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







104th CONGRESS
  1st Session
                                S. 1477

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           December 13, 1995

Mrs. Kassebaum introduced the following bill; which was read twice and 
         referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 A BILL


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

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

SECTION 1. SHORT TITLE.

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

                  TITLE I--MISSION AND ACCOUNTABILITY

SEC. 101. SHORT TITLE.

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

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 health of the American people by--
            ``(1) facilitating the rapid and efficient development and 
        availability of products subject to its regulation;
            ``(2) protecting the public from unsafe or ineffective 
        products subject to its regulation; 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.--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--
                    ``(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))--
                            ``(i) for a serious, life-threatening, or 
                        seriously debilitating disease or condition; or
                            ``(ii) for any other condition if a new 
                        drug, device, or biological product--
                                    ``(I) provides therapy not 
                                available from other approved therapy; 
                                or
                                    ``(II) offers significant 
                                improvement over other approved 
                                therapy;
                    ``(B) reduce backlogs on all applications with the 
                objective of eliminating all backlogs by January 1, 
                2000; and
                    ``(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.
        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.''.

SEC. 104. 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) 
submitted to the Food and Drug Administration requesting agency action. 
The system shall permit access by the applicant.''.

SEC. 105. 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) 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.
    ``(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.''.

SEC. 106. ADVISORY COMMITTEES.

    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 
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.
    ``(c) Membership and Meeting Requirements.--
            ``(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.
            ``(2) Nonvoting members.--A scientific review group shall 
        include a nonvoting industry representative and a nonvoting 
        public representative.
            ``(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.
            ``(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.
            ``(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.
            ``(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.
    ``(d) Persons Involvement With Review Groups.--
            ``(1) In general.--All persons, including employees of the 
        Secretary, shall have the same rights and responsibilities 
        regarding--
                    ``(A) the submission of data and information to, 
                and contact and discussion with, a scientific review 
                group;
                    ``(B) the participation of the persons at meetings 
                of the group; and
                    ``(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).
            ``(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.
            ``(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.
    ``(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.
    ``(f) Definition.--For purposes of this section, the term `center 
director' means a director of a center within the Food and Drug 
Administration.''.

SEC. 107. APPEALS WITHIN THE FOOD AND DRUG ADMINISTRATION.

    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:

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

    ``(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.
    ``(b) Review by Scientific Review Group.--
            ``(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.
            ``(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.
            ``(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 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--
                    ``(A) panels of qualified Food and Drug 
                Administration officials;
                    ``(B) panels of qualified government employees who 
                are not employees of the Food and Drug Administration; 
                and
                    ``(C) outside mediators and arbitrators who are not 
                government employees.
            ``(2) Application of faca.--The Federal Advisory Committee 
        Act (5 U.S.C. App) shall not apply to a panel described in 
        paragraph (1).
    ``(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.''.

   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 1995''.

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 section:

``SEC. 543. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS.

    ``(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--
            ``(1) the person has no comparable or satisfactory 
        alternative therapy available to treat, diagnose, or monitor 
        the disease or condition; or
            ``(2) the risk to the person from the investigational drug 
        or device is not greater than the risk from the disease or 
        condition.
    ``(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.
    ``(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.
    ``(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--
            ``(1) shall state that the drug or device is 
        investigational;
            ``(2) shall not represent that the drug or device is safe 
        or effective for any use; and
            ``(3) shall not otherwise promote or advertise the 
        availability of the product 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 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.'';
            (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 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.''.

       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 1995''.

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 
        paragraph:
    ``(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.
    ``(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.
    ``(C) The Commissioner shall establish a mechanism to ensure the 
fair and consistent application of safety standards for clinical 
investigations.''.

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).
    ``(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--
            ``(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
            ``(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.''.

SEC. 304. 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. 544. 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 one or more protocols or part 
        or all of a development plan for the drug or device.
            ``(2) Form.--A request described in paragraph (1) shall be 
        in writing and shall include a proposal for which the review is 
        requested.
            ``(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.
    ``(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.
    ``(c) Modification of Agreements by the FDA.--Agreements reached 
through meetings under subsection (a) may be changed unilaterally 
only--
            ``(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
            ``(2) in writing and specifying the basis therefor and 
        demonstrating the substantial public health reasons that 
        require the change.
    ``(d) Panel Review.--
            ``(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.
            ``(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).''.

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

SEC. 401. REFERENCE.

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

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

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

    ``(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.
    ``(b) Filing Requirements.--The Commissioner shall establish a 
mechanism to ensure the fair and consistent application of filing 
requirements.
    ``(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.
    ``(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.''.

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.--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.
    ``(b) Review of Expert's Evaluation.--
            ``(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.
            ``(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.''.

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 (including a petition, notification, 
or other similar request):
            ``(1) An application for approval of a human food additive 
        or animal feed additive under section 409.
            ``(2) An application for approval of a new drug under 
        section 505(b)(1).
            ``(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.
            ``(4) A submission for a determination that a device is 
        substantially equivalent to a predicate device under sections 
        513(f)(1) and 513(i).
            ``(5) An application for approval of a device under section 
        515.
            ``(6) An application 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 Food and Drug Administration and the applicant with 
respect to an application or submission described in subsection (a). As 
part of this collaborative process--
            ``(1) open, informal, and prompt communications shall be 
        encouraged;
            ``(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
            ``(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.
    ``(c) Approval, Disapproval, and Classification.--
            ``(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.
            ``(2) Appeal.--A person whose application has been 
        disapproved under this subsection may appeal using one of the 
        following procedures:
                    ``(A) Procedures under the act.--The procedures 
                established for the product under other provisions of 
                this Act.
                    ``(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.
    ``(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 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.
            ``(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).''.

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 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.--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).
    ``(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.
    ``(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 
subsection that conducts an inspection under this subsection 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; and
            ``(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.
    ``(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.''.

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 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--
            ``(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. INFORMATION EXCHANGE.

    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:

``SEC. 746. DISSEMINATION OF INFORMATION ON DRUGS.

    ``(a) Dissemination.--
            ``(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--
                    ``(A) a treatment use for an investigational new 
                drug (including a biological product) approved by the 
                Secretary for such treatment use; or
                    ``(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.
            ``(2) Requirements.--A person may disseminate information 
        under paragraph (1)(B) only if--
                    ``(A) the information is an unabridged--
                            ``(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
                            ``(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;
                    ``(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;
                    ``(C) the information relates to a use that is 
                recognized under Federal law for purposes of third-
                party coverage or reimbursement, and--
                            ``(i) the text of the information has been 
                        approved by an organization referred to in such 
                        Federal law; and
                            ``(ii) the information is part of a disease 
                        management program or treatment guideline with 
                        respect to the use; or
                    ``(D) the information is an accurate and truthful 
                summary of the information described in subparagraph 
                (A), (B), or (C).
    ``(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--
            ``(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;
            ``(2) if applicable, that the information is being 
        disseminated at the expense of the sponsor of the new drug;
            ``(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
            ``(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.
    ``(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).
    ``(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).

``SEC. 747. DISSEMINATION OF INFORMATION ON DEVICES.

    ``(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.
    ``(b) Disclosure Statements and Requirements.--
            ``(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.
            ``(2) Additional requirements.--A person may disseminate 
        information under subsection (a) only if--
                    ``(A) the information is an unabridged--
                            ``(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
                            ``(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;
                    ``(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;
                    ``(C) the information relates to a use that is 
                recognized under Federal law for purposes of third-
                party reimbursement, and--
                            ``(i) the text of the information has been 
                        approved by an organization referred to in such 
                        Federal law; and
                            ``(ii) the information is part of a disease 
                        management program or treatment guideline with 
                        respect to such use; or
                    ``(D) the oral or written information is--
                            ``(i) part of an exchange of information 
                        solely among health care practitioners, health 
                        care reimbursement officials, and the industry;
                            ``(ii) exchanged for educational or 
                        scientific purposes; or
                            ``(iii) presented at continuing medical 
                        education programs, seminars, workshops, or 
                        demonstrations.
            ``(3) Applicability.--The requirements under subsection 
        (a)(1)(A) and (B) of section 746 shall not apply with respect 
        to devices.

``SEC. 748. POLICY ON INFORMATION DISSEMINATION.

    ``(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.
    ``(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.

``SEC. 749. APPROVAL OF NEW USES.

    ``(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.
    ``(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--
            ``(1) has existed in clinical practice for at least five 
        years;
            ``(2) is common among clinicians experienced in the field; 
        and
            ``(3) represents reasonable medical practice based upon 
        reliable clinical experience and other confirmatory 
        information.
    ``(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.''.

SEC. 408. 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) 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--
            ``(1) relative effectiveness, unless the effectiveness of 
        the product is explicitly compared to the effectiveness of 
        another product in the labeling;
            ``(2) any potential use not explicitly included in the 
        labeling;
            ``(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
            ``(4) the clinical outcome resulting from use of a device, 
        unless the labeling explicitly includes a representation 
        regarding clinical outcome.''.

SEC. 409. 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:
    ``(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.''.

       TITLE V--DRUG, BIOLOGICAL PRODUCTS, DEVICES EXPORT REFORM

SEC. 501. SHORT TITLE.

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

SEC. 502. EXPORT OF DRUGS AND DEVICES.

    (a) Exports and Imports.--Section 801 (21 U.S.C. 381) is amended--
            (1) in subsection (d), by adding at the end thereof the 
        following new paragraph:
    ``(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.'';
            (2) in subsection (e)(1), by striking the second sentence; 
        and
            (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''.
    (b) Export of Certain Unapproved Drugs and Devices.--Section 802 
(21 U.S.C. 382) is amended to read as follows:

``SEC. 802. EXPORTS OF CERTAIN UNAPPROVED PRODUCTS.

    ``(a) In General.--A drug (including a biological product) intended 
for human or animal use or a device for human use--
            ``(1)(A) which, in the case of a drug--
                    ``(i) requires approval by the Secretary under 
                section 505 or section 512; or
                    ``(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),
        before the drug may be introduced or delivered for introduction 
        into interstate commerce to a country; and
            ``(B) which--
                    ``(i) does not have such approval or license;
                    ``(ii) is not exempt from such sections or Act; and
                    ``(iii) is introduced or delivered for introduction 
                into interstate commerce to a country; or
            ``(2) which, in the case of a device--
                    ``(A) does not comply with an applicable 
                requirement under section 514 or 515;
                    ``(B) is exempt under section 520(g) from section 
                514 or 515; or
                    ``(C) is a banned device under section 516,
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).
    ``(b) Exportation to Any Country or a Specific Country.--
            ``(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--
                    ``(A) in Australia, Canada, Israel, Japan, New 
                Zealand, or Switzerland; or
                    ``(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.
            ``(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.
    ``(c) Exportation to a Country With a Regulatory System.--
            ``(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.
            ``(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.
            ``(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.
            ``(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.
    ``(d) Limitations.--A drug or device may not be exported under this 
section if--
            ``(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;
            ``(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;
            ``(3) the requirements of subparagraphs (A) through (D) of 
        section 801(e)(1) have not been met;
            ``(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;
            ``(5) the Secretary finds that the drug or device poses an 
        unreasonable and substantial risk to public health in the 
        receiving country;
            ``(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
            ``(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.
In making a finding under paragraph (5), the Secretary, to the maximum 
extent possible, shall consult with the affected country.
    ``(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).
    ``(f) Exportation of a Drug for Tropical Disease.--
            ``(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--
                    ``(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;
                    ``(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;
                    ``(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;
                    ``(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
                    ``(E) the requirements of subparagraphs (A) through 
                (D) of section 801(d)(1) have been met.
            ``(2) Application.--Any person may apply to have a drug 
        exported under paragraph (1). The application shall--
                    ``(A) describe the drug to be exported;
                    ``(B) list each country to which the drug is to be 
                exported;
                    ``(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);
                    ``(D) identify the establishments in which the drug 
                is manufactured; and
                    ``(E) demonstrate to the Secretary that the drug 
                meets the requirements of paragraph (1).
            ``(3) Required reporting.--The holder of an approved 
        application for the export of a drug under this subsection 
        shall report to the Secretary--
                    ``(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
                    ``(B) the receipt of any information indicating any 
                adverse reactions to such drug.
            ``(4) Additional limitations.--
                    ``(A) Failure to meet certain requirements.--If the 
                Secretary determines that--
                            ``(i) a drug for which an application is 
                        approved under paragraph (2) does not continue 
                        to meet the requirements of paragraph (1);
                            ``(ii) the holder of the application has 
                        not made the report required by paragraph (3); 
                        or
                            ``(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),
        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.
                    ``(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--
                            ``(i) the holder of an approved application 
                        under paragraph (2) is exporting a drug from 
                        the United States to an importer;
                            ``(ii) the importer is exporting the drug 
                        to a country for which the Secretary cannot 
                        make a finding under paragraph (1)(A); and
                            ``(iii) the export presents an imminent 
                        hazard to the public health in the country,
                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.
                    ``(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.
                    ``(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).
                    ``(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.''.

SEC. 503. PARTIALLY PROCESSED BIOLOGICAL PRODUCTS.

    Subsection (h) of section 351 of the Public Health Service Act (42 
U.S.C. 262) is amended to read as follows:
    ``(h) A partially processed biological product that--
            ``(1) is not in a form applicable to the prevention, 
        treatment, or cure of diseases or injuries of man;
            ``(2) is not intended for sale in the United States; and
            ``(3) is intended for further manufacture into final dosage 
        form outside the United States,
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)).''.

        TITLE VI--DRUG AND BIOLOGICAL PRODUCTS REGULATORY REFORM

SEC. 601. SHORT TITLE.

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

SEC. 602. 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 one well-controlled clinical investigation (which may be 
waived by the Secretary) and confirmatory evidence (obtained either 
before or after such investigation).''.

SEC. 603. 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 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.''.

SEC. 604. MANUFACTURING CHANGES.

    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:

``SEC. 750. 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 shall require--
            ``(1) validation; and
            ``(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
            ``(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.
    ``(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--
            ``(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
            ``(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.
    ``(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.''.

SEC. 605. 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), as amended by 
section 502(b), is further amended by adding at the end thereof the 
following new subsection:
    ``(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).''.

SEC. 606. BIOLOGICAL PRODUCTS.

    (a) Modernization of Regulation of Biological Products.--
            (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:
    ``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--
            ``(A) a product license has been issued for the biological 
        product;
            ``(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
            ``(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.
    ``(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.
    ``(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.
    ``(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.
    ``(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.''.
            (2) 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.''.
            (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''.
            (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:
    ``(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 those sections to new drug applications shall be deemed to include 
product license applications.
    ``(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.
    (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).

SEC. 607. REQUIREMENTS FOR EMERGING BIOTECHNOLOGY PRODUCTS.

    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--
            (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
            (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.

                  TITLE VII--DEVICE REGULATORY REFORM

SEC. 701. SHORT TITLE.

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

SEC. 702. 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 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) (as amended by 
        paragraph (1)) the following:
``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) 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.
    ``(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).''.
    (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).
    (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:
    ``(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).''.
    (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) 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.''.

SEC. 703. MEDICAL DEVICE APPROVAL STANDARDS.

    Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended--
            (1) by striking ``well-controlled investigations'' and 
        inserting ``a scientific investigation'';
            (2) by striking ``clinical investigations'' and inserting 
        ``a clinical investigation'';
            (3) by striking ``investigations it'' and inserting 
        ``investigation it''; and
            (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.''.

SEC. 704. 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 life-threatening or 
        have permanently debilitating effects; and
            ``(2) which is--
                    ``(A) permanently implanted; or
                    ``(B) life sustaining or life supporting and used 
                outside a device user facility.''.

SEC. 705. POSTMARKET SURVEILLANCE.

    Section 522(1) (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 
first introduced or delivered for introduction into interstate commerce 
after January 1, 1991, 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.
    ``(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. 706. 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 (8), by striking ``; and'' and 
                inserting a period; and
                    (B) by striking paragraph (9); and
            (3) by striking subsection (f).

SEC. 707. 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 
        paragraph:
    ``(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 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.
            ``(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.
            ``(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.
            ``(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.
            ``(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)(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.
    ``(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.''.
    (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.

SEC. 708. 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:

                            ``product review

    ``(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.
    ``(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.
    ``(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.
    ``(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.
    ``(5) Within 150 days after the receipt by the Secretary of the 
application, the Secretary shall--
            ``(A)(i) grant the petition in whole or in part; or
            ``(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
            ``(B) publish a notice of the determination in the Federal 
        Register.
    ``(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.
    ``(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.
    ``(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.''.
    (b) Adulterated Device.--Section 501(e) (21 U.S.C. 351(e)) is 
amended by striking ``section 514'' and inserting ``section 514(b)''.

               TITLE VIII--ANIMAL DRUG REGULATORY REFORM

SEC. 801. SHORT TITLE.

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

SEC. 802. NEW ANIMAL DRUG APPROVAL STANDARDS.

    (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.''.
    (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:
    ``(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--
            ``(A) the combination affects the safety of any active 
        ingredient;
            ``(B) the combination interferes with a method of analysis 
        for any active ingredient;
            ``(C) if the active ingredients have the same intended 
        effect, each of the active ingredients makes a significant 
        contribution to the labeled effectiveness; and
            ``(D) if the active ingredients do not have the same 
        intended effect, the active ingredients provide appropriate 
        concurrent therapy for a labeled target population.''.
    (c) Approval.--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''.

SEC. 803. RESIDUE LIMITATION.

    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 in the application or 
        otherwise available to the Secretary, any labeled use of the 
        drug will result in an unsafe residue of the drug;''.

SEC. 804. 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;''.

                    TITLE IX--FOOD REGULATORY REFORM

SEC. 901. SHORT TITLE.

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

SEC. 902. 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 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.
    ``(3)(A) Within 90 days after the receipt of the notification by 
the Secretary, the Secretary shall either--
            ``(A)(i) approve the notification if the product is safe 
        for its intended use; or
            ``(ii) disapprove the notification if there is a reasonable 
        possibility that the article is not 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).
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).''.
    (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:
    ``(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.''.
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