Union Calendar No. 451

104TH CONGRESS

2D SESSION H. R. 2508

[Report No. 104–823]

A BILL

To amend the Federal Food, Drug, and Cosmetic

purposes.approving and using animal drugs, and for otherAct to provide for improvements in the process of

SEPTEMBER 24, 1996

Reported with an amendment, committed to the Commitordered to be printed tee of the Whole House on the State of the Union, and
IB

Union Calendar No. 451

104TH CONGRESS

2D SESSION H. R. 2508

[Report No. 104–823]

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.

IN THE HOUSE OF REPRESENTATIVES

OCTOBER 19, 1995

Mr. ALLARD (for himself, Mr. KLUG, Mr. STENHOLM, Mr. DINGELL, Mr.

GANSKE, Mr. BARRETT of Nebraska, Mr. BEREUTER, Mr. BOEHNER,

Mr. BROWN of California, Mr. BRYANT of Texas, Mr. BURTON of Indiana, Mr. BUYER, Mr. CHAMBLISS, Mrs. CHENOWETH, Mr. COBLE, Mr.

COMBEST, Mr. CONDIT, Mr. COOLEY of Oregon, Mr. COSTELLO, Mr.

CRAPO, Mrs. CUBIN, Mr. DE LA GARZA, Mr. DOOLEY of California, Mr.

EHLERS, Mr. EMERSON, Mr. ENSIGN, Mr. EWING, Mr. GOODLATTE, Mr.

GORDON, Mr. GUNDERSON, Mr. HAMILTON, Mr. HEFLEY, Mr. HOLDEN,

Mr. HOSTETTLER, Mr. JOHNSON of South Dakota, Mr. KLECZKA, Mr.

LAHOOD, Mrs. LINCOLN, Mr. LARGENT, Mr. LATHAM, Mr. LEACH, Mr.

LEWIS of Kentucky, Mr. LIGHTFOOT, Mr. LUCAS of Oklahoma, Mr.

MCINNIS, Mr. MCINTOSH, Ms. MCKINNEY, Mr. MILLER of Florida, Mr.

MINGE, Ms. MOLINARI, Mr. MYERS of Indiana, Mr. NORWOOD, Mr. PASTOR, Mr. PAXON, Mr. PETERSON of Minnesota, Mr. POMBO, Mr.

POMEROY, Mr. POSHARD, Mr. ROBERTS, Mr. ROEMER, Mr. ROSE, Mr.

SCHAEFER, Mr. SKEEN, Mr. SOUDER, Mr. STUMP, Mr. TAYLOR of North

Carolina, Mr. THORNBERRY, Mr. THORNTON, Mrs. THURMAN, Mr.

WALSH, Mr. WATTS of Oklahoma, and Mr. WHITFIELD) introduced the

following bill; which was referred to the Committee on Commerce

SEPTEMBER 24, 1996

Additional sponsors: Mr. BURR, Mrs. CLAYTON, Mr. GILLMOR, Mr. ROTH, Mr.

GUTKNECHT, Mr. JACOBS, Ms. DANNER, Mr. STUPAK, Mr. VOLKMER,

Mr. FUNDERBURK, Mr. FRAZER, Mr. HINCHEY, Mr. BARTON of Texas,

Mr. DEUTSCH, Mr. SKELTON, Mr. WICKER, Mr. GEJDENSON, Mr. DURBIN, Mr. RAHALL, Ms. FURSE, Mr. FROST, Mr. HANCOCK, Mr. SMITH

of Texas, Mr. HUTCHINSON, Mr. BREWSTER, Mr. HANSEN, Mr.
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BONILLA, Mr. MONTGOMERY, Mr. LAUGHLIN, Mr. WAMP, Ms. WOOLSEY,

Mr. MANTON, Mr. FIELDS of Texas, Mr. FRISA, Mr. SMITH of Michigan,

Mr. CASTLE, Mr. FORBES, Mr. RADANOVICH, Mr. BILBRAY, Mr.

CHRISTENSEN, Mr. FARR of California, Mr. BARCIA, Mr. DICKEY, Mr.

HEINEMAN, Mr. PORTER, Mr. NEY, Mr. CRAMER, Mr. JONES, Mr. JEFFERSON, Mr. GREENWOOD, Mr. TOWNS, Ms. PRYCE, Mr. KENNEDY of

Massachusetts, Mr. CHRYSLER, Mr. KILDEE, Mr. LIVINGSTON, Mr. BARR

of Georgia, Mr. CALLAHAN, Mr. CANADY of Florida, Mr. WISE, Mrs.

MEYERS of Kansas, Mr. MATSUI, Mr. BEVILL, Mr. TRAFICANT, Mr.

ABERCROMBIE, Mr. BACHUS, Ms. DUNN of Washington, Mr. SOLOMON,

Mr. FAZIO of California, Mr. UPTON, Mr. DEAL of Georgia, Mr.

PALLONE, Mr. ROHRABACHER, Mr. KNOLLENBERG, Mr. LINDER, Mr.

BUNNING of Kentucky, Mr. CUNNINGHAM, Mr. BALLENGER, Mr. INGLIS

of South Carolina, Mr. EDWARDS, Mr. NUSSLE, Mr. WYNN, Mr. LAFALCE, Mr. COLLINS of Georgia, Ms. RIVERS, Mr. FOLEY, Mr.

HAYWORTH, Ms. MCCARTHY, Mr. BRYANT of Tennessee, Mr. BISHOP,

Mr. SENSENBRENNER, Mrs. MYRICK, Mr. KASICH, Mr. PICKETT, Mr.

NETHERCUTT, and Mr. CREMEANS

SEPTEMBER 24, 1996

Reported with an amendment, committed to the Committee of the Whole

House on the State of the Union, and ordered to be printed

[Strike out all after the enacting clause and insert the part printed in italic]

[For text of introduced bill, see copy of bill as introduced on October 19, 1995]

A BILL

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,

3 SECTION 1. SHORT TITLE; REFERENCE.

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

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

6 (b) REFERENCE.—Whenever in this Act an amend7 ment or repeal is expressed in terms of an amendment to,
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1 or repeal of, a section or other provision, the reference shall

2 be considered to be made to a section or other provision

3 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

4 321 et seq.).

5 SEC. 2. EVIDENCE OF EFFECTIVENESS.

6 (a) ORIGINAL APPLICATIONS.—Paragraph (3) of sec7 tion 512(d) (21 U.S.C. 360b(d)) is amended to read as fol8 lows:

9 ‘‘(3) As used in this section, the term ‘substantial evi10 dence’ means evidence consisting of one or more adequate

11 and well controlled investigations, such as—

12 ‘‘(A) a study in a target species;

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

14 ‘‘(C) any field investigation that may be re15 quired under this section and that meets the require16 ments of subsection (b)(3) if a presubmission con17 ference is requested by the applicant;

18 ‘‘(D) a bioequivalence study; or

19 ‘‘(E) an in vitro study;

20 by experts qualified by scientific training and experience

21 to evaluate the effectiveness of the drug involved, on the

22 basis of which it could fairly and reasonably be concluded

23 by such experts that the drug will have the effect it purports

24 or is represented to have under the conditions of use pre-
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1 scribed, recommended, or suggested in the labeling or pro2 posed labeling thereof.’’.

3 (b) CONFORMING AMENDMENTS.—

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

5 (21 U.S.C. 360b(c)(2)(F)) are each amended—

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

7 field investigations (other than bioequivalence or

8 residue studies) and,’’ and inserting ‘‘substantial

9 evidence of the effectiveness of the drug involved,

10 any studies of animal safety, or,’’; and

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

12 ‘‘required for’’.

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

14 360b(c)(2)(F)(v)) is amended—

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

16 each place it appears and inserting ‘‘clause

17 (iv)’’;

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

19 investigations’’ and inserting ‘‘substantial evi20 dence of the effectiveness of the drug involved,

21 any studies of animal safety,’’; and

22 (C) by striking ‘‘essential to’’ and inserting

23 ‘‘required for’’.
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1 (c) COMBINATION DRUGS.—Section 512(d) (21 U.S.C.

2 360b(d)), as amended by subsection (a) is amended by add3 ing at the end the following:

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

5 than one active ingredient, or the labeling of the drug pre6 scribes, recommends, or suggests use of the drug in combina7 tion with one or more other animal drugs, and the active

8 ingredients or drugs intended for use in the combination

9 have previously been separately approved for particular

10 uses and conditions of use for which they are intended for

11 use in the combination—

12 ‘‘(A) the Secretary shall not issue an order under

13 paragraph (1)(A), (1)(B), or (1)(D) refusing to ap14 prove the application for such combination on human

15 food safety grounds unless the Secretary finds that the

16 application fails to establish that—

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

18 intended for use in the combination, respectively,

19 at the longest withdrawal time of any of the ac20 tive ingredients or drugs in the combination, re21 spectively, exceeds its established tolerance; or

22 ‘‘(ii) none of the active ingredients or drugs

23 in the combination interferes with the methods of

24 analysis for another of the active ingredients or

25 drugs in the combination, respectively;
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1 ‘‘(B) the Secretary shall not issue an order under

2 paragraph (1)(A), (1)(B), or (1)(D) refusing to ap3 prove the application for such combination on target

4 animal safety grounds unless the Secretary finds

5 that—

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

7 issue, specific to one or more of the active ingre8 dients or animal drugs in the combination, that

9 cannot adequately be evaluated based on infor10 mation contained in the application for the com11 bination (including any investigations, studies,

12 or tests for which the applicant has a right of

13 reference or use from the person by or for whom

14 the investigations, studies, or tests were con15 ducted); or

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

17 target animal observations contained in studies

18 submitted to the Secretary as part of the appli19 cation; and

20 ‘‘(ii) based on the Secretary’s evaluation of

21 the information contained in the application

22 with respect to the issues identified in clauses

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

24 apply;
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1 ‘‘(C) except in the case of a combination that

2 contains a nontopical antibacterial ingredient or ani3 mal drug, the Secretary shall not issue an order

4 under paragraph (1)(E) refusing to approve an ap5 plication for a combination animal drug intended for

6 use other than in animal feed or drinking water un7 less the Secretary finds that the application fails to

8 demonstrate that—

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

10 active ingredient or animal drug intended only

11 for the same use as another active ingredient or

12 animal drug in the combination makes a con13 tribution to labeled effectiveness;

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

15 intended for at least one use that is different

16 from all other active ingredients or animal drugs

17 used in the combination provides appropriate

18 concurrent use for the intended target popu19 lation; or

20 ‘‘(iii) where based on scientific information

21 the Secretary has reason to believe the active in22 gredients or animal drugs may be physically in23 compatible or have disparate dosing regimens,

24 such active ingredients or animal drugs are
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1 physically compatible or do not have disparate

2 dosing regimens; and

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

4 under paragraph (1)(E) refusing to approve an ap5 plication for a combination animal drug intended for

6 use in animal feed or drinking water unless the Sec7 retary finds that the application fails to demonstrate

8 that—

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

10 active ingredient or animal drug intended only

11 for the same use as another active ingredient or

12 animal drug in the combination makes a con13 tribution to the labeled effectiveness;

14 ‘‘(ii) each of the active ingredients or ani15 mal drugs intended for at least one use that is

16 different from all other active ingredients or ani17 mal drugs used in the combination provides ap18 propriate concurrent use for the intended target

19 population;

20 ‘‘(iii) where a combination contains more

21 than one nontopical antibacterial ingredient or

22 animal drug, there is substantial evidence that

23 each of the nontopical antibacterial ingredients

24 or animal drugs makes a contribution to the la25 beled effectiveness; or
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1 ‘‘(iv) where based on scientific information

2 the Secretary has reason to believe the active in3 gredients or animal drugs intended for use in

4 drinking water may be physically incompatible,

5 such active ingredients or animal drugs intended

6 for use in drinking water are physically compat7 ible.’’.

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

9 (21 U.S.C. 360b(b)) is amended by adding at the end the

10 following:

11 ‘‘(3) Any person intending to file an application under

12 paragraph (1) or a request for an investigational exemption

13 under subsection (j) shall be entitled to one or more con14 ferences prior to such submission to reach an agreement ac15 ceptable to the Secretary establishing a submission or an

16 investigational requirement, which may include a require17 ment for a field investigation. A decision establishing a sub18 mission or an investigational requirement shall bind the

19 Secretary and the applicant or requestor unless (A) the Sec20 retary and the applicant or requestor mutually agree to

21 modify the requirement, or (B) the Secretary by written

22 order determines that a substantiated scientific requirement

23 essential to the determination of safety or effectiveness of

24 the animal drug involved has appeared after the conference.

25 No later than 25 calendar days after each such conference,
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1 the Secretary shall provide a written order setting forth a

2 scientific justification specific to the animal drug and in3 tended uses under consideration if the agreement referred

4 to in the first sentence requires more than one field inves5 tigation as being essential to provide substantial evidence

6 of effectiveness for the intended uses of the drug. Nothing

7 in this paragraph shall be construed as compelling the Sec8 retary to require a field investigation.’’.

9 (e) IMPLEMENTATION.—

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

11 the date of enactment of this Act, the Secretary of

12 Health and Human Services shall issue proposed reg13 ulations implementing the amendments made by this

14 Act as described in paragraph (2)(A) of this sub15 section, and not later than 18 months after the date

16 of enactment of this Act, the Secretary shall issue

17 final regulations implementing such amendments. Not

18 later than 12 months after the date of enactment of

19 this Act, the Secretary shall issue proposed regula20 tions implementing the other amendments made by

21 this Act as described in paragraphs (2)(B) and (2)(C)

22 of this subsection, and not later than 24 months after

23 the date of enactment of this Act, the Secretary shall

24 issue final regulations implementing such amend25 ments.
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1 (2) CONTENTS.—In issuing regulations imple2 menting the amendments made by this Act, and in

3 taking an action to review an application for ap4 proval of a new animal drug under section 512 of the

5 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

6 360b), or a request for an investigational exemption

7 for a new animal drug under subsection (j) of such

8 section, that is pending or has been submitted prior

9 to the effective date of the regulations, the Secretary

10 shall—

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

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

13 section 512 of such Act, to require that field in14 vestigations be designed and conducted in a sci15 entifically sound manner, taking into account

16 practical conditions in the field and differences

17 between field conditions and laboratory condi18 tions;

19 (B) further define the term ‘‘substantial evi20 dence’’, as defined in subsection (d)(3) of such

21 section, in a manner that encourages the submis22 sion of applications and supplemental applica23 tions; and

24 (C) take into account the proposals con25 tained in the citizen petition (FDA Docket No.
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1 91P–0434/CP) jointly submitted by the Amer2 ican Veterinary Medical Association and the

3 Animal Health Institute, dated October 21, 1991.

4 Until the regulations required by subparagraph (A)

5 are issued, nothing in the regulations published at 21

6 C.F.R. 514.111(a)(5) (April 1, 1996) shall be con7 strued to compel the Secretary of Health and Human

8 Services to require a field investigation under section

9 512(d)(1)(E) of the Federal Food, Drug, and Cosmetic

10 Act (21 U.S.C. 360b(d)(1)(E)) or to apply any of its

11 provisions in a manner inconsistent with the consid12 erations for scientifically sound field investigations

13 set forth in subparagraph (A).

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

15 Health and Human Services shall consider legislative and

16 regulatory options for facilitating the approval under sec17 tion 512 of the Federal Food, Drug, and Cosmetic Act of

18 animal drugs intended for minor species and for minor uses

19 and, within 18 months after the date of enactment of this

20 Act, announce proposals for legislative or regulatory change

21 to the approval process under such section for animal drugs

22 intended for use in minor species or for minor uses.

23 SEC. 3. LIMITATION ON RESIDUES.

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

25 amended to read as follows:
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1 ‘‘(F) upon the basis of information submitted to

2 the Secretary as part of the application or any other

3 information before the Secretary with respect to such

4 drug, any use prescribed, recommended, or suggested

5 in labeling proposed for such drug will result in a

6 residue of such drug in excess of a tolerance found by

7 the Secretary to be safe for such drug;’’.

8 SEC. 4. IMPORT TOLERANCES.

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

10 adding the following new paragraph at the end:

11 ‘‘(6) For purposes of section 402(a)(2)(D), a use or in12 tended use of a new animal drug shall not be deemed unsafe

13 under this section if the Secretary establishes a tolerance

14 for such drug and any edible portion of any animal im15 ported into the United States does not contain residues ex16 ceeding such tolerance. In establishing such tolerance, the

17 Secretary shall rely on data sufficient to demonstrate that

18 a proposed tolerance is safe based on similar food safety

19 criteria used by the Secretary to establish tolerances for ap20 plications for new animal drugs filed under subsection

21 (b)(1). The Secretary may consider and rely on data sub22 mitted by the drug manufacturer, including data submitted

23 to appropriate regulatory authorities in any country where

24 the new animal drug is lawfully used or data available from

25 a relevant international organization, to the extent such
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1 data are not inconsistent with the criteria used by the Sec2 retary to establish a tolerance for applications for new ani3 mal drugs filed under subsection (b)(1). For purposes of this

4 paragraph, ‘relevant international organization’ means the

5 Codex Alimenterius Commission or other international or6 ganization deemed appropriate by the Secretary. The Sec7 retary may, under procedures specified by regulation, re8 voke a tolerance established under this paragraph if infor9 mation demonstrates that the use of the new animal drug

10 under actual use conditions results in food being imported

11 into the United States with residues exceeding the tolerance

12 or if scientific evidence shows the tolerance to be unsafe.’’.

13 SEC. 5. VETERINARY FEED DIRECTIVES.

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

15 353(f)(1)(A)) is amended by inserting after ‘‘other than

16 man’’ the following: ‘‘, other than a veterinary feed directive

17 drug intended for use in animal feed or an animal feed

18 bearing or containing a veterinary feed directive drug,’’.

19 (b) SECTION 504.—The Federal Food, Drug, and Cos20 metic Act is amended by inserting after section 503 the fol21 lowing:

22 ‘‘VETERINARY FEED DIRECTIVE DRUGS

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

24 animal feed which is limited by an approved application

25 filed pursuant to section 512(b) to use under the profes26 sional supervision of a licensed veterinarian is a veterinary
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1 feed directive drug. Any animal feed bearing or containing

2 a veterinary feed directive drug shall be fed to animals only

3 by or upon a lawful veterinary feed directive issued by a

4 licensed veterinarian in the course of the veterinarian’s pro5 fessional practice. When labeled, distributed, held, and used

6 in accordance with this section, a veterinary feed directive

7 drug and any animal feed bearing or containing a veteri8 nary feed directive drug shall be exempt from section 502(f).

9 ‘‘(2) A veterinary feed directive is lawful if it—

10 ‘‘(A) contains such information as the Secretary

11 may by general regulation or by order require; and

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

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

14 published pursuant to section 512(i).

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

16 of animal feed bearing or containing a veterinary feed di17 rective drug and the licensed veterinarian issuing the veteri18 nary feed directive shall maintain a copy of the veterinary

19 feed directive applicable to each such feed, except in the case

20 of a person distributing such feed to another person for fur21 ther distribution. Such person distributing the feed shall

22 maintain a written acknowledgment from the person to

23 whom the feed is shipped stating that that person shall not

24 ship or move such feed to an animal production facility

25 without a veterinary feed directive or ship such feed to an-
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1 other person for further distribution unless that person has

2 provided the same written acknowledgment to its immediate

3 supplier.

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

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

6 thereof, shall, upon request of an officer or employee des7 ignated by the Secretary, permit such officer or employee

8 at all reasonable times to have access to and copy and verify

9 such records.

10 ‘‘(C) Any person who distributes animal feed bearing

11 or containing a veterinary feed directive drug shall upon

12 first engaging in such distribution notify the Secretary of

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

14 provide such notification shall be deemed to be an act which

15 results in the drug being misbranded.

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

17 bearing or containing a veterinary feed directive drug shall

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

19 such cautionary statement and such other information as

20 the Secretary may by general regulation or by order pre21 scribe, or their advertising fails to conform to the conditions

22 and indications for use published pursuant to section 512(i)

23 or fails to contain the general cautionary statement pre24 scribed by the Secretary.
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1 ‘‘(c) Neither a drug subject to this section, nor animal

2 feed bearing or containing such a drug, shall be deemed to

3 be a prescription article under any Federal or State law.’’.

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

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

6 ‘‘(including special labeling requirements’’ the following:

7 ‘‘and any requirement that an animal feed bearing or con8 taining the new animal drug be limited to use under the

9 professional supervision of a licensed veterinarian’’.

10 (d) SECTION 301(e).—Section 301(e) (21 U.S.C.

11 331(e)) is amended by inserting after ‘‘by section 412’’ the

12 following: ‘‘, 504,’’; and by inserting after ‘‘under section

13 412,’’ the following: ‘‘504,’’.

14 SEC. 6. FEED MILL LICENSES.

15 (a) SECTION 512(a).—Paragraphs (1) and (2) of sec16 tion 512(a) (21 U.S.C. 360b(a)) are amended to read as

17 follows:

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

19 particular use or intended use of such drug, be deemed un20 safe for the purposes of section 501(a)(5) and section

21 402(a)(2)(D) unless —

22 ‘‘(A) there is in effect an approval of an applica23 tion filed pursuant to subsection (b) with respect to

24 such use or intended use of such drug, and
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1 ‘‘(B) such drug, its labeling, and such use con2 form to such approved application.

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

4 purposes in the event of removal from the establishment of

5 a manufacturer, packer, or distributor of such drug for use

6 in the manufacture of animal feed in any State unless at

7 the time of such removal such manufacturer, packer, or dis8 tributor has an unrevoked written statement from the con9 signee of such drug, or notice from the Secretary, to the

10 effect that, with respect to the use of such drug in animal

11 feed, such consignee (i) holds a license issued under sub12 section (m) and has in its possession current approved la13 beling for such drug in animal feed; or (ii) will, if the con14 signee is not a user of the drug, ship such drug only to

15 a holder of a license issued under subsection (m) .

16 ‘‘(2) An animal feed bearing or containing a new ani17 mal drug shall, with respect to any particular use or in18 tended use of such animal feed be deemed unsafe for the

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

20 ‘‘(A) there is in effect an approval of an applica21 tion filed pursuant to subsection (b) with respect to

22 such drug, as used in such animal feed,

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

24 for which there is in effect a license issued pursuant
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1 to subsection (m)(1) to manufacture such animal feed,

2 and

3 ‘‘(C) such animal feed and its labeling, distribu4 tion, holding, and use conform to the conditions and

5 indications of use published pursuant to subsection

6 (i).’’.

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

8 360b(m)) is amended to read as follows:

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

10 application for a license to manufacture animal feeds bear11 ing or containing new animal drugs. Such person shall sub12 mit to the Secretary as part of the application (A) a full

13 statement of the business name and address of the specific

14 facility at which the manufacturing is to take place and

15 the facility’s registration number, (B) the name and signa16 ture of the responsible individual or individuals for that

17 facility, (C) a certification that the animal feeds bearing

18 or containing new animal drugs are manufactured and la19 beled in accordance with the applicable regulations pub20 lished pursuant to subsection (i), and (D) a certification

21 that the methods used in, and the facilities and controls

22 used for, manufacturing, processing, packaging, and hold23 ing such animal feeds are in conformity with current good

24 manufacturing practice as described in section

25 501(a)(2)(B).
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1 ‘‘(2) Within 90 days after the filing of an application

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

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

4 the Secretary shall (A) issue an order approving the appli5 cation if the Secretary then finds that none of the grounds

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

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

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

9 question whether such application is approvable. The proce10 dure governing such a hearing shall be the procedure set

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

12 ‘‘(3) If the Secretary, after due notice to the applicant

13 in accordance with paragraph (2) and giving the applicant

14 an opportunity for a hearing in accordance with such para15 graph, finds, on the basis of information submitted to the

16 Secretary as part of the application, on the basis of a

17 preapproval inspection, or on the basis of any other infor18 mation before the Secretary—

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

20 misleading in any particular;

21 ‘‘(B) that the methods used in, and the facilities

22 and controls used for, the manufacture, processing,

23 and packing of such animal feed are inadequate to

24 preserve the identity, strength, quality, and purity of

25 the new animal drug therein; or
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1 ‘‘(C) that the facility manufactures animal feeds

2 bearing or containing new animal drugs in a manner

3 that does not accord with the specifications for manu4 facture or labels animal feeds bearing or containing

5 new animal drugs in a manner that does not accord

6 with the conditions or indications of use that are pub7 lished pursuant to subsection (i),

8 the Secretary shall issue an order refusing to approve the

9 application. If, after such notice and opportunity for hear10 ing, the Secretary finds that subparagraphs (A) through (C)

11 do not apply, the Secretary shall issue an order approving

12 the application. An order under this subsection approving

13 an application for a license to manufacture animal feeds

14 bearing or containing new animal drugs shall permit a fa15 cility to manufacture only those animal feeds bearing or

16 containing new animal drugs for which there are in effect

17 regulations pursuant to subsection (i) relating to the use

18 of such drugs in or on such animal feed.

19 ‘‘(4)(A) The Secretary shall, after due notice and op20 portunity for hearing to the applicant, revoke a license to

21 manufacture animal feeds bearing or containing new ani22 mal drugs under this subsection if the Secretary finds—

23 ‘‘(i) that the application for such license con24 tains any untrue statement of a material fact; or
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1 ‘‘(ii) that the applicant has made changes that

2 would cause the application to contain any untrue

3 statements of material fact or that would affect the

4 safety or effectiveness of the animal feeds manufac5 tured at the facility unless the applicant has supple6 mented the application by filing with the Secretary

7 adequate information respecting all such changes and

8 unless there is in effect an approval of the supple9 mental application.

10 If the Secretary (or in the Secretary’s absence the officer

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

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

13 such animal feed is intended, the Secretary may suspend

14 the license immediately, and give the applicant prompt no15 tice of the action and afford the applicant the opportunity

16 for an expedited hearing under this subsection; but the au17 thority conferred by this sentence shall not be delegated.

18 ‘‘(B) The Secretary may also, after due notice and op19 portunity for hearing to the applicant, revoke a license to

20 manufacture animal feed under this subsection if the Sec21 retary finds—

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

23 system for maintaining required records, or has re24 peatedly or deliberately failed to maintain such

25 records or to make required reports in accordance
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1 with a regulation or order under paragraph (5)(A) of

2 this subsection or section 504(a)(3)(A), or the appli3 cant has refused to permit access to, or copying or

4 verification of, such records as required by subpara5 graph (B) of such paragraph or section 504(a)(3)(B);

6 ‘‘(ii) that on the basis of new information before

7 the Secretary, evaluated together with the evidence be8 fore the Secretary when such license was issued, the

9 methods used in, or the facilities and controls used

10 for, the manufacture, processing, packing, and hold11 ing of such animal feed are inadequate to assure and

12 preserve the identity, strength, quality, and purity of

13 the new animal drug therein, and were not made ade14 quate within a reasonable time after receipt of writ15 ten notice from the Secretary, specifying the matter

16 complained of;

17 ‘‘(iii) that on the basis of new information before

18 the Secretary, evaluated together with the evidence be19 fore the Secretary when such license was issued, the

20 labeling of any animal feeds, based on a fair evalua21 tion of all material facts, is false or misleading in

22 any particular and was not corrected within a rea23 sonable time after receipt of written notice from the

24 Secretary specifying the matter complained of; or
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1 ‘‘(iv) that on the basis of new information before

2 the Secretary, evaluated together with the evidence be3 fore the Secretary when such license was issued, the

4 facility has manufactured, processed, packed, or held

5 animal feed bearing or containing a new animal drug

6 adulterated under section 501(a)(6) and the facility

7 did not discontinue the manufacture, processing,

8 packing, or holding of such animal feed within a rea9 sonable time after receipt of written notice from the

10 Secretary specifying the matter complained of.

11 ‘‘(C) The Secretary may also revoke a license to manu12 facture animal feeds under this subsection if an applicant

13 gives notice to the Secretary of intention to discontinue the

14 manufacture of all animal feed covered under this sub15 section and waives an opportunity for a hearing on the

16 matter.

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

18 findings upon which it is based.

19 ‘‘(5) When a license to manufacture animal feeds bear20 ing or containing new animal drugs has been issued—

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

22 such records, and make such reports to the Secretary,

23 or (at the option of the Secretary) to the appropriate

24 person or persons holding an approved application

25 filed under subsection (b), as the Secretary may by
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1 general regulation, or by order with respect to such

2 application, prescribe on the basis of a finding that

3 such records and reports are necessary in order to en4 able the Secretary to determine, or facilitate a deter5 mination, whether there is or may be ground for in6 voking subsection (e) or paragraph (4); and

7 ‘‘(B) every person required under this subsection

8 to maintain records, and every person in charge or

9 custody thereof, shall, upon request of an officer or

10 employee designated by the Secretary, permit such of11 ficer or employee at all reasonable times to have ac12 cess to and copy and verify such records.

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

14 the Secretary may promulgate regulations for exempting

15 from the operation of this subsection facilities that manu16 facture, process, pack, or hold animal feeds bearing or con17 taining new animal drugs.’’.

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

19 the manufacture of animal feeds bearing or containing new

20 animal drugs who holds at least one approved medicated

21 feed application for an animal feed bearing or containing

22 new animal drugs, the manufacture of which was not other23 wise exempt from the requirement for an approved medi24 cated feed application on the date of the enactment of this

25 Act, shall be deemed to hold a license for the manufacturing
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1 site identified in the approved medicated feed application.

2 The revocation of license provisions of section 512(m)(4) of

3 the Federal Food, Drug, and Cosmetic Act, as amended by

4 this Act, shall apply to such licenses. Such license shall ex5 pire within 18 months from the date of enactment of this

6 Act unless the person submits to the Secretary a completed

7 license application for the manufacturing site accompanied

8 by a copy of an approved medicated feed application for

9 such site, which license application shall be deemed to be

10 approved upon receipt by the Secretary.