals and organizations 
        under section 742 to review new applications and applications 
        for which the Secretary has failed to meet the statutory time 
        period for action for the particular product 
        category.</DELETED>
        <DELETED>    ``(2) Approval.--If an individual or organization 
        selected to conduct a review under paragraph (1) determines 
        that an application described in paragraph (1) should be 
        approved, the application shall be considered to be approved 
        unless, within 30 days after the date the Secretary receives 
        the determination of the individual or organization, the 
        Secretary publishes a notice in the Federal Register 
        disapproving the application and setting forth the reasons for 
        disapproval. An applicant may appeal the disapproval under 
        subsection (c)(2).''.</DELETED>

<DELETED>SEC. 405. GOOD MANUFACTURING PRACTICE INSPECTION.</DELETED>

<DELETED>    Chapter VII is (21 U.S.C. 371 et seq.), as amended by 
section 404, is further amended by adding at the end thereof the 
following new section:</DELETED>

<DELETED>``SEC. 744. GOOD MANUFACTURING PRACTICE INSPECTION.</DELETED>

<DELETED>    ``(a) In General.--In order to comply with inspection 
requirements of this Act, the Secretary may accredit organizations to 
conduct inspections under section 704 to evaluate compliance of a 
manufacturer with applicable requirements for good manufacturing 
practice.</DELETED>
<DELETED>    ``(b) Eligibility Requirements.--The Secretary shall by 
regulation establish the requirements that an organization shall meet 
to be eligible to be accredited to participate as a qualified 
organization to conduct inspections under subsection (a).</DELETED>
<DELETED>    ``(c) Accreditation.--Within 90 days after the date the 
Secretary receives an application for accreditation under this section, 
the Secretary shall review the application and determine whether an 
applicant is in compliance with the requirements established under this 
section. Within the 90-day period, the Secretary shall grant 
accreditation or shall deny accreditation and specify in writing the 
reasons for the denial and the requirements that shall be met to obtain 
accreditation.</DELETED>
<DELETED>    ``(d) Revocation of Accreditation.--The Secretary may at 
any time revoke accreditation granted under subsection (c) for failure 
to comply with the requirements established under this section after 
specifying in writing the reasons for the revocation and the 
requirements that shall be met to retain accreditation and after an 
informal hearing on the revocation.</DELETED>
<DELETED>    ``(e) Inspections.--Any organization accredited under this 
subsection that conducts an inspection under this subsection at the 
request of the Secretary shall--</DELETED>
        <DELETED>    ``(1) apply all relevant principles of good 
        manufacturing practice established in this Act and in 
        regulations promulgated by the Secretary; and</DELETED>
        <DELETED>    ``(2) provide to the Secretary and the 
        manufacturer within 30 days after the completion of the 
        inspection an adequate report of the findings of the 
        inspection.</DELETED>
<DELETED>    ``(f) Limitation.--When an accredited organization has 
conducted a good manufacturing practice inspection under section 704, 
the Secretary may not perform such an inspection for a period of 2 
years after the date of the receipt of the report required under 
subsection (e)(2), unless justified by good cause.''.</DELETED>

<DELETED>SEC. 406. ENVIRONMENTAL IMPACT REVIEW.</DELETED>

<DELETED>    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
405, is further amended by adding at the end thereof the following new 
section:</DELETED>

<DELETED>``SEC. 745. ENVIRONMENTAL IMPACT REVIEW.</DELETED>

<DELETED>    ``Notwithstanding any provision of other law, no action by 
the Secretary pursuant to this Act shall be subject to an environmental 
assessment, an environmental impact statement, or other environmental 
consideration unless the director of the office responsible for the 
action demonstrates, in writing and specifying the basis therefor--
</DELETED>
        <DELETED>    ``(1) that there is a reasonable probability that 
        the environmental impact of the action is sufficiently 
        substantial and within the factors that the Secretary is 
        authorized to consider under this Act; and</DELETED>
        <DELETED>    ``(2) that consideration of the environmental 
        impact will directly affect the decision on the 
        action.''.</DELETED>

<DELETED>SEC. 407. INFORMATION EXCHANGE.</DELETED>

<DELETED>    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
406, is further amended by adding at the end thereof the following new 
sections:</DELETED>

<DELETED>``SEC. 746. DISSEMINATION OF INFORMATION ON DRUGS.</DELETED>

<DELETED>    ``(a) Dissemination.--</DELETED>
        <DELETED>    ``(1) In general.--Notwithstanding sections 301(d) 
        and 502(f), and subject to the requirements of paragraph (2) 
        and subsection (b), a person may disseminate to any person that 
        is a health care practitioner or other provider of health care 
        goods or services, a pharmacy benefit manager, a health 
        maintenance organization or other managed health care 
        organization, or a health care insurer or governmental agency, 
        written information, or an oral or written summary of the 
        written information, concerning--</DELETED>
                <DELETED>    ``(A) a treatment use for an 
                investigational new drug (including a biological 
                product) approved by the Secretary for such treatment 
                use; or</DELETED>
                <DELETED>    ``(B) a use (whether or not such use is 
                contained in the official labeling) of a new drug for 
                which an approval of an application filed under section 
                505(b) is in effect.</DELETED>
        <DELETED>    ``(2) Requirements.--A person may disseminate 
        information under paragraph (1)(B) only if--</DELETED>
                <DELETED>    ``(A) the information is an unabridged--
                </DELETED>
                        <DELETED>    ``(i) reprint or copy of a peer-
                        reviewed article from a scientific or medical 
                        journal that is published by an organization 
                        that is independent of the pharmaceutical 
                        industry; or</DELETED>
                        <DELETED>    ``(ii) chapter, authored by an 
                        expert or experts in the disease to which the 
                        use relates, from a recognized reference 
                        textbook that is published by an organization 
                        that is independent of the pharmaceutical 
                        industry;</DELETED>
                <DELETED>    ``(B) the text of the information has been 
                approved by a continuing medical education accrediting 
                agency that is independent of the pharmaceutical 
                industry as part of a scientific or medical educational 
                program approved by the agency;</DELETED>
                <DELETED>    ``(C) the information relates to a use 
                that is recognized under Federal law for purposes of 
                third-party coverage or reimbursement, and--</DELETED>
                        <DELETED>    ``(i) the text of the information 
                        has been approved by an organization referred 
                        to in such Federal law; and</DELETED>
                        <DELETED>    ``(ii) the information is part of 
                        a disease management program or treatment 
                        guideline with respect to the use; or</DELETED>
                <DELETED>    ``(D) the information is an accurate and 
                truthful summary of the information described in 
                subparagraph (A), (B), or (C).</DELETED>
<DELETED>    ``(b) Disclosure Statement.--In order to afford a full and 
fair evaluation of the information described in subsection (a), a 
person disseminating the information shall include a statement that 
discloses--</DELETED>
        <DELETED>    ``(1) if applicable, that the use of a new drug 
        described in subparagraph (A) or (B) of subsection (a)(1) and 
        the information with respect to the use have not been approved 
        by the Food and Drug Administration;</DELETED>
        <DELETED>    ``(2) if applicable, that the information is being 
        disseminated at the expense of the sponsor of the new 
        drug;</DELETED>
        <DELETED>    ``(3) if applicable, that one or more authors of 
        the information being disseminated are employees of or 
        consultants to the sponsor of the new drug; and</DELETED>
        <DELETED>    ``(4) the official labeling for the drug and 
        biological product, or in the case of a treatment use of an 
        investigational new drug, the investigator brochure and all 
        updates thereof.</DELETED>
<DELETED>    ``(c) Definition.--As used in this section, the term 
`expense' includes financial, in-kind, and other contributions provided 
for the purpose of disseminating the information described in 
subsection (a).</DELETED>
<DELETED>    ``(d) Special Rule.--In the case of a professional 
disagreement between the Secretary and other qualified experts with 
respect to the application of section 502(a), the Secretary may not use 
section 502 to prohibit the dissemination of information in the types 
of circumstances and under the conditions set forth in subsections (a) 
and (b).</DELETED>

<DELETED>``SEC. 747. DISSEMINATION OF INFORMATION ON DEVICES.</DELETED>

<DELETED>    ``(a) In General.--Notwithstanding sections 301, 501(f), 
501(i), 502(a), 502(f), and 502(o), or any other provision of law, and 
subject to subsections (b) and (c), a person may disseminate to any 
person that is a health care practitioner or other provider of health 
care goods or services, a pharmacy benefit manager, a health 
maintenance organization or other managed health care organization, or 
a health care insurer or governmental agency, written or oral 
information (including information exchanged at scientific and 
educational meetings, workshops, or demonstrations) relating to a use, 
whether or not the use is described in the official labeling, of a 
device produced by a manufacturer registered pursuant to section 
510.</DELETED>
<DELETED>    ``(b) Disclosure Statements and Requirements.--</DELETED>
        <DELETED>    ``(1) Disclosure statements.--To the extent 
        practicable, the requirement with respect to a statement of 
        disclosure under subsection (b) of section 746 shall apply to 
        the dissemination of written and oral information under this 
        section, except that this paragraph shall not apply to the 
        dissemination of written or oral information with respect to 
        the intended use described in the labeling of a 
        device.</DELETED>
        <DELETED>    ``(2) Additional requirements.--A person may 
        disseminate information under subsection (a) only if--
        </DELETED>
                <DELETED>    ``(A) the information is an unabridged--
                </DELETED>
                        <DELETED>    ``(i) reprint or copy of a peer-
                        reviewed article from a scientific or medical 
                        journal that is published by an organization 
                        that is independent of the medical device 
                        industry; or</DELETED>
                        <DELETED>    ``(ii) chapter, authored by an 
                        expert or experts in the medical specialty to 
                        which the use relates, from a recognized 
                        reference textbook that is published by an 
                        organization that is independent of the medical 
                        device industry;</DELETED>
                <DELETED>    ``(B) the information has been approved by 
                a continuing medical education accrediting agency that 
                is independent of the medical device industry as part 
                of a scientific or medical educational program approved 
                by the agency;</DELETED>
                <DELETED>    ``(C) the information relates to a use 
                that is recognized under Federal law for purposes of 
                third-party reimbursement, and--</DELETED>
                        <DELETED>    ``(i) the text of the information 
                        has been approved by an organization referred 
                        to in such Federal law; and</DELETED>
                        <DELETED>    ``(ii) the information is part of 
                        a disease management program or treatment 
                        guideline with respect to such use; 
                        or</DELETED>
                <DELETED>    ``(D) the oral or written information is--
                </DELETED>
                        <DELETED>    ``(i) part of an exchange of 
                        information solely among health care 
                        practitioners, health care reimbursement 
                        officials, and the industry;</DELETED>
                        <DELETED>    ``(ii) exchanged for educational 
                        or scientific purposes; or</DELETED>
                        <DELETED>    ``(iii) presented at continuing 
                        medical education programs, seminars, 
                        workshops, or demonstrations.</DELETED>
        <DELETED>    ``(3) Applicability.--The requirements under 
        subsection (a)(1)(A) and (B) of section 746 shall not apply 
        with respect to devices.</DELETED>

<DELETED>``SEC. 748. POLICY ON INFORMATION DISSEMINATION.</DELETED>

<DELETED>    ``(a) Construction.--Notwithstanding section 502 (a), (f), 
and (o), or any other provision of law, the written or oral 
dissemination of information relating to a new use of a new drug or 
device, in accordance with sections 746 and 747, shall not be construed 
as evidence of a new intended use of the new drug or device that is 
different from the intended use of the new drug or device set forth in 
the official labeling. The dissemination shall not be considered as 
labeling, adulteration, or misbranding of the new drug or 
device.</DELETED>
<DELETED>    ``(b) Respond to Unsolicited Questions.--Nothing in this 
Act shall affect the ability of manufacturers to respond fully to 
unsolicited questions from health care practitioners and other persons 
about drugs (including biological products) or devices.</DELETED>

<DELETED>``SEC. 749. APPROVAL OF NEW USES.</DELETED>

<DELETED>    ``(a) In General.--As an alternative to the procedures 
established in section 505(c)(1) for a new drug (including a biological 
product) and section 515(d)(1)(A) for a device, the Secretary shall 
approve an application under this section for a new use of a previously 
approved new drug or device if experts qualified by scientific training 
and experience to evaluate the safety and effectiveness of drugs or 
devices conclude that a new use that has not been reviewed or approved 
by the Secretary represents sound medical practice based upon reliable 
clinical experience and other confirmatory information, unless the 
Secretary demonstrates that there are other compelling public health 
reasons related to the safety or effectiveness of the drug or device 
why approval would harm the health of individual patients.</DELETED>
<DELETED>    ``(b) Petition.--The holder of an approved application may 
submit a petition to the Secretary presenting information that new use 
of a previously approved new drug or device meets the criteria for 
approval established in this subsection. The petition shall include 
data and information relating to the new use and shall demonstrate that 
the new use--</DELETED>
        <DELETED>    ``(1) has existed in clinical practice for at 
        least five years;</DELETED>
        <DELETED>    ``(2) is common among clinicians experienced in 
        the field; and</DELETED>
        <DELETED>    ``(3) represents reasonable medical practice based 
        upon reliable clinical experience and other confirmatory 
        information.</DELETED>
<DELETED>    ``(c) Action on Petition.--Upon receipt of the petition, 
the Secretary shall obtain the conclusions and recommendations of a 
scientific review group established under section 904 and grant or deny 
the petition within 180 days of the receipt of the 
petition.''.</DELETED>

<DELETED>SEC. 408. EFFECTIVENESS, OUTCOME, AND COST-EFFECTIVENESS 
              STANDARDS.</DELETED>

<DELETED>    Section 741, as added by section 402, is amended by adding 
at the end thereof the following new subsection:</DELETED>
<DELETED>    ``(e) In reviewing an application for a product that is a 
new drug, biological product, new animal drug, animal feed bearing or 
containing a new animal drug, or device the determination of 
effectiveness shall not include the evaluation of--</DELETED>
        <DELETED>    ``(1) relative effectiveness, unless the 
        effectiveness of the product is explicitly compared to the 
        effectiveness of another product in the labeling;</DELETED>
        <DELETED>    ``(2) any potential use not explicitly included in 
        the labeling;</DELETED>
        <DELETED>    ``(3) the cost-effectiveness of the product 
        described in this subsection as compared to the cost-
        effectiveness of a similar product, unless the labeling 
        explicitly includes a representation about cost-effectiveness; 
        and</DELETED>
        <DELETED>    ``(4) the clinical outcome resulting from use of a 
        device, unless the labeling explicitly includes a 
        representation regarding clinical outcome.''.</DELETED>

<DELETED>SEC. 409. DEFINITION OF A DAY FOR PURPOSES OF PRODUCT 
              REVIEW.</DELETED>

<DELETED>    Section 201 (21 U.S.C. 321) is amended by adding at the 
end thereof the following:</DELETED>
<DELETED>    ``(gg) For purposes of reviewing any application, 
notification or petition, or any document, with respect to a product 
that is a new drug, biological product, new animal drug, device, or 
food additive that is submitted to the Secretary to obtain approval of 
marketing, or to establish or clarify the regulatory status of the 
product, the term `day' means a calendar day (excluding any calendar 
day between the date of receipt by the submitter of a written 
communication from the Secretary setting forth the action of the 
Secretary on a submission and the date of receipt by the Secretary of 
the written response of the submitter to the action) in which the 
Secretary has responsibility to review such a submission.''.</DELETED>

      <DELETED>TITLE V--DRUG, BIOLOGICAL PRODUCTS, DEVICES EXPORT 
                            REFORM</DELETED>

<DELETED>SEC. 501. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Drug, Biological 
Products, Devices Export Reform Act of 1995''.</DELETED>

<DELETED>SEC. 502. EXPORT OF DRUGS AND DEVICES.</DELETED>

<DELETED>    (a) Exports and Imports.--Section 801 (21 U.S.C. 381) is 
amended--</DELETED>
        <DELETED>    (1) in subsection (d), by adding at the end 
        thereof the following new paragraph:</DELETED>
<DELETED>    ``(3) No component, part or accessory of a drug, 
biological product, or device, including a drug in bulk form, shall be 
excluded from importation into the United States under paragraph (a), 
if the component, part, or accessory will be incorporated into a 
device, drug, or biological product that will be exported from the 
United States in accordance with subsection (e) of section 802 or 
section 351(h) of the Public Health Service Act.'';</DELETED>
        <DELETED>    (2) in subsection (e)(1), by striking the second 
        sentence; and</DELETED>
        <DELETED>    (3) in subsection (e)(2), by inserting before the 
        period at the end thereof the following: ``or that the device 
        is eligible for export under section 802''.</DELETED>
<DELETED>    (b) Export of Certain Unapproved Drugs and Devices.--
Section 802 (21 U.S.C. 382) is amended to read as follows:</DELETED>

<DELETED>``SEC. 802. EXPORTS OF CERTAIN UNAPPROVED PRODUCTS.</DELETED>

<DELETED>    ``(a) In General.--A drug (including a biological product) 
intended for human or animal use or a device for human use--</DELETED>
        <DELETED>    ``(1)(A) which, in the case of a drug--</DELETED>
                <DELETED>    ``(i) requires approval by the Secretary 
                under section 505 or section 512; or</DELETED>
                <DELETED>    ``(ii) requires licensing by the Secretary 
                under section 351 of the Public Health Service Act or 
                by the Secretary of Agriculture under the Act of March 
                4, 1913 (known as the Virus-Serum Toxin Act),</DELETED>
        <DELETED>before the drug may be introduced or delivered for 
        introduction into interstate commerce to a country; 
        and</DELETED>
        <DELETED>    ``(B) which--</DELETED>
                <DELETED>    ``(i) does not have such approval or 
                license;</DELETED>
                <DELETED>    ``(ii) is not exempt from such sections or 
                Act; and</DELETED>
                <DELETED>    ``(iii) is introduced or delivered for 
                introduction into interstate commerce to a country; 
                or</DELETED>
        <DELETED>    ``(2) which, in the case of a device--</DELETED>
                <DELETED>    ``(A) does not comply with an applicable 
                requirement under section 514 or 515;</DELETED>
                <DELETED>    ``(B) is exempt under section 520(g) from 
                section 514 or 515; or</DELETED>
                <DELETED>    ``(C) is a banned device under section 
                516,</DELETED>
<DELETED>is adulterated, misbranded, and in violation of such sections 
or Act unless the export of the drug or device is authorized under 
subsection (b), (c), (e), or (f) or under section 801(e)(2).</DELETED>
<DELETED>    ``(b) Exportation to Any Country or a Specific Country.--
</DELETED>
        <DELETED>    ``(1) Exportations to any country.--Except as 
        otherwise provided in this section, a drug (including a 
        biological product) or device may be exported to any country, 
        if the drug or device complies with the laws of that country 
        and has valid marketing authorization by the appropriate 
        approval authority--</DELETED>
                <DELETED>    ``(A) in Australia, Canada, Israel, Japan, 
                New Zealand, or Switzerland; or</DELETED>
                <DELETED>    ``(B) in the European Union or a country 
                in the European Economic Area (the countries in the 
                European Union and the European Free Trade Association) 
                if the drug or device is marketed in that country or 
                the drug or device is authorized for general marketing 
                in the European Economic Area.</DELETED>
        <DELETED>    ``(2) Exportation to a certain country.--A drug or 
        device may be exported to the countries described in paragraph 
        (1) if the drug or device complies with the laws of any such 
        country and has a valid marketing authorization by the 
        appropriate approval authority in that country.</DELETED>
<DELETED>    ``(c) Exportation to a Country With a Regulatory System.--
</DELETED>
        <DELETED>    ``(1) In general.--A drug or device may be 
        exported under this section to any other country that has an 
        adequate regulatory system to protect the health of the 
        citizens of such a country. The Comptroller General, in 
        consultation with the Secretary and other appropriate parties, 
        shall develop a list of countries to which a drug or device may 
        be exported under this paragraph and a list of recommended 
        criteria for additions or deletions of countries to the list of 
        countries.</DELETED>
        <DELETED>    ``(2) Request designation.--An appropriate country 
        official, manufacturer, or exporter, may request the Secretary 
        to designate a country to receive drugs or devices exported 
        under this section that meets the requirements of paragraph (1) 
        by submitting documentation in support of such designation to 
        the Secretary. Any person other than an appropriate country 
        official requesting such designation shall provide a letter 
        from the country indicating the desire of the country to be 
        designated.</DELETED>
        <DELETED>    ``(3) Time limitation for designation.--If the 
        Secretary fails to, within 90 days of the date of the receipt 
        of a request under paragraph (2), respond to the request with a 
        denial of the requested designation, the request shall be 
        considered granted and the country that is the subject of the 
        request shall be designated as eligible to receive drugs or 
        devices exported under this subsection.</DELETED>
        <DELETED>    ``(4) Withdrawal of designation.--If information 
        is provided to the Secretary that indicates that, due to a 
        public health emergency or systematic patterns of abuse of the 
        regulatory system in a country designated under paragraph (3), 
        the country is no longer able to carry out the functions 
        described in paragraph (1), or if the country no longer meets 
        the requirements for designation under this subsection, the 
        Secretary may withdraw the designation of the 
        country.</DELETED>
<DELETED>    ``(d) Limitations.--A drug or device may not be exported 
under this section if--</DELETED>
        <DELETED>    ``(1) the drug or device is not manufactured, 
        processed, packaged, and held in conformity with current good 
        manufacturing practice or is adulterated under paragraph (1), 
        (2)(A), or (3) of section 501(a) or subsection (c) or (d) of 
        section 501;</DELETED>
        <DELETED>    ``(2) the drug or device is not labeled and 
        advertised in accordance with the requirements and conditions 
        for use of any country in which the drug or device is approved, 
        either in English or the predominant language of the country to 
        which the drug or device is being exported, except that with 
        respect to advertising alternative methods of communication 
        that are consistent with the requirements of the approving 
        country shall be allowed if authorized by the receiving 
        country;</DELETED>
        <DELETED>    ``(3) the requirements of subparagraphs (A) 
        through (D) of section 801(e)(1) have not been met;</DELETED>
        <DELETED>    ``(4) the drug or device has been the subject of a 
        finding by the Secretary under section 505, 512 or 515 or under 
        section 351 of the Public Health Service Act (42 U.S.C. 262), 
        or by the Secretary of Agriculture under the Act of March 4, 
        1913 (37 Stat. 832-833) (commonly known as the `Virus Serum 
        Toxin Act') that the drug or device has not been shown to be 
        safe or effective for labeled indication of the drug or 
        device;</DELETED>
        <DELETED>    ``(5) the Secretary finds that the drug or device 
        poses an unreasonable and substantial risk to public health in 
        the receiving country;</DELETED>
        <DELETED>    ``(6) the drug or device is the subject of a 
        notice by the Secretary or the Secretary of Agriculture of a 
        determination that the possibility of reimportation of the 
        exported drug or device would present an imminent hazard to the 
        public health and safety of the United States and the only 
        means of limiting the hazard is to prohibit the export of the 
        drug or device; or</DELETED>
        <DELETED>    ``(7) the drug or device will be re-exported or 
        transshipped to a country not authorized to receive an exported 
        drug or device under this section.</DELETED>
<DELETED>In making a finding under paragraph (5), the Secretary, to the 
maximum extent possible, shall consult with the affected 
country.</DELETED>
<DELETED>    ``(e) Exportation of Drug for Investigational Use.--A drug 
intended for investigational use in any country described in subsection 
(b) or designated under subsection (c) may be exported in accordance 
with the laws of that country and still be exempt from regulation under 
section 505(i) or section 512(j).</DELETED>
<DELETED>    ``(f) Exportation of a Drug for Tropical Disease.--
</DELETED>
        <DELETED>    ``(1) In general.--A drug (including a biological 
        product) that is to be used in the prevention or treatment of a 
        tropical disease may, upon approval of an application submitted 
        under paragraph (2), be exported if--</DELETED>
                <DELETED>    ``(A) the Secretary finds, based on 
                credible scientific evidence, including clinical 
                investigations, that the drug is safe and effective in 
                the country to which the drug is to be exported in the 
                prevention or treatment of a tropical disease in such 
                country;</DELETED>
                <DELETED>    ``(B) the drug is manufactured, processed, 
                packaged, and held in conformity with current good 
                manufacturing practice and is not adulterated under 
                paragraphs (1), (2)(A), and (3) of subsection (a), and 
                subsection (c) or (d), of section 501;</DELETED>
                <DELETED>    ``(C) the outside of the shipping package 
                is labeled with the following statement: `This drug may 
                be sold or offered for sale only in the following 
                countries:', the blank space being filled with a list 
                of the countries to which export of the drug is 
                authorized under this subsection;</DELETED>
                <DELETED>    ``(D) the drug is not the subject of a 
                notice by the Secretary or the Secretary of Agriculture 
                of a determination that the manufacture of the drug in 
                the United States for export to a country is contrary 
                to the public health and safety of the United States; 
                and</DELETED>
                <DELETED>    ``(E) the requirements of subparagraphs 
                (A) through (D) of section 801(d)(1) have been 
                met.</DELETED>
        <DELETED>    ``(2) Application.--Any person may apply to have a 
        drug exported under paragraph (1). The application shall--
        </DELETED>
                <DELETED>    ``(A) describe the drug to be 
                exported;</DELETED>
                <DELETED>    ``(B) list each country to which the drug 
                is to be exported;</DELETED>
                <DELETED>    ``(C) contain a certification by the 
                applicant that the drug will not be exported to a 
                country for which the Secretary cannot make a finding 
                described in paragraph (1)(A);</DELETED>
                <DELETED>    ``(D) identify the establishments in which 
                the drug is manufactured; and</DELETED>
                <DELETED>    ``(E) demonstrate to the Secretary that 
                the drug meets the requirements of paragraph 
                (1).</DELETED>
        <DELETED>    ``(3) Required reporting.--The holder of an 
        approved application for the export of a drug under this 
        subsection shall report to the Secretary--</DELETED>
                <DELETED>    ``(A) the receipt of any information 
                indicating that the drug is being or may have been 
                exported from a country for which the Secretary made a 
                finding under paragraph (1)(A) to a country for which 
                the Secretary cannot make such a finding; and</DELETED>
                <DELETED>    ``(B) the receipt of any information 
                indicating any adverse reactions to such 
                drug.</DELETED>
        <DELETED>    ``(4) Additional limitations.--</DELETED>
                <DELETED>    ``(A) Failure to meet certain 
                requirements.--If the Secretary determines that--
                </DELETED>
                        <DELETED>    ``(i) a drug for which an 
                        application is approved under paragraph (2) 
                        does not continue to meet the requirements of 
                        paragraph (1);</DELETED>
                        <DELETED>    ``(ii) the holder of the 
                        application has not made the report required by 
                        paragraph (3); or</DELETED>
                        <DELETED>    ``(iii) the manufacture of the 
                        drug in the United States for export is 
                        contrary to the public health and safety of the 
                        United States and an application for the export 
                        of the drug has been approved under paragraph 
                        (2),</DELETED>
        <DELETED>then before taking action against the holder of an 
        application for which a determination was made under clause 
        (i), (ii), or (iii), the Secretary shall notify the holder in 
        writing of the determination and provide the holder 30 days to 
        take such corrective actions as may be required by the 
        Secretary to prevent the Secretary from taking action against 
        the holder. If the Secretary takes action against the holder 
        because of the determination, the Secretary shall provide the 
        holder a written statement specifying the reasons for the 
        determination and provide the holder, on request, an 
        opportunity for an informal hearing with respect to the 
        determination.</DELETED>
                <DELETED>    ``(B) Limitation on the exportation of a 
                hazardous drug by an importer.--If at any time the 
                Secretary, or in the absence of the Secretary, the 
                official designated to act on behalf of the Secretary 
                determines that--</DELETED>
                        <DELETED>    ``(i) the holder of an approved 
                        application under paragraph (2) is exporting a 
                        drug from the United States to an 
                        importer;</DELETED>
                        <DELETED>    ``(ii) the importer is exporting 
                        the drug to a country for which the Secretary 
                        cannot make a finding under paragraph (1)(A); 
                        and</DELETED>
                        <DELETED>    ``(iii) the export presents an 
                        imminent hazard to the public health in the 
                        country,</DELETED>
                <DELETED>the Secretary shall immediately prohibit the 
                export of the drug to the importer, provide the person 
                exporting the drug from the United States prompt notice 
                of the determination, and afford the person an 
                opportunity for an expedited hearing. A determination 
                by the Secretary under this subparagraph may not be 
                stayed pending final action by a reviewing court. The 
                authority conferred by this subparagraph may not be 
                delegated by the Secretary.</DELETED>
                <DELETED>    ``(C) Limitation on the exportation of a 
                hazard drug by a holder.--If the Secretary, or in the 
                absence of the Secretary, the official designated to 
                act on behalf of the Secretary determines that the 
                holder of an approved application under paragraph (2) 
                is exporting a drug to a country for which the 
                Secretary cannot make a finding under paragraph (1)(A), 
                and that the export of the drug presents an imminent 
                hazard, the Secretary shall immediately prohibit the 
                export of the drug to such country, provide the holder 
                prompt notice of the determination, and afford the 
                holder an opportunity for an expedited hearing. A 
                determination by the Secretary under this subparagraph 
                may not be stayed pending final action by a reviewing 
                court. The authority conferred by this subparagraph 
                shall not be delegated by the Secretary.</DELETED>
                <DELETED>    ``(D) Limitation on the exportation of 
                other drugs by a holder.--If the Secretary receives 
                credible evidence that the holder of an application 
                approved under paragraph (2) is exporting a drug to a 
                country for which the Secretary cannot make a finding 
                under paragraph (1)(A), the Secretary shall give the 
                holder 60 days to provide information to the Secretary 
                respecting such evidence and shall provide the holder 
                an opportunity for an informal hearing on such 
                evidence. Upon the expiration of such 60 days, the 
                Secretary shall prohibit the export of such drug to 
                such country if the Secretary determines the holder is 
                exporting the drug to a country for which the Secretary 
                cannot make a finding under paragraph (1)(A).</DELETED>
                <DELETED>    ``(E) Limitation of the exportation of 
                other drugs by an importer.--If the Secretary receives 
                credible evidence that an importer is exporting a drug 
                to a country for which the Secretary cannot make a 
                finding under paragraph (1)(A), the Secretary shall 
                notify the holder of the application authorizing the 
                export of such drug of such evidence and shall require 
                the holder to investigate the export by such importer 
                and to report to the Secretary within 14 days of the 
                receipt of such notice the findings of the holder. If 
                the Secretary determines that the importer has exported 
                a drug to such a country, the Secretary shall prohibit 
                such holder from exporting such drug to the importer 
                unless the Secretary determines that the export by the 
                importer was unintentional.''.</DELETED>

<DELETED>SEC. 503. PARTIALLY PROCESSED BIOLOGICAL PRODUCTS.</DELETED>

<DELETED>    Subsection (h) of section 351 of the Public Health Service 
Act (42 U.S.C. 262) is amended to read as follows:</DELETED>
<DELETED>    ``(h) A partially processed biological product that--
</DELETED>
        <DELETED>    ``(1) is not in a form applicable to the 
        prevention, treatment, or cure of diseases or injuries of 
        man;</DELETED>
        <DELETED>    ``(2) is not intended for sale in the United 
        States; and</DELETED>
        <DELETED>    ``(3) is intended for further manufacture into 
        final dosage form outside the United States,</DELETED>
<DELETED>shall be subject to no restriction on the export of the 
product under this Act or the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et seq.) if the product is manufactured, processed, 
packaged, and held in conformity with current good manufacturing 
practice and meets the requirements of section 801(e)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(1)).''.</DELETED>

      <DELETED>TITLE VI--DRUG AND BIOLOGICAL PRODUCTS REGULATORY 
                            REFORM</DELETED>

<DELETED>SEC. 601. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Drug and Biological 
Product Regulatory Reform Act of 1995''.</DELETED>

<DELETED>SEC. 602. NEW DRUG APPROVAL STANDARD.</DELETED>

<DELETED>    Section 505(d) (21 U.S.C. 355(d)) is amended by adding at 
the end thereof the following new sentence: ``Substantial evidence may 
consist of data from one well-controlled clinical investigation (which 
may be waived by the Secretary) and confirmatory evidence (obtained 
either before or after such investigation).''.</DELETED>

<DELETED>SEC. 603. PILOT AND SMALL SCALE MANUFACTURE.</DELETED>

<DELETED>    Section 505(c) (21 U.S.C. 355(c)) is amended by adding at 
the end thereof the following new paragraph:</DELETED>
<DELETED>    ``(4) A new drug or biological product manufactured in a 
pilot or other small facility may be used to demonstrate the safety and 
effectiveness of the drug or product and to obtain approval prior to 
scaling up to a larger facility, unless the Secretary demonstrates in 
writing and specifying in detail the reasons, after an informal 
hearing, that a full scale production facility is necessary to ensure 
the safety or effectiveness of the drug or product.''.</DELETED>

<DELETED>SEC. 604. MANUFACTURING CHANGES.</DELETED>

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

<DELETED>``SEC. 750. MANUFACTURING CHANGES.</DELETED>

<DELETED>    ``(a) In General.--A change in the manufacture of a new 
drug, biological product, or new animal drug, may be made in accordance 
with this section.</DELETED>
<DELETED>    ``(b) Drug and Biological Product.--A change in the 
manufacture of a new drug, a biological product that is the subject of 
a monograph in an official compendium, a biological product that can be 
adequately characterized by chemical, physical, or biological means, or 
a new animal drug shall require--</DELETED>
        <DELETED>    ``(1) validation; and</DELETED>
        <DELETED>    ``(2)(A) if there is no change in the approved 
        qualitative and quantitative formulation or in the approved 
        release specifications, or if there is a change in the approved 
        qualitative or quantitative formula or in the approved release 
        specifications of a type permitted by the Secretary by 
        regulation, may be made at any time and shall be reported 
        annually to the Secretary; and</DELETED>
        <DELETED>    ``(B) for any other change, shall require 
        completion of an appropriate study demonstrating equivalence 
        according to criteria established by the Secretary (unless such 
        requirement is waived by the Secretary), may be made at any 
        time, and shall be reported to the Secretary through a 
        supplement or amendment submitted at the time the change is 
        made.</DELETED>
<DELETED>    ``(c) Biological Product Not Subject to a Monograph.--A 
change in the manufacture of a biological product that is not the 
subject of a monograph in an official compendium and cannot be 
adequately characterized by chemical, physical, or biological means 
shall require validation and--</DELETED>
        <DELETED>    ``(1) if the change relates solely to a 
        modification of the manufacturing facility or change in 
        personnel, with no change in the approved manufacturing process 
        or release specifications, may be made at any time and shall be 
        reported annually to the Secretary; and</DELETED>
        <DELETED>    ``(2) for any other change, shall require 
        completion of a bioassay or other appropriate study 
        demonstrating equivalence according to criteria established by 
        the Secretary (unless such requirement is waived by the 
        Secretary), may be made at any time, and shall be reported to 
        the Secretary through an amendment submitted at the time the 
        change is made.</DELETED>
<DELETED>    ``(d) Special Determination for a Biological Product.--A 
determination shall be made prior to approval of a biological product 
under section 351(a) of the Public Health Service Act (42 U.S.C. 
262(a)) whether the product can be adequately characterized for 
purposes of this subsection. With respect to biological products 
approved prior to the date of enactment of the Food and Drug 
Administration Performance and Accountability Act of 1995, the 
determination shall be made within 90 days after the date of enactment 
of such Act. Any determination under this subsection is subject to 
change based upon new scientific information.''.</DELETED>

<DELETED>SEC. 605. INSULIN AND ANTIBIOTICS.</DELETED>

<DELETED>    (a) Certification of Drugs Containing Insulin.--Section 
506 (21 U.S.C. 356) is repealed.</DELETED>
<DELETED>    (b) Certification of Antibiotics.--Section 507 (21 U.S.C. 
357) is repealed.</DELETED>
<DELETED>    (c) Exportation.--Section 802 (21 U.S.C. 382), as amended 
by section 502(b), is further amended by adding at the end thereof the 
following new subsection:</DELETED>
<DELETED>    ``(g) Exportation of Unapproved Products.--Insulin and 
antibiotics may be exported without regard to the requirements in this 
section if the insulin and antibiotics meet the requirements in 
subsection (e)(1).''.</DELETED>

<DELETED>SEC. 606. BIOLOGICAL PRODUCTS.</DELETED>

<DELETED>    (a) Modernization of Regulation of Biological Products.--
</DELETED>
        <DELETED>    (1) In general.--Section 351 of the Public Health 
        Service Act (42 U.S.C. 262) is amended by striking ``Sec. 351. 
        (a)'' and all that follows through ``exchange the same.'' and 
        inserting the following:</DELETED>
<DELETED>    ``Sec. 351. (a)(1) Except as provided in paragraph (4), no 
person shall introduce or deliver for introduction into interstate 
commerce any biological product unless--</DELETED>
        <DELETED>    ``(A) a product license has been issued for the 
        biological product;</DELETED>
        <DELETED>    ``(B) the biological product has been propagated, 
        manufactured, or prepared in accordance with good manufacturing 
        practices established by the Secretary under section 501(a) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)); 
        and</DELETED>
        <DELETED>    ``(C) each package of the biological product is 
        plainly marked with the proper name of the biological product 
        contained therein, the name, address and license number of the 
        manufacturer of the biological product, and the expiration date 
        of the biological product.</DELETED>
<DELETED>    ``(2) The Secretary shall establish, by regulation, 
requirements for product license applications for biological products. 
A product license application for a biological product, other than 
blood, blood components, and blood products, shall be approved based 
upon a demonstration that the product that is the subject of the 
application is safe and effective in accordance with section 505(d) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)). A license 
application for blood, a blood component, or a blood product shall be 
approved based upon a demonstration that the product that is the 
subject of the application is safe, pure, and, where appropriate, 
potent.</DELETED>
<DELETED>    ``(3)(A) If the Secretary determines that grounds for a 
suspension or revocation of a license for a biological product exist 
that constitute a danger to health, the Secretary shall suspend the 
license, notify the licensee of the suspension, and require 
notification of the suspension to any consignee. Within 30 days after 
the date of the receipt by the licensee of a notification of 
suspension, the Secretary shall afford the licensee an opportunity for 
a hearing in accordance with section 554 of title 5, United States 
Code.</DELETED>
<DELETED>    ``(B) If at any time before the Secretary has taken final 
action to suspend or revoke a license the licensee requests an 
inspection by the Secretary to determine whether the licensee is in 
compliance with applicable standards, the Secretary shall conduct an 
inspection within 30 days of the date of the request. If the Secretary 
fails to conduct the inspection within the 30 days, the action to 
suspend or revoke the license shall become null and void. If the 
inspection confirms that the licensee is in compliance with all 
applicable requirements, the Secretary shall withdraw any proposed 
action within 30 days of the inspection.</DELETED>
<DELETED>    ``(4) The requirements of paragraph (1) do not apply to a 
biological product for which there is in effect an investigational new 
drug application under section 505(i) of the Federal Food, Drug, and 
Cosmetic Act.''.</DELETED>
        <DELETED>    (2) Labeling.--Section 351(b) of the Public Health 
        Service Act (42 U.S.C. 262(b)) is amended to read as 
        follows:</DELETED>
<DELETED>    ``(b) No person shall falsely label or mark any package or 
container of any biological product or alter any label or mark on the 
package so as to falsify the label or mark.''.</DELETED>
        <DELETED>    (3) Inspection.--Section 351(c) of the Public 
        Health Service Act (42 U.S.C. 262(c)) is amended by striking 
        ``virus, serum, toxin, antitoxin, vaccine, blood, blood 
        component, or blood product, or derivative allergenic product 
        or other product aforesaid'' and inserting ``biological 
        product''.</DELETED>
        <DELETED>    (4) Definition; application.--Part F of title III 
        of the Public Health Service Act (42 U.S.C. 262 et seq.) is 
        amended by adding at the end thereof the following new 
        subsections:</DELETED>
<DELETED>    ``(i) For purposes of this section, the term `biological 
product' means a virus, therapeutic serum, toxin, antitoxin, vaccine, 
blood, blood component or derivative, allergenic biologic product, or 
arsphenamine or its derivative (or any other analogous biological 
product) applicable to the prevention, treatment, or cure of diseases 
or conditions of human beings.</DELETED>
<DELETED>    ``(j)(1) Sections 505(i), 903, and 904 of the Federal 
Food, Drug, and Cosmetic Act shall apply to all biological products and 
references in those sections to new drug applications shall be deemed 
to include product license applications.</DELETED>
<DELETED>    ``(2) Requirements involving labeling or advertising for 
biological products shall be established in accordance with sections 
201(m) and 502(n) of the Federal Food, Drug, and Cosmetic 
Act.</DELETED>
<DELETED>    (b) Harmonization of Regulation of Biological Products and 
New Drugs.--Not later than 2 years after the date of enactment of this 
section, the Secretary of Health and Human Services shall harmonize 
regulations governing product license applications required under 
section 351 of the Public Health Service Act (42 U.S.C. 262) with the 
regulations governing new drug applications required under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).</DELETED>

<DELETED>SEC. 607. REQUIREMENTS FOR EMERGING BIOTECHNOLOGY 
              PRODUCTS.</DELETED>

<DELETED>    Not later than 180 days after the date of enactment of 
this Act, the Secretary of Health and Human Services shall establish 
proposed regulations governing products of human tissue and cell 
therapy that shall--</DELETED>
        <DELETED>    (1) ensure the safety and effectiveness of the 
        products under section 351 of the Public Health Service Act (42 
        U.S.C. 262 et seq.); and</DELETED>
        <DELETED>    (2) take in account whether regulation of 
        facilities in which the products are manufactured or processed 
        is sufficient to ensure safety and effectiveness of the 
        products.</DELETED>

         <DELETED>TITLE VII--DEVICE REGULATORY REFORM</DELETED>

<DELETED>SEC. 701. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Medical Device Reform Act 
of 1995''.</DELETED>

<DELETED>SEC. 702. PREMARKET NOTIFICATION.</DELETED>

<DELETED>    (a) Exemption of Certain Devices.--Section 510 (21 U.S.C. 
360) is amended--</DELETED>
        <DELETED>    (1) in subsection (k), by striking ``intended for 
        human use'' and inserting `` intended for human use (except a 
        device that is classified into class I under section 513 or 520 
        or a device that is classified into class II under section 513 
        or 520, and is exempt from the requirements of this subsection 
        under subsection (l))'';</DELETED>
        <DELETED>    (2) by adding at the end of subsection (k) (as 
        amended by paragraph (1)) the following:</DELETED>
<DELETED>``The Secretary shall review the notification required by this 
subsection and make a determination under section 513(f)(1)(A) within 
90 days of receiving the notification.''; and</DELETED>
        <DELETED>    (3) by adding at the end thereof the following new 
        subsections:</DELETED>
<DELETED>    ``(l) Within 30 days of the date of enactment of this 
subsection, the Secretary shall publish in the Federal Register a list 
of each type of class II device that does not require a report under 
subsection (k) to provide reasonable assurance of safety and 
effectiveness. Each type of class II device so identified by the 
Secretary not to require the report shall be exempt from the 
requirement to file a report under subsection (k) as of the date of the 
publication of the list in the Federal Register. Beginning on the date 
that is 1 day after the date of the publication of a list under this 
subsection, any person may petition the Secretary to exempt a type of 
class II device from subsection (k). The Secretary shall respond to the 
petition within 120 days of the receipt of the petition and determine 
whether or not to grant the petition in whole or in part.</DELETED>
<DELETED>    ``(m) The Secretary may not withhold a determination of 
the initial classification of a device under subsection 513(f)(1) 
because of a failure to comply with any provision of this Act unrelated 
to a substantial equivalence decision, including a finding that the 
facility in which a device is manufactured is not in compliance with 
good manufacturing practice requirements as set forth in regulations 
promulgated under the authority of subsection 520(f).''.</DELETED>
<DELETED>    (b) Initial Classification.--Section 513(f)(1) (21 U.S.C. 
360c(f)(1)) is amended in the second sentence, by striking the period 
at the end thereof and inserting the following: ``, unless within 30 
days of receiving an order classifying the device into class III, the 
individual who submits a notification under section 510(k) requests an 
advisory committee review and recommendation with respect to the 
classification of the device and a final order of classification from 
the Secretary. After the request, a device classified into class III 
under this paragraph shall not be deemed to be finally classified until 
an advisory committee established under subsection (b) reviews the 
request with respect to the classification of the device and, within 60 
days of the date of receiving the request, recommends to the Secretary 
a classification for the device based on the classification criteria 
set forth in subparagraphs (A) through (C) of subsection(a)(1). 
Thereafter, the Secretary shall have 10 days to determine by order the 
final classification of the device by applying the classification 
criteria set forth in subparagraphs (A) through (C) of 
subsection(a)(1).</DELETED>
<DELETED>    (c) Substantial Equivalence.--Section 513(i)(1) (21 U.S.C. 
360c(i)(1)) is amended by adding at the end thereof the following new 
subparagraph:</DELETED>
<DELETED>    ``(C) For the purpose of determining the intended use of a 
predicate device under paragraph (A), each use included within a 
general use for the predicate device shall be deemed a legally marketed 
use of the predicate device for purposes of premarket notifications 
required under subsection 510(k).''.</DELETED>
<DELETED>    (d) Device Modification.--Section 513(i) (21 U.S.C. 
360c(i)) is amended by adding at the end thereof the following new 
paragraph:</DELETED>
<DELETED>    ``(4) Any change or modification to a device initially 
classified under section 513(f), other than a major change (including 
any major modification) in the intended use, shall not require an 
additional submission under section 510(k) if such change or 
modification is supported by appropriate data or information, and the 
change or modification can be shown to not adversely affect the safety 
or effectiveness of the device. All data or information relied upon to 
document that a change to (including any modification of) the device 
does not require an additional notification under section 510(k) shall 
be made available to the Secretary upon request and shall be 
maintained, at least for a period of time equal to the commercial life 
of the device.''.</DELETED>

<DELETED>SEC. 703. MEDICAL DEVICE APPROVAL STANDARDS.</DELETED>

<DELETED>    Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is 
amended--</DELETED>
        <DELETED>    (1) by striking ``well-controlled investigations'' 
        and inserting ``a scientific investigation'';</DELETED>
        <DELETED>    (2) by striking ``clinical investigations'' and 
        inserting ``a clinical investigation'';</DELETED>
        <DELETED>    (3) by striking ``investigations it'' and 
        inserting ``investigation it''; and</DELETED>
        <DELETED>    (4) by adding the following to the end thereof the 
        following new sentence: ``The Secretary may require a well-
        controlled clinical investigation to demonstrate effectiveness 
        if the director of the Office of Device Evaluation explains in 
        writing the basis therefor.''.</DELETED>

<DELETED>SEC. 704. TRACKING.</DELETED>

<DELETED>    Section 519(e) (21 U.S.C. 360i(e)) is amended to read as 
follows:</DELETED>

                  <DELETED>``device tracking</DELETED>

<DELETED>    ``(e) The Secretary may by regulation require a 
manufacturer to adopt a method of tracking a class II or class III 
device--</DELETED>
        <DELETED>    ``(1) the failure of which would be life-
        threatening or have permanently debilitating effects; 
        and</DELETED>
        <DELETED>    ``(2) which is--</DELETED>
                <DELETED>    ``(A) permanently implanted; or</DELETED>
                <DELETED>    ``(B) life sustaining or life supporting 
                and used outside a device user facility.''.</DELETED>

<DELETED>SEC. 705. POSTMARKET SURVEILLANCE.</DELETED>

<DELETED>    Section 522(1) (21 U.S.C. 360l) is amended to read as 
follows:</DELETED>

<DELETED>``SEC. 522. POSTMARKET SURVEILLANCE.</DELETED>

<DELETED>    ``(a) In General.--The Secretary may require a 
manufacturer to conduct postmarket surveillance for any device of the 
manufacturer first introduced or delivered for introduction into 
interstate commerce after January 1, 1991, that--</DELETED>
        <DELETED>    ``(1) is a permanent implant the failure of which 
        may cause serious, adverse health consequences or 
        death;</DELETED>
        <DELETED>    ``(2) is intended for a use in supporting or 
        sustaining human life; or</DELETED>
        <DELETED>    ``(3) potentially presents a serious risk to human 
        health.</DELETED>
<DELETED>    ``(b) Surveillance Approval.--Each manufacturer required 
to conduct a surveillance of a device under subsection (a) shall, 
within 30 days of receiving notice from the Secretary that the 
manufacturer is required under this section to conduct the 
surveillance, submit for the approval of the Secretary, a protocol for 
the required surveillance. The Secretary, within 60 days of the date of 
the receipt of the protocol, shall determine if the principal 
investigator proposed to be used in the surveillance has sufficient 
qualifications and experience to conduct the surveillance and if the 
protocol will result in collection of useful data or other information 
necessary to protect the public health and to provide safety and 
effectiveness information for the device. The Secretary may not approve 
the protocol until the protocol has been reviewed by a qualified 
scientific and technical review committee established by the 
Secretary.''.</DELETED>

<DELETED>SEC. 706. DEVICE DISTRIBUTOR REPORTING.</DELETED>

<DELETED>    Section 519 (21 U.S.C. 360i) is amended--</DELETED>
        <DELETED>    (1) by striking ``, importer, or distributor'' 
        each place it appears and inserting ``or importer'';</DELETED>
        <DELETED>    (2) in subsection (a)--</DELETED>
                <DELETED>    (A) in paragraph (8), by striking ``; 
                and'' and inserting a period; and</DELETED>
                <DELETED>    (B) by striking paragraph (9); 
                and</DELETED>
        <DELETED>    (3) by striking subsection (f).</DELETED>

<DELETED>SEC. 707. PREMARKET APPROVAL.</DELETED>

<DELETED>    (a) Action on Application.--Section 515(d) (21 U.S.C. 
360e(d)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1)(A), by striking ``paragraph 
        (2) of this subsection'' each place it appears and inserting 
        ``paragraph (4)'';</DELETED>
        <DELETED>    (2) in paragraph (1)(B), by adding at the end 
        thereof the following new clause:</DELETED>
<DELETED>    ``(iii) The Secretary shall accept and review data and any 
other information from investigations conducted under the authority of 
regulations required by section 520(g) to make a determination of 
whether there is a reasonable assurance of safety and effectiveness of 
a device subject to a pending application under this section if--
</DELETED>
        <DELETED>    ``(I) the data or information is derived from 
        investigations of an earlier version of the device, the device 
        has been modified during or after the investigations, and the 
        modification of the device does not constitute a significant 
        change in the design or in the basic principles of operation of 
        the device that would invalidate the data or information; 
        or</DELETED>
        <DELETED>    ``(II) the data or information on a device 
        approved under this section is available for use under this Act 
        and is relevant to the design and intended use of the device 
        subject to the pending application.'';</DELETED>
        <DELETED>    (3) by redesignating paragraphs (2) and (3) as 
        paragraphs (4) and (5), respectively; and</DELETED>
        <DELETED>    (4) by inserting after paragraph (1) the following 
        new paragraph:</DELETED>
<DELETED>    ``(2) Each application received under section 515(c) shall 
be reviewed in the following manner to achieve final action on the 
application within 180 days of the receipt of the 
application:</DELETED>
        <DELETED>    ``(A) The Secretary shall meet with an applicant 
        within 90 days of the receipt of the application to discuss the 
        review status of the application. If the application does not 
        appear in a form that would require an approval under 
        subsection (d), the Secretary shall in writing, and prior to 
        the meeting, present to the applicant a description of any 
        deficiencies in the application and what information is 
        required to bring the application into a form that would 
        require an approval.</DELETED>
        <DELETED>    ``(B) The Secretary shall refer an application to 
        a panel established under section 513 for review and an 
        approval recommendation, unless a panel is not required under 
        subsection (c)(2), within 30 days of the date of the meeting 
        referred to in subparagraph (A) or at the next scheduled panel 
        meeting following the meeting referred to in subparagraph (A), 
        whichever occurs later.</DELETED>
        <DELETED>    ``(C) The Secretary shall meet with the applicant 
        within 15 days of the date of the panel review to discuss the 
        status of the application, including a discussion on what 
        action is necessary to bring the application into a form that 
        would require approval under this subsection. Prior to the 
        meeting, the Secretary shall in writing shall set forth an 
        agenda for the meeting (including a complete description of the 
        subject matter to the discussed at the meeting), and a full 
        description of the additional information necessary to bring 
        the application into a form that would require an approval 
        under subsection (d). Participation of the applicant at such a 
        meeting shall be at the discretion of the applicant.</DELETED>
        <DELETED>    ``(D) The Secretary shall meet with the applicant 
        not later than 135 days after the receipt of an application 
        under subsection (c), if an advisory panel is not required 
        under subsection (c)(2), and inform the applicant whether or 
        not the application is in a form that would require approval 
        under subsection (d). If the application is in such form, the 
        Secretary shall, at or prior to the meeting, present in writing 
        to the applicant a description of all additional information 
        necessary to require an approval of the application under 
        subsection (d). If the application is not in such form, the 
        Secretary shall deny approval of the application and prior to 
        the meeting, present in writing to the applicant each basis for 
        denying approval of the application and the additional 
        information required to bring the application into a form that 
        would require approval.</DELETED>
        <DELETED>    ``(E) The Secretary shall issue an order approving 
        or denying an application within 180 days of the receipt of the 
        application under subsection (c).</DELETED>
<DELETED>    ``(3)(A) Except as provided in subparagraph (B), the time 
for the review of an application by the Secretary under this subsection 
shall take not more than 180 days and may not be extended if the 
application is amended.</DELETED>
<DELETED>    ``(B) The Secretary may not take more than 120 days for 
the review of an application subject to an expedited review under 
paragraph (1)(A) and may not extend the 120-day period if the 
application is amended.''.</DELETED>
<DELETED>    (b) Regulations.--The Secretary shall revise through 
notice and comment procedures the regulations set forth in part 814 of 
title 21 of the Code of Federal Regulations, to conform to the 
amendment made by paragraph (1) and to eliminate premarket approval of 
supplements that relate to manufacturing changes and other changes that 
do not affect device safety or effectiveness.</DELETED>

<DELETED>SEC. 708. DEVICE PERFORMANCE STANDARDS.</DELETED>

<DELETED>    (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) 
is amended by adding at the end thereof the following new 
subsection:</DELETED>

                  <DELETED>``product review</DELETED>

<DELETED>    ``(c)(1) For the purpose of facilitating a review of a 
device under sections 510(k), 515, and 520, any person may submit a 
petition under this subsection for the recognition by the Secretary of 
an existing performance standard for a device.</DELETED>
<DELETED>    ``(2) A petition under this subsection shall be made 
following the adoption of a voluntary performance standard by any 
qualified governmental or nongovernmental organization established to 
develop performance standards.</DELETED>
<DELETED>    ``(3) The petition shall identify the specific standard, 
the organization that adopted the standard, and the date on which the 
standard was adopted by the organization.</DELETED>
<DELETED>    ``(4) Upon the receipt of a petition under this 
subsection, the Secretary shall place the petition on public display 
and within 30 days after the date of the receipt of the petition, the 
Secretary shall publish a notice in the Federal Register setting forth 
the proposed standard, stating that the entire application is publicly 
available for review, and providing 60 days for public 
comment.</DELETED>
<DELETED>    ``(5) Within 150 days after the receipt by the Secretary 
of the application, the Secretary shall--</DELETED>
        <DELETED>    ``(A)(i) grant the petition in whole or in part; 
        or</DELETED>
        <DELETED>    ``(ii) deny the petition in whole or in part if 
        the Secretary demonstrates that the standard does not establish 
        an adequate performance standard for the functions of a device 
        for which the standard is represented to apply; and</DELETED>
        <DELETED>    ``(B) publish a notice of the determination in the 
        Federal Register.</DELETED>
<DELETED>    ``(6) Upon the approval of the petition, the Secretary 
shall publish in the Federal Register the order listing the name of the 
recognized standard and shall provide any person who requests the 
recognized standard a copy of the standard.</DELETED>
<DELETED>    ``(7) Following the publication of a final regulation 
listing a recognized standard, any premarket notification for a device 
submitted under sections 510(k), 513(f)(1), and 513(i) and any 
premarket approval application submitted under section 515 may include 
a certification of compliance with the standard, which shall constitute 
full and complete satisfaction of the requirements for safety and 
effectiveness for the functions of the device for which the standard is 
represented to apply.</DELETED>
<DELETED>    ``(8) Any modification of a recognized standard shall be 
subject to review under the procedure established in this subsection 
for the modified standard to become a recognized standard.''.</DELETED>
<DELETED>    (b) Adulterated Device.--Section 501(e) (21 U.S.C. 351(e)) 
is amended by striking ``section 514'' and inserting ``section 
514(b)''.</DELETED>

      <DELETED>TITLE VIII--ANIMAL DRUG REGULATORY REFORM</DELETED>

<DELETED>SEC. 801. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Animal Drug Regulatory 
Reform Act of 1995''.</DELETED>

<DELETED>SEC. 802. NEW ANIMAL DRUG APPROVAL STANDARDS.</DELETED>

<DELETED>    (a) Substantial Evidence.--Section 512(d)(3) (21 U.S.C. 
360b(d)(3)) is amended by adding at the end thereof the following new 
sentences: ``Substantial evidence shall consist of at least data from 
one scientifically sound study (designed and conducted in a manner that 
is consistent with generally recognized scientific procedures and 
principles), which may be waived by the Secretary, and confirmatory 
evidence obtained before or after the study. The Director of the Center 
for Veterinary Medicine may require a field trial as part of 
substantial evidence if the Director of the Center for Veterinary 
Medicine demonstrates, in writing and specifying the basis therefor, 
that no other form of scientifically sound study is adequate to show 
the effectiveness of the drug.''.</DELETED>
<DELETED>    (b) Combination of Drugs.--Section 512(d) (21 U.S.C. 
360b(d)) is amended by adding at the end thereof the following new 
paragraph:</DELETED>
<DELETED>    ``(4) If a new animal drug contains more than one active 
ingredient or the labeling provides for the drug's use in combination 
with one or more other animal drugs, in evaluating such combination the 
Secretary shall consider whether--</DELETED>
        <DELETED>    ``(A) the combination affects the safety of any 
        active ingredient;</DELETED>
        <DELETED>    ``(B) the combination interferes with a method of 
        analysis for any active ingredient;</DELETED>
        <DELETED>    ``(C) if the active ingredients have the same 
        intended effect, each of the active ingredients makes a 
        significant contribution to the labeled effectiveness; 
        and</DELETED>
        <DELETED>    ``(D) if the active ingredients do not have the 
        same intended effect, the active ingredients provide 
        appropriate concurrent therapy for a labeled target 
        population.''.</DELETED>
<DELETED>    (c) Approval.--Section 512(c)(2)(F)(iii) (21 U.S.C. 
360b(c)(2)(F)(iii)) is amended--</DELETED>
        <DELETED>    (1) by striking ``reports of new clinical or field 
        investigations (other than bioequivalence or residue studies) 
        and'' and inserting ``substantial evidence of effectiveness as 
        defined in subsection (d)(4), any study of animal safety, or''; 
        and</DELETED>
        <DELETED>    (2) by striking ``essential to'' and inserting ``, 
        required for''.</DELETED>

<DELETED>SEC. 803. RESIDUE LIMITATION.</DELETED>

<DELETED>    Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is amended 
to read as follows:</DELETED>
        <DELETED>    ``(F) on the basis of information in the 
        application or otherwise available to the Secretary, any 
        labeled use of the drug will result in an unsafe residue of the 
        drug;''.</DELETED>

<DELETED>SEC. 804. ADULTERATED DRUGS.</DELETED>

<DELETED>    Section 501(a)(2)  (21  U.S.C.  351(a)(2))  is  amended--
</DELETED>
        <DELETED>    (1) in subparagraph (A), by striking ``health; 
        or'' and inserting ``health''; and</DELETED>
        <DELETED>    (2) in subparagraph (B), by striking ``possess;'' 
        and inserting the following: ``possess; or (C) if it is a drug 
        intended for use by animals other than man and the methods used 
        in, or the facilities or controls used for, its manufacture, 
        processing, packing, or holding do not conform to or are not 
        operated or administered in conformity with current good 
        manufacturing practice requirements (appropriate for animal 
        drugs) adopted pursuant to regulations issued by the Secretary 
        to ensure that such drug meets the requirements of this Act as 
        to safety and has the identity and strength, and meets the 
        quality and purity characteristics, which it purports or is 
        represented to possess for use in animals other than 
        man;''.</DELETED>

          <DELETED>TITLE IX--FOOD REGULATORY REFORM</DELETED>

<DELETED>SEC. 901. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Food Regulatory Reform 
Act of 1995''.</DELETED>

<DELETED>SEC. 902. INDIRECT FOOD ADDITIVES.</DELETED>

<DELETED>    (a) Approval.--Section 409 (21 U.S.C. 348) is amended by 
adding at the end thereof the following new subsection:</DELETED>

          <DELETED>``alternative approval procedure</DELETED>

<DELETED>    ``(j)(1) As an alternative to the approval procedure 
established under subsection (b), any person may submit a notification 
for an indirect food additive under this subsection.</DELETED>
<DELETED>    ``(2) Any person who proposes to begin the introduction or 
delivery for introduction into interstate commerce of a product 
intended for use as an indirect food additive may submit to the 
Secretary, at least 90 days prior to making such introduction or 
delivery, a notification containing information demonstrating that the 
labeled use of the product is safe.</DELETED>
<DELETED>    ``(3)(A) Within 90 days after the receipt of the 
notification by the Secretary, the Secretary shall either--</DELETED>
        <DELETED>    ``(A)(i) approve the notification if the product 
        is safe for its intended use; or</DELETED>
        <DELETED>    ``(ii) disapprove the notification if there is a 
        reasonable possibility that the article is not safe for its 
        intended use; and</DELETED>
        <DELETED>    ``(B) publish a notice of this determination in 
        the Federal Register and, if the notification is approved, 
        promulgate an appropriate regulation pursuant to subsection 
        (c).</DELETED>
<DELETED>If the Secretary does not publish such a notice in the Federal 
Register within the 90-day period, the notification shall be deemed to 
be approved and the Secretary shall immediately approve the 
notification and promulgate an appropriate regulation in the Federal 
Register pursuant to subsection (c).''.</DELETED>
<DELETED>    (b) Definition.--Section 201 (21 U.S.C. 321), as amended 
by section 606(c), is further amended by adding at the end thereof the 
following new subsection:</DELETED>
<DELETED>    ``(ii) The term `indirect food additive' means a food 
additive that is intended to contact food but that is not intended for 
consumption as a food ingredient.''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Food and Drug Administration 
Performance and Accountability Act of 1996''.

SEC. 2. TABLE OF CONTENTS.

    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.
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.

               TITLE X--PROGRAM IN CLINICAL PHARMACOLOGY

Sec. 1001. Reauthorization of clinical pharmacology program.

SEC. 3. REFERENCES.

    Except as otherwise expressly provided, whenever in this Act an 
amendment or repeal is expressed in terms of an amendment to, or repeal 
of, a section or other provision, the reference shall be considered to 
be made to a section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321 et seq.).

                  TITLE I--MISSION AND ACCOUNTABILITY

SEC. 101. SHORT TITLE.

    This title may be cited as the ``Food and Drug Administration 
Regulatory Reform Act of 1996''.

SEC. 102. THE MISSION OF THE FOOD AND DRUG ADMINISTRATION.

    Section 903(a) (21 U.S.C. 393(a)) is amended by adding at the end 
thereof the following: ``The mission of the Administration is to 
promote and protect the public health by--
            ``(1) facilitating the rapid and efficient development and 
        availability of articles subject to the regulation of the 
        Administration;
            ``(2) protecting the public from unsafe or ineffective 
        articles subject to the regulation of the Administration; and
            ``(3) enforcing the applicable statutes and regulations in 
        a timely, fair, consistent, and decisive manner.''.

SEC. 103. PERFORMANCE STANDARDS AND REVIEW.

    Section 903(b) (21 U.S.C. 393(b)) is amended by adding at the end 
thereof the following new paragraph:
            ``(3) Performance standards and review.--
                    ``(A) In general.--Not later than 180 days after 
                the date of enactment of this paragraph, the Secretary, 
                after consultation with experts in the development, 
                clinical investigation, and regulation of drugs, 
                biological products, new animal drugs, devices, food 
                additives, and color additives and representatives of 
                patient and consumer advocacy groups, health and 
                technology professionals, and the regulated industries, 
                shall develop and publish in the Federal Register 
                quantifiable performance standards for action by the 
                Administration on--
                            ``(i) applications or submissions 
                        (including petitions, notifications, or any 
                        other similar form of request) for review of a 
                        protocol, a product investigation, a product 
                        approval, a new use approval, a manufacturing 
                        change, a change in labeling, or any other form 
                        of regulatory action relating to the review of 
                        an article that is a new drug, biological 
                        product, new animal drug, device, food 
                        additive, or color additive and that is subject 
                        to premarket review or approval under this Act; 
                        and
                            ``(ii) the scheduling of advisory committee 
                        meetings, and the action taken by the 
                        Administration following an advisory committee 
                        recommendation, relating to the applications 
                        and submissions described in clause (i).
                    ``(B) Review of performance standards.--The 
                performance standards required by subparagraph (A) 
                shall be reviewed annually by the Secretary, and after 
                consultation with experts in the development, clinical 
                investigation, and regulation of drugs, biological 
                products, new animal drugs, devices, food additives, 
                and color additives, and representatives of patient and 
                consumer advocacy groups, health and technology 
                professionals, and the regulated industries, may be 
                revised, annually by the Secretary.
                    ``(C) Agency objectives.--The performance standards 
                required by subparagraph (A) shall establish objectives 
                for the Administration that--
                            ``(i) expedite the clinical investigation 
                        of an article that is a new drug, device, or 
                        biological product through closer collaboration 
                        between the Administration and the sponsor of 
                        the investigation;
                            ``(ii) expedite the review of an 
                        application for a new drug, device, or 
                        biological product--
                                    ``(I) for an immediately life-
                                threatening disease or condition; or
                                    ``(II) for any other serious 
                                condition if the new drug, device, or 
                                biological product provides therapy 
                                that is not available from another 
                                approved therapy or offers significant 
                                improvement over another approved 
                                therapy or diagnostic or monitoring 
                                agents;
                            ``(iii) reduce backlogs in the review of 
                        all applications with the objective of 
                        eliminating all backlogs in the review of 
                        applications by January 1, 1998;
                            ``(iv) establish a schedule to bring the 
                        Administration into full compliance by July 1, 
                        1998, with the time periods specified in this 
                        Act for the review of all applications; and
                            ``(v) improve the consistency and fairness 
                        of the regulatory process of the 
                        Administration.
                The Secretary shall issue such other performance 
                standards that the Secretary determines will contribute 
                to the efficient, fair, and effective operation of the 
                Administration.
                    ``(D) Annual report.--The Secretary shall prepare 
                and publish in the Federal Register for public comment 
                an annual report that--
                            ``(i) provides detailed data on the actual 
                        performance of the Administration relating to 
                        the action taken by the Administration with 
                        respect to the applications and submissions 
                        described in subparagraph (A)(i) and the 
                        activities relating to advisory committees 
                        described in subparagraph (A)(ii);
                            ``(ii) compares the performance of the 
                        Administration with each applicable performance 
                        standard developed and published under 
                        subparagraph (A);
                            ``(iii) describes--
                                    ``(I) any priorities established 
                                with respect to action to be taken by 
                                the Administration on matters relating 
                                to the applications and submissions 
                                described in subparagraph (A)(i) and 
                                the activities relating to advisory 
                                committees described in subparagraph 
                                (A)(ii);
                                    ``(II) how such priorities are 
                                implemented; and
                                    ``(III) the data on each priority 
                                category;
                            ``(iv) analyzes any failure to achieve any 
                        of the performance standards;
                            ``(v) identifies regulatory policies that 
                        have a significant impact on compliance with 
                        the performance standards and analyzes how such 
                        policies could be modified in order to achieve 
                        compliance with the performance standards; and
                            ``(vi) sets forth a plan to achieve 
                        compliance with the performance standards that 
                        have not been met.
                    ``(E) Statistical information.--The report 
                described in subparagraph (D) shall include a full 
                statistical presentation relating to all applications, 
                petitions, or notifications for a new drug, device, 
                biological product, new animal drug, food additive, or 
                color additive approved by the Administration during 
                the year, taking into account the date of--
                            ``(i) the submission of any investigational 
                        application;
                            ``(ii) the application of any clinical 
                        hold;
                            ``(iii) the submission of any application, 
                        petition, or notification for approval or 
                        clearance;
                            ``(iv) the acceptance for filing of any 
                        application, petition, or notification for 
                        approval or clearance;
                            ``(v) the occurrence of any unapprovable 
                        action;
                            ``(vi) the occurrence of any approvable 
                        action; and
                            ``(vii) the approval or clearance of any 
                        application, petition, or notification.''.

SEC. 104. INTERAGENCY COLLABORATION.

    Section 903(b) (21 U.S.C. 393(b)), as amended by section 103, is 
further amended by adding at the end thereof the following new 
paragraph:
            ``(4) Interagency collaboration.--The Secretary shall 
        implement programs and policies that will foster collaboration 
        between the Administration, the National Institutes of Health, 
        and other Federal science-based agencies, to enhance the 
        scientific expertise available to the Commissioner for the 
        evaluation of emerging medical therapies, including 
        complementary therapies, and advances in nutrition and food 
        science.''.

SEC. 105. INFORMATION SYSTEM.

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

``SEC. 906. INFORMATION SYSTEM.

    ``The Secretary shall establish and maintain an information system 
to track the status and progress of each application or submission 
(including a petition, notification, or other similar form of request) 
for the approval or clearance of a drug, biological product, new animal 
drug, device, food additive, or color additive submitted to the Food 
and Drug Administration. The system shall permit access by the 
applicant, petitioner, or the person who submits a notification.''.

SEC. 106. POLICY STATEMENTS.

    Section 701(a) (21 U.S.C. 371(a)) is amended--
            (1) by striking ``(a) The'' and inserting ``(a)(1) The''; 
        and
            (2) by adding at the end thereof the following new 
        paragraph:
    ``(2)(A) Not later than 180 days after the date of enactment of the 
Food and Drug Administration Performance and Accountability Act of 
1996, the Secretary shall establish a procedure governing the 
development and use of all policy statements of general applicability 
that provide guidance relating to the conduct of preclinical or 
clinical investigations or other testing to support an application or 
submission (including a petition, notification, or any other similar 
form of request) under section 409, 505, 510(k), 512, 515, or 721 or 
that provide guidance on the submission of an application or submission 
(including a petition, notification, or any other similar form of 
request) under section 409, 505, 510(k), 512, 515, or 721 (including 
any guidance, guideline, points-to-consider, protocol, recommendation, 
or similar document regardless of the form or designation). The 
procedure shall provide an opportunity for affected persons to 
participate in the development and continued use of a policy statement 
by sharing expertise or experience, or providing comment, before the 
policy statement is adopted and after the policy statement is 
implemented, except that if the Secretary determines that there is a 
public health need to issue the policy statement immediately, the 
Secretary shall provide an opportunity for affected persons to provide 
comment promptly after the policy statement is issued.
    ``(B) The Secretary shall establish a procedure for the periodic 
compilation and publication of all policy statements of general 
applicability (including any guideline, points-to-consider, protocol, 
recommendation, or similar document regardless of the form or 
designation).''.

SEC. 107. SCIENTIFIC REVIEW GROUPS.

    Section 904 (21 U.S.C. 394) is amended--
            (1) by striking ``Without'' and inserting ``(a) In 
        General.--Without''; and
            (2) by adding at the end thereof the following new 
        subsections:
    ``(b) Delegation of Appointment Authority.--The Commissioner may 
not delegate the appointment and oversight authority granted under 
subsection (a).
    ``(c) Membership and Meeting Requirements.--
            ``(1) Scope.--The Commissioner shall consult with a 
        scientific review group in determining the matters that the 
        group will consider at the meetings of the scientific review 
        group.
            ``(2) Notification of scope of discussion.--To the extent 
        feasible, the specific matters (including questions) to be 
        discussed at a meeting of a scientific review group shall be 
        publicly announced and published in the Federal Register at 
        least 30 days prior to the date of the meeting.
            ``(3) Terms.--A member of a scientific review group shall 
        serve for a term of 3 years, and may have such membership 
        renewed for not more than 1 additional term. An individual may 
        serve on more than one scientific review group. The chairperson 
        of a scientific review group shall be a member who has served 
        on the scientific group for at least 3 years. The term of the 
        chairperson may be renewed for not more than 3 terms.
            ``(4) Training.--Prior to service on a scientific review 
        group, a member of the group shall be given adequate education 
        and training relating to the responsibilities of the member.
            ``(5) Frequency of meetings.--The Secretary shall take 
        whatever action is necessary to ensure that regular meetings 
        are held by scientific review groups, at appropriate intervals 
        and for a sufficient length of time. The meetings shall occur 
        not less than 3 times each year unless the Secretary determines 
        that there are sufficient reasons for fewer meetings.
    ``(d) Access to Information; Participation by Interested Persons in 
Meetings.--
            ``(1) In general.--When a scientific review group reviews 
        an application or submission (including a petition, 
        notification, or any other similar form of request) for 
        approval or clearance, or some part thereof, submitted for an 
        article under section 409, 505, 510(k), 513(f), 512, 515, or 
        721, the Secretary shall provide the person who submitted the 
        application or submission with copies of all documents provided 
        to the members of the scientific review group in preparation 
        for a meeting of the scientific review group. The Secretary 
        shall provide such documents to the person at the same time 
        such documents are provided to the members of the scientific 
        review group. Before the meeting, the person shall have an 
        opportunity to submit documents to the members of the 
        scientific review group in response to the Secretary's 
        documents. The person shall provide the documents to the 
        Secretary, who shall immediately provide copies of the 
        documents to the members of the scientific review group.
            ``(2) Participation in meetings.--Any meeting of a 
        scientific review group shall include adequate time for initial 
        presentations and for response to any differing views and the 
        group shall encourage free and open participation by all 
        interested persons.
    ``(e) FDA Actions.--Not later than 60 days after the date a 
scientific review group makes its conclusions and recommendations on 
any matter under review of the group, the official of the Food and Drug 
Administration responsible for the matter shall review the conclusions 
and recommendations of the group, make a final determination on the 
matter, and notify the affected persons of the determination in writing 
and, if the determination differs from the conclusions and 
recommendations of the group, include the reasons for the 
difference.''.

SEC. 108. APPEALS WITHIN THE FOOD AND DRUG ADMINISTRATION.

    Chapter IX (21 U.S.C. 391 et seq.), as amended by section 105, is 
further amended by adding at the end thereof the following new section:

``SEC. 907. APPEALS WITHIN THE FOOD AND DRUG ADMINISTRATION.

    ``(a) Employee Decisions.--The Secretary shall by regulation 
establish an internal appeal system within the Food and Drug 
Administration for the appeal of any decision made by an employee of 
the Food and Drug Administration, except that this subsection shall not 
apply to decisions involving formal administrative or judicial 
proceedings. As the final stage in the internal appeal system, the 
Secretary shall provide for the right to request an evaluation by an 
appropriate scientific review group of a final decision of the 
Secretary on an appeal involving a significant scientific issue. Upon 
receipt of such a request, the Secretary shall refer the request to the 
chairperson of the appropriate scientific review group, or a member 
designated by the chairperson, who shall review the request and 
determine whether the scientific review group should conduct an 
evaluation. The Secretary shall make publicly known the existence of 
the internal appeal system and the procedures for an internal appeal.
    ``(b) Review by Scientific Review Group.--
            ``(1) In general.--The sponsor of a preclinical or clinical 
        investigation, or the applicant for the approval or clearance 
        of an application or submission (including a petition, 
        notification, or any other similar form of request), shall have 
        the right to request an evaluation by an appropriate scientific 
        review group established under section 904 of any significant 
        scientific issue pending before, or any significant scientific 
        decision made by, the Secretary under this Act. An appropriate 
scientific review group shall review the request and determine whether 
to conduct an evaluation within 30 days after the date the request is 
received by the Secretary.
            ``(2) Scope.--The significant scientific issues that a 
        scientific review group may evaluate include matters involving 
        a decision by the Secretary not to permit a clinical 
        investigation to begin or to continue, a refusal by the 
        Secretary to file an application, a protocol design, and 
        decisions relating to a pending application or submission 
        (including a petition, notification, or any other similar form 
        of request). The significant scientific issues shall not have 
        been previously reviewed by a scientific review group.
            ``(3) Time limitation.--If a scientific review group agrees 
        to conduct an evaluation on an issue under paragraph (1), the 
        evaluation shall be scheduled for the next meeting of the 
        group.
    ``(c) Additional Informal and Formal Procedures.--
            ``(1) In general.--For purposes of obtaining conclusions 
        and recommendations regarding the resolution of any significant 
        scientific dispute, the Secretary is authorized to use such 
        additional informal and formal procedures as may be considered 
        useful. The procedures may include the use of--
                    ``(A) panels of qualified Food and Drug 
                Administration officials to make conclusions and 
                recommendations regarding the resolution of any 
                significant scientific dispute;
                    ``(B) panels of qualified Federal Government 
                employees who are not employees of the Food and Drug 
                Administration to make conclusions and recommendations 
                regarding the resolution of any significant scientific 
                dispute; and
                    ``(C) outside mediators and arbitrators who are not 
                Federal Government employees to make conclusions and 
                recommendations regarding the resolution of any 
                significant scientific dispute.
            ``(2) Application of faca.--The Federal Advisory Committee 
        Act (5 U.S.C. App. 2) shall not apply to a panel described in 
        paragraph (1).
    ``(d) Review of Recommendations.--Not later than 60 days after the 
date on which a matter that is presented for resolution under this 
section has been the subject of conclusions and recommendations, the 
official of the Food and Drug Administration responsible for the matter 
shall review the conclusions and recommendations, make a final 
determination on the matter, and notify the parties of the 
determination in writing and if the determination differs from the 
conclusions and recommendations, the reasons for the difference.''.

SEC. 109. APPOINTMENT AND TERM OF THE COMMISSIONER OF FOOD AND DRUGS.

    (a) Purpose.--It is the purpose of this section to promote 
increased accountability of the Commissioner of Food and Drugs by 
providing for a limited term of appointment for the Commissioner of 
Food and Drugs.
    (b) Limitation.--Section 903(b)(1) (21 U.S.C. 393(b)(1)) is amended 
by striking ``the Senate.'' and inserting ``the Senate for a term of 5 
years. The Commissioner shall be appointed to serve 1 term. An 
individual serving in the office of Commissioner may be removed from 
office only pursuant to a finding by the President of neglect of duty 
or malfeasance in office.''.
    (c) Applicability.--The amendment made by subsection (b) shall not 
apply to the tenure of the individual who is serving as the 
Commissioner of Food and Drugs on the date of enactment of this Act.

   TITLE II--EXPEDITED ACCESS TO PRODUCTS FOR SERIOUSLY ILL PATIENTS

SEC. 201. SHORT TITLE.

    This title may be cited as the ``Patient Rights Regulatory Reform 
Act of 1996''.

SEC. 202. ACCESS TO UNAPPROVED THERAPIES.

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

``Subchapter D--Unapproved Therapies and Diagnostics and Collaborative 
                                Research

``SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS.

    ``(a) In General.--Any person, through a licensed health care 
practitioner or licensed health care professional, may request from a 
manufacturer or distributor, and any manufacturer or distributor may 
provide to a person after compliance with the provisions of this 
section, an investigational drug (including a biological product) or 
investigational device for the diagnosis, monitoring, or treatment of a 
serious disease or condition, an immediately life-threatening or 
seriously debilitating disease or condition, or any other disease or 
condition designated by the Secretary as appropriate for expanded 
access under this section if--
            ``(1) the person has no comparable or satisfactory 
        alternative therapy available to treat, diagnose, or monitor 
        the disease or condition;
            ``(2) the risk to the person from the investigational drug 
        or device is not greater than the risk from the disease or 
        condition; and
            ``(3) an exemption for the investigational drug or device 
        is in effect under a regulation promulgated pursuant to section 
        505(i) or 520(g) and the sponsor and investigators comply with 
        such regulation.
    ``(b) Protocols.--A manufacturer or distributor may submit to the 
Secretary 1 or more expanded access protocols covering expanded access 
use of a drug or device described in subsection (a). The protocols 
shall be subject to the provisions of section 505(i) for a drug and 
section 520(g) for a device and may include any form of use of the drug 
or device outside a clinical investigation, prior to approval of the 
drug or device for marketing, including protocols for treatment, use, 
parallel track, emergency use, uncontrolled trials, and single patient 
protocols.
    ``(c) Fees.--A manufacturer or distributor may assess a fee for an 
investigational drug or device under an expanded access protocol so 
long as the fee is not more than that necessary to recover the costs of 
the manufacture and handling of the drug or device. The Secretary shall 
be notified in advance of the assessing of any such fees.
    ``(d) Notification of Availability.--The Commissioner shall inform 
national, State, and local medical associations and societies, 
voluntary health associations, and other appropriate persons about the 
availability of an investigational drug or device under expanded access 
protocols under this section. Such notification shall identify--
            ``(1) the investigational drug or device;
            ``(2) the expanded access use of the investigational drug 
        or device; and
            ``(3) the name and address of the manufacturer or 
        distributor that is providing the investigational drug or 
        device for expanded access use.''.

SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES.

    Section 520(m) (21 U.S.C. 360j(m)) is amended--
            (1) in paragraph (2), by inserting at the end thereof the 
        following flush sentences:
``The request shall be in the form of an application submitted to the 
Secretary. Not later than 30 days after the date of the receipt of the 
application, the Secretary shall issue an order approving or denying 
the application.'';
            (2) by striking paragraph (5); and
            (3) by striking paragraph (6).

SEC. 204. EXPEDITING APPROVAL OF NEW DRUGS, BIOLOGICS, AND MEDICAL 
              DEVICES FOR SERIOUS CONDITIONS.

    (a) New Drugs.--Section 505(c)(1) (21 U.S.C. 355(c)(1)) is amended 
by adding at the end thereof the following flush sentence:
``In a case in which an application is submitted under subsection 
(b)(1) for a new drug, or section 351(a) of the Public Health Service 
Act for a biological product, that is intended for use for an 
immediately life-threatening or serious disease or condition and that 
provides therapy or diagnosis not available from another approved drug 
or biological product or offers significant improvement over another 
approved drug or biological product, the Secretary shall approve or 
deny approval of the application within 180 days after the receipt of 
the application.''.
    (b) Premarket Approval.--
            (1) Amendment.--Section 515(d)(1)(A) (21 U.S.C. 
        360e(d)(1)(A)) is amended by adding at the end thereof the 
        following flush sentence:
``With respect to an application submitted under this subsection for a 
device for a life-threatening disease or condition, a seriously 
debilitating disease or condition, or for any other serious disease or 
condition that provides therapy or diagnosis not available from another 
approved device or offers a significant improvement over another 
approved device, the Secretary shall approve or deny the approval of 
the application within 180 days after the receipt of the 
application.''.
            (2) Effective date.--The amendment made by paragraph (1) 
        shall take effect on July 1, 1998.

       TITLE III--REVITALIZING THE INVESTIGATION OF NEW PRODUCTS

SEC. 301. SHORT TITLE.

    This title may be cited as the ``Investigational Products 
Regulatory Reform Act of 1996''.

SEC. 302. TIMELY REVIEW AND REASONABLE DATA REQUIREMENTS FOR CLINICAL 
              RESEARCH ON DRUGS AND BIOLOGICAL PRODUCTS.

    Section 505(i) (21 U.S.C. 355(i)) is amended--
            (1) by striking ``(i) The'' and inserting ``(i)(1) The'';
            (2) by redesignating paragraphs (1), (2), and (3) as 
        subparagraphs (A), (B), and (C), respectively; and
            (3) by adding at the end thereof the following new 
        paragraphs:
    ``(2)(A) A clinical investigation of a new drug (including a 
biological product) may begin 30 days after the date on which the 
Secretary receives from the sponsor of the investigation a notification 
containing information about the drug and the clinical investigation 
unless, prior to the 30-day period, the Secretary informs the sponsor 
in writing that the investigation may not begin, and specifies the 
basis for the decision and the information needed in order for the 
clinical investigation to commence.
    ``(B) Not later than 1 year after the date of enactment of the Food 
and Drug Administration Performance and Accountability Act of 1996, the 
Secretary, after consultation with experts in the development, clinical 
investigation, and regulation of drugs, physicians and other health 
care practitioners, and representatives of patient and consumer 
advocacy groups and the regulated industries, shall publish in the 
Federal Register criteria for the type and amount of information 
relating to the safety of an investigational drug to be included in a 
notification described in subparagraph (A). In the establishment of the 
criteria, the Secretary shall take into account the recommendations of 
the International Conference on Harmonization of Technical Requirements 
for Registration of Pharmaceuticals for Human Use. The Secretary shall 
periodically review, and may revise, the criteria.
    ``(C) The Secretary shall establish a mechanism to ensure the fair 
and consistent application of safety standards for clinical 
investigations.
    ``(3)(A) The Secretary may place a clinical hold on any ongoing 
clinical investigation if the Secretary determines that such action is 
necessary for the protection of human subjects.
    ``(B) If the Secretary places a clinical hold on a clinical 
investigation, the Secretary shall immediately advise the sponsor for 
the investigation in writing of such action, and provide the sponsor an 
opportunity to meet with the Secretary, not later than 10 business days 
after the receipt of such a communication, to discuss the clinical 
hold. Not later than 10 days after such a meeting, the Secretary shall 
provide to the sponsor in writing the conditions for the withdrawal of 
the clinical hold. Any written request received by the Secretary from 
the sponsor requesting that a clinical hold be removed shall receive a 
decision, in writing and specifying the reasons therefor, not later 
than 20 days after the receipt of the request.''.

SEC. 303. TIMELY REVIEW AND REASONABLE DATA REQUIREMENTS FOR CLINICAL 
              RESEARCH ON DEVICES.

    Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end 
thereof the following new paragraphs:
    ``(6) The procedures and conditions prescribed pursuant to 
paragraph (2)(A) shall be subject to subparagraphs (B) and (C) of 
section 505(i)(2), except that the provision of subparagraph (B) of 
such section relating to the consideration of the recommendations of 
the International Conference on Harmonization of Technical Requirements 
for Registration of Pharmaceuticals for Human Use shall not apply to 
this paragraph.
    ``(7) The Secretary shall, not later than 120 days after the date 
of enactment of this paragraph, by regulation amend the content of 
parts 812 and 813 of title 21 of the Code of Federal Regulations to 
update the procedures and conditions under which devices intended for 
human use may upon application be granted an exemption from certain 
requirements under this Act. The regulation shall--
            ``(A) permit developmental changes in devices, including 
        manufacturing changes, in response to information collected 
        during an investigation without requiring an additional 
        approval of an application for an investigational device 
        exemption or the approval of a supplement to the application, 
        if the sponsor of the investigation determines that, prior to 
        making any changes, the changes do not constitute a significant 
        change in design or a significant change in basic principles of 
        operation; and
            ``(B) permit, without approval of a supplement to an 
        application for an investigational device exemption, changes or 
        modifications to clinical protocols that do not affect the 
        validity of data or information resulting from the completion 
        of an approved protocol so long as such changes do not affect 
        any patient protection provisions of the protocol.''.

SEC. 304. SENSE OF THE COMMITTEE CONCERNING MUTUAL RECOGNITION 
              AGREEMENTS.

    (a) Findings.--The Committee on Labor and Human Resources of the 
Senate finds that there have been lengthy discussions between the 
members of the European Union and the Commissioner of Food and Drugs on 
the issue of mutual recognition agreements relating to the regulation 
of drugs, biological products, devices, foods, food additives, and 
color additives, and the regulation of good manufacturing practices.
    (b) Sense of the Committee.--It is the sense of the Committee on 
Labor and Human Resources of the Senate that--
            (1) the Secretary of Health and Human Services, in 
        consultation with the Secretary of Commerce, should move toward 
        the acceptance of mutual recognition agreements relating to the 
        regulation of drugs, biological products, devices, foods, food 
        additives, and color additives, and the regulation of good 
        manufacturing practices, reached between the European Union and 
        the Commissioner of Food and Drugs;
            (2) the Secretary of Health and Human Services should 
        regularly participate in meetings with other foreign 
        governments to discuss and reach agreement on methods and 
        approaches to harmonize regulatory requirements; and
            (3) the Office of International Relations of the Department 
        of Health and Human Services (as established under section 803 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 383)) 
        should have the responsibility of ensuring that the process of 
        harmonizing international regulatory requirements is 
        continuous.

SEC. 305. COLLABORATIVE RESEARCH DESIGN.

    Chapter V (21 U.S.C. 351 et seq.), as amended by section 202, is 
further amended by adding at the end thereof the following new section:

``SEC. 552. COLLABORATIVE RESEARCH DESIGN.

    ``(a) Review of Design.--
            ``(1) Request.--Any person who intends to sponsor a 
        preclinical or clinical investigation of a drug (including a 
        biological product) or device may request a meeting with the 
        Secretary to review the design of 1 or more protocols for the 
        preclinical or clinical testing of the drug or device.
            ``(2) Form.--A request described in paragraph (1) shall be 
        in writing and shall include any protocol for which the review 
        is requested. A protocol shall be designed so that the fewest 
        number of patients and procedures necessary to obtain data 
        necessary for the approval of a new drug, biological product, 
        or device is required, consistent with public health and 
        safety.
            ``(3) Written review.--The Secretary shall meet with the 
        person within 30 days after the request and shall provide to 
        the person a written review of the protocol, including any 
        deficiencies in the protocol. A written summary shall be made 
        of the meeting. The summary shall include the written review of 
        the protocol and, after agreement by the person and the 
        Secretary, shall be made part of the product review file 
        maintained by the Food and Drug Administration.
    ``(b) Modification of Agreements.--Any agreements reached through 
meetings with respect to the design of any protocol under subsection 
(a) may be modified only in accordance with the following provisions:
            ``(1) An agreement may be modified at any time by mutual 
        consent of the sponsor of a preclinical or clinical 
        investigation and the Secretary.
            ``(2) An agreement may be modified by the sponsor 
        unilaterally, if the change is to a protocol and the change is 
        one that would not require the approval of the Secretary under 
        the applicable regulations.
            ``(3) An agreement may be modified by the Secretary 
        unilaterally, if the change to the agreement is--
                    ``(A) made by the director of the office of the 
                Food and Drug Administration responsible for regulating 
                the drug or device that is the subject of the 
                agreement; and
                    ``(B) set forth in writing, including an 
                explanation of the scientific or clinical need for the 
                change.
The director described in paragraph (3)(A) may not delegate the 
regulatory responsibility described in such paragraph.
    ``(c) Appeals.--Any person requesting a meeting under subsection 
(a) may appeal the decision of the Secretary to disapprove or modify an 
agreement or protocol under section 907.
    ``(d) Guidelines and Limitation.--The Secretary shall issue 
guidelines to implement this section. Such guidelines shall address the 
responsibilities of the person requesting the meeting, as well as the 
responsibilities of the Secretary. Repeated failure to follow the 
guidelines may be grounds for a refusal by the Secretary to meet with a 
person requesting a meeting under this section.''.

       TITLE IV--EFFICIENT, ACCOUNTABLE, AND FAIR PRODUCT REVIEW

SEC. 401. SHORT TITLE.

    This title may be cited as the ``Product Review Regulatory Reform 
Act of 1996''.

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

    Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at the end 
thereof the following new subchapter:

  ``Subchapter D--Review of Applications, Inspections, Environmental 
               Impact Reviews, and Manufacturing Changes

``SEC. 741. CONTENT AND REVIEW OF AN APPLICATION.

    ``(a) In General.--This section applies to an application or 
submission (including a petition, notification, or any other similar 
form of request) submitted for approval or clearance of a new drug, 
device, biological product, new animal drug, animal feed bearing or 
containing a new animal drug, color additive, or food additive.
    ``(b) Filing Requirements.--Not later than 60 days after the date 
of enactment of this section, the Commissioner shall establish and 
publish in the Federal Register a mechanism to ensure the fair and 
consistent application of filing requirements.
    ``(c) Classification of a Product.--Not later than 60 days after 
the receipt of a written request of a person who submits an application 
or submission (including a petition, notification, or any other similar 
form of request) for information respecting the classification of an 
article as a drug, biological product, or device or the component of 
the Food and Drug Administration that will regulate the article 
(including a request respecting a combination product subject to 
section 503(g)), the Secretary shall provide the person a written 
statement that identifies the classification of the article or the 
component of the Food and Drug Administration that will regulate the 
article. The Secretary's statement shall be binding and may not be 
modified by the Secretary except with the written agreement of the 
person who submitted the request. If the Secretary does not provide the 
statement within the 60-day period, the classification and component 
designated by the person submitting the request shall be final and 
binding and may not be modified by the Secretary except with the 
written agreement of the person.
    ``(d) Reasonable Data Requirements.--Not later than 1 year after 
the date of enactment of the Food and Drug Administration Performance 
and Accountability Act of 1996, the Secretary, after consultation with 
experts in the development and testing of articles that are new drugs, 
biological products, devices, food additives, new animal drugs, animal 
feed bearing or containing a new animal drug, color additives, or food 
additives, experts in the regulation of such articles, consumer and 
patient advocacy groups, and the regulated industries, shall publish in 
the Federal Register criteria for the type and amount of information 
relating to safety or effectiveness to be included in an application 
for the approval of an article that is a new drug, biological product, 
device, food additive, new animal drug, animal feed bearing or 
containing a new animal drug, color additive, or food additive, or a 
new use of an approved article that is a new drug, biological product, 
device, food additive, new animal drug, animal feed bearing or 
containing a new animal drug, color additive, or food additive. In 
establishing the criteria for drugs, the Secretary shall consider any 
recommendations of the International Conference on Harmonization of 
Technical Requirements for Registration of Pharmaceuticals for Human 
Use.''.

SEC. 403. CONTRACTS FOR EXPERT REVIEW.

    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 402, is 
further amended by adding at the end thereof the following new section:

``SEC. 742. CONTRACTS FOR EXPERT REVIEW.

    ``(a) In General.--
            ``(1) Authority.--The Secretary may contract with outside 
        organizations and individuals, with expertise in relevant 
        disciplines, to review, evaluate, and make conclusions and 
        recommendations to the Secretary on parts or all of any 
        application or submission (including a petition, notification, 
        or any other similar form of request). The Secretary shall 
        retain full authority to make determinations with respect to 
        the approval or disapproval of any article, or the 
        classification of a device under section 513(f)(1). Any such 
        contract shall be subject to the requirements of section 708. 
        Funds obtained under part 2 of subchapter C may be used for 
        external review of any drug (including a biological product) 
        for which a user fee was paid.
            ``(2) Increased efficiency and expertise through 
        contracts.--The Secretary shall use the authority granted in 
        paragraph (1)--
                    ``(A) for the review of categories of indirect food 
                additive petitions and notifications for clearance 
                under section 510(k);
                    ``(B) whenever contracts will improve the 
                efficiency, timeliness, and quality of the review of 
                applications or submissions (including petitions, 
                notifications, or any other similar form of requests) 
                for the approval or clearance of new drugs, new animal 
                drugs, biological products, devices, and food 
                additives; and
                    ``(C) whenever contracts will increase the 
                scientific and technical expertise that is necessary to 
                keep informed of emerging new therapies and 
                technologies that pose significant new scientific and 
                technical issues.
        The Secretary shall retain full authority to make 
        determinations with respect to the approval or disapproval of 
        an article, or the classification of an article as a device 
        under section 513(f)(1).
    ``(b) Eligibility Requirements.--Not later than 90 days after the 
date of enactment of this section, the Secretary shall by regulation 
establish the requirements that an organization or individual shall 
meet to be eligible to conduct reviews under subsection (a). Such 
regulations shall provide for the protection of confidential or 
proprietary information and shall provide for protection against 
conflicts of interest.
    ``(c) Review of Expert's Evaluation.--
            ``(1) In general.--Subject to paragraph (2), the official 
        of the Food and Drug Administration responsible for any matter 
        for which expert review is used pursuant to this section shall 
        review the conclusions and recommendations of the expert review 
        organization or individual and shall make a final decision 
        regarding the matter under review within 60 days after 
        receiving the conclusions and recommendation.
            ``(2) Limitation.--A final decision under paragraph (1) 
        shall be made within the applicable prescribed time period for 
        review of an application as set forth in this Act.
    ``(d) Report to Congress.--Not later than 2 years after the date of 
enactment of this section, the Secretary shall prepare and submit to 
Congress a report on the use of the authority to contract with outside 
organizations and individuals for expert reviews. Such report shall 
include an evaluation of the extent to which such contracting improves 
the efficiency of review and the expertise available to the Food and 
Drug Administration.''.

SEC. 404. PROMPT AND EFFICIENT REVIEW.

    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 403, is 
further amended by adding at the end thereof the following new section:

``SEC. 743. PROMPT AND EFFICIENT REVIEW.

    ``(a) In General.--The provisions of this section shall apply to 
any of the following applications, petitions, and notifications:
            ``(1) A petition for the issuance of a regulation 
        prescribing the safe use of a human food additive or animal 
        feed additive under section 409.
            ``(2) An application for approval of a new drug under 
        section 505.
            ``(3) An application for approval of a new animal drug or 
        an animal feed bearing or containing a new animal drug under 
        subsection (b) or (m) of section 512, respectively.
            ``(4) A notification submitted under section 510(k) for 
        classification of a device.
            ``(5) An application for approval of a device under section 
        515.
            ``(6) A petition for issuance of a regulation for the 
        listing of a color additive under section 721.
    ``(b) Review Procedures and Policies.--The Secretary shall 
establish procedures and policies to facilitate a collaborative review 
process between the Commissioner and the applicant, petitioner, or 
person who submits a notification with respect to an application, 
petition, or notification described in subsection (a). As part of this 
collaborative process--
            ``(1) open, informal, and prompt communications shall be 
        encouraged;
            ``(2) meetings (except that meetings shall not be required 
        with respect to matters relating to a notification submitted 
        under section 510(k)) shall be held before the expiration of 
        one-half of the statutory time period for review of the 
        application or petition and before the expiration of three-
        quarters of such period, or within 15 days after a scientific 
        review group has convened and made recommendations on an 
        application or petition, unless the Commissioner and the 
        applicant or petitioner determine that a meeting is 
        unnecessary;
            ``(3) by mutual consent, the Commissioner and the applicant 
        or petitioner may establish a different schedule for meetings 
        required under paragraph (2); and
            ``(4) the Secretary shall, prior to the meetings described 
        in paragraph (2), present to the applicant or petitioner in 
        writing a description of any deficiencies of the application or 
        petition and the information necessary to bring the application 
        or petition into a form that would require approval.
The Secretary and the applicant or petitioner may agree to supersede 
any procedures and policies adopted under this section and the 
requirements of paragraphs (2) and (3). Any such agreement shall be in 
writing, and shall specify how any such agreement shall be modified or 
set aside.
    ``(c) Approval, Disapproval, and Classification.--
            ``(1) Consideration of international approvals.--Beginning 
        July 1, 1998, if the Secretary fails to meet a time period for 
        action on an application or notification for the approval or 
        clearance of an article that is a new drug, device, biological 
        product, or new animal drug that offers a significant 
        improvement over an existing approved article or a petition for 
        the approval of a direct food additive that has the potential 
        to make foods more wholesome and contribute to a healthier 
        diet, and such an article has been approved for marketing in 
        the European Union or the United Kingdom, the Secretary shall, 
        within 30 days after a request of a person who submits an 
        application, notification, or petition described in this 
        paragraph, either approve or disapprove the application, 
        notification, or petition and notify the person in writing of 
        that decision. In the case of a disapproval, or a determination 
        that a device is not substantially equivalent, such 
        notification shall set forth the reasons for the disapproval or 
        the determination.
            ``(2) Appeal.--A person whose application, notification, or 
        petition has been disapproved (including a determination that a 
        device does not meet the requirements relating to substantial 
        equivalence) under paragraph (1) may obtain judicial review 
        under--
                    ``(A) section 505(h) for the disapproval of a new 
                drug under paragraph (1);
                    ``(B) section 517 for the disapproval of a device 
                or a determination of not substantially equivalent 
                relating to a device under paragraph (1);
                    ``(C) chapter VII of title 5, United States Code, 
                for the disapproval of a license for a biological 
                product under paragraph (1);
                    ``(D) section 512(h) for the disapproval of a new 
                animal drug under paragraph (1); and
                    ``(E) section 409(g) for the disapproval of a 
                direct food additive under paragraph (1).
    ``(d) Contracts for Expert Review.--
            ``(1) In general.--Beginning July 1, 1998, if the Secretary 
        in any fiscal year fails to meet the statutory time period for 
        action on an application, notification, or petition for at 
        least 95 percent of the applications, notifications, and 
        petitions submitted in a particular product category, the 
        Secretary shall--
                    ``(A) in the following fiscal year, contract with 
                expert organizations and individuals under section 742, 
                to review applications, notifications, and petitions of 
                persons who submit the applications, notifications, and 
                petitions in that following fiscal year and who consent 
                to the review; and
                    ``(B) in the following fiscal year and with the 
                consent of the persons described in this subparagraph, 
                contract with expert organizations and individuals 
                under section 742, to review applications, 
                notifications, and petitions that were submitted by 
                persons in any preceding fiscal year and that the 
                Secretary has failed to review within the statutory 
                time period for action on the applications, 
                notifications, and petitions with respect to the 
                particular product category.
            ``(2) Approval.--If an organization or individual selected 
        to conduct a review under paragraph (1) recommends the approval 
        or clearance of an application, notification, or petition 
        described in paragraph (1), the Secretary shall, within 60 days 
        after receiving the determination of the organization or 
        individual (but not later than the time period for review set 
        forth in this Act), either approve or disapprove the 
        application, notification, or petition, and, in the case of a 
        disapproval, notify the person who submitted the application, 
        notification, or petition in writing of the basis for the 
        disapproval. The person may appeal an adverse decision under 
        subsection (c)(2).''.

SEC. 405. GOOD MANUFACTURING PRACTICE INSPECTION.

    Chapter VII is (21 U.S.C. 371 et seq.), as amended by section 404, 
is further amended by adding at the end thereof the following new 
section:

``SEC. 744. GOOD MANUFACTURING PRACTICE INSPECTION.

    ``(a) In General.--In order to comply with the inspection 
requirements of this Act, the Secretary may accredit organizations to 
conduct inspections under section 704 to evaluate compliance of a 
manufacturer with applicable requirements for good manufacturing 
practice.
    ``(b) Eligibility Requirements.--If the Secretary elects to 
accredit organizations to conduct inspections under section 704, the 
Secretary shall by regulation, within 90 days after the date of 
enactment of this section, establish the requirements that an 
organization shall meet to be eligible to be accredited to participate 
as a qualified organization to conduct inspections under subsection 
(a). Such regulation shall provide for the protection of confidential 
or proprietary information and shall provide for protection against 
conflicts of interest.
    ``(c) Accreditation.--Not later than 90 days after the date on 
which the Secretary receives an application for accreditation under 
this section, the Secretary shall review the application and determine 
whether an applicant is in compliance with the requirements established 
under this section. Within the 90-day period, the Secretary shall grant 
accreditation or shall deny accreditation and specify in writing the 
reasons for the denial and the requirements that shall be met to obtain 
accreditation.
    ``(d) Revocation of Accreditation.--The Secretary may at any time 
revoke accreditation granted under subsection (c) for failure to comply 
with the requirements established under this section after specifying 
in writing the reasons for the revocation and the requirements that 
shall be met to retain accreditation and after an informal hearing on 
the revocation.
    ``(e) Inspections.--Any organization accredited under this section 
that conducts an inspection under this section at the request of the 
Secretary shall--
            ``(1) apply all relevant principles of good manufacturing 
        practice established in this Act and in regulations promulgated 
        by the Secretary;
            ``(2) provide to the Secretary and the manufacturer within 
        30 days after the completion of the inspection a report of the 
        findings of the inspection; and
            ``(3) immediately provide the Secretary with a notice of 
        any condition that could cause or contribute to a significant 
        threat to the public health.''.

SEC. 406. ENVIRONMENTAL IMPACT REVIEW.

    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 405, is 
further amended by adding at the end thereof the following new section:

``SEC. 745. ENVIRONMENTAL IMPACT REVIEW.

    ``Notwithstanding any other provision of law, no action by the 
Secretary pursuant to this Act shall be subject to an environmental 
assessment, an environmental impact statement, or other environmental 
consideration unless the director of the office responsible for the 
action demonstrates, in writing--
            ``(1) that there is a reasonable probability that the 
        environmental impact of the action is sufficiently substantial 
        and within the factors that the Secretary is authorized to 
        consider under this Act; and
            ``(2) that consideration of the environmental impact will 
        directly affect the decision on the action.''.

SEC. 407. EFFECTIVENESS, OUTCOME, AND COST-EFFECTIVENESS STANDARDS.

    Section 741, as added by section 402, is amended by adding at the 
end thereof the following new subsection:
    ``(e) Limitation on Determination of Effectiveness.--In a review of 
an application for an article that is a new drug, device, biological 
product, new animal drug, or animal feed bearing or containing a new 
animal drug, the determination of effectiveness shall not include the 
evaluation of--
            ``(1) any potential use not included in the labeling;
            ``(2) the cost-effectiveness of an article described in 
        this subsection, unless the proposed labeling explicitly 
        includes a representation about cost-effectiveness; and
            ``(3) the clinical outcome resulting from the use of a 
        diagnostic device, unless the labeling explicitly includes a 
        representation regarding clinical outcome.''.

SEC. 408. DEFINITION OF A DAY FOR PURPOSES OF PRODUCT REVIEW.

    Section 201 (21 U.S.C. 321) is amended by adding at the end thereof 
the following new paragraph:
    ``(gg) For purposes of reviewing any application or submission 
(including a petition, notification, or any other similar form of 
request), or any document, with respect to an article that is a new 
drug, device, biological product, new animal drug, an animal feed 
bearing or containing a new animal drug, color additive, or food 
additive, that is submitted to the Secretary to obtain marketing 
approval, to obtain classification of a device under section 513(f)(1), 
or to establish or clarify the regulatory status of the article, the 
term `day' means a calendar day in which the Secretary has 
responsibility to review such a submission (excluding any calendar day 
between the date of receipt by the submitter of a written communication 
from the Secretary setting forth the action of the Secretary on a 
submission and the date of receipt by the Secretary of the written 
response of the submitter to the action).''.

SEC. 409. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED PRODUCTS.

    (a) Performance Standards.--Not later than 180 days after the date 
of enactment of this section, the Secretary of Health and Human 
Services shall publish in the Federal Register performance standards 
for the prompt review of supplemental applications submitted for 
approved articles under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et seq.).
    (b) Guidance to Industry.--Not later than 180 days after the date 
of enactment of this section, the Secretary of Health and Human 
Services shall issue guidances to clarify the requirements and 
facilitate the submission of data to support the approval of 
supplemental applications for the approved articles described in 
subsection (a). The guidances shall--
            (1) clarify circumstances in which published matter may be 
        the basis for approval of a supplemental application;
            (2) specify data requirements that will avoid duplication 
        by recognizing the availability of data previously submitted in 
        support of an original application; and
            (3) define supplemental applications that are eligible for 
        priority review.
    (c) Responsibilities of Centers.--The Secretary of Health and Human 
Services shall designate an individual in each center within the Food 
and Drug Administration (except the Center for Food Safety and Applied 
Nutrition) to be responsible for--
            (1) encouraging the prompt review of supplemental 
        applications for approved products; and
            (2) working with sponsors to facilitate the development and 
        submission of data to support supplemental applications.
    (d) Collaboration.--The Secretary of Health and Human Services 
shall implement programs and policies that will foster collaboration 
between the Food and Drug Administration, the National Institutes of 
Health, professional medical and scientific societies, and others 
persons, to identify published and unpublished studies that could 
support a supplemental application, and to encourage sponsors to make 
supplemental applications or conduct further research in support of a 
supplemental application based, in whole or in part, on such studies.

SEC. 410. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 505 the following 
new section:

``SEC. 505A. PEDIATRIC STUDIES FOR NEW DRUG APPLICATIONS.

    ``(a) Market Exclusivity for Approved Applications With Pediatric 
Studies Submitted by an Applicant.--If an application submitted under 
section 505(b)(1) is approved on or after the date of enactment of this 
section, and such application includes reports of pediatric studies 
described and requested in subsection (c), and such studies are 
completed and the reports thereof submitted in accordance with 
subsection (c)(2) or completed and the reports thereof accepted in 
accordance with subsection (c)(3), the Secretary may not make the 
approval of an application submitted under section 505(b)(2) or 505(j) 
that refers to the drug for which the section 505(b)(1) approval is 
granted effective prior to the expiration of 6 months from the earliest 
date on which the approval of such application for the drug under 
section 505(b)(2) or 505(j), respectively, could otherwise be made 
effective under the applicable provisions of this chapter.
    ``(b) Market Exclusivity for Approved Applications With Pediatric 
Studies Requested by the Secretary.--If the Secretary makes a written 
request for pediatric studies described in subsection (c) to the holder 
of an approval under section 505(b)(1) for a drug, and such studies are 
completed and the reports thereof submitted in accordance with 
subsection (c)(2) or completed and the reports thereof accepted in 
accordance with subsection (c)(3), the Secretary may not make the 
approval of an application submitted under section 505(b)(2) or 505(j) 
that refers to the drug subject to the section 505(b)(1) approval 
effective prior to the expiration of 6 months from the earliest date on 
which an approval of such application under section 505(b)(2) or 
505(j), respectively, could otherwise be made effective under the 
applicable provisions of this chapter. Nothing in this subsection shall 
affect the ability of the Secretary to make effective a section 
505(b)(2) or 505(j) approval for a subject drug if such approval is 
proper under such section and is made effective prior to the submission 
of the reports of pediatric studies described in subsection (c).
    ``(c) Conduct of Pediatric Studies.--
            ``(1) Agreement for studies.--The Secretary may, pursuant 
        to a written request for studies and after consultation with 
        the sponsor of an application or holder of an approval for a 
        drug under section 505(b)(1), agree with the sponsor or holder 
        concerning the conduct of pediatric studies for such drug.
            ``(2) Written protocols to meet the studies requirement.--
        If the sponsor or holder and the Secretary agree upon written 
        protocols for such studies, the studies requirement of 
        subsection (a) or (b) is satisfied upon the completion of the 
        studies in accordance with the protocols and the submission of 
        the reports thereof to the Secretary. Not later than 60 days 
        after the submission of the report of the studies, the 
        Secretary shall determine if such studies were or were not 
        conducted in accordance with the written protocols and reported 
        in accordance with the requirements of the Secretary for filing 
        and so notify the sponsor or holder.
            ``(3) Other methods to meet the studies requirement.--If 
        the sponsor or holder and the Secretary have not agreed in 
        writing on the protocols for the studies, the studies 
        requirement of subsection (a) or (b) is satisfied when such 
        studies have been completed and the reports accepted by the 
        Secretary. Not later than 90 days after the submission of the 
        reports of the studies, the Secretary shall accept or reject 
        such reports and so notify the sponsor or holder. The 
        Secretary's only responsibility in accepting or rejecting the 
        reports shall be to determine, within 90 days, that the studies 
        fairly respond to the written request, that such studies have 
        been conducted in accordance with commonly accepted scientific 
        principles and protocols, and that such studies have been 
        reported in accordance with the requirements of the Secretary 
        for filing.
    ``(d) Delay of Effective Date for Certain Applications; Period of 
Market Exclusivity.--If the Secretary determines that an approval of an 
application under section 505(b)(2) or 505(j) for a drug may be made 
effective after the submission of reports of pediatric studies under 
this section but before the Secretary has determined whether the 
requirements of subsection (c) have been satisfied, the Secretary may 
delay the effective date of any approval under section 505(b)(2) or 
505(j), respectively, until the determination under subsection (c) is 
made, but such delay shall not exceed 90 days. In the event that the 
requirements of this section are satisfied, the 6-month period referred 
to in subsection (a) or (b) shall be deemed to have begun on the date 
an approval of an application under section 505(b)(2) or 505(j), 
respectively, would have been permitted absent action under this 
subsection.
    ``(e) Notice of Determinations on Studies Requirement.--The 
Secretary shall publish notice of any determination that the 
requirements of paragraph (2) or (3) of subsection (c) have been met 
and that approvals under section 505(b)(2) or 505(j) for a drug will be 
subject to deferred effective dates under this section.
    ``(f) Definitions.--As used in this section, the term `pediatric 
studies' or `studies' means at least 1 human clinical investigation in 
a population of adolescent age or younger. At the Secretary's 
discretion, pharmacokinetic studies may be considered as clinical 
investigations.''.

SEC. 411. NOTIFICATIONS FOR DEVICE MARKET CLEARANCE.

    Section 510(k) (21 U.S.C. 360(k)) is amended by striking ``report 
to'' and inserting ``shall notify the Secretary to report to''.

        TITLE V--DRUG AND BIOLOGICAL PRODUCTS REGULATORY REFORM

SEC. 501. SHORT TITLE.

    This title may be cited as the ``Drug and Biological Product 
Regulatory Reform Act of 1996''.

SEC. 502. NEW DRUG APPROVAL STANDARD.

    Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end 
thereof the following new sentence: ``Substantial evidence may consist 
of data from 1 well-controlled clinical investigation and confirmatory 
evidence obtained prior to, or after, such investigation.''.

SEC. 503. PILOT AND SMALL SCALE MANUFACTURE.

    Section 505(c) (21 U.S.C. 355(c)) is amended by adding at the end 
thereof the following new paragraph:
    ``(4) A new drug or biological product manufactured in a pilot or 
other small facility may be used to demonstrate the safety and 
effectiveness of the drug or product and to obtain approval prior to 
scaling up to a larger facility, unless the Secretary demonstrates in 
writing and specifies in detail the reasons, after an informal hearing, 
that a full scale production facility is necessary to ensure the safety 
or effectiveness of the drug or product.''.

SEC. 504. MANUFACTURING CHANGES.

    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 406, is 
further amended by adding at the end thereof the following new section:

``SEC. 746. MANUFACTURING CHANGES.

    ``(a) In General.--A change in the manufacture of a new drug, 
biological product, or new animal drug, may be made in accordance with 
this section.
    ``(b) Drug and Biological Product.--A change in the manufacture of 
a new drug, a biological product that is the subject of a monograph in 
an official compendium, a biological product that can be adequately 
characterized by chemical, physical, or biological means, or a new 
animal drug--
            ``(1) shall require validation; and
            ``(2)(A) if there is no change in the approved qualitative 
        and quantitative formulation relating to the new drug, 
        biological product, or new animal drug or in the approved 
        release specifications relating to the new drug, biological 
        product, or new animal drug, or if there is a change in the 
        approved qualitative or quantitative formula or in the approved 
        release specifications of a type permitted by the Secretary by 
        regulation, may be made at any time so long as the change is 
        reported annually to the Secretary; or
            ``(B) in the case of a change other than a change described 
        in subparagraph (A), shall require completion of an appropriate 
        study demonstrating equivalence according to criteria 
        established by the Secretary (unless such requirement is waived 
        by the Secretary), may be made at any time, and shall be 
        reported to the Secretary through a supplement or amendment 
        submitted at the time the change is made.
    ``(c) Biological Product Not Subject to a Monograph.--A change in 
the manufacture of a biological product that is not the subject of a 
monograph in an official compendium and cannot be adequately 
characterized by chemical, physical, or biological means--
            ``(1) shall require validation; and
            ``(2)(A) if the change relates solely to a modification of 
        the manufacturing facility or change in personnel, with no 
        change in the approved manufacturing process or release 
        specifications, may be made at any time so long as the change 
        is reported annually to the Secretary; or
            ``(B) in the case of a change other than a change described 
        in subparagraph (A), shall require completion of a bioassay or 
        other appropriate study demonstrating equivalence according to 
        criteria established by the Secretary (unless such requirement 
        is waived by the Secretary), may be made at any time, and shall 
        be reported to the Secretary through an amendment submitted at 
        the time the change is made.
    ``(d) Special Determination for a Biological Product.--A 
determination shall be made, prior to the approval of a biological 
product under section 351(a) of the Public Health Service Act (42 
U.S.C. 262(a)), whether the product can be adequately characterized for 
purposes of this section. With respect to biological products approved 
prior to the date of enactment of the Food and Drug Administration 
Performance and Accountability Act of 1996, the determination shall be 
made not later than 90 days after the date of enactment of such Act. 
Any determination made under this subsection is subject to change based 
upon new scientific information.''.

SEC. 505. INSULIN AND ANTIBIOTICS.

    (a) Certification of Drugs Containing Insulin.--Section 506 (21 
U.S.C. 356) is repealed.
    (b) Certification of Antibiotics.--Section 507 (21 U.S.C. 357) is 
repealed.
    (c) Exportation.--Section 802 (21 U.S.C. 382) is amended--
            (1) by redesignating subsection (h) as subsection (i); and
            (2) by inserting after subsection (g) the following new 
        subsection:
    ``(h) Exportation of Unapproved Products.--Insulin and antibiotics 
may be exported without regard to the requirements in this section if 
the insulin and antibiotics meet the requirements of section 
801(e)(1).''.

SEC. 506. MODERNIZATION OF REGULATION OF BIOLOGICAL PRODUCTS.

    (a) In General.--Section 351 of the Public Health Service Act (42 
U.S.C. 262) is amended by striking ``Sec. 351. (a)'' and all that 
follows through ``barter, or exchange the same.'' and inserting the 
following:
    ``Sec. 351. (a)(1) Except as provided in paragraph (6), no person 
shall introduce or deliver for introduction into interstate commerce 
any biological product unless--
            ``(A) a license is in effect for the biological product; 
        and
            ``(B) each package of the biological product is plainly 
        marked with the proper name of the biological product contained 
        therein, the name, address, and applicable license number of 
        the manufacturer of the biological product, and the expiration 
        date of the biological product.
    ``(2) The license required under paragraph (1)(A) shall, as 
determined by the Secretary, cover the biological product, any facility 
in which the biological product is manufactured, processed, packed, or 
held, or both the product and facility.
    ``(3)(A) The Secretary shall establish, by regulation, requirements 
for license applications for biological products.
    ``(B) Except as provided in subparagraph (D), a license application 
that covers a biological product shall be approved based upon a 
demonstration that--
            ``(i) the product that is the subject of the application is 
        safe and effective in accordance with sections 505(c) and 
        505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355 (c) and (d)), or meets standards designed to ensure that 
        the product is safe, pure, and where appropriate, potent; and
            ``(ii) the methods used in, and the facilities and control 
        used for, the manufacture, processing, packing, and holding of 
        such product meet standards designed to ensure that the product 
        meets the requirements of clause (i).
    ``(C) A license application that covers a facility shall ensure 
that the product and the facility meet standards designed to ensure 
that the product meets applicable requirements of subparagraph (B).
    ``(D) A license application for blood or a blood component 
(including plasma) shall be approved based on a demonstration that the 
product is safe, pure, and where appropriate, potent, and that the 
facility in which the product is manufactured, processed, packed, or 
held meets standards designed to ensure that such product is safe, 
pure, and where appropriate, potent.
    ``(4)(A) Requirements prescribed under paragraph (3) shall include 
a requirement for preapproval inspection under subsection (c).
    ``(B) A license shall be approved only on condition that the 
licensee agrees to permit inspection of the facility of the licensee in 
accordance with subsection (c).
    ``(5)(A) Except as provided in subparagraph (C), an approved 
license for a biological product may be revoked if the Secretary 
determines, on the record after providing an opportunity for a hearing 
in accordance with section 554 of title 5, United States Code, that the 
requirements for approval as specified in paragraph (3) are no longer 
met with respect to such product, or that other public health reasons, 
prescribed by regulation, exist. No action to revoke a license based on 
the findings of an inspection shall be initiated prior to the 
submission and review by the Secretary of a written response submitted 
by the licensee to a notice of inspectional findings so long as such 
written response is received within 30 days after the date of receipt 
by the licensee of the findings. The revocation of any product license 
shall not prevent the continued use of any licensed biological product 
that has been sold and delivered by the licensee unless the biological 
product is subject to recall under subsection (d).
    ``(B) If at any time before the Secretary has taken final action to 
revoke a license, the licensee requests an inspection by the Secretary 
to determine whether the licensee is in compliance with applicable 
standards, the Secretary shall conduct an inspection within 30 days 
after the date of the request. If the inspection confirms that the 
licensee is not in compliance with applicable standards, the 30-day 
requirement for inspection shall not apply to any subsequent request by 
the licensee under this subparagraph for inspection. If the inspection 
confirms that the licensee is in compliance with all applicable 
requirements, the Secretary shall withdraw any proposed action within 
30 days after the inspection.
    ``(C) If the Secretary determines that conditions exist that 
constitute a danger to health, the Secretary shall suspend the license, 
notify the licensee that the licensee's license is suspended, and 
require notification of the suspension to any consignee. Within 30 days 
thereafter, the Secretary shall initiate the hearing process under 
subparagraph (A).
    ``(6) The requirements of paragraph (1) do not apply to a 
biological product for which there is in effect an investigational new 
drug application under section 505(i) of the Federal Food, Drug, and 
Cosmetic Act.''.
    (b) Deletion of ELA Requirement.--Section 351(d) of the Public 
Health Service Act (42 U.S.C. 262(d)) is amended--
            (1) by striking ``(d)(1)'' and all that follows through 
        ``of this section.'';
            (2) by redesignating paragraph (2)(A) as subsection (d)(1);
            (3) by redesignating subparagraph (B) as paragraph (2); and
            (4) in paragraph (2) (as so redesignated), by striking 
        ``subparagraph (A)'' and inserting ``paragraph (1)''.
    (c) Labeling.--Section 351(b) of the Public Health Service Act (42 
U.S.C. 262(b)) is amended to read as follows:
    ``(b) No person shall falsely label or mark any package or 
container of any biological product or alter any label or mark on the 
package so as to falsify the label or mark.''.
    (d) Inspection.--Section 351(c) of the Public Health Service Act 
(42 U.S.C. 262(c)) is amended by striking ``virus, serum,'' and all 
that follows through ``other product aforesaid'' and inserting 
``biological product''.
    (e) Definition; Application.--Section 351 of the Public Health 
Service Act (42 U.S.C. 262) is amended by adding at the end thereof the 
following new subsections:
    ``(i) For purposes of this section, the term `biological product' 
means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, 
blood component or derivative, allergenic biologic product, or 
arsphenamine or its derivative (or any other analogous biological 
product) applicable to the prevention, treatment, or cure of diseases 
or conditions of human beings.
    ``(j)(1) Sections 505(i), 903, and 904 of the Federal Food, Drug, 
and Cosmetic Act shall apply to all biological products, and references 
in such sections to new drug applications shall be deemed to include 
product license applications for biological products.
    ``(2) Requirements involving labeling or advertising for biological 
products shall be established in accordance with sections 201(m) and 
502(n) of the Federal Food, Drug, and Cosmetic Act.''.

SEC. 507. EFFECTIVE MEDICATION GUIDES.

    Chapter IX (21 U.S.C. 391 et seq.), as amended by section 108, is 
further amended by adding at the end thereof the following new section:

``SEC. 908. EFFECTIVE MEDICATION GUIDES.

    ``(a) In General.--Not later than 30 days after the date of 
enactment of this section, the Secretary shall request that national 
organizations representing health care professionals, consumer 
organizations, voluntary health agencies, the pharmaceutical industry, 
drug wholesalers, patient drug information database companies, and 
other relevant parties collaborate to develop a long-range 
comprehensive action plan to achieve goals consistent with the goals of 
the proposed rule of the Food and Drug Administration on `Prescription 
Drug Product Labeling: Medication Guide Requirements (60 Fed. Reg. 
44182; relating to the provision of oral and written prescription 
information to consumers).
    ``(b) Plan.--The plan described in subsection (a) shall--
            ``(1) identify the plan goals;
            ``(2) assess the effectiveness of the current private-
        sector approaches used to provide oral and written prescription 
        information to consumers;
            ``(3) develop guidelines for providing effective oral and 
        written prescription information consistent with the findings 
        of any such assessment;
            ``(4) develop a mechanism to assess periodically the 
        quality of the oral and written prescription information and 
        the frequency with which the information is provided to 
        consumers; and
            ``(5) provide for compliance with relevant State board 
        regulations.
    ``(c) Limitation on the Authority of the Secretary.--The Secretary 
shall have no authority to implement the proposed rule described in 
subsection (a), or to develop any similar regulation, policy statement, 
or other guideline specifying a uniform content or format for written 
information voluntarily provided to consumers about prescription drugs 
if, not later than 120 days after the date of enactment of this 
section, the national organizations described in subsection (a) develop 
and begin to implement a comprehensive, long-range action plan (as 
described in subsection (a)) regarding the provision of oral and 
written prescription information.
    ``(d) Secretary Review.--Not later than January 1, 2001, the 
Secretary shall review the status of private-sector initiatives 
designed to achieve the goals of the plan described in subsection (a), 
and if such goals are not achieved, the limitation in subsection (c) 
shall not apply, and the Secretary shall seek public comment on other 
initiatives that may be carried out to meet such goals. The Secretary 
shall not delegate such review authority to the Commissioner.''.

SEC. 508. STATE AND LOCAL REQUIREMENTS RESPECTING NONPRESCRIPTION DRUGS 
              INTENDED FOR HUMAN USE.

    Subchapter A of chapter V (21 U.S.C. 351 et seq.) is amended by 
inserting after section 522 the following new section:

``SEC. 523. STATE AND LOCAL REQUIREMENTS RESPECTING NONPRESCRIPTION 
              DRUGS INTENDED FOR HUMAN USE.

    ``(a) Limitation.--
            ``(1) In general.--Except as provided in subsection (b), no 
        State or political subdivision thereof may establish or 
        continue in effect any requirement--
                    ``(A) that relates to the regulation of a drug 
                intended for human use that is not subject to the 
                requirements of section 503(b)(1); and
                    ``(B) that is different from or in addition to, or 
                that is otherwise not identical with, a requirement of 
                this Act or the Fair Packaging and Labeling Act (15 
                U.S.C. 1451 et seq.), and the administrative 
                implementation of such Act.
            ``(2) Special rule.--For purposes of this section, a 
        requirement relating to the regulation of a drug described in 
        paragraph (1) shall be deemed to include any requirement 
        relating to the subject matter in any provision of this Act, 
        the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.), 
        and any requirement relating to the dissemination of 
        information in any manner about such drug, but shall not 
        include any requirement relating to the dispensing of a drug 
        only upon prescription of a practitioner licensed by law to 
        administer such drug.
    ``(b) Exemption.--Upon application of a State, the Secretary may by 
regulation, after providing notice and an opportunity for written and 
oral presentation of views, exempt from the provisions of subsection 
(a), under such conditions as the Secretary may impose, a proposed 
requirement relating to the regulation of a drug intended for human 
use--
            ``(1) that is justified by compelling local conditions or 
        protects an important public interest that would otherwise be 
        unprotected;
            ``(2) that would not cause any drug intended for human use 
        that is not subject to the requirements of section 503(b)(1) to 
        be in violation of any applicable requirement or prohibition 
        under Federal law; and
            ``(3) that would not unduly burden interstate commerce.''.

SEC. 509. REQUIREMENT OF RADIOPHARMACEUTICALS.

    (a) Requirements.--
            (1) Regulations.--Not later than 180 days after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services, after consultation with patient advocacy groups, 
        associations, physicians licensed to use radiopharmaceuticals, 
        and the regulated industry, shall establish proposed 
        regulations governing the approval of a radiopharmaceutical 
        designed for diagnosis and monitoring that shall assess the 
        safety and effectiveness of the radiopharmaceutical taking into 
        account the appropriate use of the radiopharmaceutical in the 
        practice of medicine, the pharmacological and toxicological 
        activity of the radiopharmaceutical, and the estimated absorbed 
        radiation dose of the radiopharmaceutical. Not later than 1 
        year after the date of enactment of this Act, the Secretary 
        shall issue final regulations.
            (2) Special rule.--In the case of a radiopharmaceutical 
        intended to be used for diagnostic purposes, the indications 
        for which such radiopharmaceutical is approved under this 
        section may refer to manifestations of disease (such as 
        biochemical, physiological, anatomic, or pathological 
        processes) common to or present in 1 or more disease states, or 
        may refer to a diagnostic procedure used in the diagnosis of 1 
        or more diseases or conditions.
    (b) Approval.--All applications or petitions requesting approval of 
a radiopharmaceutical and all other matters relating to such 
radiopharmaceutical shall be reviewed and acted upon by a single office 
in the Center for Drug Evaluation and Research, and that office shall 
report directly to the director of the Center for Drug Evaluation and 
Research. A single scientific review group may provide conclusions and 
recommendations regarding any such matter relating to the approval of a 
radiopharmaceutical. Such group shall be appointed and administered 
pursuant to section 904 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 394), as amended by section 107.
    (c) Definition.--As used in this section, the term 
``radiopharmaceutical'' means--
            (1) an article that is intended for use in vivo in the 
        diagnosis, cure, mitigation, treatment, or prevention of a 
        disease or a manifestation of disease in man, and that exerts 
        its primary effect by the spontaneous disintegration of 
        unstable nuclei with the emission of ionizing radiation; or
            (2) a reagent kit or nuclide generator that is intended to 
        be used in the preparation of any such article.
    (d) Approval Assessed Under Performance Standards.--The approval of 
radiopharmaceuticals shall be assessed under quantifiable performance 
standards established by the Secretary under section 903(b)(3) of the 
Federal Food, Drug, and Cosmetic Act, as added by section 103.

                   TITLE VI--DEVICE REGULATORY REFORM

SEC. 601. SHORT TITLE.

    This title may be cited as the ``Medical Device Reform Act of 
1996''.

SEC. 602. PREMARKET NOTIFICATION.

    (a) Exemption of Certain Devices.--Section 510 (21 U.S.C. 360) is 
amended--
            (1) in subsection (k), by striking ``intended for human 
        use'' and inserting ``intended for human use (except a device 
        that is classified into class I under section 513 or 520 and is 
        not identified in a list under subsection (n), or a device that 
        is classified into class II under section 513 or 520 and is 
        exempt from the requirements of this subsection under 
        subsection (l))'';
            (2) by adding at the end of subsection (k) the following 
        flush sentence:
``The Secretary shall review the notification required by this 
subsection and make a determination under section 513(f)(1)(A) within 
90 days of receiving the notification.''; and
            (3) by adding at the end thereof the following new 
        subsections:
    ``(l) Not later than 30 days after the date of enactment of this 
subsection, the Secretary shall publish in the Federal Register a list 
of each type of class II device that does not require a notification 
under subsection (k) to provide reasonable assurance of safety and 
effectiveness. Each type of class II device so identified by the 
Secretary not to require the notification shall be exempt from the 
requirement to provide notification under subsection (k) as of the date 
of the publication of the list in the Federal Register. Beginning on 
the date that is 1 day after the date of the publication of a list 
under this subsection, any person may petition the Secretary to exempt 
a type of class II device from the notification requirement of 
subsection (k). The Secretary shall respond to the petition within 120 
days of the receipt of the petition and determine whether or not to 
grant the petition in whole or in part.
    ``(m) The Secretary may not withhold a determination of the initial 
classification of a device under section 513(f)(1) because of a failure 
to comply with any provision of this Act unrelated to a substantial 
equivalence decision, including a failure to comply with good 
manufacturing practices under section 520(f).
    ``(n) Not later than 15 days after the date of enactment of this 
subsection, the Secretary shall publish in the Federal Register a list 
of each type of class I device that shall not be considered exempt from 
the notification requirement of section 510(k) because such 
notification is necessary to protect the public health. If the 
Secretary fails to publish the list within 15 days after the date of 
enactment of this subsection, all types of class I devices shall be 
exempt from the requirement to provide notification under section 
510(k).''.
    (b) Initial Classification.--Section 513(f)(1) (21 U.S.C. 
360c(f)(1)) is amended in the second sentence, by striking the period 
at the end thereof and inserting the following: ``, unless within 30 
days of receiving an order classifying the device into class III, the 
individual who submits a notification under section 510(k) requests an 
advisory committee review and recommendation with respect to the 
classification of the device and a final order of classification from 
the Secretary. After the request, a device classified into class III 
under this paragraph shall not be deemed to be finally classified until 
an advisory committee established under subsection (b) reviews the 
request with respect to the classification of the device and, within 60 
days of the date of receiving the request, recommends to the Secretary 
a classification for the device based on the classification criteria 
set forth in subparagraphs (A) through (C) of subsection(a)(1). 
Thereafter, the Secretary shall have 10 days after the date of 
receiving the recommendation of the advisory committee to determine by 
order the final classification of the device by applying the 
classification criteria set forth in subparagraphs (A) through (C) of 
subsection(a)(1).''.
    (c) Substantial Equivalence.--Section 513(i)(1)(A) (21 U.S.C. 
360c(i)(1)(A)) is amended by inserting after ``intended use'' the 
following: ``, which, as determined by the Secretary, shall include 
each use reasonably included within a general use,''.
    (d) Device Modification.--Section 513(i) (21 U.S.C. 360c(i)) is 
amended by adding at the end thereof the following new paragraph:
    ``(4)(A) Any change or modification to a device initially 
classified under section 513(f), other than a major change (including 
any major modification) in the intended use or a change or modification 
in design that is significant and significantly affects safety or 
effectiveness, shall not require an additional notification under 
section 510(k) if, prior to the commercial distribution of the device--
            ``(i) the change or modification is supported by 
        appropriate data or information, (including data or information 
        demonstrating compliance with good manufacturing practice 
        regulations promulgated under section 520(f)); and
            ``(ii) the change or modification is shown by such data or 
        information to not adversely affect the safety or effectiveness 
        of the device.
    ``(B) All data or information relied upon to document that a change 
to (including any modification of) the device does not require an 
additional notification under section 510(k) shall be made available to 
the Secretary upon request and shall be maintained, at least for a 
period of time equal to the expected life of the device or 2 years 
after the date of commercial distribution of the device by the 
manufacturer, whichever is greater.''.

SEC. 603. MEDICAL DEVICE APPROVAL STANDARDS.

    (a) Device Classes.--Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) 
is amended--
            (1) by striking ``well-controlled'' and inserting ``one or 
        more well-controlled''; and
            (2) by striking ``clinical investigations'' and inserting 
        ``one or more clinical investigations''.
    (b) Supplement to Application.--Section 513(a)(3) (21 U.S.C. 
360c(a)(3)) is amended by adding at the end thereof the following new 
subparagraphs:
    ``(C) The Secretary shall accept, for the purpose of facilitating a 
review of a premarket application, a supplement to a premarket 
application, or a premarket notification of a device, retrospective or 
historical clinical data as a control, or for use, in determining 
whether there is a reasonable assurance of effectiveness of a device if 
sufficient valid data are available and the effects of the device on 
the cure, mitigation, treatment, or prevention of a disease are clearly 
defined and well understood.
    ``(D) The Secretary may not require a person intending to conduct 
clinical trials to conduct clinical trials using prospective concurrent 
controls in determining whether there is a reasonable assurance of 
effectiveness for a device or whether a device is substantially 
equivalent to a predicate device unless--
            ``(i) the effects of the device on the cure, mitigation, 
        treatment, or prevention of a disease or condition are not 
        clearly defined and well understood as determined by the 
        Secretary;
            ``(ii) retrospective or historical data are not available 
        that meet the standards of the Secretary for quality and 
        completeness; or
            ``(iii) there is a compelling public health reason to not 
        rely on retrospective or historical data as a control.''.

SEC. 604. TRACKING.

    Section 519(e) (21 U.S.C. 360i(e)) is amended to read as follows:

                           ``Device Tracking

    ``(e) The Secretary may by regulation require a manufacturer to 
adopt a method of tracking a class II or class III device--
            ``(1) the failure of which would be reasonably likely to be 
        life-threatening or have serious adverse health consequences; 
        and
            ``(2) which is--
                    ``(A) permanently implantable; or
                    ``(B) life sustaining or life supporting and used 
                outside a device user facility.
Any patient receiving a device subject to tracking under this section 
may refuse to release, or refuse permission to release, the patient's 
name, address, social security number, or other identifying information 
for the purpose of tracking.''.

SEC. 605. POSTMARKET SURVEILLANCE.

    Section 522 (21 U.S.C. 360l) is amended to read as follows:

``SEC. 522. POSTMARKET SURVEILLANCE.

    ``(a) In General.--The Secretary may require a manufacturer to 
conduct postmarket surveillance for any device of the manufacturer 
that--
            ``(1) is a permanent implant the failure of which may cause 
        serious, adverse health consequences or death;
            ``(2) is intended for a use in supporting or sustaining 
        human life; or
            ``(3) potentially presents a serious risk to human health 
        or creates public health concerns that justify surveillance 
        under this section.
    ``(b) Surveillance Approval.--Each manufacturer required to conduct 
a surveillance of a device under subsection (a) shall, within 30 days 
of receiving notice from the Secretary that the manufacturer is 
required under this section to conduct the surveillance, submit for the 
approval of the Secretary, a protocol for the required surveillance. 
The Secretary, within 60 days of the date of the receipt of the 
protocol, shall determine if the principal investigator proposed to be 
used in the surveillance has sufficient qualifications and experience 
to conduct the surveillance and if the protocol will result in 
collection of useful data or other information necessary to protect the 
public health and to provide safety and effectiveness information for 
the device. The Secretary may not approve the protocol until the 
protocol has been reviewed by a qualified scientific and technical 
review committee established by the Secretary.''.

SEC. 606. DEVICE DISTRIBUTOR REPORTING.

    Section 519 (21 U.S.C. 360i) is amended--
            (1) by striking ``, importer, or distributor'' each place 
        it appears and inserting ``or importer'';
            (2) in subsection (a)--
                    (A) in paragraph (7), by striking the semicolon at 
                the end thereof and inserting ``; and'';
                    (B) in paragraph (8), by striking ``; and'' and 
                inserting a period; and
                    (C) by striking paragraph (9); and
            (3) in subsection (d), by striking ``, importer, and 
        distributor'' and inserting ``and importer''.

SEC. 607. PREMARKET APPROVAL.

    (a) Action on Application.--Section 515(d) (21 U.S.C. 360e(d)) is 
amended--
            (1) in paragraph (1)(A), by striking ``paragraph (2) of 
        this subsection'' each place it appears and inserting 
        ``paragraph (4)'';
            (2) in paragraph (1)(B), by adding at the end thereof the 
        following new clause:
    ``(iii) The Secretary shall accept and review data and any other 
information from investigations conducted under the authority of 
regulations required by section 520(g) to make a determination of 
whether there is a reasonable assurance of safety and effectiveness of 
a device subject to a pending application under this section if--
            ``(I) the data or information is derived from 
        investigations of an earlier version of the device, the device 
        has been modified during or after the investigations, and the 
        modification of the device does not constitute a significant 
        change in the design or in the basic principles of operation of 
        the device that would invalidate the data or information; or
            ``(II) the data or information on a device approved under 
        this section is available for use under this Act and is 
        relevant to the design and intended use of the device subject 
        to the pending application.'';
            (3) by redesignating paragraphs (2) and (3) as paragraphs 
        (4) and (5), respectively; and
            (4) by inserting after paragraph (1) the following new 
        paragraphs:
    ``(2) Each application received under section 515(c) shall be 
reviewed in the following manner to achieve final action on the 
application within 180 days of the receipt of the application:
            ``(A) The Secretary shall meet with an applicant within 90 
        days of the receipt of the application to discuss the review 
        status of the application. If the application does not appear 
        in a form that would require an approval under this subsection, 
        the Secretary shall in writing, and prior to the meeting, 
        present to the applicant a description of any deficiencies in 
        the application and what information is required to bring the 
        application into a form that would require an approval.
            ``(B) The Secretary shall refer an application to a panel 
        established under section 513 for review and an approval 
        recommendation (unless a panel is not required under subsection 
        (c)(2)) within 30 days of the date of the meeting referred to 
        in subparagraph (A) or at the next scheduled panel meeting 
        following the meeting referred to in subparagraph (A), 
        whichever occurs first.
            ``(C) The Secretary shall meet with the applicant within 15 
        days of the date of the panel review to discuss the status of 
        the application, including a discussion on what action is 
        necessary to bring the application into a form that would 
        require approval under this subsection. Prior to the meeting, 
        the Secretary shall in writing, set forth an agenda for the 
        meeting (including a complete description of the subject matter 
        to be discussed at the meeting), and a full description of the 
        additional information required to bring the application into a 
        form that would require an approval under this subsection. 
        Participation of the applicant at such a meeting shall be at 
        the discretion of the applicant.
            ``(D) The Secretary shall meet with the applicant not later 
        than 135 days after the receipt of an application under 
        subsection (c), if an advisory panel is not required under 
        subsection (c)(2), and inform the applicant whether or not the 
        application is in a form that would require approval under this 
        subsection. If the application is in such form, the Secretary 
        shall, at or prior to the meeting, present in writing to the 
        applicant a description of all additional information necessary 
        to require an approval of the application under this 
        subsection. If the application is not in such form, the 
        Secretary shall deny approval of the application and prior to 
        the meeting, present in writing to the applicant each basis for 
        denying approval of the application and the additional 
        information required to bring the application into a form that 
        would require approval.
            ``(E) The Secretary shall issue an order approving or 
        denying an application within 180 days of the receipt of the 
        application under subsection (c).
    ``(3) The time for the review of an application by the Secretary 
under this subsection shall not take more than 180 days and such time 
may not be extended if the application is amended.''.
    (b) Revisions of Regulations.--
            (1) Premarket approval of applications.--The Secretary of 
        Health and Human Services shall revise, through notice and 
        comment procedures, the regulations set forth in part 814 of 
        title 21 of the Code of Federal Regulations, to conform to the 
        amendment made by subsection (a).
            (2) Premarket approval of supplements.--The Secretary of 
        Health and Human Services shall revise regulations relating to 
        premarket approval of devices to eliminate premarket approval 
        of supplements that relate to manufacturing or product changes 
        (excluding changes in intended use) of a device that have been 
        demonstrated through appropriate data or information to not 
        adversely affect safety or effectiveness. The Secretary of 
        Health and Human Services shall require the manufacturer of a 
        device to notify the Secretary of Health and Human Services of 
        significant manufacturing changes or other changes not subject 
        to a supplement under section 515 within 10 days of 
        implementing such changes. All information relied upon in 
        making such changes shall be made a part of the device master 
        record. The information shall be maintained for a period of 
        time equal to the period of time for the design and expected 
        life of the device, but not less than 2 years after the date of 
        release of the device for commercial distribution by the 
        manufacturer.

SEC. 608. DEVICE PERFORMANCE STANDARDS.

    (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is amended 
by adding at the end thereof the following new subsection:

       ``Performance Standards of Standard-Setting Organizations

    ``(c)(1) For the purpose of facilitating a review of a device under 
section 510(k), 513(f), 515, or 520, the Secretary shall recognize 
appropriate device performance standards developed by any standard-
setting organization accredited by the American National Standards 
Institute (ANSI), the International Standards Organization (ISO), or 
the International Electrotechnical Commission (IEC).
    ``(2)(A) For any standard-setting organization not identified in 
paragraph (1), and for the purpose of facilitating a review of devices 
under section 510(k), 513(f), 515, or 520, the Secretary shall 
establish a procedure governing the certification by the Food and Drug 
Administration of the competence of such an organization to develop 
standards for devices.
    ``(B) A certification of a standard-setting organization not 
identified in paragraph (1) shall be based on formal, written criteria 
that include requirements with respect to the role of the organization 
in the scientific community, scientific or medical expertise, standard-
writing experience, conflict of interest considerations, and the 
openness of the standard-setting process of the organization.
    ``(C) The Secretary may impose a reasonable one-time fee on the 
standard-setting organization for certification pursuant to this 
paragraph.
    ``(3)(A) Upon being notified by a standard-setting organization 
described in paragraph (1) that a standard has been adopted by the 
organization, the Secretary shall recognize the standard by publishing 
a notice in the Federal Register listing the name of the standard.
    ``(B) Upon being notified by a standard-setting organization 
certified under paragraph (2) that a standard has been adopted by the 
organization, the Secretary shall review and may recognize the standard 
by publishing a notice in the Federal Register listing the name of the 
standard.
    ``(4) The Secretary may withdraw recognition of a performance 
standard adopted by a standard-setting organization described in 
paragraph (1) or a standard-setting organization certified under 
paragraph (2) if the Secretary determines that the standard is 
insufficient to facilitate a review of a device. The Secretary shall 
notify the standard-setting organization and specify the basis for the 
withdrawal.
    ``(5) The Secretary shall promulgate regulations under which the 
Secretary may withdraw the certification of a standard-setting 
organization described in paragraph (2), or may no longer rely upon 
standards adopted by a standard-setting organization described in 
paragraph (1), if the Secretary determines that such organization no 
longer possesses the appropriate scientific or medical expertise, 
conflict of interest practices, standard-writing experience, or any 
other qualification necessary to the development of device standards.
    ``(6) As provided for in this section, the Secretary may promulgate 
performance standards for a device that differs from or is not 
established by, an organization described in paragraph (1) or an 
organization certified under paragraph (2).
    ``(7) The Secretary shall not require, as a condition for approving 
an application under section 515 or 520 or classifying a device under 
sections 510(k) and 513(f), conformity with a device standard 
recognized under this subsection if the person requesting such approval 
or classification submits evidence to demonstrate a reasonable 
assurance that the device is substantially equivalent to a legally 
marketed predicate device or provides reasonable assurance that the 
device is safe and effective.
    ``(8) A performance standard recognized pursuant to this subsection 
for a device--
            ``(A) shall include provisions to provide reasonable 
        assurance of the safe and effective performance of the device;
            ``(B) shall, where necessary to provide reasonable 
        assurances of the safe and effective performance of the device, 
        include--
                    ``(i) provisions with respect to the construction, 
                components, ingredients, and properties of the device 
                and the compatibility of the device with power systems 
                and connections to the systems;
                    ``(ii) provisions for the testing (on a sample 
                basis or, if necessary, on an individual basis) of the 
                device or, if it is determined that no other more 
                practicable means are available to the Secretary to 
                assure the conformity of a device to the standard, 
                provisions for the testing (on a sample basis or, if 
                necessary, on an individual basis) of the device by the 
                Secretary or by another person at the direction of the 
                Secretary;
                    ``(iii) provisions for the measurement of the 
                performance characteristics of the device; and
                    ``(iv) provisions requiring that the results of 
                each or certain of the tests of the device required to 
                be made under clause (ii) demonstrate that the device 
                is in conformity with those portions of the standard 
                for which the test or tests were required; and
            ``(C) shall, where appropriate, require the procedures, for 
        the proper installation, maintenance, operation, and use of the 
        device.
    ``(9) The Secretary shall accept a certification by a person who 
has made a submission pursuant to section 510(k), 515, or 520 that the 
device conforms with each standard identified in the certification. The 
Secretary may, where appropriate, require data demonstrating conformity 
with a standard recognized under this subsection.
    ``(10) The Secretary shall require a person who makes a 
certification under paragraph (9) that a device conforms to an 
applicable performance standard recognized under this subsection or who 
makes a certification that a device conforms to a standard established 
under subsection (a) or (b) to maintain data demonstrating conformity 
of the device to the standard for a period of time equal to the period 
of time for the design and expected life of the device. Such data shall 
be made available to the Secretary upon request.''.
    (b) Adulterated Device.--Section 501(e) (21 U.S.C. 351(e)) is 
amended--
            (1) by striking ``(e)'' and inserting ``(e)(1)'';
            (2) by striking ``section 514'' and inserting ``section 
        514(b)''; and
            (3) by inserting at the end thereof the following:
    ``(2) If it is, or purports to be or is represented as, a device 
which is certified to be in compliance with any voluntary standard 
recognized under section 514(c), unless such a device is in all 
respects in conformity with such a standard.''.

SEC. 609. ACCREDITED-PARTY PARTICIPATION.

    Subchapter A of chapter V (21 U.S.C. 351 et seq.), as amended by 
section 508, is further amended by adding at the end the following new 
section:

``SEC. 523A. ACCREDITED-PARTY PARTICIPATION.

    ``(a) In General.--Not later than 1 year after the date of 
enactment of this section, the Secretary shall accredit persons, 
including any entity or any individual who is not an employee of the 
Department to review and initially classify devices under section 
513(f)(1) that are subject to a report under section 510(k) and to 
review and recommend to the Secretary approval or denial of 
applications submitted under section 515(c)(1).
    ``(b) Accreditation.--Not later than 6 months after the date of 
enactment of this section, the Secretary shall establish and publish in 
the Federal Register requirements to accredit or deny accreditation to 
a person who makes a request for accreditation to carry out the 
activities described in subsection (a). The requirements shall, at a 
minimum, advise such person how to become accredited, and set forth 
criteria for accreditation including criteria to avoid conflicts of 
interest and to ensure that persons to be accredited are capable of 
maintaining the confidentiality of submissions consistent with section 
552 of title 5, United States Code, and the regulations of the Food and 
Drug Administration. The Secretary shall respond to a request for 
accreditation not later than 60 days after the receipt of the request. 
The accreditation of a person shall specify the activities under 
subsection (a) which such person is authorized to carry out in the 
place of the Secretary.
    ``(c) Withdrawal of Accreditation.--The Secretary may suspend or 
withdraw the accreditation of any person accredited under this section, 
after providing notice and an opportunity for an informal hearing, if 
such person acts in a manner that is substantially inconsistent with 
the purposes of this section, including the failure to avoid conflicts 
of interest, the failure to protect confidentiality of information, or 
the failure to competently review premarket submissions for devices.
    ``(d) Selection and Compensation.--A person who submits a premarket 
submission for a device to the Secretary for review and classification, 
or approval of a device, shall have the option to select an accredited 
person to review such submission. The Secretary shall identify for the 
person no less than 2 accredited persons from whom the selection may be 
made. Compensation for an accredited person shall be determined by 
agreement between the accredited person and the person who engages the 
services of the accredited person.
    ``(e) Review by Secretary.--
            ``(1) In general.--If a person exercises the option to 
        obtain review of a premarket submission that is an application 
        or a notification by an accredited person, the Secretary shall 
        complete a filing review for a premarket approval application 
        under section 515(c)(1) not later than 30 days after the 
        receipt of such application, or shall ensure the completeness 
        of a premarket notification submission under section 510(k) not 
        later than 15 days after the receipt of such submission, prior 
        to referring the premarket submission for review by the 
        accredited person selected by the person submitting the 
        premarket submission.
            ``(2) Report on classification, approval, or denial.--The 
        Secretary shall require an accredited person, upon recommending 
        a classification of a device or approval or disapproval of an 
        application for a device, to report to the Secretary the 
        reasons of the accredited person for such classification or 
        approval or disapproval. For devices reviewed and initially 
        classified under section 513(f)(1) and subject to a report 
        under section 510(k), the Secretary shall have not more than 15 
        days to review the submission. For applications submitted under 
        section 515(c)(1), the Secretary shall have not more than 45 
        days to review the application. The Secretary may change the 
        classification under section 513(f)(1), or the approval or 
        disapproval of the application under section 515(d), that is 
        recommended by the accredited person, and in such case shall 
        notify the person making the submission of the detailed reasons 
        for the change.
    ``(f) Duration.--This section shall remain in force for a period of 
3 years from the date on which the Secretary accredits the first person 
to conduct initial classifications under section 513(f)(1) and to 
conduct premarket approval reviews under section 515.
    ``(g) Reports.--
            ``(1) Implementation of accreditation process.--Not later 
        than 1 year after the date of enactment of this section, the 
        Secretary shall prepare and submit to the committees of 
        Congress with oversight authority over the Food and Drug 
        Administration a report concerning each action the Secretary 
        has taken to implement the accreditation of persons to 
        undertake the activities described in subsection (a).
            ``(2) Examination of the use of accredited persons.--
                    ``(A) In general.--Not later than 2 years after the 
                date on which the Secretary accredits the first person 
                to conduct initial classifications under section 
                513(f)(1) and to conduct premarket approval reviews 
                under section 515, the Secretary shall contract with an 
                independent research organization to prepare and submit 
                to the Secretary a written report examining the use of 
                accredited persons under this section. The Secretary 
                shall submit the report to the committees described in 
                paragraph (1) not later than 30 months after the date 
                on which the Secretary accredits the first person to 
                conduct initial classifications under section 513(f)(1) 
                and to conduct premarket approval reviews under section 
                515.
                    ``(B) Contents.--The report by the independent 
                research organization described in subparagraph (A) 
                shall identify the benefits or detriments to public and 
                patient health of using accredited persons to conduct 
                such reviews, and shall summarize all relevant data, 
                including data on the review of accredited persons 
                (including review times, recommendations, and 
                compensation), and data on the review of the Secretary 
                (including review times, changes, and reasons for 
                changes).''.

                TITLE VII--ANIMAL DRUG REGULATORY REFORM

SEC. 701. SHORT TITLE.

    This title may be cited as the ``Animal Drug Regulatory Reform Act 
of 1996''.

SEC. 702. EVIDENCE OF EFFECTIVENESS.

    (a) Substantial Evidence.--Section 512(d) (21 U.S.C. 360b(d)) is 
amended--
            (1) by striking paragraph (3); and
            (2) by adding at the end thereof the following new 
        paragraph:
    ``(4)(A) As used in this subsection and subsections (c)(2)(F)(iii) 
and (e)(1)(C), the term `substantial evidence' means evidence from 1 or 
more scientifically sound studies, including as appropriate in vitro 
studies, studies in laboratory animals (including a target species), 
bioequivalence studies, and any studies voluntarily undertaken by or 
for the applicant, that taken together provide reasonable assurance 
that the drug will have the claimed or intended effect of the drug.
    ``(B) For purposes of subparagraph (A), a study shall be considered 
to be scientifically sound if the study is designed and conducted in a 
manner that is consistent with generally recognized scientific 
procedures and principles.''.
    (b) Combination of Drugs.--Section 512(d) (21 U.S.C. 360b(d)) is 
amended by inserting before paragraph (4) (as added by subsection (a)) 
the following new paragraph:
    ``(3) In a case in which a new animal drug contains more than 1 
active ingredient, or the labeling of the drug prescribes, recommends, 
or suggests use of the drug in combination with another animal drug, 
and the active ingredients or drugs in the combination have been 
separately approved for particular uses and species prior to the 
approval of the application for the same uses and species in 
combination (or, in the absence of such approvals, after evaluating the 
safety and efficacy of the combination itself), the Secretary may only 
consider with respect to the combination whether any of the active 
ingredients or any of the drugs in the combination, respectively, at 
the longest withdrawal time of any of the active ingredients or drugs 
in the combination, respectively--
            ``(A) is above its safe concentration (such as exceeding 
        its established tolerance, as measured by its marker residue); 
        or
            ``(B) interferes with the methods of analysis for another 
        of the active ingredients or drugs in the combination, 
        respectively.''.
    (c) Supplemental Applications.--Section 512(c)(2)(F)(iii) (21 
U.S.C. 360b(c)(2)(F)(iii)) is amended--
            (1) by striking ``reports of new clinical or field 
        investigations (other than bioequivalence or residue studies) 
        and'' and inserting ``substantial evidence of effectiveness as 
        defined in subsection (d)(4), any study of animal safety, or''; 
        and
            (2) by striking ``essential to'' and inserting ``, required 
        for''.
    (d) Minor Species and Uses.--Section 512(d)(1) (21 U.S.C. 
360b(d)(1)) is amended by adding at the end the following new sentence: 
``Subparagraph (E) shall not apply to a claim for use of the drug 
described in subparagraph (E) in a minor species, or for a minor use of 
the drug, as the terms `minor species' and `minor use' are defined in 
regulations issued by the Secretary, if there is an application filed 
under subsection (b) for the drug, and the application is approved, 
prior to the submission of the claim.''.
    (e) Withdrawal of Approval.--Section 512(e)(1)(C) (21 U.S.C. 
360b(e)(1)(C)) is amended by inserting after ``substantial evidence'' 
the following: ``(as defined in subsection (d)(4))''.
    (f) Implementation.--
            (1) In general.--Not later than 6 months after the date of 
        enactment of this Act, the Secretary shall issue proposed 
        regulations implementing the amendments made by this section. 
        Not later than 18 months after the date of enactment of this 
        Act, the Secretary shall issue final regulations implementing 
        the amendments.
            (2) Contents.--In issuing regulations implementing the 
        amendments made by this section, and in taking an action to 
        review an application for approval of a new animal drug under 
        section 512 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360b), or a request for an investigational exemption for 
        a new animal drug under subsection (j) of such section, that is 
        pending or has been submitted prior to the effective date of 
        the regulations, the Secretary shall--
                    (A) further define the term ``substantial 
                evidence'', as defined in subsection (d)(4) of such 
                section, in a manner that encourages the submission of 
                applications for production drugs that conserve food 
                resources, of applications for veterinary prescription 
                drugs whose use is designed to rely on the experience 
                and training of practitioners in establishing effective 
                doses for such drugs, and of supplemental applications, 
                including applications seeking approval for uses of 
                animal drugs in minor species, for minor uses of such 
                drugs, and for permitted unlabeled uses of such drugs;
                    (B) take into account the proposals contained in 
                the citizen petition (FDA Docket No. 91P-0434/CP) 
                jointly submitted by the American Veterinary Medical 
                Association and the Animal Health Institute, dated 
                October 21, 1991; and
                    (C)(i) provide for the opportunity for a conference 
                prior to the submission of an application for approval 
                of a new animal drug under such section, and prior to 
                the submission of a request for an investigational 
                exemption under subsection (j) of such section, to make 
                a decision establishing any submission or 
                investigational requirement relating to the application 
                or request (which decision shall bind the Secretary and 
                the applicant or requester unless the Secretary by 
                order determines that a documented scientific issue 
                that occurred subsequent to the conference requires the 
                decision to be modified in order to ensure that an 
                appropriate determination can be made with respect to 
                the safety or effectiveness of the animal drug 
                involved); and
                    (ii) not later than 10 days after each such 
                conference, by written order, provide a scientific 
                justification specific to the animal drug and intended 
                uses under consideration for requiring studies of types 
                other than the types of studies specified in subsection 
                (d)(4) of such section, as being essential to provide 
                substantial evidence of effectiveness for the intended 
                uses of the drug.

SEC. 703. LIMITATION OF RESIDUES.

    Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is amended to read 
as follows:
            ``(F) on the basis of information submitted to the 
        Secretary as part of the application or any other information 
        before the Secretary with respect to such drug, any use 
        prescribed, recommended, or suggested in labeling proposed for 
        such drug will result in a residue of such drug in excess of a 
        tolerance found by the Secretary to be safe for such drug;''.

SEC. 704. ADULTERATED DRUGS.

    Section 501(a)(2) (21 U.S.C. 351(a)(2)) is amended--
            (1) in subparagraph (A), by striking ``health; or'' and 
        inserting ``health;''; and
            (2) in subparagraph (B), by striking ``possess;'' and 
        inserting the following: ``possess; or (C) if it is a drug 
        intended for use by animals other than man and the methods used 
        in, or the facilities or controls used for, its manufacture, 
        processing, packing, or holding do not conform to or are not 
        operated or administered in conformity with current good 
        manufacturing practice requirements (appropriate for animal 
        drugs) adopted pursuant to regulations issued by the Secretary 
        to ensure that such drug meets the requirements of this Act as 
        to safety and has the identity and strength, and meets the 
        quality and purity characteristics, which it purports or is 
        represented to possess for use in animals other than man;''.

SEC. 705. VETERINARY FEED DIRECTIVES.

    (a) Written or Oral Orders.--Section 503(f)(1)(A) (21 U.S.C. 
353(f)(1)(A)) is amended by striking ``other than man'' and inserting 
the following: ``other than man, other than a veterinary feed directive 
drug intended for use in animal feed or an animal feed bearing or 
containing a veterinary feed directive drug,''.
    (b) General Requirements.--Chapter V (21 U.S.C. 351 et seq.) is 
amended by inserting after section 503 the following new section:

                   ``veterinary feed directives drugs

    ``Sec. 504. (a)(1) A drug intended for use in or on animal feed 
that is limited by an approved application filed pursuant to section 
512(b) to use under the professional supervision of a licensed 
veterinarian is a veterinary feed directive drug. Any animal feed 
bearing or containing a veterinary feed directive drug shall be fed to 
animals only by or upon the lawful veterinary feed directive issued by 
a licensed veterinarian in the course of the professional practice of 
the veterinarian. When labeled, distributed, held, and used in 
accordance with this section, a veterinary feed directive drug and any 
animal feed bearing or containing a veterinary feed directive drug 
shall be exempt from section 502(f).
    ``(2) A veterinary feed directive is lawful if it--
            ``(A) contains such information as the Secretary may, by 
        general regulation or by order, require; and
            ``(B) is in compliance with the conditions and indications 
        for use of the drug set forth in the notice published pursuant 
        to section 512(i).
    ``(3)(A) Any persons involved in the distribution or use of animal 
feed bearing or containing a veterinary feed directive drug, and the 
licensed veterinarian issuing the veterinary feed directive, shall 
maintain a copy of the veterinary feed directive applicable to each 
such feed, except in the case of a person distributing such feed to 
another person for further distribution, such person distributing the 
feed shall maintain a written acknowledgment from the person to whom 
the feed is shipped stating that that person shall not ship or move 
such feed to an animal production facility without a veterinary feed 
directive or ship such feed to another person for further distribution 
unless that person has provided the same written acknowledgment to the 
immediate supplier of that person.
    ``(B) Every person required under subparagraph (A) to maintain 
records, and every person in charge or custody thereof, shall, upon 
request of an officer or employee designated by the Secretary, permit 
such officer or employee at all reasonable times to have access to and 
copy and verify such records.
    ``(C) Any person who distributes animal feed bearing or containing 
a veterinary feed directive drug shall upon first engaging in such 
distribution notify the Secretary of the name and place of business of 
that person. The failure to provide such notification shall be deemed 
to be an act which results in the drug being misbranded.
    ``(b) A veterinary feed directive drug and any feed bearing or 
containing a veterinary feed directive drug shall be deemed to be 
misbranded if the drug and feed labeling fails to bear such cautionary 
statement and such other information as the Secretary may, by general 
regulation or by order, prescribe, or the drug and feed advertising 
fails to conform to the conditions and indications for use published 
pursuant to section 512(i) or fails to contain the general cautionary 
statement prescribed by the Secretary.
    ``(c) Neither a drug subject to this section, nor animal feed 
bearing or containing such a drug, shall be deemed to be a prescription 
article under any Federal or State law.''.
    (c) Conforming Amendments.--Section 512 (21 U.S.C. 360b) is 
amended--
            (1) in subsection (a)(2)(C), by striking ``its labeling'' 
        and inserting ``its labeling, its distribution, its holding,'';
            (2) in subsection (i), by striking ``requirements)'' and 
        inserting ``requirements and any requirement that an animal 
        feed bearing or containing the new animal drug be limited to 
        use under the professional supervision of a licensed 
        veterinarian)''; and
            (3) in subsection (m)(4)(B)(i)--
                    (A) by striking ``paragraph (5)(A) of this 
                subsection'' and inserting ``paragraph (5)(A) or under 
                section 504(a)(3)(A)''; and
                    (B) by striking ``subparagraph (B) of such 
                paragraph'' and inserting ``paragraph (5)(B) or section 
                504(a)(3)(B)''.
    (d) Prohibited Acts.--Section 301(e) (21 U.S.C. 331(e)) is 
amended--
            (1) by striking ``section 412'' and inserting ``section 
        412, 504,''; and
            (2) by striking ``under section 412,'' and inserting 
        ``under section 412, 504,''.

SEC. 706. TIMEFRAMES FOR APPROVAL.

    The first sentence of section 512(c)(1) (21 U.S.C. 360b(c)(1)) is 
amended by striking ``one hundred and eighty'' and inserting ``90''.

                   TITLE VIII--FOOD REGULATORY REFORM

SEC. 801. SHORT TITLE.

    This title may be cited as the ``Food Regulatory Reform Act of 
1996''.

SEC. 802. INDIRECT FOOD ADDITIVES.

    (a) Approval.--Section 409 (21 U.S.C. 348) is amended by adding at 
the end thereof the following new subsection:

                    ``Alternative Approval Procedure

    ``(j)(1) As an alternative to the approval procedure established 
under subsection (b), any person may submit a notification for an 
indirect food additive under this subsection.
    ``(2) Any person who proposes to begin the introduction or delivery 
for introduction into interstate commerce of an article intended for 
use as an indirect food additive may submit to the Secretary, at least 
90 days prior to making such introduction or delivery, a notification 
containing information demonstrating that the labeled use of the 
article is safe.
    ``(3) Within 90 days after the receipt of the notification by the 
Secretary, the Secretary shall--
            ``(A) either--
                    ``(i) approve the notification if the article is 
                safe for its intended use; or
                    ``(ii) disapprove the notification if the article 
                has not been shown to be safe for its intended use; and
            ``(B) publish a notice of this determination in the Federal 
        Register and, if the notification is approved, promulgate an 
        appropriate regulation pursuant to subsection (c).''.
    (b) Definition.--Section 201 (21 U.S.C. 321), as amended by section 
408, is further amended by adding at the end thereof the following new 
paragraph:
    ``(hh) The term `indirect food additive' means a food additive that 
is intended to contact food but that is not intended for consumption as 
a food ingredient.''.

SEC. 803. HEALTH CLAIMS OF FOOD PRODUCTS.

    Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by adding at the 
end thereof the following new subparagraph:
    ``(C) Notwithstanding the provisions of subparagraphs (A)(i) and 
(B), a claim of the type described in paragraph (1)(B) which is not 
authorized by the Secretary in a regulation promulgated in accordance 
with subparagraph (B) shall be authorized and may be made if--
            ``(i) an authoritative scientific body of the United States 
        Government with official responsibility for public health 
        protection or research directly relating to human nutrition 
        (such as the National Institutes of Health or the Centers for 
        Disease Control and Prevention), the National Academy of 
        Sciences, or subdivisions of the scientific body or the 
        National Academy of Sciences, has published statements, 
        conclusions, or recommendations in effect recognizing that the 
        relationship between the nutrient and disease or health-related 
        condition to which the claim refers is supported by pertinent 
        scientific evidence; and
            ``(ii) the manufacturer or distributor of the food for 
        which such claim is made has submitted to the Secretary at 
        least 90 days before the first introduction of such food into 
        interstate commerce a notice of claim, including a concise 
        description of the basis upon which such manufacturer or 
        distributor relied for determining that the requirements of 
        clause (i) have been satisfied.''.

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.

    Chapter IX (21 U.S.C. 391 et seq.), as amended by section 507, is 
further amended by adding at the end thereof the following new section:

``SEC. 909. CENTERS FOR EDUCATION AND RESEARCH ON DRUGS, DEVICES, AND 
              BIOLOGICAL PRODUCTS.

    ``(a) In General.--The Secretary, acting through the Commissioner, 
shall establish a consortium of 3 or more centers for research and 
education on drugs, devices, and biological products in accordance with 
subsection (b).
    ``(b) Grant Authority.--The Secretary, acting through the 
Commissioner, shall make grants to 3 or more private entities to assist 
each of the entities in the establishment and operation of a center for 
research and education on drugs, devices, and biological products. In 
awarding a grant under this subsection, the Secretary shall use a peer-
review selection procedure.
    ``(c) Authorized Grant Activities.--
            ``(1) Required activities.--A grant awarded under 
        subsection (b) shall be used to--
                    ``(A) conduct state-of-the-art clinical and 
                laboratory research that--
                            ``(i) increases awareness of new uses of 
                        drugs, devices, or biological products and the 
                        unforeseen risks of new uses of drugs, devices, 
                        or biological products;
                            ``(ii) provides objective clinical 
                        information to--
                                    ``(I) health care practitioners or 
                                other providers of health care goods or 
                                services;
                                    ``(II) pharmacy benefit managers;
                                    ``(III) health maintenance 
                                organizations or other managed health 
                                care organizations; and
                                    ``(IV) health care insurers or 
                                governmental agencies; and
                            ``(iii) improves the quality of health care 
                        while reducing the cost of health care through 
                        the prevention of adverse effects of drugs, 
                        devices, or biological products and the 
                        consequences of such effects, such as 
                        unnecessary hospitalizations; and
                    ``(B) conduct research on the comparative 
                effectiveness and safety of drugs, devices, or 
                biological products.
            ``(2) Discretionary activities.--A grant awarded under 
        subsection (b) may be used to conduct--
                    ``(A) surveillance of the adverse effects of drugs, 
                devices, or biological products;
                    ``(B) a study of new or unapproved uses for 
                marketed drugs, devices, or biological products; or
                    ``(C) a study of the therapeutic characteristics of 
                clinically special populations, such as children, 
                women, and elderly individuals.
            ``(3) Limitation.--A grant awarded under subsection (b) may 
        not be used to assist the Secretary in the review of new drugs.
    ``(d) Application.--An entity that desires to receive a grant under 
this section shall submit to the Secretary an application at such time, 
in such manner, and accompanied by such information as the Secretary 
may require.
    ``(e) Establishment of an Oversight Committee.--The Secretary shall 
establish within the Food and Drug Administration a committee to 
provide oversight of the research and educational activities of the 
consortium of centers described in subsection (a). The committee shall 
be composed of--
            ``(1) a representative from each of the centers;
            ``(2) a representative from the Food and Drug 
        Administration;
            ``(3) a representative from consumer advocacy groups; and
            ``(4) a representative from the pharmaceutical, device, or 
        biological products industry.
    ``(f) Report.--Not later than September 30, 1999, the Secretary 
shall prepare and submit to the Chairmen and Ranking Members of the 
Committee on Labor and Human Resources of the Senate and the Committee 
on Commerce of the House of Representatives a report on the activities 
of the consortium of centers established pursuant to this section. The 
report shall include an analysis on the impact of the centers on the 
safe use of drugs, devices, and biological products and recommendations 
on whether the funding for the centers should be extended and 
increased.
    ``(g) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $9,000,000 for fiscal year 1997, 
$12,000,000 for fiscal year 1998, $15,000,000 for fiscal year 1999, and 
$15,000,000 for fiscal year 2000.''.

               TITLE X--PROGRAM IN CLINICAL PHARMACOLOGY

SEC. 1001. REAUTHORIZATION OF CLINICAL PHARMACOLOGY PROGRAM.

    Section 2(b) of Public Law 102-222 (105 Stat. 1677) is amended by 
striking ``to carry out this section'' and inserting ``, and fiscal 
years 1997 and 1998, $1,900,000 for each fiscal year, to carry out this 
section''.
```