II

104TH CONGRESS

2D SESSION H. R. 2508

IN THE SENATE OF THE UNITED STATES

SEPTEMBER 24 legislative day, SEPTEMBER 20, 1996

Received

AN ACT

To amend the Federal Food, Drug, and Cosmetic Act to

provide for improvements in the process of approving

and using animal drugs, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE; REFERENCE.

2 (a) SHORT TITLE.—This Act may be cited as the

3 ‘‘Animal Drug Availability Act of 1996’’.

4 (b) REFERENCE.—Whenever in this Act an amend5 ment or repeal is expressed in terms of an amendment

6 to, or repeal of, a section or other provision, the reference

7 shall be considered to be made to a section or other provi8 sion of the Federal Food, Drug, and Cosmetic Act (21

9 U.S.C. 321 et seq.).

10 SEC. 2. EVIDENCE OF EFFECTIVENESS.

11 (a) ORIGINAL APPLICATIONS.—Paragraph (3) of sec12 tion 512(d) (21 U.S.C. 360b(d)) is amended to read as

13 follows:

14 ‘‘(3) As used in this section, the term ‘substantial evi15 dence’ means evidence consisting of one or more adequate

16 and well controlled investigations, such as—

17 ‘‘(A) a study in a target species;

18 ‘‘(B) a study in laboratory animals;

19 ‘‘(C) any field investigation that may be re20 quired under this section and that meets the require21 ments of subsection (b)(3) if a presubmission con22 ference is requested by the applicant;

23 ‘‘(D) a bioequivalence study; or

24 ‘‘(E) an in vitro study;

25 by experts qualified by scientific training and experience

26 to evaluate the effectiveness of the drug involved, on the
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1 basis of which it could fairly and reasonably be concluded

2 by such experts that the drug will have the effect it

3 purports or is represented to have under the conditions

4 of use prescribed, recommended, or suggested in the label5 ing or proposed labeling thereof.’’.

6 (b) CONFORMING AMENDMENTS.—

7 (1) Clauses (ii) and (iii) of section 512(c)(2)(F)

8 (21 U.S.C. 360b(c)(2)(F)) are each amended—

9 (A) by striking ‘‘reports of new clinical or

10 field investigations (other than bioequivalence

11 or residue studies) and,’’ and inserting ‘‘sub12 stantial evidence of the effectiveness of the drug

13 involved, any studies of animal safety, or,’’; and

14 (B) by striking ‘‘essential to’’ and inserting

15 ‘‘required for’’.

16 (2) Section 512(c)(2)(F)(v) (21 U.S.C.

17 360b(c)(2)(F)(v)) is amended—

18 (A) by striking ‘‘subparagraph (B)(iv)’’

19 each place it appears and inserting ‘‘clause

20 (iv)’’;

21 (B) by striking ‘‘reports of clinical or field

22 investigations’’ and inserting ‘‘substantial evi23 dence of the effectiveness of the drug involved,

24 any studies of animal safety,’’; and
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1 (C) by striking ‘‘essential to’’ and inserting

2 ‘‘required for’’.

3 (c) COMBINATION DRUGS.—Section 512(d) (21

4 U.S.C. 360b(d)), as amended by subsection (a) is amended

5 by adding at the end the following:

6 ‘‘(4) In a case in which an animal drug contains more

7 than one active ingredient, or the labeling of the drug pre8 scribes, recommends, or suggests use of the drug in com9 bination with one or more other animal drugs, and the

10 active ingredients or drugs intended for use in the com11 bination have previously been separately approved for par12 ticular uses and conditions of use for which they are in13 tended for use in the combination—

14 ‘‘(A) the Secretary shall not issue an order

15 under paragraph (1)(A), (1)(B), or (1)(D) refusing

16 to approve the application for such combination on

17 human food safety grounds unless the Secretary

18 finds that the application fails to establish that—

19 ‘‘(i) none of the active ingredients or drugs

20 intended for use in the combination, respec21 tively, at the longest withdrawal time of any of

22 the active ingredients or drugs in the combina23 tion, respectively, exceeds its established toler24 ance; or
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1 ‘‘(ii) none of the active ingredients or

2 drugs in the combination interferes with the

3 methods of analysis for another of the active in4 gredients or drugs in the combination, respec5 tively;

6 ‘‘(B) the Secretary shall not issue an order

7 under paragraph (1)(A), (1)(B), or (1)(D) refusing

8 to approve the application for such combination on

9 target animal safety grounds unless the Secretary

10 finds that—

11 ‘‘(i)(I) there is a substantiated scientific

12 issue, specific to one or more of the active in13 gredients or animal drugs in the combination,

14 that cannot adequately be evaluated based on

15 information contained in the application for the

16 combination (including any investigations, stud17 ies, or tests for which the applicant has a right

18 of reference or use from the person by or for

19 whom the investigations, studies, or tests were

20 conducted); or

21 ‘‘(II) there is a scientific issue raised by

22 target animal observations contained in studies

23 submitted to the Secretary as part of the appli24 cation; and
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1 ‘‘(ii) based on the Secretary’s evaluation of

2 the information contained in the application

3 with respect to the issues identified in clauses

4 (i)(I) and (II), paragraph (1)(A), (B), or (D)

5 apply;

6 ‘‘(C) except in the case of a combination that

7 contains a nontopical antibacterial ingredient or ani8 mal drug, the Secretary shall not issue an order

9 under paragraph (1)(E) refusing to approve an ap10 plication for a combination animal drug intended for

11 use other than in animal feed or drinking water un12 less the Secretary finds that the application fails to

13 demonstrate that—

14 ‘‘(i) there is substantial evidence that any

15 active ingredient or animal drug intended only

16 for the same use as another active ingredient or

17 animal drug in the combination makes a con18 tribution to labeled effectiveness;

19 ‘‘(ii) each active ingredient or animal drug

20 intended for at least one use that is different

21 from all other active ingredients or animal

22 drugs used in the combination provides appro23 priate concurrent use for the intended target

24 population; or
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1 ‘‘(iii) where based on scientific information

2 the Secretary has reason to believe the active

3 ingredients or animal drugs may be physically

4 incompatible or have disparate dosing regimens,

5 such active ingredients or animal drugs are

6 physically compatible or do not have disparate

7 dosing regimens; and

8 ‘‘(D) the Secretary shall not issue an order

9 under paragraph (1)(E) refusing to approve an ap10 plication for a combination animal drug intended for

11 use in animal feed or drinking water unless the Sec12 retary finds that the application fails to demonstrate

13 that—

14 ‘‘(i) there is substantial evidence that any

15 active ingredient or animal drug intended only

16 for the same use as another active ingredient or

17 animal drug in the combination makes a con18 tribution to the labeled effectiveness;

19 ‘‘(ii) each of the active ingredients or ani20 mal drugs intended for at least one use that is

21 different from all other active ingredients or

22 animal drugs used in the combination provides

23 appropriate concurrent use for the intended tar24 get population;
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1 ‘‘(iii) where a combination contains more

2 than one nontopical antibacterial ingredient or

3 animal drug, there is substantial evidence that

4 each of the nontopical antibacterial ingredients

5 or animal drugs makes a contribution to the la6 beled effectiveness; or

7 ‘‘(iv) where based on scientific information

8 the Secretary has reason to believe the active

9 ingredients or animal drugs intended for use in

10 drinking water may be physically incompatible,

11 such active ingredients or animal drugs in12 tended for use in drinking water are physically

13 compatible.’’.

14 (d) PRESUBMISSION CONFERENCE.—Section 512(b)

15 (21 U.S.C. 360b(b)) is amended by adding at the end the

16 following:

17 ‘‘(3) Any person intending to file an application

18 under paragraph (1) or a request for an investigational

19 exemption under subsection (j) shall be entitled to one or

20 more conferences prior to such submission to reach an

21 agreement acceptable to the Secretary establishing a sub22 mission or an investigational requirement, which may in23 clude a requirement for a field investigation. A decision

24 establishing a submission or an investigational require25 ment shall bind the Secretary and the applicant or reques-
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1 tor unless (A) the Secretary and the applicant or requestor

2 mutually agree to modify the requirement, or (B) the Sec3 retary by written order determines that a substantiated

4 scientific requirement essential to the determination of

5 safety or effectiveness of the animal drug involved has ap6 peared after the conference. No later than 25 calendar

7 days after each such conference, the Secretary shall pro8 vide a written order setting forth a scientific justification

9 specific to the animal drug and intended uses under con10 sideration if the agreement referred to in the first sentence

11 requires more than one field investigation as being essen12 tial to provide substantial evidence of effectiveness for the

13 intended uses of the drug. Nothing in this paragraph shall

14 be construed as compelling the Secretary to require a field

15 investigation.’’.

16 (e) IMPLEMENTATION.—

17 (1) IN GENERAL.—Not later than 6 months

18 after the date of enactment of this Act, the Sec19 retary of Health and Human Services shall issue

20 proposed regulations implementing the amendments

21 made by this Act as described in paragraph (2)(A)

22 of this subsection, and not later than 18 months

23 after the date of enactment of this Act, the Sec24 retary shall issue final regulations implementing

25 such amendments. Not later than 12 months after
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1 the date of enactment of this Act, the Secretary

2 shall issue proposed regulations implementing the

3 other amendments made by this Act as described in

4 paragraphs (2)(B) and (2)(C) of this subsection,

5 and not later than 24 months after the date of en6 actment of this Act, the Secretary shall issue final

7 regulations implementing such amendments.

8 (2) CONTENTS.—In issuing regulations imple9 menting the amendments made by this Act, and in

10 taking an action to review an application for ap11 proval of a new animal drug under section 512 of

12 the Federal Food, Drug, and Cosmetic Act (21

13 U.S.C. 360b), or a request for an investigational ex14 emption for a new animal drug under subsection (j)

15 of such section, that is pending or has been submit16 ted prior to the effective date of the regulations, the

17 Secretary shall—

18 (A) further define the term ‘‘adequate and

19 well controlled’’, as used in subsection (d)(3) of

20 section 512 of such Act, to require that field in21 vestigations be designed and conducted in a sci22 entifically sound manner, taking into account

23 practical conditions in the field and differences

24 between field conditions and laboratory condi25 tions;
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1 (B) further define the term ‘‘substantial

2 evidence’’, as defined in subsection (d)(3) of

3 such section, in a manner that encourages the

4 submission of applications and supplemental

5 applications; and

6 (C) take into account the proposals con7 tained in the citizen petition (FDA Docket No.

8 91P–0434/CP) jointly submitted by the Amer9 ican Veterinary Medical Association and the

10 Animal Health Institute, dated October 21,

11 1991.

12 Until the regulations required by subparagraph (A)

13 are issued, nothing in the regulations published at

14 21 C.F.R. 514.111(a)(5) (April 1, 1996) shall be

15 construed to compel the Secretary of Health and

16 Human Services to require a field investigation

17 under section 512(d)(1)(E) of the Federal Food,

18 Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)(E))

19 or to apply any of its provisions in a manner incon20 sistent with the considerations for scientifically

21 sound field investigations set forth in subparagraph

22 (A).

23 (f) MINOR SPECIES AND USES.—The Secretary of

24 Health and Human Services shall consider legislative and

25 regulatory options for facilitating the approval under sec-
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1 tion 512 of the Federal Food, Drug, and Cosmetic Act

2 of animal drugs intended for minor species and for minor

3 uses and, within 18 months after the date of enactment

4 of this Act, announce proposals for legislative or regu5 latory change to the approval process under such section

6 for animal drugs intended for use in minor species or for

7 minor uses.

8 SEC. 3. LIMITATION ON RESIDUES.

9 Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is

10 amended to read as follows:

11 ‘‘(F) upon the basis of information submitted to

12 the Secretary as part of the application or any other

13 information before the Secretary with respect to

14 such drug, any use prescribed, recommended, or

15 suggested in labeling proposed for such drug will re16 sult in a residue of such drug in excess of a toler17 ance found by the Secretary to be safe for such

18 drug;’’.

19 SEC. 4. IMPORT TOLERANCES.

20 Section 512(a) (21 U.S.C. 360b(a)) is amended by

21 adding the following new paragraph at the end:

22 ‘‘(6) For purposes of section 402(a)(2)(D), a use or

23 intended use of a new animal drug shall not be deemed

24 unsafe under this section if the Secretary establishes a tol25 erance for such drug and any edible portion of any animal
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1 imported into the United States does not contain residues

2 exceeding such tolerance. In establishing such tolerance,

3 the Secretary shall rely on data sufficient to demonstrate

4 that a proposed tolerance is safe based on similar food

5 safety criteria used by the Secretary to establish toler6 ances for applications for new animal drugs filed under

7 subsection (b)(1). The Secretary may consider and rely on

8 data submitted by the drug manufacturer, including data

9 submitted to appropriate regulatory authorities in any

10 country where the new animal drug is lawfully used or

11 data available from a relevant international organization,

12 to the extent such data are not inconsistent with the cri13 teria used by the Secretary to establish a tolerance for

14 applications for new animal drugs filed under subsection

15 (b)(1). For purposes of this paragraph, ‘relevant inter16 national organization’ means the Codex Alimenterius

17 Commission or other international organization deemed

18 appropriate by the Secretary. The Secretary may, under

19 procedures specified by regulation, revoke a tolerance es20 tablished under this paragraph if information dem21 onstrates that the use of the new animal drug under actual

22 use conditions results in food being imported into the

23 United States with residues exceeding the tolerance or if

24 scientific evidence shows the tolerance to be unsafe.’’.
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1 SEC. 5. VETERINARY FEED DIRECTIVES.

2 (a) SECTION 503.—Section 503(f)(1)(A) (21 U.S.C.

3 353(f)(1)(A)) is amended by inserting after ‘‘other than

4 man’’ the following: ‘‘, other than a veterinary feed direc5 tive drug intended for use in animal feed or an animal

6 feed bearing or containing a veterinary feed directive

7 drug,’’.

8 (b) SECTION 504.—The Federal Food, Drug, and

9 Cosmetic Act is amended by inserting after section 503

10 the following:

11 ‘‘VETERINARY FEED DIRECTIVE DRUGS

12 ‘‘SEC. 504. (a)(1) A drug intended for use in or on

13 animal feed which is limited by an approved application

14 filed pursuant to section 512(b) to use under the profes15 sional supervision of a licensed veterinarian is a veterinary

16 feed directive drug. Any animal feed bearing or containing

17 a veterinary feed directive drug shall be fed to animals

18 only by or upon a lawful veterinary feed directive issued

19 by a licensed veterinarian in the course of the veterinar20 ian’s professional practice. When labeled, distributed,

21 held, and used in accordance with this section, a veteri22 nary feed directive drug and any animal feed bearing or

23 containing a veterinary feed directive drug shall be exempt

24 from section 502(f).

25 ‘‘(2) A veterinary feed directive is lawful if it—
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1 ‘‘(A) contains such information as the Secretary

2 may by general regulation or by order require; and

3 ‘‘(B) is in compliance with the conditions and

4 indications for use of the drug set forth in the notice

5 published pursuant to section 512(i).

6 ‘‘(3)(A) Any persons involved in the distribution or

7 use of animal feed bearing or containing a veterinary feed

8 directive drug and the licensed veterinarian issuing the

9 veterinary feed directive shall maintain a copy of the vet10 erinary feed directive applicable to each such feed, except

11 in the case of a person distributing such feed to another

12 person for further distribution. Such person distributing

13 the feed shall maintain a written acknowledgment from

14 the person to whom the feed is shipped stating that that

15 person shall not ship or move such feed to an animal pro16 duction facility without a veterinary feed directive or ship

17 such feed to another person for further distribution unless

18 that person has provided the same written acknowledg19 ment to its immediate supplier.

20 ‘‘(B) Every person required under subparagraph (A)

21 to maintain records, and every person in charge or custody

22 thereof, shall, upon request of an officer or employee des23 ignated by the Secretary, permit such officer or employee

24 at all reasonable times to have access to and copy and

25 verify such records.
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1 ‘‘(C) Any person who distributes animal feed bearing

2 or containing a veterinary feed directive drug shall upon

3 first engaging in such distribution notify the Secretary of

4 that person’s name and place of business. The failure to

5 provide such notification shall be deemed to be an act

6 which results in the drug being misbranded.

7 ‘‘(b) A veterinary feed directive drug and any feed

8 bearing or containing a veterinary feed directive drug shall

9 be deemed to be misbranded if their labeling fails to bear

10 such cautionary statement and such other information as

11 the Secretary may by general regulation or by order pre12 scribe, or their advertising fails to conform to the condi13 tions and indications for use published pursuant to section

14 512(i) or fails to contain the general cautionary statement

15 prescribed by the Secretary.

16 ‘‘(c) Neither a drug subject to this section, nor ani17 mal feed bearing or containing such a drug, shall be

18 deemed to be a prescription article under any Federal or

19 State law.’’.

20 (c) CONFORMING AMENDMENT.—Section 512 (21

21 U.S.C. 360b) is amended in subsection (i) by inserting

22 after ‘‘(including special labeling requirements’’ the follow23 ing: ‘‘and any requirement that an animal feed bearing

24 or containing the new animal drug be limited to use under

25 the professional supervision of a licensed veterinarian’’.
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1 (d) SECTION 301(e).—Section 301(e) (21 U.S.C.

2 331(e)) is amended by inserting after ‘‘by section 412’’

3 the following: ‘‘, 504,’’; and by inserting after ‘‘under sec4 tion 412,’’ the following: ‘‘504,’’.

5 SEC. 6. FEED MILL LICENSES.

6 (a) SECTION 512(a).—Paragraphs (1) and (2) of sec7 tion 512(a) (21 U.S.C. 360b(a)) are amended to read as

8 follows:

9 ‘‘(a)(1) A new animal drug shall, with respect to any

10 particular use or intended use of such drug, be deemed

11 unsafe for the purposes of section 501(a)(5) and section

12 402(a)(2)(D) unless —

13 ‘‘(A) there is in effect an approval of an appli14 cation filed pursuant to subsection (b) with respect

15 to such use or intended use of such drug, and

16 ‘‘(B) such drug, its labeling, and such use con17 form to such approved application.

18 A new animal drug shall also be deemed unsafe for such

19 purposes in the event of removal from the establishment

20 of a manufacturer, packer, or distributor of such drug for

21 use in the manufacture of animal feed in any State unless

22 at the time of such removal such manufacturer, packer,

23 or distributor has an unrevoked written statement from

24 the consignee of such drug, or notice from the Secretary,

25 to the effect that, with respect to the use of such drug
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1 in animal feed, such consignee (i) holds a license issued

2 under subsection (m) and has in its possession current ap3 proved labeling for such drug in animal feed; or (ii) will,

4 if the consignee is not a user of the drug, ship such drug

5 only to a holder of a license issued under subsection (m).

6 ‘‘(2) An animal feed bearing or containing a new ani7 mal drug shall, with respect to any particular use or in8 tended use of such animal feed be deemed unsafe for the

9 purposes of section 501(a)(6) unless—

10 ‘‘(A) there is in effect an approval of an appli11 cation filed pursuant to subsection (b) with respect

12 to such drug, as used in such animal feed,

13 ‘‘(B) such animal feed is manufactured at a site

14 for which there is in effect a license issued pursuant

15 to subsection (m)(1) to manufacture such animal

16 feed, and

17 ‘‘(C) such animal feed and its labeling, distribu18 tion, holding, and use conform to the conditions and

19 indications of use published pursuant to subsection

20 (i) .’’.

21 (b) SECTION 512(m).—Section 512(m) (21 U.S.C.

22 360b(m)) is amended to read as follows:

23 ‘‘(m)(1) Any person may file with the Secretary an

24 application for a license to manufacture animal feeds bear-
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1 ing or containing new animal drugs. Such person shall

2 submit to the Secretary as part of the application (A) a

3 full statement of the business name and address of the

4 specific facility at which the manufacturing is to take

5 place and the facility’s registration number, (B) the name

6 and signature of the responsible individual or individuals

7 for that facility, (C) a certification that the animal feeds

8 bearing or containing new animal drugs are manufactured

9 and labeled in accordance with the applicable regulations

10 published pursuant to subsection (i), and (D) a certifi11 cation that the methods used in, and the facilities and con12 trols used for, manufacturing, processing, packaging, and

13 holding such animal feeds are in conformity with current

14 good manufacturing practice as described in section

15 501(a)(2)(B).

16 ‘‘(2) Within 90 days after the filing of an application

17 pursuant to paragraph (1), or such additional period as

18 may be agreed upon by the Secretary and the applicant,

19 the Secretary shall (A) issue an order approving the appli20 cation if the Secretary then finds that none of the grounds

21 for denying approval specified in paragraph (3) applies,

22 or (B) give the applicant notice of an opportunity for a

23 hearing before the Secretary under paragraph (3) on the

24 question whether such application is approvable. The pro-
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1 cedure governing such a hearing shall be the procedure

2 set forth in the last two sentences of subsection (c)(1).

3 ‘‘(3) If the Secretary, after due notice to the appli4 cant in accordance with paragraph (2) and giving the ap5 plicant an opportunity for a hearing in accordance with

6 such paragraph, finds, on the basis of information submit7 ted to the Secretary as part of the application, on the basis

8 of a preapproval inspection, or on the basis of any other

9 information before the Secretary—

10 ‘‘(A) that the application is incomplete, false, or

11 misleading in any particular;

12 ‘‘(B) that the methods used in, and the facili13 ties and controls used for, the manufacture, process14 ing, and packing of such animal feed are inadequate

15 to preserve the identity, strength, quality, and purity

16 of the new animal drug therein; or

17 ‘‘(C) that the facility manufactures animal

18 feeds bearing or containing new animal drugs in a

19 manner that does not accord with the specifications

20 for manufacture or labels animal feeds bearing or

21 containing new animal drugs in a manner that does

22 not accord with the conditions or indications of use

23 that are published pursuant to subsection (i),

24 the Secretary shall issue an order refusing to approve the

25 application. If, after such notice and opportunity for hear-
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1 ing, the Secretary finds that subparagraphs (A) through

2 (C) do not apply, the Secretary shall issue an order ap3 proving the application. An order under this subsection

4 approving an application for a license to manufacture ani5 mal feeds bearing or containing new animal drugs shall

6 permit a facility to manufacture only those animal feeds

7 bearing or containing new animal drugs for which there

8 are in effect regulations pursuant to subsection (i) relating

9 to the use of such drugs in or on such animal feed.

10 ‘‘(4)(A) The Secretary shall, after due notice and op11 portunity for hearing to the applicant, revoke a license to

12 manufacture animal feeds bearing or containing new ani13 mal drugs under this subsection if the Secretary finds—

14 ‘‘(i) that the application for such license con15 tains any untrue statement of a material fact; or

16 ‘‘(ii) that the applicant has made changes that

17 would cause the application to contain any untrue

18 statements of material fact or that would affect the

19 safety or effectiveness of the animal feeds manufac20 tured at the facility unless the applicant has supple21 mented the application by filing with the Secretary

22 adequate information respecting all such changes

23 and unless there is in effect an approval of the sup24 plemental application.
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1 If the Secretary (or in the Secretary’s absence the officer

2 acting as the Secretary) finds that there is an imminent

3 hazard to the health of humans or of the animals for which

4 such animal feed is intended, the Secretary may suspend

5 the license immediately, and give the applicant prompt no6 tice of the action and afford the applicant the opportunity

7 for an expedited hearing under this subsection; but the

8 authority conferred by this sentence shall not be delegated.

9 ‘‘(B) The Secretary may also, after due notice and

10 opportunity for hearing to the applicant, revoke a license

11 to manufacture animal feed under this subsection if the

12 Secretary finds—

13 ‘‘(i) that the applicant has failed to establish a

14 system for maintaining required records, or has re15 peatedly or deliberately failed to maintain such

16 records or to make required reports in accordance

17 with a regulation or order under paragraph (5)(A)

18 of this subsection or section 504(a)(3)(A), or the ap19 plicant has refused to permit access to, or copying

20 or verification of, such records as required by sub21 paragraph (B) of such paragraph or section

22 504(a)(3)(B);

23 ‘‘(ii) that on the basis of new information be24 fore the Secretary, evaluated together with the evi25 dence before the Secretary when such license was is-
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1 sued, the methods used in, or the facilities and con2 trols used for, the manufacture, processing, packing,

3 and holding of such animal feed are inadequate to

4 assure and preserve the identity, strength, quality,

5 and purity of the new animal drug therein, and were

6 not made adequate within a reasonable time after

7 receipt of written notice from the Secretary, specify8 ing the matter complained of;

9 ‘‘(iii) that on the basis of new information be10 fore the Secretary, evaluated together with the evi11 dence before the Secretary when such license was is12 sued, the labeling of any animal feeds, based on a

13 fair evaluation of all material facts, is false or mis14 leading in any particular and was not corrected

15 within a reasonable time after receipt of written no16 tice from the Secretary specifying the matter com17 plained of; or

18 ‘‘(iv) that on the basis of new information be19 fore the Secretary, evaluated together with the evi20 dence before the Secretary when such license was is21 sued, the facility has manufactured, processed,

22 packed, or held animal feed bearing or containing a

23 new animal drug adulterated under section

24 501(a)(6) and the facility did not discontinue the

25 manufacture, processing, packing, or holding of such
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1 animal feed within a reasonable time after receipt of

2 written notice from the Secretary specifying the

3 matter complained of.

4 ‘‘(C) The Secretary may also revoke a license to man5 ufacture animal feeds under this subsection if an applicant

6 gives notice to the Secretary of intention to discontinue

7 the manufacture of all animal feed covered under this sub8 section and waives an opportunity for a hearing on the

9 matter.

10 ‘‘(D) Any order under this paragraph shall state the

11 findings upon which it is based.

12 ‘‘(5) When a license to manufacture animal feeds

13 bearing or containing new animal drugs has been issued—

14 ‘‘(A) the applicant shall establish and maintain

15 such records, and make such reports to the Sec16 retary, or (at the option of the Secretary) to the ap17 propriate person or persons holding an approved ap18 plication filed under subsection (b), as the Secretary

19 may by general regulation, or by order with respect

20 to such application, prescribe on the basis of a find21 ing that such records and reports are necessary in

22 order to enable the Secretary to determine, or facili23 tate a determination, whether there is or may be

24 ground for invoking subsection (e) or paragraph (4);

25 and
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1 ‘‘(B) every person required under this sub2 section to maintain records, and every person in

3 charge or custody thereof, shall, upon request of an

4 officer or employee designated by the Secretary, per5 mit such officer or employee at all reasonable times

6 to have access to and copy and verify such records.

7 ‘‘(6) To the extent consistent with the public health,

8 the Secretary may promulgate regulations for exempting

9 from the operation of this subsection facilities that manu10 facture, process, pack, or hold animal feeds bearing or

11 containing new animal drugs.’’.

12 (c) TRANSITIONAL PROVISION.—A person engaged in

13 the manufacture of animal feeds bearing or containing

14 new animal drugs who holds at least one approved medi15 cated feed application for an animal feed bearing or con16 taining new animal drugs, the manufacture of which was

17 not otherwise exempt from the requirement for an ap18 proved medicated feed application on the date of the en19 actment of this Act, shall be deemed to hold a license for

20 the manufacturing site identified in the approved medi21 cated feed application. The revocation of license provisions

22 of section 512(m)(4) of the Federal Food, Drug, and Cos23 metic Act, as amended by this Act, shall apply to such

24 licenses. Such license shall expire within 18 months from

25 the date of enactment of this Act unless the person sub-
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1 mits to the Secretary a completed license application for

2 the manufacturing site accompanied by a copy of an ap3 proved medicated feed application for such site, which li4 cense application shall be deemed to be approved upon re5 ceipt by the Secretary.

Passed the House of Representatives September 24,

1996.

Attest: ROBIN H. CARLE,

Clerk.