Food Amendments and the Animal Drug Availability Act of 1996

.

    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,''.

Summary: TABLE OF CONTENTS: Title I: Food Amendments Title II: Animal Drugs Food Amendments and the Animal Drug Availability Act of 1996 - Title I: Food Amendments - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to state the mission of the Food and Drug Administration. Modifies requirements regarding label claims of a relationship between a nutritional ingredient and a health-related condition. Prohibits construing FDCA provisions relating to misbranding or food additives to require a separate disclosure of a method of production or an ingredient other than in the statement of ingredients, unless necessary to protect the public health. Allows certain labeling and additive petitions to be submitted to an accredited person and deems the person's recommendation to be a decision of the Secretary of Health and Human Services unless the Secretary makes certain findings. Provides for accreditation. Allows an additive in feed for food-producing animals, and allows approval of a new animal drug, if the additive or drug presents a small risk . Prohibits States and subdivisions from having any requirement for a human food, a drug or biological product, or a cosmetic of the type authorized or required under the adulteration, misbranding, or new drug provisions of the FDCA, subject to exception and waiver. Directs the Secretary to regularly meet with other countries regarding reducing regulation and seeking reciprocal arrangements. Prohibits the Secretary from relying on statements that have not been promulgated in accordance with Federal rulemaking requirements to require any action to be taken to satisfy an FDCA requirement. Amends the FDCA and the Federal Trade Commission Act to remove or repeal provisions regulating the sale, public eating place serving, and advertising of colored oleomargarine or colored margarine. Repeals related definitions. Title II: Animal Drugs - Amends the FDCA to revise the definition of substantial evidence. Modifies requirements regarding approval of supplemental applications. Exempts use in a minor species and the minor use of a drug from provisions prohibiting approval if there is a lack of substantial evidence that the drug will have its purported effect. Revises requirements regarding combination drugs. Reduces the period for approval of new animal drug applications. Empowers applicants to declare that a review impasse exists. Sets forth a dispute resolution process. Revises requirements regarding drug residues and tolerances. Regulates animal feed drugs that are limited by approved applications to use under the supervision of a licensed veterinarian (VFDDs). Deems animal feed with a new animal drug unsafe unless its labeling, distribution, holding, and use conform to specified FDCA requirements. Allows withdrawal of approval for certain VFDD recordkeeping violations. Adds to the prohibited acts list the refusal to permit record access as required by VFDD provisions and the failure to maintain records or make reports as required by VFDD provisions.