sued, the methods used in, or the facilities and con-
trols used for, the manufacture, processing, packing,
and holding of such animal feed are inadequate to
assure and preserve the identity, strength, quality,
and purity of the new animal drug therein, and were
not made adequate within a reasonable time after
receipt of written notice from the Secretary, specify-
ing the matter complained of;
‘‘(iii) that on the basis of new information be-
fore the Secretary, evaluated together with the evi-
dence before the Secretary when such license was is-
sued, the labeling of any animal feeds, based on a
fair evaluation of all material facts, is false or mis-
leading in any particular and was not corrected
within a reasonable time after receipt of written no-
tice from the Secretary specifying the matter com-
plained of; or
‘‘(iv) that on the basis of new information be-
fore the Secretary, evaluated together with the evi-
dence before the Secretary when such license was is-
sued, the facility has manufactured, processed,
packed, or held animal feed bearing or containing a
new 
animal 
drug 
adulterated 
under 
section
501(a)(6) and the facility did not discontinue the
manufacture, processing, packing, or holding of such
animal feed within a reasonable time after receipt of
written notice from the Secretary specifying the
matter complained of.
‘‘(C) The Secretary may also revoke a license to man-
ufacture animal feeds under this subsection if an applicant
gives notice to the Secretary of intention to discontinue
the manufacture of all animal feed covered under this sub-
section and waives an opportunity for a hearing on the
matter.
‘‘(D) Any order under this paragraph shall state the
findings upon which it is based.
‘‘(5) When a license to manufacture animal feeds
bearing or containing new animal drugs has been issued—
‘‘(A) the applicant shall establish and maintain
such records, and make such reports to the Sec-
retary, or (at the option of the Secretary) to the ap-
propriate person or persons holding an approved ap-
plication filed under subsection (b), as the Secretary
may by general regulation, or by order with respect
to such application, prescribe on the basis of a find-
ing that such records and reports are necessary in
order to enable the Secretary to determine, or facili-
tate a determination, whether there is or may be
ground for invoking subsection (e) or paragraph (4);
and
‘‘(B) every person required under this sub-
section to maintain records, and every person in
charge or custody thereof, shall, upon request of an
officer or employee designated by the Secretary, per-
mit such officer or employee at all reasonable times
to have access to and copy and verify such records.
‘‘(6) To the extent consistent with the public health,
the Secretary may promulgate regulations for exempting
from the operation of this subsection facilities that manu-
facture, process, pack, or hold animal feeds bearing or
containing new animal drugs.’’.
(c) TRANSITIONAL PROVISION.—A person engaged in
the manufacture of animal feeds bearing or containing
new animal drugs who holds at least one approved medi-
cated feed application for an animal feed bearing or con-
taining new animal drugs, the manufacture of which was
not otherwise exempt from the requirement for an ap-
proved medicated feed application on the date of the en-
actment of this Act, shall be deemed to hold a license for
the manufacturing site identified in the approved medi-
cated feed application. The revocation of license provisions
of section 512(m)(4) of the Federal Food, Drug, and Cos-
metic Act, as amended by this Act, shall apply to such
licenses. Such license shall expire within 18 months from
the date of enactment of this Act unless the person sub-
mits to the Secretary a completed license application for
the manufacturing site accompanied by a copy of an ap-
proved medicated feed application for such site, which li-
cense application shall be deemed to be approved upon re-
ceipt by the Secretary.
Passed the House of Representatives September 24,
1996.
Attest:
Clerk.