Animal Drug Availability Act of 1996
PL 104-250 (H.R.2508), enacted 10/09/1996

PUBLIC LAW 104-250—OCT. 9, 1996 
110 STAT. 3151 
Public Law 104-250 
104th Congress 
An Act 
To amend the Federal Food, Drug, and Cosmetic Act to provide for improvements 
Oct. 9, 1996 
in the process of approving and using animal drugs, and for other purposes. 
[H.R. 2508] 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled. 
Animal Drug 
Availability Act 
SECTION 1. SHORT TITLE; REFERENCE. 
of 1996. 
(a) SHORT TITLE.—This Act may be cited as the "Animal Drug ^^ ^^^ ^°^ ''°*®-
Availability Act of 1996". 
(b) REFERENCE.—^Whenever in this Act 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 (21 U.S.C. 321 et seq.). 
SEC. 2. EVIDENCE OF EFFECTIVENESS. 
(a) ORIGINAL APPLICATIONS.—Paragraph (3) of section 512(d) 
(21 U.S.C, 360b(d)) is amended tp read as follows: 
"(3) As used in this section, the term 'substantial evidence' 
means evidence consisting of one or more adequate and well 
controlled investigations, such as— 
"(A) a study in a target species; 
"(B) a study in laboratory animals; 
"(C) any field investigation that may be required under 
this section and that meets the requirements of subsection 
(b)(3) if a presubmission conference is requested by the 
appUcant; 
"(D) a bioequivalence study; or 
"(E) an in vitro study; 
by experts qualified by scientific training and experience to evaluate 
the effectiveness of the drug involved, on the basis of which it 
could fairly and reasonably be concluded by such experts that 
the drug will have the effect it purports or is represented to have 
under the conditions of use prescribed, recommended, or suggested 
in the labeling or proposed labeling thereof". 
(b) CONFORMING AMENDMENTS.— 
(1) Clauses (ii) and (iii) of section 512(c)(2)(F) (21 U.S.C. 
360b(cX2)(F)) are each amended— 
(A) by striking "reports of new clinical or field inves-
tigations (other than bioequivalence or residue studies) 
and," and inserting "substantial evidence of the effective-
ness of the drug involved, any studies of animal safety, 
or,"; and 
(B) by striking "essential to" and inserting "required 
for". 
110 STAT. 3152 
PUBLIC LAW 104-250—OCT. 9, 1996 
(2) Section 512(c)(2)(F)(v) (21 U.S.C. 360b(c)(2)(F)(v)) is 
amended— 
(A) by striking "subparagraph (B)(iv)" each place it 
appears and inserting "clause (iv)"; 
(B) by striking "reports of clinical or field investiga-
tions" 
and 
inserting 
"substantial 
evidence 
of 
the 
effectiveness of the drug involved, any studies of animal 
safety,"; and 
(C) by striking "essential to" and inserting "required 
for". 
(c) COMBINATION DRUGS.—Section 512(d) (21 U.S.C. 360b(d)), 
as amended by subsection (a) is amended by adding at the end 
the following: 
"(4) In a case in which an animal drug contains more than 
one active ingredient, or the labeling of the drug prescribes, rec-
ommends, or suggests use of the drug in combination with one 
or more other animal drugs, and the active ingredients or drugs 
intended for use in the combination have previously been separately 
approved for particular uses and conditions of use for which they 
are intended for use in the combination— 
"(A) the Secretary shall not issue an order under paragraph 
(1)(A), (1)(B), or (1)(D) refusing to approve the application for 
such combination on human food safety grounds unless the 
Secretary finds that the application fails to establish that— 
"(i) none of the active ingredients or drugs intended 
for use in the combination, respectively, at the longest 
withdrawal time of any of the active ingredients or drugs 
in the combination, respectively, exceeds its established 
tolerance; or 
"(ii) none of the active ingredients or drugs in the 
combination interferes with the methods of analysis for 
another of the active ingredients or drugs in the combina-
tion, respectively; 
"(B) the Secretary shall not issue an order under paragraph 
(1)(A), (1)(B), or (1)(D) refusing to approve the application for 
such combination on target animal safety grounds unless the 
Secretary finds that— 
"(i)(I) there is a substantiated scientific issue, specific 
to one or more of the active ingredients or animal drugs 
in the combination, that cannot adequately be evaluated 
based on information contained in the application for the 
combination (including any investigations, studies, or tests 
for which the applicant has a right of reference or use 
fi-om the person by or for whom the investigations, studies, 
or tests were conducted); or 
"(II) there is a scientific issue raised by target animal 
observations 
contained 
in 
studies 
submitted 
to 
the 
Secretary as part of the application; and 
"(ii) based on the Secretary's evaluation of the informa-
tion contained in the application with respect to the issues 
identified in clauses (i) (I) and (II), paragraph (1)*(A), 
(B), or (D) apply; 
"(C) except in the case of a combination that contains 
a nontopical antibacterial ingredient or animal drug, the 
Secretary shall not issue an order under paragraph (1)(E) refus-
ing to approve an application for a combination animal drug 
intended for use other than in animal feed or drinking water 
PUBLIC LAW 104-250—OCT. 9, 1996 
110 STAT. 3153 
unless the Secretary finds that the appUcation fails to dem-
onstrate that— 
"(i) there is substantial evidence that any active 
ingredient or animal drug intended only for the same use 
as another active ingredient or animal drug in the combina-
tion makes a contribution to labeled effectiveness; 
"(ii) each active ingredient or animal drug intended 
for at least one use that is different fi'om all other active 
ingredients or animal drugs used in the combination 
provides appropriate concurrent use for the intended target 
population; or 
"(iii) where based 
on scientific 
information 
the 
Secretary has reason to believe the active ingredients or 
animal drugs may be physically incompatible or have 
disparate dosing regimens, such active ingredients or 
animal drugs Eire physically compatible or do not have 
disparate dosing regimens; and 
"(D) the Secretary shall not issue an order under paragraph 
(IXE) refusing to approve an application for a combination 
animal drug intended for use in animal feed or drinking water 
unless the Secretary finds that the application fails to dem-
onstrate that— 
"(i) there is substantial evidence that any active 
ingredient or animal drug intended only for the same use 
as another active ingredient or animal drug in the combina-
tion makes a contribution to the labeled effectiveness; 
"(ii) each of the active ingredients or animal drugs 
intended for at least one use that is different from all 
other active ingredients or animal drugs used in the com-
bination provides appropriate concurrent use for the 
intended t£u*get population; 
"(iii) where a combination contains more than one non-
topical antibacterial ingredient or animal drug, there is 
substantial evidence that each of the nontopical anti-
bacterial ingredients or animal drugs makes a contribution 
to the labeled effectiveness; or 
"(iv) where based 
on 
scientific 
information 
the 
Secretary has reason to believe the active ingredients or 
animal drugs intended for use in drinking water may be 
, 
physically incompatible, such active ingredients or sinimal 
drugs intended for use in drinking water are physically 
compatible.", 
(d) PRESUBMISSION CONFERENCE.—Section 512(b) (21 U.S.C. 
360b(b)) is amended by adding at the end the following: 
"(3) Any person intending to file an application under paragraph 
(1) or a request for an investigational exemption under subsection 
(j) shall be entitled to one or more conferences prior to such submis-
sion to reach an agreement acceptable to the Secretary establishing 
a submission or an investigational requirement, which may include 
a requirement for a field investigation. A decision establishing 
a submission or an investigational requirement shall bind the Sec-
retary and the applicant or requestor unless (A) the Secretary 
and the applicant or requestor mutually agree to modify the require-
ment, or (B) the Secretary by written order determines that a 
substantiated scientific requirement essential to the determination 
of safety or effectiveness of the animal drug involved has appeared 
after the conference. No later than 25 c^endar days after each 
110 STAT. 3154 
PUBLIC LAW 104-250—OCT. 9, 1996 
such conference, the Secretary shall provide a written order setting 
forth a scientific justification specific to the animal drug and 
intended uses under consideration if the agreement referred to 
in the first sentence requires more than one field investigation 
as being essential to provide substantial evidence of effectiveness 
for the intended uses of the drug. Nothing in this paragraph shall 
be construed as compelling the Secretary to require a field investiga-
tion.". 
(e) IMPLEMENTATION.— 
Regulations. 
(1) IN GENERAL.—Not later than 6 months after the date 
91 Ti^p^finvf' 
°^ enactment of this Act, the Secretary of Health and Human 
note 
Services shall issue proposed regulations implementing the 
amendments made by this Act as described in paragraph (2)(A) 
of this subsection, and not later than 18 months after the 
date of enactment of this Act, the Secretary shall issue final 
regulations implementing such amendments. Not later than 
12 months after the date of enactment of this Act, the Secretary 
shall issue proposed regulations implementing the other amend-
ments made by this Act as described in paragraphs (2)(B) 
and (2)(C) of this subsection, and not later than 24 months 
sifter the date of enactment of this Act, the Secretary shall 
issue final regulations implementing such amendments. 
(2) CONTENTS.—In issuing regulations implementing the 
amendments made by this Act, 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 "adequate and well 
controlled", as used in subsection (d)(3) of section 512 of 
such Act, to require that field investigations be designed 
and conducted in a scientifically sound manner, taking 
into accoimt practical conditions in the field and differences 
between field conditions and laboratory conditions; 
(B) further define the term "substantial evidence", as 
defined in subsection (d)(3) of such section, in a manner 
that encourages the submission of applications and supple-
mental applications; and 
(C) tgdce 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. 
Until the regulations required by subparagraph (A) are issued, 
nothing in the regulations published at 21 C.F.R. 514.111(a)(5) 
(April 1, 1996) shall be construed to compel the Secretary 
of Health and Human Services to require a field investigation 
under section 512(d)(1)(E) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(d)(l)(E)) or to apply any of its 
provisions in a manner inconsistent with the considerations 
for scientifically sound field investigations set forth in subpara-
graph (A). 
21 use 360b 
(f) MINOR SPECIES AND USES.—The Secretary of Health and 
note. 
Human Services shall consider legislative and regulatory options 
for facilitating the approval under section 512 of the Federal Food, 
Drug, and Cosmetic Act of animal drugs intended for minor species 
PUBLIC LAW 104-250—OCT. 9, 1996 
110 STAT. 3155 
and for minor uses and, within 18 months after the date of enact-
ment of this Act, announce proposals for legislative or regulatory 
change to the approval process under such section for animal drugs 
intended for use in minor species or for minor uses. 
SEC. 3. LIMITATION ON RESIDUES. 
Section 512(d)(1)(F) (21 U.S.C. 360b(d)(l)(F)) is amended to 
read as follows: 
"(F) upon the basis of information submitted to the Sec-
retary as part of the application or any other information 
before the Secretary with respect to such drug, any use pre-
scribed, 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. 4. IMPORT TOLERANCES. 
Section 512(a) (21 U.S.C. 360b(a)) is amended by adding the 
following new paragraph at the end: 
"(6) For purposes of section 402(a)(2)(D), a use or intended 
use of a new animal drug shall not be deemed unsafe under this 
section if the Secretary establishes a tolerance for such drug and 
any edible portion of any animal imported into the United States 
does not contain residues exceeding such tolerance. In establishing 
such tolerance, the Secretary shall rely on data sufficient to 
demonstrate that a proposed tolerance is safe based on similar 
food safety criteria used by the Secretary to establish tolerances 
for applications for new animal drugs filed under subsection (b)(1). 
The Secretary may consider and rely on data submitted by the 
drug manufacturer, including data submitted to appropriate regu-
latory authorities in any country where the new animal drug is 
lawfully used or data available from a relevant international 
organization, to the extent such data are not inconsistent with 
the criteria used by the Secretary to establish a tolerance for 
applications for new animal drugs filed under subsection (b)(1). 
For purposes of this paragraph, 'relevant international organization' 
means the Codex Alimenterius Commission or other international 
organization deemed appropriate by the Secretary. The Secretary 
may, under procedures specified by regulation, revoke a tolerance 
established under this paragraph if information demonstrates that 
the use of the new animal drug under actual use conditions results 
in food being imported into the United States with residues exceed-
ing the tolerance or if scientific evidence shows the tolerance to 
be unsafe.". 
SEC. 5. VETERINARY FEED DIRECTIVES. 
(a) SECTION 503.—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) SECTION 504.—The Federal Food, Drug, and Cosmetic Act 
is amended by inserting after section 503 the following: 
"VETERINARY FEED DIRECTIVE DRUGS 
"SEC. 504. (a)(1) A drug intended for use in or on animal 21USC354. 
feed which is limited by an approved application filed pursuant 
to section 512(b) to use under the professional supervision of a 
110 STAT. 3156 
PUBLIC LAW 104-250—OCT. 9, 1996 
licensed veterinarian is a veterinary feed directive drug. Any einimal 
feed bearing or containing a veterinary feed directive drug shall 
be fed to animals only by or upon a 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 veterineiry feed direc-
tive 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 appUcable 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 acknowledgment 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 acknowledgment 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 contain-
ing a veterinary feed directive drug shall upon first engaging in 
such distribution notify the Secretary of that person's name £ind 
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 prescrip-
tion article under any Federal or State law.". 
(c) CoiSfFORMiNG AMENDMENT.—Section 512 (21 U.S.C. 360b) 
is amended 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 
hmited to use under the profession^ supervision of a licensed 
veterinarian". 
(d) SECTION 301(e).—Section 301(e) (21 U.S.C. 331(e)) is 
amended by inserting after "by section 412" the following: ", 504,"; 
and by inserting after "imder section 412," the following: "504,". 
PUBLIC LAW 104-250—OCT. 9, 1996 
110 STAT. 3157 
SEC. 6. FEED MILL LICENSES. 
(a) SECTION 512(a).—Paragraphs (1) and (2) of section 512(a) 
(21 U.S.C. 360b(a)) are amended to read as follows: 
"(a)(1) A new animal drug shall, with respect to any particular 
use or intended use of such drug, be deemed unsafe for the purposes 
of section 501(a)(5) and section 402(a)(2)(D) unless — 
"(A) there is in effect an approval of an application filed 
pursuant to subsection (b) with respect to such use or intended 
use of such drug, and 
"(B) such drug, its labeling, and such use conform to such 
approved application. 
A new animal drug shall also be deemed unsafe for such purposes 
in the event of removal from the establishment of a memufacturer, 
packer, or distributor of such drug for use in the manufacture 
of animal feed in any State unless at the time of such removal 
such manufacturer, packer, or distributor has an unrevoked written 
statement from the consignee of such drug, or notice from the 
Secretary, to the effect that, with respect to the use of such drug 
in animal feed, such consignee (i) holds a license issued under 
subsection (m) and has in its possession current approved labeling 
for such drug in animal feed; or (ii) will, if the consignee is not 
a user of the drug, ship such drug only to a holder of a license 
issued under subsection (m). 
"(2) An animal feed bearing or containing a new animal drug 
shall, with respect to any particular use or intended use of such 
animal feed be deemed imsafe for the purposes of section 501(a)(6) 
unless— 
"(A) there is in effect an approval of an application filed 
pursuant to subsection (b) with respect to such drug, as used 
in such animal feed, 
"(B) such animal feed is manufactured at a site for which 
there is in effect a license issued pursuant to subsection (m)(l) 
to manufacture such animal feed, and 
"(C) such animal feed and its labeling, distribution, holding, 
and use conform to the conditions and indications of use 
published pursuant to subsection (i).". 
(b) SECTION 512(m).—Section 512(m) (21 U.S.C. 360b(m)) is 
amended to read as follows: 
"(m)(l) Any person may file with the Secretary an application 
for a license to manufacture animal feeds bearing or containing 
new animal drugs. Such person shall submit to the Secretary as 
part of the application (A) a fiiU statement of the business name 
and address of the specific facility at which the manufacturing 
is to take place and the facility's registration number, (B) the 
name and signature of the responsible individual or individuals 
for that facility, (C) a certification that the animal feeds bearing 
or containing new animal drugs are manufactured and labeled 
in accordance with the applicable regulations published pursuant 
to subsection (i), and (D) a certification that the methods used 
in, and the facilities and controls used for, manufacturing, process-
ing, packaging, and holding such animal feeds are in conformity 
with current good manufacturing practice as described in section 
501(a)(2)(B). 
"(2) Within 90 days after the filing of an application pursuant 
to paragraph (1), or such additional period as may be agreed upon 
by the Secretary and the applicEint, the Secretary shall (A) issue 
an order approving the application if the Secretary then finds 
110 STAT. 3158 
PUBLIC LAW 104-250—OCT. 9, 1996 
that none of the grounds for den3dng approval specified in paragraph 
(3) appKes, or (B) give the appHcant notice of an opportunity for 
a hearing before the Secretary under paragraph (3) on the question 
whether such appHcation is approvable. The procedure governing 
such a hearing shall be the procedure set forth in the last two 
sentences of subsection (c)(1). 
"(3) If the Secretary, after due notice to the applicant in accord-
ance with paragraph (2) and giving the applicant an opportunity 
for a hearing in accordance with such paragraph, finds, on the 
basis of information submitted to the Secretary as part of the 
application, on the basis of a preapproval inspection, or on the 
basis of any other information before the Secretary— 
"(A) that the application is incomplete, false, or misleading 
in any particular; 
"(B) that the methods used in, and the facilities and con-
trols used for, the manufacture, processing, and packing of 
such animal feed are inadequate to preserve the identity, 
strength, quality, and purity of the new animal drug therein; 
or 
"(C) that the facility manufactures animal feeds bearing 
or containing new animal drugs in a manner that does not 
accord with the specifications for manufacture or labels animal 
feeds bearing or containing new animal drugs in a manner 
that does not accord with the conditions or indications of use 
that are published pursuant to subsection (i), 
title Secretary shall issue an order refusing to approve the applica-
tion. If, after such notice and opportunity for hearing, the Secretary 
finds that subparagraphs (A) through (C) do not apply, the Secretary 
shall issue an order approving the application. An order imder 
this subsection approving an application Ifbr a lifcense to manufac-
ture animal feeds bearing or containing new animal drugs shall 
permit a facility to manufacture only those animal feeds bearing 
or containing new animal drugs for which there are in effect regula-
tions pursuant to subsection (i) relating to the use of such drugs 
in or on such animal feed. 
"(4XA) The Secretary shall, after due notice and opportunity 
for hearing to the applicant, revoke a Hcense to manufacture animal 
feeds bearing or containing new animal drugs under this subsection 
if the Secretary finds— 
"(i) that the application for such hcense contains any untrue 
statement of a material fact; or 
"(ii) that the applicemt has made changes tiiat would cause 
the application to contain any imtrue statements of material 
fact or that would affect the safety or effectiveness of the 
animal feeds manufactured at the facility unless the applicant 
has supplemented the application by filing with the Secretary 
adequate information respecting all such changes and unless 
there is in effect an approval of the supplemental application. 
If the Secretary (or in the Secretary's absence the officer acting 
as the Secretary) finds that there is an imminent hazard to the 
health of humans or of the animals for which such animed feed 
is intended, the Secretary may suspend the license immediately, 
and give the appUcant prompt notice of the action and afford 
the applicant the opportunity for an expedited hearing under this 
subsection; but the authority conferred by this sentence shall not 
be delegated. 
PUBLIC LAW 104-250—OCT. 9, 1996 
110 STAT. 3159 
"(B) The Secretary may also, after due notice and opportunity 
for hearing to the appUcant, revoke a Ucense to manufacture animal 
feed under this subsection if the Secretary finds— 
"(i) that the applicant has failed to establish a system 
for maintaining required records, or has repeatedly or delib-
erately failed to maintain such records or to make required 
reports in accordance with a regulation or order under para-
graph (5)(A) of this subsection or section 504(a)(3)(A), or the 
applicant has refused to permit access to, or copying or verifica-
• 
tion of, such records as required by subparagraph (B) of such 
paragraph or section 504(a)(3)(B); 
"(ii) that on the basis of new information before the 
Secretsiry, evaluated together with the evidence before the Sec-
retary when such license was issued, the methods used in, 
or the facilities and controls used for, the manufacture, process-
ing, 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 fi-om the Secretary, specifying the matter complained 
of; 
"(iii) that on the basis of new information before the 
Secretary, evaluated together with the evidence before the Sec-
retary when such license was issued, the labeling of any animal 
feeds, based on a fair evaluation of all materi£j facts, is false 
or misleading in any particular and was not corrected within 
a reasonable time after receipt of written notice fi*om the Sec-
retary specifying the matter complained of; or 
"(iv) that on the basis of new information before the 
Secretary, evaluated together with the evidence before the Sec-
retary when such license was issued, the facility has manufac-
tured, processed, packed, or held animal feed bearing or 
containing a new animal drug adulterated under section 
501(a)(6) and the faciUty 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 manufacture 
animal feeds luider this subsection if an applicant gives notice 
to the Secretary of intention to discontinue the manufacture of 
all animal feed covered under this subsection and waives an oppor-
tunity 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 
contEuning new animal drugs has been issued— 
"(A) the applicant shall establish and maintain such 
records, and make such reports to the Secretary, or (at the 
option of the Secretary) to the appropriate person or persons 
holding an approved application 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 finding 
that such records and reports are necessary in order to enable 
the Secretary to determine, or facilitate a determination, 
whether there is or may be ground for invoking subsection 
(e) or paragraph (4); and 
110 STAT. 3160 
PUBLIC LAW 104-250—OCT. 9, 1996 
"(B) every person required under this subsection to meiin-
tain 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. 
"(6) To the extent consistent with the public health, the 
Secretary may promulgate regulations for exempting from the oper-
ation of this subsection facihties that manufacture, process, pack, 
or hold animal feeds bearing or containing new animal drugs.". 
21 use 360b 
(c) TRANSITIONAL PROVISION.—A person engaged in the manu-
note. 
facture of animal feeds bearing or containing new animal drugs 
who holds at least one approved medicated feed application for 
an animal feed bearing or containing new animal drugs, the manu-
facture of which was not otherwise exempt from the requirement 
for an approved medicated feed application on the date of the 
enactment of this Act, shall be deemed to hold a license for the 
manufacturmg site identified in the approved medicated feed 
application. Tiie revocation of license provisions of section 512(m)(4) 
of the Federal Food, Drug, and Cosmetic Act, as simended by tiiis 
Act, shall apply to such ucenses. Such license shall expire within 
18 months from the date of enactment of this Act unless the 
person submits to the Secretary a completed license application 
for the manufacturing site accompanied by a copy of an approved 
medicated feed application for such site, which license application 
shall be deemed to be approved upon receipt by the Secretary. 
Approved October 9, 1996. 
LEGISLATIVE HISTORY—H.R. 2508 (S. 773): 
HOUSE REPORTS: No. 104-823 (Comm. on Commerce). 
CONGRESSIONAL RECORD, Vol. 142 (1996): 
Sept. 24, considered and passed House. S. 773 considered and passed Senate. 
Sept. 25, H.R. 2508 considered and passed Senate.