[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3199 Introduced in House (IH)]


104th CONGRESS
  2d Session
                                H. R. 3199

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
Service Act to facilitate the development and approval of new drugs and 
              biological products, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 29, 1996

 Mr. Burr (for himself, Mr. Greenwood, Mr. Richardson, Mr. Bilirakis, 
Mr. Towns, Mr. Barton of Texas, Mr. Hall of Texas, Mr. Klug, Ms. Eshoo, 
   Mr. Upton, Mr. Gordon, Mr. Bilbray, Mr. Brewster, Mr. Coburn, Mr. 
 Dooley of California, Mr. Ganske, Mr. McHale, Mr. Oxley, Mr. Payne of 
  Virginia, Mr. Fields of Texas, Mr. Rose, Mr. Paxon, Mr. Holden, Mr. 
  Tauzin, Mr. Schaefer, Mr. Fox of Pennsylvania, Mr. Funderburk, Mr. 
    Campbell, Mr. McIntosh, Mr. Cox of California, Mr. Dreier, Mr. 
 Heineman, Mr. Weldon of Florida, Mr. Shays, Mr. Hastert, Mr. Norwood, 
Mr. Burton of Indiana, Mr. Frazer, Mr. Stearns, Mr. Frisa, Mr. Ramstad, 
Mr. Martini, and Ms. Dunn of Washington) introduced the following bill; 
            which was referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
Service Act to facilitate the development and approval of new drugs 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, REFERENCE, AND TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Drug and 
Biological Products Reform Act of 1996''.
    (b) Reference.--Whenever in this Act (other than in sections 13 and 
24) an amendment is expressed in terms of an amendment to a section or 
other provision, the reference shall be considered to be made to a 
section or other provision of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321) et seq.) except as otherwise specified.
    (c) Table of Contents.--The table of contents is as follows:

Sec. 1. Short title, reference, and table of contents.
Sec. 2. FDA mission and annual report.
Sec. 3. Streamlining clinical research on drugs and biological 
                            products.
Sec. 4. The content and review of a new drug application.
Sec. 5. Effectiveness determination.
Sec. 6. Scientific review groups.
Sec. 7. Marketing approval.
Sec. 8. Accreditation of third parties.
Sec. 9. Dispute resolution.
Sec. 10. Good manufacturing practice inspections.
Sec. 11. Good manufacturing practices.
Sec. 12. Pilot and small scale manufacture.
Sec. 13. Manufacturing changes.
Sec. 14. Insulin and antibiotics.
Sec. 15. Nonprescription drugs.
Sec. 16. Information system.
Sec. 17. Environmental impact review.
Sec. 18. Application of State and Federal law to the practice of 
                            pharmacy compounding.
Sec. 19. Harmonization.
Sec. 20. Use of scientific and medical information.
Sec. 21. Informal agency statements.
Sec. 22. Research and education; practice of medicine.
Sec. 23. Delegation of authority.
Sec. 24. Judicial review.
Sec. 25. Publication of notice of deviation.
Sec. 26. Biological products.

SEC. 2. FDA MISSION AND ANNUAL REPORT.

    (a) Mission.--Section 903 (21 U.S.C. 393) is amended by 
redesignating subsections (b) and (c) as subsections (c) and (d), 
respectively, and by adding after subsection (a) the following:
    ``(b) Mission.--The Food and Drug Administration shall protect the 
public health and safety and promptly and efficiently review and 
approve clinical research and marketing of products in a manner that 
does not unduly impede innovation or product availability. The Food and 
Drug Administration shall participate with other countries to reduce 
the burden of regulation, harmonize regulatory requirements, and 
achieve appropriate reciprocal arrangements.''.
    (b) Annual Report.--Section 903 (21 U.S.C. 393), as amended by 
subsection (a), is amended by adding at the end the following:
    ``(e) Annual Report.--The Secretary shall, simultaneously with the 
submission each year of the budget for the Food and Drug 
Administration, submit to the Committee on Commerce of the House of 
Representatives and the Committee on Labor and Human Resources of the 
Senate an annual report which shall--
            ``(1) review the performance of the Food and Drug 
        Administration in meeting its mission and the development of 
        Food and Drug Administration policies to implement such 
        mission;
            ``(2) review the performance of the Food and Drug 
        Administration in meeting its own performance standards, 
        including its own outcome measurements and statutory deadlines 
        for the approval of products or for other purposes contained in 
        this Act;
            ``(3) describe the staffing and resources of the Food and 
        Drug Administration and list those persons and organizations 
        accredited to conduct investigations under section 505(i), 
        product approvals under sections 505 and 506, and to perform 
        good manufacturing practice reviews under sections 505(d)(3) 
        and 520(f);
            ``(4) describe the goals, activities, and accomplishments 
        of the Food and Drug Administration in bilateral and 
        multinational meetings that addressed methods and approaches to 
        reduce the burden of regulation, harmonize regulation, and to 
        seek appropriate reciprocal arrangements, list each such 
        meeting, and list pending issues specifying those that are not 
        consistent with or are contrary to the provisions of this Act; 
        and
            ``(5) compare the performance of the Food and Drug 
        Administration in approving innovative products with that of 
        the most successful agencies performing similar functions in 
        other countries and compare the resources used by such 
        agencies.''.

SEC. 3. STREAMLINING CLINICAL RESEARCH ON DRUGS AND BIOLOGICAL 
              PRODUCTS.

    Section 505(i) (21 U.S.C. 355(i)) is amended by adding ``(1)'' 
prior to the first sentence, by redesignating paragraphs (1), (2), and 
(3) as subparagraphs (A), (B), and (C), respectively, and by adding the 
following new paragraphs at the end thereof:
    ``(2) A clinical investigation of a new drug may begin 21 days 
after the Secretary has received from the sponsor of the investigation 
a submission containing information about the drug and the clinical 
investigation as follows: The submission shall contain--
            ``(A) adequate reports of basic information, certified by 
        the applicant to be accurate reports, necessary to assess the 
        safety of the drug for use in clinical investigation; and
            ``(B) adequate information on the chemistry of the drug, 
        manufacturing of the drug, controls available for the drug, and 
        primary data tabulations for the drug from animal or human 
        studies, except that for phase I or phase II clinical 
        investigations detailed information shall not be required 
        unless the director of the office responsible for the review of 
        the drug makes a request within 21 days after the submission 
        regarding such detailed information in writing and specifies 
        the reasons for the request.
    ``(3)(A) At any time, the Secretary may issue to the sponsor of an 
investigation a clinical hold in writing prohibiting the sponsor from 
conducting the investigation and specifying the basis for the clinical 
hold. The Secretary may issue a clinical hold upon a demonstration, 
based on specific information available to the Secretary, that the drug 
to be investigated represents an unreasonable risk to the safety of the 
persons who are the subject of the clinical investigation, taking into 
account the design of the clinical investigation, the condition for 
which the drug is to be investigated, and the health status of the 
subjects involved.
    ``(B) Any response from the sponsor of an investigation to the 
Secretary requesting that a clinical hold be removed shall receive a 
decision, in writing and specifying the reasons therefor, within 15 
days after receipt of such response or the clinical hold shall be 
deemed to be withdrawn.
    ``(4) As an alternative to the procedure established in paragraph 
(2), a Phase I or Phase II clinical investigation may begin after an 
accredited institution has approved the investigation and the sponsor 
of the investigation has submitted to the Secretary a notification 
setting forth the name and address of the sponsor, the identity of the 
drug, and the uses of the drug that the sponsor intends to investigate. 
Data and information developed through such an investigation may be 
submitted in support of an application for approval of a new drug and 
shall be considered by the Secretary to the same extent as data and 
information developed through an investigation under paragraph (2). 
Paragraph (3) shall apply to such an investigation. The Secretary shall 
establish by regulation the requirements and qualifications that an 
accredited institution shall meet to be eligible to approve an 
investigation for purposes of this paragraph.
    ``(5) The Food and Drug Administration shall have exclusive 
regulatory jurisdiction in the Department of Health and Human Services 
over the use of a new drug in any clinical investigation.''.

SEC. 4. THE CONTENT AND REVIEW OF A NEW DRUG APPLICATION.

    (a) Section 505(b).--Section 505(b) (21 U.S.C. 355(b)) is amended 
by adding at the end the following:
    ``(4)(A) An application submitted under paragraph (1) shall include 
adequate reports of clinical and preclinical investigations on safety 
and effectiveness certified by the applicant to be accurate and 
supported by tables of the relevant data, and forms and tabulations 
related to deaths and dropouts due to adverse reactions. The director 
of the office responsible for review of the drug may request, in 
writing and specifying the reasons for the request for a particular 
application, the submission of specific primary data tabulations or 
case report forms or tabulations for a specific investigation.
    ``(B) The Secretary shall establish standards for the review of 
applications submitted under paragraph (1) relating to promptness, 
technical excellence, lack of bias and conflict of interest, and a 
knowledge of regulatory and scientific standards which shall apply 
equally to outside reviewers and to employees of the Secretary who 
review such applications.
    ``(C) Food and Drug Administration employees shall meet with a 
sponsor of an investigation or an applicant under an application 
submitted under paragraph (1) within 30 days of any reasonable request 
for a meeting by the sponsor or applicant for the purpose of reaching 
agreement on the design and size of clinical trials. Minutes of any 
such meeting shall be exchanged. Advice provided to a sponsor or 
applicant at its request by a Food and Drug Administration employee, 
which is reduced to writing and made part of the administrative record 
by the sponsor or applicant or by the Food and Drug Administration, 
regarding appropriate testing of a new drug shall not be changed after 
such testing begins, except with the written agreement of the sponsor 
or applicant or by a decision in writing, after an informal hearing, by 
the director of the office in which the drug is reviewed where such 
change is needed because there is a demonstrated need to protect the 
public health.
    ``(D) The written decisions of the office responsible for the 
review of a drug on all aspects of scientific and medical matters 
relating to a new drug shall be binding upon, and may not directly or 
indirectly be changed by, the field personnel or the offices of 
compliance of the office responsible for the review.
    ``(E) No action by the office responsible for the review of a drug 
on any matter relating to a new drug for which an application has been 
submitted under paragraph (1) may at any time, or under any 
circumstance other than a demonstrable extraordinary circumstance, be 
delayed because of the unavailability of information from or action by 
field personnel.''.
    (b) Section 735(7).--Section 735(7) is amended--
            (1) by striking ``applications for'' and inserting 
        ``applications'' and by inserting ``for'' after ``(A)'', 
        ``(B)'', and ``(C)'';
            (2) by striking ``and'' at the end of subparagraph (C),
            (3) by striking the period at the end of subparagraph (D) 
        and inserting ``, and'', and
            (4) by inserting the following after subparagraph (D):
                    ``(E) by outside organizations and individuals.''.

SEC. 5. EFFECTIVENESS DETERMINATION.

    Section 505(d) (21 U.S.C. 355(d)) is amended--
            (1) in the last sentence, by adding ``one or more'' before 
        ``clinical investigations'';
            (2) by adding at the end the following: ``For purposes of 
        the preceding sentence, a well-controlled investigation shall 
        only include methods of control that are appropriate to the 
        disease or condition for which a drug is intended as 
        prescribed, recommended, or suggested in its labeling. The 
        Secretary may waive the requirement to conduct any well-
        controlled investigation, as defined in the preceding 
        sentence.''; and
            (3) by inserting ``(1)'' after ``(d)'', by redesignating 
        clauses (1) through (6) as clauses (A) through (F), by striking 
        ``(1) through (6)'' and inserting ``(A) through (F)'', and by 
        adding at the end the following:
    ``(2) For purposes of clause (E) of paragraph (1)--
            ``(A) an application for a new drug for a serious or life-
        threatening condition shall be considered to have substantial 
        evidence if it could be fairly and responsibly concluded by the 
        experts referred to in paragraph (1) that there is a reasonable 
        likelihood that the drug will be effective in a significant 
        number of patients and that the risk from the drug is no 
        greater than the risk from the condition; and
            ``(B) if an application has been submitted for a new use of 
        a previously approved new drug, such drug shall be considered 
        to have substantial evidence by a demonstration that the new 
        use is common among clinicians experienced in the field and 
        represents reasonable clinical practice based upon reliable 
        clinical experience and confirmatory information.
    ``(3) For purposes of paragraph (1), the determination of 
effectiveness shall not include--
            ``(A) relative effectiveness, unless the effectiveness of 
        the drug is explicitly compared in the labeling to the 
        effectiveness of another drug;
            ``(B) any potential use not explicitly included in the 
        labeling; and
            ``(C) the cost-effectiveness of the drug as compared to the 
        cost-effectiveness of another drug unless the labeling 
        explicitly includes a representation about cost-
        effectiveness.''.

SEC. 6. SCIENTIFIC ADVISORY PANELS.

    Section 505 (21 U.S.C. 355) is amended by adding at the end the 
following:
    ``(n)(1) For the purpose of providing expert scientific advice and 
recommendations to the Secretary regarding a clinical investigation of 
a drug or biological product or the approval for marketing of a drug or 
biological product under section 505 or 506, the Secretary shall 
establish panels of experts or use panels of experts established before 
the date of the enactment of this subsection, or both. Scientific 
advisory panels shall consider scientific issues and shall not include 
considerations of cost, economic aspects, comparative effectiveness, or 
legal matters.
    ``(2) The Secretary may delegate the appointment and oversight 
authority granted under section 904 to a director of a center or 
successor entity within the Food and Drug Administration.
    ``(3) The Secretary shall appoint to each panel established under 
paragraph (1) persons who are qualified by training and experience to 
evaluate the safety and effectiveness of the drugs and biological 
products to be referred to the panel and who, to the extent feasible, 
possess skill in the use of, or experience in, the development, 
manufacture, or utilization of, such drugs or biological products. The 
Secretary shall make appointments to each panel so that each panel 
shall consist of members with adequately diversified expertise in such 
fields as clinical and administrative medicine, engineering, biological 
and physical sciences, and other related professions. In addition, each 
panel shall include as nonvoting members a representative of consumer 
interests and a representative of interests of the drug and biological 
product manufacturing industry. Scientific, trade, and consumer 
organizations shall be afforded an opportunity to nominate individuals 
for appointment to the panels. No individual who is in the regular 
full-time employ of the United States and engaged in the administration 
of this Act may be a member of any panel. The Secretary shall designate 
one of the members of each panel to serve as chairman thereof.
    ``(4) Each member of a panel shall publically disclose all 
conflicts of interest that member may have with the work to be 
undertaken by the panel. No member of a panel may vote on any matter 
where the member could gain financially from the advice given to the 
Secretary. The Secretary may grant a waiver of any conflict of interest 
upon public disclosure of such conflict of interest if such waiver 
contributes to the ability of a panel to contribute to the public 
health, except that the Secretary may not grant a waiver for a member 
of a panel when the member's own scientific work is involved.
    ``(5) The Secretary shall provide education and training to each 
new panel member before such member participates in a panel's 
activities. Such education and training shall include a familiarization 
with certain requirements under this Act and any related regulation of 
the Secretary and the administrative process and procedures related to 
panel meetings.
    ``(6) Panel members (other than officers or employees of the United 
States), while attending meetings or conferences of a panel or 
otherwise engaged in its business, shall be entitled to receive 
compensation at rates to be fixed by the Secretary, but not at rates 
exceeding the daily equivalent of the rate in effect for grade GS-18 of 
the General Schedule, for each day so engaged, including traveltime. 
While so serving away from their homes or regular places of business, 
each member may be allowed travel expenses (including per diem in lieu 
of subsistence) as authorized by section 5703 of title 5, United States 
Code, for persons in the Government service employed intermittently.
    ``(7) The Secretary shall take whatever action is necessary to 
ensure that regular meetings are held by scientific advisory panels, at 
appropriate intervals and for a sufficient length of time, so that any 
matter to be reviewed by any such panel shall be presented to the panel 
not more than 60 days after the matter is ready for review by the 
panel. The meetings shall occur not less than 6 times each year unless 
there are compelling reasons for fewer meetings. Such meetings shall be 
held with the physical presence of panel members at least 3 times each 
calendar year. Other meetings of the panel may be held using electronic 
communication to convene the meeting.
    ``(8)(A) All persons, including employees of the Secretary, shall 
have the same rights and responsibilities regarding--
            ``(i) the submission of data and information to, and 
        contact and discussion with, a scientific advisory panel;
            ``(ii) the participation of the persons at meetings of the 
        panel; and
            ``(iii) access to data and information submitted to a 
        scientific advisory panel (except for data and information that 
        are not available for public disclosure under section 552 of 
        title 5, United States Code).
    ``(B) In a case in which a scientific advisory panel reviews an 
application submitted under section 505 or 506 (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 such panel but shall not otherwise be 
publicly disclosed.
    ``(C) Any meetings of a scientific advisory panel 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.
    ``(9) Within 30 days after the date a scientific advisory panel 
makes its conclusions and recommendations on any matter under review by 
the panel, the Food and Drug Administration official responsible for 
the matter shall review the conclusions and recommendations of the 
panel, shall make a final decision on the matter, and shall notify the 
affected persons of the decision in writing and, if the decision 
differs from the conclusions and recommendations of the panel, shall 
include the reasons for the difference.
    ``(10) A scientific advisory panel under this subsection shall not 
be subject to the annual chartering and annual report requirements of 
the Federal Advisory Committee Act. Such a panel shall make an annual 
report of its activities to the Secretary.''.

SEC. 7. MARKETING APPROVAL.

    Section 505(b) (21 U.S.C. 355(b)), as amended by section 4(a), is 
amended--
            (1) in the first sentence of paragraph (1), by inserting 
        immediately after ``the Secretary'' the following: ``or may 
        file such application with a person authorized to review 
        applications for marketing approval under section 712''; and
            (2) by adding after paragraph (4) the following:
    ``(5)(A) The scope of review responsibilities of accredited persons 
authorized to conduct reviews of marketing approval applications under 
section 712 shall include the review of applications to determine 
whether there is a reasonable assurance that a drug is safe and 
effective under the conditions prescribed, recommended, or suggested in 
the proposed labeling. The review shall be conducted under the 
standards and requirements of this Act applicable to reviews by the 
Secretary. Prior to 60 days before the end of the period prescribed by 
subsection (c), the accredited person shall submit a report of its 
review to the Secretary and its recommendations. Recommendations to the 
Secretary shall specify whether an application should be approved or 
denied and shall state the basis for the recommendation.
    ``(B) The recommendation of the accredited person shall be deemed 
to be approved by the Secretary unless the Secretary finds that there 
is a reasonable probability that the drug is not safe or effective. 
Upon receipt of the recommendation from an accredited person to approve 
or deny an application, the Secretary shall evaluate the recommendation 
within 60 days of such receipt. In the event that the Secretary makes 
such a finding, the Secretary shall provide a detailed explanation of 
the basis of the difference.''.

SEC. 8. ACCREDITATION OF THIRD PARTIES.

    (a) Amendment.--Subchapter A of chapter VII is amended by adding at 
the end the following:

``SEC. 712. ACCREDITED PERSONS.

    ``(a) In General.--The Secretary shall, within 180 days of the date 
of the enactment of this section, by regulation establish procedures 
for the accreditation of persons for the purposes of--
            ``(1) reviewing applications under section 505(b) or 506, 
        providing written reviews to the Secretary for the Secretary's 
        consideration, and making recommendations on whether or not 
        such applications should be approved; and
            ``(2) conducting good manufacturing practice inspections to 
        determine the conformance of a facility with regulations 
        promulgated under sections 501(a)(2), 505(d)(3), and 520(f).
    ``(b) Accreditation.--
            ``(1) Programs.--The Secretary shall provide for such 
        accreditation through programs administered by government 
        agencies or by other qualified organizations.
            ``(2) Implementation.--The Secretary may designate one or 
        more qualified non-government organizations to implement such 
        programs. Such organizations shall implement such programs from 
        fees charged to applicants for accreditation.
            ``(3) Qualifications.--An accredited person shall meet the 
        following requirements:
                    ``(A) Such person shall be an independent 
                organization which is not owned or controlled by 
                manufacturer, supplier or vendor of drugs and which has 
                no organizational, material, or financial affiliation 
                with such a manufacturer, supplier, or vendor.
                    ``(B) Such person shall be a legally constituted 
                entity permitted to conduct the activities for which it 
                seeks accreditation.
                    ``(C) Such person shall not engage in the 
                development, manufacture, promotion, or sale of drugs.
                    ``(D) Such person shall be operated in accordance 
                with generally accepted professional and ethical 
                business practices and shall agree in writing that as a 
                minimum it will--
                            ``(i) certify that reported information 
                        accurately reflects data reviewed;
                            ``(ii) limit work to that for which 
                        competence and capacity are available;
                            ``(iii) treat information received, 
                        records, reports, and recommendations as 
                        proprietary information; and
                            ``(iv) promptly respond and attempt to 
                        resolve complaints regarding its activities for 
                        which it is accredited.''.
    (b) Conforming Amendment.--Section 301 (21 U.S.C. 321) is amended 
by redesignating the second paragraph (u) as paragraph (v) and by 
adding after that paragraph the following:
    ``(w) in the case of a drug, device, or food--
            ``(A) the submission of a report or recommendation by a 
        person accredited under section 712 that is false or misleading 
        in any material respect;
            ``(B) the disclosure by a person accredited under section 
        712 of confidential commerical information or any trade secret 
        without the express written consent of the person who submitted 
        such information or secret to such person; or
            ``(C) the receipt by a person accredited under section 712 
        of a bribe in any form or the doing of any corrupt act by such 
        person associated with a responsibility delegated to such 
        person under this Act.''.

SEC. 9. DISPUTE RESOLUTION.

    Chapter V, as amended by section 14(b)(1), is amended by adding 
after section 506 the following:

                          ``dispute resolution

    ``Sec. 507. (a) At any time before the issuance of the notice under 
section 505(c)(1)(B) or an exemption for investigational use under 
section 505(i) for a drug subject to section 505 or 506, the applicant 
may, in writing, notify the Secretary that an impasse exists in the 
review of the application for a drug under section 505(b) or the 
submission for such an exemption with respect to a specifically 
identified issue.
    ``(b) On receipt of the notification from the applicant, the 
Secretary shall refer the disputed issue--
            ``(1) to an existing (as of the date of the notification) 
        scientific advisory panel having expertise related to the 
        issue;
            ``(2) to a special Government employee, as defined in 
        section 202(a) of title 18, United States Code, or to a non-
        governmental person qualified to mediate or arbitrate the 
        substance of such impasse who is acceptable to the Secretary 
        and the applicant.
    ``(c) The applicant and representatives of the Secretary may 
consult with the panel, special Government employee, or non-
governmental person on the matter referred. The panel, special 
Governmental employee, or non-governmental person shall submit to the 
Secretary and the applicant a report containing recommendations 
(including a statement of reasons for the recommendations) regarding 
the matter not later than 60 days after the date of the referral, or 
not later than 90 days after the date of the referral if the panel, 
special Governmental employee, or non-governmental person considers the 
additional 30 days to be necessary. Not later than 30 days after the 
date of receiving the report, the Secretary shall, in writing, confirm 
or modify the recommendations received, providing reasons and reference 
to data before the panel, special Governmental employee, or non-
governmental person for any modification. If the Secretary fails to act 
on such a recommendation within 30 days of its receipt, the 
recommendation of the panel, special Government employee, or non-
governmental person shall be deemed to be the recommendation of the 
Secretary.
    ``(d) The Federal Advisory Committee Act shall not apply to any 
scientific advisory panel acting under this section.''.

SEC. 10. GOOD MANUFACTURING PRACTICE INSPECTIONS.

    (a) Section 704 (21 U.S.C. 374) is amended--
            (1) in subsection (a)(1), by inserting ``, or an accredited 
        person to conduct good manufacturing practice inspections under 
        section 712'' after ``Secretary'';
            (2) in subsection (a)(3), by inserting ``, or an accredited 
        organization or individual under section 712,'' after 
        ``employee'';
            (3) in subsection (b), by inserting ``, or an accredited 
        person under section 712,'' after ``employee'';
            (4) in subsection (b), by inserting ``(1)'' after ``(b)'', 
        by redesignating clauses (1) and (2) as clauses (A) and (B), 
        respectively, and by adding at the end the following:
    ``(2) The Secretary shall provide, at least 10 days from the date 
of presentation of the report of conditions or practices identified in 
paragraph (1), for the person receiving such report to respond. The 
Secretary shall take no regulatory action against a person or article 
identified in such a report until completing a review of such response 
which is timely submitted to the Secretary, except the Secretary may 
take immediate action when the Secretary finds that there is a 
reasonable probability that a drug intended for human use would cause 
serious, adverse health consequences or death or that any regulated 
article could present an unreasonable and substantial risk of injury or 
illness to the public health. The Secretary shall provide to the 
regulated person, within 30 days of receiving a response to the report 
identified in paragraph (1), a written detailed assessment of the 
response.
    ``(3) At the time an accredited person completes an inspection 
under the authority of this section and section 712, such person shall 
identify in writing to the person subject to the inspection each 
condition or practice observed during such inspection which suggests a 
deviation from requirements of this Act. However, such accredited 
person shall immediately submit to the Secretary the findings of the 
inspection when the drug to which such findings relate is intended for 
human use and presents a reasonable probability that such drug would 
cause serious, adverse health consequences or death or that such drug 
could present an unreasonable and substantial risk of injury or illness 
to the public unless the person subject to the inspection--
            ``(A) immediately ceases distribution of the drug;
            ``(B) immediately notifies health professionals and drug 
        user facilities to instruct such professionals and facilities 
        to cease use of the drug; and
            ``(C) immediately undertakes all corrections identified by 
        the accredited person.
When such compliance is complete, the accredited person shall provide 
the inspected person a certification of compliance which includes the 
dates of inspections, a statement that the inspected facility is in 
compliance with the requirements of section 520(f), the date the 
compliance was achieved at the facility, and the signature of the 
accredited person attesting to the finding that the inspected facility 
is in good manufacturing practices compliance as defined by such 
section. When an accredited person has certified compliance with good 
manufacturing practices requirements and provided the Secretary with a 
copy of the certification within 10 days of its being made, the 
Secretary may not perform a good manufacturing practices inspection of 
the person subject to an inspection for a period of 2 years after the 
date of the certification unless justified by good cause.''; and
            (5) in subsection (c), by striking ``or employee'' and 
        inserting ``, employee, or accredited person'';
            (6) in subsection (e), by striking ``or employee'' each 
        place it occurs and inserting ``, employee, or accredited 
        person''; and
            (7) by adding at the end the following:
    ``(f) Persons duly designated by the Secretary to conduct 
inspections under this section shall not request any information not 
permitted under subsections (a) and (e) unless such person states with 
specificity and in writing the identification of the information 
subject to the request, the reason for the request, and that the 
written request seeks to obtain information not required to be produced 
under this section. Such request shall not include information related 
to sales (other than distribution), personnel, or pricing data.''.

SEC. 11. GOOD MANUFACTURING PRACTICES.

    (a) Amendment.--Section 501(a) (21 U.S.C. 351(a)) is amended--
            (1) by striking ``(a)(1)'' and inserting ``(a)(1)(A)'';
            (2) by redesignating subclauses (A) and (B) in clauses (2) 
        and (4) as subclauses (i) and (ii), respectively; and
            (3) by redesignating clauses (2) through (6) as clauses (B) 
        through (F), respectively;
            (4) by adding at the end the following:
    ``(2) All chemistry, manufacturing, and controls which comply with 
an approved new drug application under section 505 or an approved drug 
application under section 506 or with the opinion of an appropriate 
official in the component of the Food and Drug Administration 
responsible for the review of such chemistry, manufacturing, or 
controls and which is reduced to writing and made part of the 
administrative record shall be deemed to comply with current good 
manufacturing practice. The Secretary shall not take action to delay or 
prevent the manufacture or marketing of a drug under section 505 or 506 
for failure to conform to current good manufacturing practice unless 
there is reasonable probability of actual harm to the public health or 
the Secretary determines in writing, after an informal hearing, that 
the drug is--
            ``(A) not bioequivalent,
            ``(B) deviates from the specifications for the drug 
        established in the approved new drug application from the 
        specifications for the drug established by the manufacturer,
            ``(C) lacks adequate assurance that it will meet the 
        represented sterility, or
            ``(D) has been rendered unsafe or ineffective.''.
    (b) Conforming Amendments.--
            (1) Section 303.--Section 303(g)(1)(B)(iii) (21 U.S.C. 
        333(g)(1)(B)(iii)) is amended by striking ``501(a)(2)(A)'' and 
        inserting ``501(a)(1)(B)(i)''.
            (2) Section 304.--Section 304(d)(1) (21 U.S.C. 334(d)(1)) 
        is amended by striking ``501(a)(3)'' and inserting 
        ``501(a)(1)(C)''.
            (3) Section 512.--Section 512(a)(1) (21 U.S.C. 360c(a)(1)) 
        is amended by striking ``501(a)(5)'' and inserting 
        ``501(a)(1)(E)'', section 512(a)(2) (21 U.S.C. 360c(a)(2)) is 
        amended by striking ``501(a)(6)'' and inserting 
        ``501(a)(1)(F)'', and section 512(a)(3) (21 U.S.C. 360c(a)(3)) 
        is amended by striking ``501(a)(5) or (6)'' and inserting 
        ``501(a)(1)(E) or 501(a)(1)(F)''.
            (4) Section 721.--Section 721(a) (21 U.S.C 379e(a)) is 
        amended by striking ``501(a)(4)'' and inserting 
        ``501(a)(1)(D)''.
            (5) Section 802.--Sections 802(b)(1)(D) and 802(f)(1)(B) 
        (21 U.S.C.382(b)(1)(D),382(f)(1)(B)) are each amended by 
        striking ``(a)(1), (a)(2)(A), (a)(3)'' and inserting 
        ``(a)(1)(A), (a)(1)(B)(i), (a)(1)(C)'' .

SEC. 12. PILOT AND SMALL SCALE MANUFACTURE.

    Section 505(c) (21 U.S.C. 355(c)) is amended by adding at the end 
thereof the following:
    ``(4) A new drug manufactured in a pilot or other small facility 
may be used to demonstrate the safety and effectiveness of the drug 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.''.

SEC. 13. MANUFACTURING CHANGES.

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

                 ``Subchapter D--Manufacturing Changes

``SEC. 740. MANUFACTURING CHANGES.

    ``(a) In General.--A change in the manufacture of a new drug, 
biological product, new animal drug, blood, or blood component shall be 
made in accordance with this section.
    ``(b) Drug and Biological Product.--A change in the manufacture of 
a new drug or 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, blood, or blood component 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 506 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 Drug and Biological 
Products Reform Act of 1996, 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. 14. INSULIN AND ANTIBIOTICS.

    (a) Certification of Drugs Containing Insulin.--
            (1) Amendment.--Section 506 (21 U.S.C. 356) is repealed.
            (2) Conforming amendments.--
                    (A) Sections 301(i)(1) and 301(j)(1) (21 U.S.C. 
                321(i)(1), 321(j)(1)) are each amended by striking 
                ``506, 507,''.
                    (B) Section 501(k) (21 U.S.C. 351(k)) is repealed
                    (C) Section 502(k) (21 U.S.C. 352(k) is repealed.
                    (D) Sections 510(j)(1)(A) and 510(j)(1)(D) (21 
                U.S.C. 360(j)(1)(A), 360(j)(1)(D)) are each amended by 
                striking ``506, 507,''.
                    (E) Section 8126(h)(2) of title 38, United States 
                Code, is amended by inserting ``or'' at the end of 
                subparagraph (B), by striking ``; or'' at the end of 
                subparagraph (C) and inserting a period, and by 
                striking subparagraph (D).
                    (F) Section 1927(k)(2) of the Social Security Act 
                (42 U.S.C. 1396r-8(k)(2)) is amended by striking ``; 
                and'' at the end of subparagraph (B) and inserting a 
                period and by striking subparagraph (C).
    (b) Certification of Antibiotics.--
            (1) Amendment.--Section 507 (21 U.S.C. 357), as in effect 
        on the date of the enactment of this Act, is repealed.
            (2) Conforming amendments.--
                    (A) Section 201(aa) (21 U.S.C. 321(aa)) is amended 
                by striking out ``or 507'', section 201(dd) (21 U.S.C. 
                321(dd)) is amended by striking ``507,'', and sections 
                201(ff)(2)(B) and 201(ff)(3) (21 U.S.C. 321(ff)(2)(B), 
                321(ff)(3)) are each amended by striking ``, certified 
                as an antibiotic under section 507,''.
                    (B) Section 301(e) (21 U.S.C. 331(e)) is amended by 
                striking ``507(d) or (g),''.
                    (C) Sections 301(i)(1) and 301(j) (21 U.S.C. 
                321(i)(1), 321(j)) are each amended by striking 
                ``507,''.
                    (D) Section 306(d)(4)(B)(ii) (21 U.S.C. 
                335a(d)(4)(B)(ii)) is amended by striking ``or 507''.
                    (E) Section 502 (21 U.S.C. 352) is amended by 
                striking subsection (l).
                    (F) Section 510(j)(1)(D) (21 U.S.C. 360(j)(1)(D)) 
                is amended by striking ``507,''.
                    (G) Section 520(l) is amended by striking paragraph 
                (4) and by striking ``or Antibiotic Drugs'' in the 
                subsection heading.
                    (H) Section 525(a) (21 U.S.C. 360aa(a)) is amended 
                by inserting ``or'' at the end of paragraph (1), by 
                striking paragraph (2), and by redesignating paragraph 
                (3) as paragraph (2).
                    (I) Section 525(a) (21 U.S.C. 360aa(a)) is amended 
                by striking ``, certification of such drug for such 
                disease or condition under section 507,''.
                    (J) Section 526(a)(1) (21 U.S.C. 360bb) is amended 
                by striking ``the submission of an application for 
                certification of the drug under section 507,'', by 
                inserting ``or'' at the end of subparagraph (A), by 
                striking subparagraph (B), and by redesignating 
                subparagraph (C) as subparagraph (B).
                    (K) Section 526(b) (21 U.S.C. 360bb(b)) is amended 
                by striking ``, a certificate was issued for the drug 
                under section 507,'' each time it appears and by 
                striking ``, approval of an application for 
                certification under section 507,''.
                    (L) Section 527(a) (21 U.S.C. 360cc(a)) is amended 
                by inserting ``or'' at the end of paragraph (1), by 
                striking paragraph (2), by redesignating paragraph (3) 
                as paragraph (2), and by striking ``, issue another 
                certificate under section 507,''.
                    (M) Section 527(b) (21 U.S.C. 360cc(b)) is amended 
                by striking ``, if a certification is issued under 
                section 507 for such a drug,'', and ``, of the issuance 
                of the certification under section 507,''.
                    (N) Section 704(a)(1) (21 U.S.C. 374) is amended by 
                striking ``, section 507 (d) or (g)''.
                    (O) Section 735(1) (21 U.S.C. 379g(1)(C)) is 
                amended by inserting ``or'' at the end of subparagraph 
                (B), by striking subparagraph (C), and by redesignating 
                subparagraph (D) as subparagraph (C).
                    (P) Sections 5(b)(1)(A) and 5(b)(1)(B) of the 
                Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A), 
                360ee(b)(1)(B)) are each amended by striking ``or 
                507''.
                    (Q) Section 28(b)(2)(A)(ii)(II) of the Internal 
                Revenue Code of 1986 is amended by striking ``or 507''.
                    (R) Section 156(f)(4)(B) of title 35, United States 
                Code, is amended by striking ``507,'' each place it 
                occurs.
                    (S) Section 1927(k)(2)(A)(i) of the Social Security 
                Act (42 U.S.C. 1396r-8(k)(2)(A)(ii)(II)) is amended by 
                striking ``or 507''.
    (c) Exportation.--Section 802 (21 U.S.C. 382) is amended by adding 
at the end thereof the following:
    ``(h) Exportation of Insulin and Antibiotics.--Insulin and 
antibiotics may be exported without regard to the requirements in this 
section if the insulin and antibiotics meet the requirements in section 
801(e)(1).''.

SEC. 15. NONPRESCRIPTION DRUGS.

    Chapter V is amended by adding after section 510 (21 U.S.C. 360) 
the following:

                        ``nonprescription drugs

    ``Sec. 511. All applications or petitions requesting that a drug be 
switched from prescription to nonprescription status and all other 
matters relating to nonprescription drugs shall be reviewed and acted 
upon solely by a single office in the Center for Drug Evaluation and 
Research or a successor entity, and that office shall report directly 
to the Director of the Center. A single scientific advisory panel may 
provide conclusions and recommendations regarding any such matter.''.

SEC. 16. INFORMATION SYSTEM.

    Chapter IX, as amended by section 9, is amended by adding at the 
end the following:

``SEC. 907. 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. 17. ENVIRONMENTAL IMPACT REVIEW.

    Chapter VII, as amended by section 13, is amended by adding at the 
end the following:

              ``Subchapter E--Environmental Impact Review

``SEC. 745. ENVIRONMENTAL IMPACT REVIEW.

    ``No action by the Secretary pursuant to this Act shall require, 
with respect to an action to be taken by the Secretary, the preparation 
of an environmental impact statement under the National Environmental 
Policy Act of 1969 or an environmental assessment unless the Secretary 
demonstrates that--
            ``(1) because of extraordinary circumstances the action 
        will have a significant effect on the human environment; and
            ``(2) the consideration of such significant effect on the 
        human environment will directly affect the Secretary's decision 
        on the action.''.

SEC. 18. APPLICATION OF FEDERAL LAW TO THE PRACTICE OF PHARMACY 
              COMPOUNDING.

    Section 503 (21 U.S.C. 353) is amended by adding at the end the 
following:
    ``(h)(1) Sections 501(a)(1)(B)(ii), 501(f), 501(h), 502(f)(1), 
502(l), 502(o), 502(s), 502(t), 505, 506, and 510 and sections 510 
through 520 shall not apply to a drug that is compounded by a licensed 
pharmacist on the order of a licensed physician.
    ``(2) No provision of this Act shall apply to a bulk drug product 
or other drug, including an imported product drug, that is intended for 
use by a licensed pharmacist in compounding a drug or device on the 
order of a licensed physician, except to the extent that the provision 
relates directly to the quality, purity, or identity of such drug.''.

SEC. 19. HARMONIZATION.

    Section 803 (21 U.S.C. 383) is amended by adding at the end the 
following:
    ``(c)(1) The Secretary shall regularly and continuously participate 
in meetings with other countries to discuss methods and approaches to 
reduce the burden of regulation, harmonize regulatory requirements, and 
seek appropriate reciprocal arrangements. The Secretary shall, within 
180 days of the date of enactment of this subsection, make public a 
plan that establishes a framework for achieving mutual recognition of 
good manufacturing practices.
    ``(2) The Secretary shall report to the Committee on Commerce of 
the House of Representatives and the Committee on Labor and Human 
Resources of the Senate at least 60 days before executing any bilateral 
or multilateral agreement under paragraph (1).''.

SEC. 20. USE OF SCIENTIFIC AND MEDICAL INFORMATION.

    Section 502(f) (21 U.S.C. 352(f)) is amended by adding at the end 
the following: ``The dissemination of medical texts, articles from 
peer-reviewed scientific publications, information from Federal 
Government agencies, and presentations at medical and scientific 
meetings shall not form a basis to require adequate directions for use 
under clause (1) or information for use (or the equivalent thereof) 
under any exemption to clause (1) and shall not form a basis to require 
the filing of a report required under section 510(k) or the filing of 
an application under section 505 or 515 unless such person, in addition 
to disseminating the above-referenced information, encourages the 
unapproved use of a legally marketed drug or device through labeling, 
advertising, or other means of promotion. Mere knowledge that a legally 
available drug or device is used by licensed practitioners for the 
treatment or diagnosis of diseases or conditions in individual patients 
shall not form a basis to require adequate directions for use under 
clause (1), or information for use (or the equivalent thereof) under 
any exemption to clause (1), and shall not form a basis to require 
either the filing of a notification required under section 510(k) or an 
application under section 505 or 515. The Secretary shall not consider 
the dissemination of medical texts, articles from peer review 
scientific publications, information from Federal Government agencies, 
presentations at medical and scientific meetings, and displays at trade 
shows relating to a drug or device which is not approved for marketing 
or investigational use within the meaning of section 505(i) or 520(g) 
to be activities prohibited under published regulations of the 
Secretary unless the sponsor of an investigation for the drug or 
device, or an agent of such sponsor, in addition to the aforementioned 
activities encourages the use of a drug or device.''.

SEC. 21. INFORMAL AGENCY STATEMENTS.

    Section 701 (21 U.S.C. 371) is amended by adding at the end the 
following:
    ``(h)(1) The Secretary shall not rely upon informal agency 
statements, including guidance documents, policy statements, points to 
consider documents, or any other statements that have not been 
promulgated in accordance with the rulemaking requirements of chapter V 
of title 5, United States Code, to require any action be taken to 
satisfy a requirement of this Act.
    ``(2) The Secretary shall publish notice in the Federal Register of 
the availability to the public of each type of statement identified in 
paragraph (1). Additionally, the Secretary shall undertake to make 
available all such statements by electronic or other similar means.''.

SEC. 22. EDUCATION AND RESEARCH; PRACTICE OF MEDICINE.

    Chapter IX, as amended by section 16, is amended by adding at the 
end the following:

``SEC. 908. EDUCATION AND RESEARCH.

    ``(a) Education.--The Secretary shall conduct training and 
education programs for the employees of the Food and Drug 
Administration relating to the regulatory responsibilities and policies 
established by this Act, including programs for scientific training, 
administrative process and procedure, and integrity issues.
    ``(b) Research.--The Secretary, acting through the Food and Drug 
Administration, may conduct or contract for scientific research only if 
it is directly related to the implementation of this Act.

``SEC. 909. PRACTICE OF MEDICINE.

    ``Nothing in this Act shall be construed to limit or interfere with 
the authority of a health care practitioner, licensed by law to 
administer drugs and devices, to prescribe or administer any legally 
marketed drug or device to a patient for any condition or disease 
within a legitimate health care practitioner-patient relationship.''.

SEC. 23. DELEGATION OF AUTHORITY.

    Section 903 (21 U.S.C. 393), as amended by section 2(b), is amended 
by adding at the end the following:
    ``(f) Delegation of Authority.--The reference in sections 
505(b)(4)(A), 505(b)(4)(C), 505(i)(2)(B), and 505(n)(1) to the 
authority of a specific official or position in the Food and Drug 
Administration to perform a particular function is an authority which 
shall be only exercised by such official or individual in such position 
and the authority to exercise such authority may not be delegated.''.

SEC. 24. JUDICIAL REVIEW.

    Section 505(h) (21 U.S.C. 355(h)) is amended to read as follows:
    ``(h)(1) Not later than 30 days after--
            ``(A) any written decision respecting any aspect of an 
        investigational new drug; or
            ``(B) any written decision respecting any aspect of an 
        application, petition, or notification for marketing review or 
        approval for a drug under this section;
any person adversely affected by such decision, notice, or warning may 
file a petition with the United States Court of Appeals for the 
District of Columbia or for the circuit wherein such person resides or 
such person has a principal place of business for judicial review of 
such decision, notice, or warning. A copy of the petition shall be 
transmitted by the clerk of the court to the Secretary or other officer 
designated by the Secretary for that purpose. The Secretary shall file 
in the court the record of the proceedings on which the Secretary based 
the Secretary's decision, notice, or warning as provided in section 
2112 of title 28, United States Code. For purposes of this subsection, 
the term ``record'' means all notices and other matter published in the 
Federal Register with respect to the decision, notice, or warning 
reviewed, all information submitted to the Secretary with respect to 
such decision, notice, or warning, proceedings of any scientific 
advisory panel with respect to such decision, notice, or warning, any 
hearing held with respect to such decision, notice, or warning, and any 
other information identified by the Secretary, in the administrative 
proceeding held with respect to such decision, notice, or warning as 
being relevant to such regulation or order.
    ``(2) If the petitioner applies to the court for leave to adduce 
additional data, views, or arguments respecting the decision, notice, 
or warning being reviewed and shows to the satisfaction of the court 
that such additional data, views, or arguments are material and that 
there were reasonable grounds for the petitioner's failure to adduce 
such data, views, or arguments in the proceedings before the Secretary, 
the court may order the Secretary to provide additional opportunity for 
the oral presentation of data, views, or arguments and for written 
submissions. The Secretary may modify the Secretary's findings, or make 
new findings by reason of the additional data, views, or arguments so 
taken and shall file with the court such modified or new findings, and 
the Secretary's recommendation, if any, for the modification or setting 
aside of the decision, notice, or warning being reviewed, with the 
return of such additional data, views, or arguments.
    ``(3) Upon the filing of the petition under paragraph (1) for 
judicial review of a decision, notice, or warning, the court shall have 
jurisdiction to review the decision, notice, or warning in accordance 
with chapter 7 of title 5, United States Code, and to grant appropriate 
relief, including interim relief, as provided in such chapter.
    ``(4) The judgment of the court affirming or setting aside, in 
whole or in part, any decision, notice, or warning shall be final, 
subject to review by the Supreme Court of the United States upon 
certiorari or certification, as provided in section 1254 of title 28 of 
the United States Code.
    ``(5) The remedies provided for in this subsection shall be in 
addition to and not in lieu of any other remedies provided by law.
    ``(6) To facilitate judicial review under this subsection or under 
any other provision of law of a decision, notice, or warning issued 
under this section, each such decision, notice, or warning shall 
contain a statement of the reasons for its issuance and the basis, in 
the record of the proceedings held in connection with its issuance, for 
its issuance.''.

SEC. 25. PUBLICATION OF NOTICE OF DEVIATION.

    Section 705 (21 U.S.C 375) is amended by adding at the end the 
following:
    ``(c) The Secretary may make public or communicate to any person 
outside the Food and Drug Administration any information regarding a 
notice which informs a regulated person of a purported deviation from a 
requirement of this Act only after the Secretary has completed the 
investigation of such deviation.''.

SEC. 26. BIOLOGICAL PRODUCTS.

    (a) Definitions.--
            (1) Biological product and tissue.--Section 201 (21 U.S.C. 
        321) is amended by adding at the end the following:
    ``(gg) The term `biological product' means a virus, therapeutic 
serum, toxin, antitoxin, vaccine, allergenic product, derivative of 
blood and blood components, or analogous product, or arsphenamine or 
its derivatives, intended for use in the diagnosis, cure, mitigation, 
treatment, or prevention of a disease or physiologic condition in man, 
but does not include blood, blood components, organs, eyes, milk, or 
human tissue. A biological product is a drug within the meaning of 
paragraph (g) but is not a new drug within the meaning of paragraph 
(p).
    ``(hh) The term `human tissue' means a collection of human cells 
which are intended for use in the diagnosis, cure, mitigation, 
treatment, or prevention of a disease or physiological condition in man 
or for the augmentation of a natural bodily function. Human tissue may 
be combined with biologically inactive substances and subjected to any 
form of processing before use subject to operating standards 
established under section 506(a)(2)(A). Human tissue achieves its 
primary intended purposes through structural support or cellular 
function and not systemic action. Human tissue is not a drug or device 
and does not include blood, blood components, organs, or milk.''.
            (2) Blood, blood components, organs, milk, or human 
        tissue.--Section 201(g)(1) (21 U.S.C 321(g)(1)) is amended by 
        adding at the end the following: ``Blood, a blood component, an 
        organ, milk, or human tissue is not a drug.''.
            (3) Device.--Section 201(h) (21 U.S.C. 321(h)) is amended 
        by adding at the end the following: ``Computer software 
        developed by, modified by, and used in a human tissue 
        establishment shall not be subject to any premarket clearance 
        requirement under this Act but such software shall be validated 
        to demonstrate that it achieves its intended purpose before use 
        and it shall be subject to the good manufacturing requirements 
        of this Act.''.
    (b) Regulation of Biological Products.--Chapter V, as amended by 
section 14, is amended by adding after section 505 the following:

                         ``biological products

    ``Sec. 506. (a) No person shall introduce or deliver for 
introduction into interstate commerce a biological product unless an 
approval of a product license application filed pursuant to this 
section is effective with respect to such product and the biological 
product meets the good manufacturing practice requirement of section 
501(a)(1)(B)(ii).
    ``(b) A product license application for a biological product 
shall--
            ``(1) contain the information that is required for a new 
        drug under the second sentence of section 505(b)(1);
            ``(2) be subject to the procedures and standards 
        established for a new drug in sections 505(c)(1), 505(d), 
        505(e), 505(f), 505(g), and 505(h) but not the standards of 
        sections 505(d)(6) and 505(e)(4);
            ``(3) be subject to the provisions for an investigational 
        new drug in section 505(i);
            ``(4) be subject to the requirements for a new drug 
        established in section 505(k); and
            ``(5) in the case of a derivative of blood and blood 
        components, apply to all facilities of the applicant that are 
        licensed under subsection (c).
Within 2 years of the date of enactment of this section the Secretary 
shall harmonize the regulations governing product license applications 
with the regulations governing new drug applications filed pursuant to 
section 505(b)(1) and the regulations governing good manufacturing 
practices promulgated under section 501(a)(1)(B)(ii). If the Secretary 
fails to implement such harmonization within 2 years, the regulations 
governing product license applications shall be null and void and all 
biological products shall be subject to the regulations governing new 
drug applications filed pursuant to section 505(b)(1). The amendments 
made to section 505 by the Drug Price Competition and Patent Term 
Restoration Act of 1984 shall not apply to biological products.
    ``(c)(1) No person shall introduce or deliver for introduction into 
interstate commerce blood or blood components unless an approval of a 
product license application filed pursuant to this section is effective 
with respect to such product. Blood and blood components intended for 
use in the diagnosis, cure, mitigation, treatment, or prevention of a 
disease or physiologic condition in man shall be subject to--
            ``(A) performance standards for safety, purity, and where 
        applicable, potency,
            ``(B) good manufacturing practices, and
            ``(C) labeling,
established by regulations promulgated by the Secretary, and shall be 
obtained and processed only in facilities licensed by the Secretary.
    ``(2) Licensed establishments shall be subject to inspection under 
section 704. During such an inspection the Secretary shall have access 
to or copies of patient and donor names and other donor identifying 
information when such access is critical to public health. Such an 
inspection may be conducted by nonprofit membership organizations that 
meet requirements established by the Secretary for individuals and 
organizations accredited by the Secretary under section 712.
    ``(3)(A) The Secretary shall by regulation establish the 
requirements that a facility or a group of facilities within one 
corporate entity shall meet to be eligible to be licensed under a 
single facility license to obtain and process a specific set of blood 
and blood components.
    ``(B) Within 90 days after the Secretary receives an application 
for a license under this subsection from a facility, the Secretary 
shall review the application and may inspect the facility to determine 
compliance with the requirements established under this subsection. 
Such inspection may be conducted by non-profit organizations that meet 
requirements established by the Secretary or by persons accredited by 
the Secretary under section 712. Within such 90 days, the Secretary 
shall grant a license or shall deny a license and specify in writing 
the reasons for the denial and the requirements that must be met to 
obtain a license.
    ``(C) The Secretary may at any time revoke or suspend a license in 
accordance with this paragraph for failure to comply with the 
requirements established under this subsection as follows:
            ``(i) The license may be immediately suspended with an 
        informal hearing to follow if the Secretary demonstrates that 
        the deficiencies identified constitute an immediate danger of 
        serious adverse health consequences or death.
            ``(ii) Before revoking a license, the Secretary shall 
        provide the facility in writing a list of specific deficiencies 
        that must be corrected in order to retain the license and shall 
        provide 30 days for a written response and for correction of 
        the deficiencies. If the facility fails to provide an adequate 
        response or to make a correction, the Secretary shall provide 
        the opportunity for an informal hearing. Such hearing shall be 
        held within 30 days of the receipt of the written response.
            ``(iii) The revocation or suspension of any license shall 
        not prevent the continued use of any blood or blood component 
        which has left the control of the licensee unless the Secretary 
        determines, as part of the revocation or suspension order, that 
        such use represents an actual harm to the public health.
    ``(4) Blood and blood components are not biological products, 
drugs, devices, or human tissue. Computer software developed by, 
modified by, and used in a blood or blood component establishment shall 
not be subject to any premarket clearance requirement under this Act 
but such software shall be validated to demonstrate that it achieves 
its intended purpose before use and it shall be subject to the good 
manufacturing requirements of this Act.
    ``(5) Blood components and derivatives of blood and blood 
components intended for use as a blood test or in the diagnosis of 
disease are devices and are not drugs, biological products, or human 
tissue.
    ``(d)(1) Human tissue shall be subject to regulation under this 
subsection only if the Secretary demonstrates, in writing published in 
the Federal Register and after a hearing before the Commissioner, that 
voluntary regulation under generally accepted scientific standards is 
inadequate to protect the public health with respect to any particular 
type of human tissue or human tissue generally.
    ``(2)(A) Based upon such a demonstration, the Secretary may 
establish by regulation operating standards for the safety of human 
tissue and may require human tissue to be processed only in an 
establishment registered in accordance with the procedures established 
for drugs under section 510.
    ``(B) The operating standards authorized under this paragraph shall 
be limited to the following general requirements for the recovery, 
processing, storage, and shipment of human tissue:
            ``(i) Requirements for universal infection control designs 
        to prevent transmission of disease.
            ``(ii) Good processing practices that assure the safety, 
        maintenance of structure, and preservation of original cellular 
        function of tissue.
            ``(iii) Labeling requirements for the identification of the 
        type of tissue, the addition of any foreign substance, and 
        information needed to permit tracing.
    ``(C) Registered establishments shall be subject to inspection 
under section 704. During such an inspection the Secretary shall have 
access to or copies of patient and donor names and other donor 
identifying information when such access is critical to public health 
as defined in regulations to be promulgated by the Secretary for 
particular types of tissue. Such inspection may be conducted by 
nonprofit membership organizations that meet requirements established 
by the Secretary for individuals and organizations accredited by the 
Secretary under section 712.
    ``(3) The requirements established under paragraph (2) shall not 
apply to human tissue not stored for a significant period or not 
significantly processed.
    ``(e) The Secretary may take action to enforce the requirements of 
good manufacturing practice for blood, blood components, and good 
operating standards for human tissue in the same manner as is done for 
drugs.''.
    (c) Transition.--The requirements of the interim regulation 
promulgated by the Secretary of Health and Human Services on December 
1993, shall remain in effect for a period of 18 months after the date 
of the enactment of this section so that the Secretary may have an 
opportunity to establish general controls for tissue pursuant to 
section 506(d)(1)(A) of the Federal Food, Drug, and Cosmetic Act. The 
Secretary shall not regulate eyes until such time that the Secretary 
makes a finding under section 506(d)(1)(A) of such Act that voluntary 
regulation under generally accepted standards is inadequate to protect 
the public health.
    (d) Conforming Amendments.--
            (1) Section 301(d).--Section 301(d) (21 U.S.C. 331(d)) is 
        amended by striking ``or 505'' and inserting ``, 505, or 506''.
            (2) Section 301(e).--Section 301(e) (21 U.S.C. 331(e)) is 
        amended by inserting after ``(k),'' the following: ``506(b),''.
            (3) Section 301.--Section 301 (21 U.S.C. 331), as amended 
        by section 8(b), is amended by adding after paragraph (w) the 
        following:
    ``(x) The failure of blood, blood component, or human tissue to 
comply with any applicable requirement established under section 
506.''.
            (4) Section 501.--Section 501 (21 U.S.C. 351) is amended by 
        adding at the end the following:
    ``(j) If it is a biological product, blood, blood component, or 
human tissue and it does not comply with any applicable requirement 
established under section 506.''.
            (5) Section 351.--Section 351 of the Public Health Service 
        Act (42 U.S.C. 262) is amended by striking the section heading 
        and ``Sec. 351.'' and subsections (a) through (d)(1) and (e) 
        through (g) of such section 351 are repealed.
            (6) Section 351.--Subsection (d)(2) of such section 351 is 
        redesignated as subsection (g) of section 511.
            (7) Multiple sections.--Sections 525(a), 526(a)(1), 
        526(a)(1)(C), 526(b)(1), 526(b)(2), 527(a), 527(b), 735(1)(D), 
        735(3), 735(6)(D), 802(a)(1)(B), 802(b)(1)(A)(ii)(II), 
        802(b)(1)(C), 802(c)(1)(C), 802(d)(3), 802(d)(4), and 902(c) 
        (21 U.S.C. 360aa(a), 360bb(a)(1), (a)(1)(C), (b)(1), (b)(2), 
        360cc(a), (b), 379g(1)(D), (3), (6)(D), 382(a)(1)(B), 
        (b)(1)(A)(ii)(II), (b)(1)(C), (c)(1)(C), (d)(3), (d)(4), 
        392(c)) are each amended by striking ``section 351 of the 
        Public Health Service Act'' wherever it appears and inserting 
        ``section 506''.
            (8) Section 201.--Section 201(ff)(3)(A) (21 U.S.C 
        321(ff)(3)(A)) is amended by striking ``under section 351 of 
        the Public Health Service Act (42 U.S.C.262)'' and inserting 
        ``section 506''.
            (9) Section 503.--Section 503(g)(4)(A) (21 U.S.C 
        353(g)(4)(A)) is amended by striking ``in section 351(a) of the 
        Public Health Service Act (42 U.S.C. 262(a))'' and inserting 
        ``in section 506''.
            (10) Section 503.--Section 503(g)(4)(B) (21 U.S.C. 
        353(g)(4)(B)) is amended to read as follows:
            ``(B) As used in this subsection, the term `market 
        clearance' includes--
                    ``(i) approval of an application under section 505, 
                507, 511, 515, or 520(g) and
                    ``(ii) a finding of substantial equivalence under 
                this subchapter.''.
            (11) Public health service Act.--The following sections of 
        the Public Health Service Act are amended as follows:
                    (A) Section 227(c)(5) (42 U.S.C. 236(c)(5)) is 
                amended by striking ``under section 351 of this Act'' 
                and inserting ``under section 506 of such Act''.
                    (B) Sections 352(a) and 352(b) (42 U.S.C. 263(a), 
                263(b)) are each amended by striking ``in section 351'' 
                and inserting ``in section 506 of the Federal Food, 
                Drug, and Cosmetic Act''.
                    (C) Section 2122(b)(2) (42 U.S.C. 360aa-22(b)(2)) 
                is amended by striking ``section 351 of the Public 
                Health Service Act'' and inserting ``section 506 of the 
                Federal Food, Drug, and Cosmetic Act''.
                    (D) Section 2123(d)(2)(A) (42 U.S.C 360aa-
                23(d)(2)(A)) is amended by striking ``under section 
                351'' and inserting ``under section 506 of the Federal 
                Food, Drug, and Cosmetic Act''.
            (12) Section 1927.--Section 1927(k)(2)(B) of the Social 
        Security Act (42 U.S.C. 1396r-8(k)(2)(B)) is amended by 
        striking ``under section 351 of the Public Health Service Act'' 
        and inserting ``under section 506 of the Federal Food, Drug, 
        and Cosmetic Act''.
            (13) Orphan drug act.--Sections 5(b)(1)(A) and 5(b)(1)(B) 
        of the Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A), 
        360ee(b)(1)(B)) are each amended by striking ``section 351 of 
        the Public Health Service Act'' and inserting ``section 506 of 
        the Federal Food, Drug, and Cosmetic Act''.
            (14) Patents.--Section 156 of title 35, United States Code, 
        is amended--
                    (A) in subsection (f)(2)(A), by striking ``and the 
                Public Health Service Act'';
                    (B) in subsection (f)(4)--
                            (i) by striking subparagraph (A) and 
                        redesignating subparagraphs (B) and (C) as 
                        subparagraphs (A) and (B), respectively; and
                            (ii) by inserting ``506,'' after ``505,'' 
                        each place it appears in subparagraph (A) (as 
                        so redesignated); and
                    (C) in subsection (g)(1)(B)(ii), by striking 
                ``under section 351, subsection (b) of section 505'' 
                and inserting ``under subsection (b) of section 505, 
                506''.
            (15) Internal revenue code of 1986.--Section 
        28(b)(2)(A)(ii)(II) of the Internal Revenue Code of 1986 is 
        amended by striking ``under section 351 of the Public Health 
        Service Act'' and inserting ``under section 506 of such Act''.
    (d) Licenses.--All licenses effective under section 351 of the 
Public Health Service Act as of the date of enactment of the Drug and 
Biological Products Reform Act of 1996 shall be deemed to have been 
granted under the applicable provisions of this Act as of such date and 
shall be subject to the provisions of this Act as of such date.
                                 <all>