```

[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3200 Introduced in House (IH)]

104th CONGRESS
  2d Session
                                H. R. 3200

To amend the Federal Food, Drug, and Cosmetic Act to increase access to 
 nutritional information about foods, to increase the availability of 
              safe food products, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 29, 1996

  Mr. Klug (for himself, Mr. Greenwood, Mr. Towns, Mr. Bilirakis, Mr. 
   Richardson, Mr. Burr, Mr. Hall of Texas, Mr. Barton of Texas, Mr. 
 Gordon, Mr. Upton, Mr. Brewster, Mr. Bilbray, Mr. Payne of Virginia, 
   Mr. Coburn, Mr. Dooley of California, Mr. Ganske, Mr. McHale, Mr. 
 Oxley, Mr. Holden, Mr. Fields of Texas, Mr. Paxon, Mr. Whitfield, Mr. 
   Schaefer, Mr. Tauzin, Mr. Fox of Pennsylvania, Mr. Campbell, Mr. 
    McIntosh, Mr. Cox of California, Mr. Dreier, Mr. Heineman, Mr. 
Funderburk, Mr. Weldon of Florida, Mr. Shays, Mr. Hastert, Mr. Norwood, 
 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 to increase access to 
 nutritional information about foods, to increase the availability of 
              safe food 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; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Food Amendments 
and the Animal Drug Availability Act of 1996''.
    (b) Reference.--Whenever in this Act (other than in section 111) an 
amendment or repeal is expressed in terms of an amendment to, or repeal 
of, a section or other provision, the reference shall be considered to 
be made to a section or other provision of the Federal Food, Drug, and 
Cosmetic Act.
    (c) Table of Contents.--The table of contents is as follows:

Sec. 1. Short title; reference; table of contents.
                        TITLE I--FOOD AMENDMENTS

Sec. 101. FDA mission and annual report.
Sec. 102. Access to disease prevention information.
Sec. 103. Access to nutrient descriptor information.
Sec. 104. Special labeling to protect public health.
Sec. 105. Accredited person review.
Sec. 106. Accredited persons.
Sec. 107. Improving the delaney clause.
Sec. 108. National uniformity.
Sec. 109. Harmonization.
Sec. 110. Informal agency statements.
Sec. 111. Colored margarine.
                         TITLE II--ANIMAL DRUGS

Sec. 201. Evidence of effectiveness for animal drugs.
Sec. 202. Timeframe for approval for animal drugs.
Sec. 203. Dispute resolution.
Sec. 204. Limitation on residues.
Sec. 205. Veterinary feed directives.

                        TITLE I--FOOD AMENDMENTS

SEC. 101. 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 review petitions under sections 403(r), 409, and 
        721 and applications under section 512;
            ``(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. 102. ACCESS TO DISEASE PREVENTION INFORMATION.

    Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended--
            (1) in clause (B)(i), by adding at the end ``Significant 
        scientific agreement does not require consensus or 
        unanimity.''; and
            (2) by adding at the end the following:
    ``(C) Information in materials prepared or distributed by a Federal 
health agency or by the National Academy of Sciences or its component 
organizations shall be deemed to comply with clauses (A)(i) and (B).''.

SEC. 103. ACCESS TO NUTRIENT DESCRIPTOR INFORMATION.

    Section 403(r)(2)(A)(i) (21 U.S.C. 343(r)(2)(A)(i)) is amended by 
adding at the end the following: ``or terms which are synonyms of such 
defined terms and are not false or misleading''.

SEC. 104. SPECIAL LABELING TO PROTECT PUBLIC HEALTH.

    Section 403 (21 U.S.C. 343) is amended by adding at the end the 
following:
    ``(t) No provision of this section or section 409 shall be 
construed to require on a food a separate disclosure of--
            ``(1) a method of production, or
            ``(2) an ingredient other than in the statement of 
        ingredients,
unless such disclosure is necessary to protect the public health.''.

SEC. 105. ACCREDITED PERSON REVIEW.

    (a) Health Claims.--Section 403(r)(4)(A) (21 U.S.C. 343(r)(4)(A)) 
is amended by inserting at the end of the first sentence in subclauses 
(i), (ii), and (iii) the following: ``or may file such a petition with 
a person authorized to review it under section 712''.
    (b) Accredited Person Review.--Section 403(r)(4) (21 U.S.C. 
434(r)(4)) is amended by adding at the end the following:
    ``(D)(i) In reviewing a petition submitted under clause (A) to an 
accredited person such a person shall determine if the petition meets 
the requirements for petitions to the Secretary. The review of such a 
petition shall be conducted under the standards and requirements of 
this Act that are applicable to the review of petitions to the 
Secretary. After a period of 120 days after such a petition is 
submitted, the accredited person shall submit a report of its review of 
such petition to the Secretary and include its recommendations. Such 
recommendations to the Secretary shall specify--
            ``(I) in the case of a petition under subclause (i), 
        whether the claim with respect to which the petition was made 
        should be approved or denied;
            ``(II) in the case of a petition under subclause (ii), 
        whether such claim may use the terms specified in the petition, 
        and
            ``(III) in the case of a petition under subclause (iii), 
        whether such claim may be made in a brand name, and
shall state the basis for the recommendation.
    ``(ii) The recommendation of an accredited person to approve or 
deny a petition submitted to such person shall be deemed to be the 
decision of the Secretary unless the Secretary finds that such 
recommendation is contrary to the findings required in this Act. If the 
Secretary makes such a finding, the Secretary shall provide a detailed 
explanation of the basis of the finding.''.
    (c) Food Additives.--Section 409 (21 U.S.C. 348) is amended--
            (1) by inserting at the end of subsection (b)(1) the 
        following: ``Any person may submit such a petition to a person 
        accredited under section 712.'';
            (2) by inserting at the end of subsection (c)(2) the 
        following: ``This paragraph shall apply to a petition submitted 
        to an accredited person under subsection (b)(1).''; and
            (3) by adding at the end of subsection (c) the following:
    ``(6)(A) An accredited person shall review a petition submitted to 
it under subsection (b)(1) to determine whether there is reasonable 
assurance that the food additive with respect to which the petition was 
submitted may be safely used under the proposed conditions of use. The 
review of such a petition shall be conducted under the standards and 
requirements of this Act that are applicable to the review of petitions 
to the Secretary. After expiration of the period prescribed by 
paragraph (2), the accredited person shall submit a report of its 
review of such petition to the Secretary and include its 
recommendations. Such recommendations to the Secretary shall specify 
whether a petition should be approved or denied and shall state the 
basis for the recommendation.
    ``(B) The recommendation of an accredited person to approve or deny 
a petition submitted to such person shall be deemed to be the decision 
of the Secretary unless the Secretary finds that there is a reasonable 
probability it is not safe. If the Secretary makes such a finding, the 
Secretary shall provide a detailed explanation of the basis of the 
finding.''.
    (d) Color Additives.--Section 721 (21 U.S.C 379e) is amended by 
adding at the end the following:
    ``(g) Petition to Accredited Person.--(1) Any person may submit a 
petition to a person accredited under section 712 for the issuance of a 
regulation under subsection (b) or (c) or for the issuance of an 
exemption under subsection (f).
    ``(2) In reviewing a petition submitted under paragraph (1) to an 
accredited person, such a person shall determine if the petition meets 
the requirements for the issuance of a regulation under subsection (b) 
or (c) or for the issuance of an exemption under subsection (f). The 
review of such a petition shall be conducted under the standards and 
requirements of this Act that are applicable to the review of petitions 
to the Secretary for the issuance of such a regulation or exemption. 
After a period of 120 days after such a petition is submitted, the 
accredited person shall submit a report of its review of such petition 
to the Secretary and include its recommendations. Such recommendations 
to the Secretary shall specify if such a regulation or exemption should 
be issued and shall state the basis for its recommendation.
    ``(3) The recommendation of an accredited person to approve or deny 
a petition submitted to such person shall be deemed to be the decision 
of the Secretary unless the Secretary finds that there is a reasonable 
probability it is not safe. If the Secretary makes such a finding, the 
Secretary shall provide a detailed explanation of the basis of the 
finding.''.

SEC. 106. ACCREDITED PERSONS.

    (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 third parties for the purposes of--
            ``(1) reviewing petitions under sections 403(r), 409, and 
        721(g), an application under section 512, providing written 
        reviews to the Secretary for the Secretary's consideration, and 
        making recommendations on whether or not such petitions or 
        application should be approved; and
            ``(2) conducting good manufacturing practice inspections to 
        determine the conformance of a facility with regulations 
        promulgated under section 402.
    ``(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 food or animal 
                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 design, 
                manufacture, promotion, or sale of food or animal 
                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 commercial 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. 107. IMPROVING THE DELANEY CLAUSE.

    (a) Food Additives.--
            (1) Amendment.--Section 409(c)(3)(A) (21 U.S.C. 
        348(c)(3)(A)) is amended by striking all after ``substance'' 
        and inserting ``that presents a negligible or de minimus 
        risk''.
            (2) Regulations.-- The Secretary shall, within 180 days of 
        the date of the enactment of this Act, issue a proposed 
        regulation to establish criteria to determine a negligible or 
        insignificant risk for purposes of section 409(c)(3)(A) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(c)(3)(A)). 
        Such proposed regulation shall become final unless the 
        Secretary issues a final regulation before 18 months after such 
        date of enactment.
    (b) Animal Drugs.--
            (1) Amendment.--Section 512(d)(1)(I) (21 U.S.C 
        360b(d)(1)(I)) is amended by striking everything after ``if'' 
        and inserting ``if such drug presents a negligible or 
        insignificant risk to humans or animals.''.
            (2) Regulations.-- The Secretary shall, within 180 days of 
        the date of the enactment of this Act, issue a proposed 
        regulation to establish criteria to determine a negligible or 
        insignificant risk for purposes of section 512(d)(1)(I) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)(I)). 
        Such proposed regulation shall become final unless the 
        Secretary issues a final regulation before 18 months after such 
        date of enactment.
    (c) Color Additive.--
            (1) Amendment.--Section 721(b)(5)(B) (21 U.S.C 
        379e(b)(5)(B)) is amended by striking all after ``with respect 
        to the use of a color additive'' and inserting ``if such color 
        additive presents a negligible or insignificant risk to humans 
        or animals.''.
            (2) Regulations.-- The Secretary shall, within 180 days of 
        the date of the enactment of this Act, issue a proposed 
        regulation to establish criteria to determine a negligible or 
        insignificant risk for purposes of section 721(b)(5)(B) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e(b)(5)(B)). 
        Such proposed regulation shall become final unless the 
        Secretary issues a final regulation before 18 months after such 
        date of enactment.

SEC. 108. NATIONAL UNIFORMITY.

    Chapter VII is amended by adding at the end the following:

                  ``Subchapter D--National Uniformity

    ``Sec. 741. (a)(1) Except as provided in paragraph (2) or 
subsections (b) and (c), no State or political subdivision of a State 
may, directly or indirectly, establish or continue in effect under any 
authority any requirement (including a prohibition) for a--
            ``(A) food for human use,
            ``(B) a drug (including a biological product), or
            ``(C) a cosmetic,
which is of the type authorized or required under the adulteration, 
misbranding, or new drug provisions of this Act or any regulation to 
implement such provisions if such State or political subdivision 
requirement is not identical to a requirement imposed under this Act.
    ``(2) Paragraph (1) does not apply to a State or political 
subdivision requirement relating to the practice of pharmacy or the 
dispensing of a drug for human use only upon prescription of a 
practitioner licensed by law to administer such drug.
    ``(b)(1) Except as provided in subsection (c), no State or 
political subdivision of a State may, directly or indirectly, establish 
or continue in effect under any authority any notification requirement 
for a food, drug, or cosmetic that provides--
            ``(A) for disclosure of the constituents, source, or method 
        of production or processing of the food, drug, or cosmetic, or
            ``(B) for a warning concerning the safety of the food, 
        drug, or cosmetic or any component or package thereof,
unless such notification requirement has been prescribed under the 
authority of this Act and the State or political subdivision 
notification requirement is identical to the notification requirement 
prescribed under the authority of this Act.
    ``(2) For purposes of paragraph (1)--
            ``(A) the term `warning' with respect to a food, drug, or 
        cosmetic means any statement, vignette, or other representation 
        which indicates, directly or by implication, that the food, 
        drug, or cosmetic presents or may present a hazard to human 
        health or safety; and
            ``(B) the term `notification requirement' includes any 
        requirement relating to the dissemination of information about 
        a food, drug, or cosmetic in any manner, such as labels, 
        labeling, posters, public notices, advertising, or any other 
        means of communication.
    ``(c) Upon application of a State, the Secretary may by regulation, 
after notice and opportunity for written and oral presentation of 
views, exempt from subsection (a) or (b), under such conditions as the 
Secretary may impose, a State requirement which--
            ``(1) is justified by compelling and unique local 
        conditions;
            ``(2) protects an important public interest that would 
        otherwise by unprotected;
            ``(3) would not cause any food, drug, or cosmetic to be in 
        violation of any applicable requirement or prohibition under 
        Federal law; and
            ``(4) would not unduly burden interstate commerce.''.

SEC. 109. 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. 110. 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. 111. COLORED MARGARINE.

    (a) Section 301(m).--Paragraph (m) of section 301 (21 U.S.C. 321) 
is repealed.
    (b) Section 407.--Section 407 (21 U.S.C. 347) is repealed.
    (c) Act of March 16, 1950.--Sections 3(a) and 6 of the Act of March 
16, 1950 (21 U.S.C. 347a, 347b) are repealed.
    (d) Federal Trade Commission Act.--Section 15 of the Federal Trade 
Commission Act (15 U.S.C. 55) is amended--
            (1) in subsection (a), by striking ``(a)(1)'' and inserting 
        ``(a)'' and by striking paragraph (2); and
            (2) by striking subsection (f).

                         TITLE II--ANIMAL DRUGS

SEC. 201. EVIDENCE OF EFFECTIVENESS FOR ANIMAL DRUGS.

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

SEC. 202. TIMEFRAME FOR APPROVAL FOR ANIMAL DRUGS.

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

SEC. 203. DISPUTE RESOLUTION.

    Section 512(c)(1) (21 U.S.C. 360b(c)(1)) is amended--
            (1) in the first sentence--
                    (A) by redesignating subparagraphs (A) and (B) as 
                clauses (i) and (ii), respectively; and
                    (B) by inserting ``(A)'' after ``(1)'';
            (2) in the second sentence, by striking ``If'' and 
        inserting the following:
    ``(C) If''; and
            (3) by inserting after subparagraph (A) (as designated by 
        paragraph (1)(B)) the following new subparagraph:
    ``(B)(i) At any time prior to the issuance of the notice under 
subparagraph (A)(ii), the applicant may, in writing, notify the 
Secretary that an impasse exists in the review of the application with 
respect to a specifically identified issue that is preventing the 
issuance of an order under subparagraph (A)(i).
    ``(ii) On receipt of the notification from the applicant, the 
Secretary shall refer the disputed issue--
            ``(I) to an existing (as of the date of the notification) 
        scientific advisory panel having expertise related to the 
        issue;
            ``(II) to a special Government employee, as defined in 
        section 202(a) of title 18, United States Code, or to a 
        nongovernmental person qualified to mediate or arbitrate the 
        substance of such impasse who is acceptable to the Secretary 
        and the applicant.
    ``(iii) The applicant and representatives of the Secretary may 
consult with the committee, special Government employee, or 
nongovernmental person on the matter referred. The committee, special 
Governmental employee, or nongovernmental 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 committee, 
special Governmental employee, or nongovernmental 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 committee, special Governmental employee, or 
nongovernmental person for any modification.
    ``(iv) The Federal Advisory Committee Act shall not apply to any 
scientific advisory panel acting under this subparagraph.''.

SEC. 204. LIMITATION ON RESIDUES.

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

SEC. 205. VETERINARY FEED DIRECTIVES.

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

                   ``veterinary feed directive drugs

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