(2) in the second sentence, by striking ‘‘If’’ and
inserting the following:
‘‘(C) If’’; and
(3) by inserting after subparagraph (A) (as des-
ignated by paragraph (1)(B)) the following new sub-
paragraph:
‘‘(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 notifi-
cation) scientific advisory panel having expertise re-
lated to the issue;
‘‘(II) to a special Government employee, as de-
fined 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 Sec-
retary may consult with the committee, special Govern-
ment 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 recommenda-
tions) 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 Govern-
mental 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 non-
governmental 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 re-
sult in a residue of such drug in excess of a toler-
ance 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 follow-
ing: ‘‘, other than a veterinary feed directive drug intended
for use in animal feed or an animal feed bearing or con-
taining 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 profes-
sional 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 veterinar-
ian’s professional practice. When labeled, distributed,
held, and used in accordance with this section, a veteri-
nary 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 vet-
erinary 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 pro-
duction facility without a veterinary feed directive or ship
such feed to another person for further distribution unless
that person has provided the same written acknowledge-
ment 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 des-
ignated 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 pre-
scribe, or their advertising fails to conform to the condi-
tions 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 ani-
mal 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 ‘‘includ-
ing 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 vet-
erinarian’’;
(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 fol-
lowing: ‘‘, 504,’’; and
(2) by inserting after ‘‘under section 412,’’ the
following: ‘‘504,’’.
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