104TH CONGRESS

2D SESSION S. 773

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,

3 SECTION 1. SHORT TITLE; REFERENCE.

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

5 ‘‘Animal Drug Availability Act of 1996’’.
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1 (b) REFERENCE.—Whenever in this Act an amend2 ment or repeal is expressed in terms of an amendment

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

4 shall be considered to be made to a section or other provi5 sion of the Federal Food, Drug, and Cosmetic Act (21

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

7 SEC. 2. EVIDENCE OF EFFECTIVENESS.

8 (a) ORIGINAL APPLICATIONS.—Paragraph (3) of sec9 tion 512(d) (21 U.S.C. 360b(d)) is amended to read as

10 follows:

11 ‘‘(3) As used in this section, the term ‘substantial evi12 dence’ means evidence consisting of one or more adequate

13 and well controlled investigations, such as—

14 ‘‘(A) a study in a target species;

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

16 ‘‘(C) any field investigation that may be re17 quired under this section and that meets the require18 ments of subsection (b)(3) if a presubmission con19 ference is requested by the applicant;

20 ‘‘(D) a bioequivalence study; or

21 ‘‘(E) an in vitro study;

22 by experts qualified by scientific training and experience

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

24 basis of which it could fairly and reasonably be concluded

25 by such experts that the drug will have the effect it
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1 purports or is represented to have under the conditions

2 of use prescribed, recommended, or suggested in the label3 ing or proposed labeling thereof.’’.

4 (b) CONFORMING AMENDMENTS.—

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

6 (21 U.S.C. 360b(c)(2)(F)) are each amended—

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

8 field investigations (other than bioequivalence

9 or residue studies) and,’’ and inserting ‘‘sub10 stantial evidence of the effectiveness of the drug

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

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

13 ‘‘required for’’.

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

15 360b(c)(2)(F)(v)) is amended—

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

17 each place it appears and inserting ‘‘clause

18 (iv)’’;

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

20 investigations’’ and inserting ‘‘substantial evi21 dence of the effectiveness of the drug involved,

22 any studies of animal safety,’’; and

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

24 ‘‘required for’’.
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1 (c) COMBINATION DRUGS.—Section 512(d) (21

2 U.S.C. 360b(d)) , as amended by subsection (a) is amend3 ed by adding 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 com7 bination with one or more other animal drugs, and the

8 active ingredients or drugs intended for use in the com9 bination have previously been separately approved for par10 ticular uses and conditions of use for which they are in11 tended for use in the combination—

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

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

14 to approve the application for such combination on

15 human food safety grounds unless the Secretary

16 finds that the application fails to establish that—

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

18 intended for use in the combination, respec19 tively, at the longest withdrawal time of any of

20 the active ingredients or drugs in the combina21 tion, respectively, exceeds its established toler22 ance; or

23 ‘‘(ii) none of the active ingredients or

24 drugs in the combination interferes with the

25 methods of analysis for another of the active in-
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1 gredients or drugs in the combination, respec2 tively;

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

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

5 to approve the application for such combination on

6 target animal safety grounds unless the Secretary

7 finds that—

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

9 issue, specific to one or more of the active in10 gredients or animal drugs in the combination,

11 that cannot adequately be evaluated based on

12 information contained in the application for the

13 combination (including any investigations, stud14 ies, or tests for which the applicant has a right

15 of reference or use from the person by or for

16 whom the investigations, studies, or tests were

17 conducted); or

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

19 target animal observations contained in studies

20 submitted to the Secretary as part of the appli21 cation; and

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

23 the information contained in the application

24 with respect to the issues identified in clauses
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1 (i)(I) and (II), paragraph (1)(A), (B), or (D)

2 apply;

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

4 contains a nontopical antibacterial ingredient or ani5 mal drug, the Secretary shall not issue an order

6 under paragraph (1)(E) refusing to approve an ap7 plication for a combination animal drug intended for

8 use other than in animal feed or drinking water un9 less the Secretary finds that the application fails to

10 demonstrate that—

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

12 active ingredient or animal drug intended only

13 for the same use as another active ingredient or

14 animal drug in the combination makes a con15 tribution to labeled effectiveness;

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

17 intended for at least one use that is different

18 from all other active ingredients or animal

19 drugs used in the combination provides appro20 priate concurrent use for the intended target

21 population; or

22 ‘‘(iii) where based on scientific information

23 the Secretary has reason to believe the active

24 ingredients or animal drugs may be physically

25 incompatible or have disparate dosing regimens,
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1 such active ingredients or animal drugs are

2 physically compatible or do not have disparate

3 dosing regimens; and

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

5 under paragraph (1)(E) refusing to approve an ap6 plication for a combination animal drug intended for

7 use in animal feed or drinking water unless the Sec8 retary finds that the application fails to demonstrate

9 that—

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

11 active ingredient or animal drug intended only

12 for the same use as another active ingredient or

13 animal drug in the combination makes a con14 tribution to the labeled effectiveness;

15 ‘‘(ii) each of the active ingredients or ani16 mal drugs intended for at least one use that is

17 different from all other active ingredients or

18 animal drugs used in the combination provides

19 appropriate concurrent use for the intended tar20 get population;

21 ‘‘(iii) where a combination contains more

22 than one nontopical antibacterial ingredient or

23 animal drug, there is substantial evidence that

24 each of the nontopical antibacterial ingredients
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1 or animal drugs makes a contribution to the la2 beled effectiveness; or

3 ‘‘(iv) where based on scientific information

4 the Secretary has reason to believe the active

5 ingredients or animal drugs intended for use in

6 drinking water may be physically incompatible,

7 such active ingredients or animal drugs in8 tended for use in drinking water are physically

9 compatible.’’.

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

11 (21 U.S.C. 360b(b)) is amended by adding at the end the

12 following:

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

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

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

16 more conferences prior to such submission to reach an

17 agreement acceptable to the Secretary establishing a sub18 mission or an investigational requirement, which may in19 clude a requirement for a field investigation. A decision

20 establishing a submission or an investigational require21 ment shall bind the Secretary and the applicant or reques22 tor unless (A) the Secretary and the applicant or requestor

23 mutually agree to modify the requirement, or (B) the Sec24 retary by written order determines that a substantiated

25 scientific requirement essential to the determination of
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1 safety or effectiveness of the animal drug involved has ap2 peared after the conference. No later than 25 calendar

3 days after each such conference, the Secretary shall pro4 vide a written order setting forth a scientific justification

5 specific to the animal drug and intended uses under con6 sideration if the agreement referred to in the first sentence

7 requires more than one field investigation as being essen8 tial to provide substantial evidence of effectiveness for the

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

10 be construed as compelling the Secretary to require a field

11 investigation.’’.

12 (e) IMPLEMENTATION.—

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

14 after the date of enactment of this Act, the Sec15 retary of Health and Human Services shall issue

16 proposed regulations implementing the amendments

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

18 of this subsection, and not later than 18 months

19 after the date of enactment of this Act, the Sec20 retary shall issue final regulations implementing

21 such amendments. Not later than 12 months after

22 the date of enactment of this Act, the Secretary

23 shall issue proposed regulations implementing the

24 other amendments made by this Act as described in

25 paragraphs (2)(B) and (2)(C) of this subsection,
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1 and not later than 24 months after the date of en2 actment of this Act, the Secretary shall issue final

3 regulations implementing such amendments.

4 (2) CONTENTS.—In issuing regulations imple5 menting the amendments made by this Act, and in

6 taking an action to review an application for ap7 proval of a new animal drug under section 512 of

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

9 U.S.C. 360b), or a request for an investigational ex10 emption for a new animal drug under subsection (j)

11 of such section, that is pending or has been submit12 ted prior to the effective date of the regulations, the

13 Secretary shall—

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

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

16 section 512 of such Act, to require that field in17 vestigations be designed and conducted in a sci18 entifically sound manner, taking into account

19 practical conditions in the field and differences

20 between field conditions and laboratory condi21 tions;

22 (B) further define the term ‘‘substantial

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

24 such section, in a manner that encourages the
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1 submission of applications and supplemental

2 applications; and

3 (C) take into account the proposals con4 tained in the citizen petition (FDA Docket No.

5 91P–0434/CP) jointly submitted by the Amer6 ican Veterinary Medical Association and the

7 Animal Health Institute, dated October 21,

8 1991.

9 Until the regulations required by subparagraph (A)

10 are issued, nothing in the regulations published at

11 21 C.F.R. 514.111(a)(5) (April 1, 1996) shall be

12 construed to compel the Secretary of Health and

13 Human Services to require a field investigation

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

15 Drug, and Cosmetic Act (21 US.C. 360b(d)(1)(E))

16 or to apply any of its provisions in a manner incon17 sistent with the considerations for scientifically

18 sound field investigations set forth in subparagraph

19 (A).

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

21 Health and Human Services shall consider legislative and

22 regulatory options for facilitating the approval under sec23 tion 512 of the Federal Food, Drug, and Cosmetic Act

24 of animal drugs intended for minor species and for minor

25 uses and, within 18 months after the date of enactment
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1 of this Act, announce proposals for legislative or regu2 latory change to the approval process under such section

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

4 minor uses.

5 SEC. 3. LIMITATION ON RESIDUES.

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

7 amended to read as follows:

8 ‘‘(F) Upon the basis of information submitted

9 to the Secretary as part of the application or any

10 other information before the Secretary with respect

11 to such drug, any use prescribed, recommended, or

12 suggested in labeling proposed for such drug will re13 sult in a residue of such drug in excess of a toler14 ance found by the Secretary to be safe for such

15 drug.’’.

16 SEC. 4. IMPORT TOLERANCES.

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

18 adding the following new paragraph at the end:

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

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

21 unsafe under this section if the Secretary establishes a tol22 erance for such drug and any edible portion of any animal

23 imported into the United States does not contain residues

24 exceeding such tolerance. In establishing such tolerance,

25 the Secretary shall rely on data sufficient to demonstrate
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1 that a proposed tolerance is safe based on similar food

2 safety criteria used by the Secretary to establish toler3 ances for applications for new animal drugs filed under

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

5 data submitted by the drug manufacturer, including data

6 submitted to appropriate regulatory authorities in any

7 country where the new animal drug is lawfully used or

8 data available from a relevant international organization,

9 to the extent such data are not inconsistent with the cri10 teria used by the Secretary to establish a tolerance for

11 applications for new animal drugs filed under subsection

12 (b)(1). For purposes of this paragraph, ‘relevant inter13 national organization’ means the Codex Alimenterius

14 Commission or other international organization deemed

15 appropriate by the Secretary. The Secretary may, under

16 procedures specified by regulation, revoke a tolerance es17 tablished under this paragraph if information dem18 onstrates that the use of the new animal drug under actual

19 use conditions results in food being imported into the

20 United States with residues exceeding the tolerance or if

21 scientific evidence shows the tolerance to be unsafe.’’.

22 SEC. 5. VETERINARY FEED DIRECTIVES.

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

24 353(f)(1)(A)) is amended by inserting after ‘‘other than

25 man’’ the following: ‘‘, other than a veterinary feed direc-
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1 tive drug intended for use in animal feed or an animal

2 feed bearing or containing a veterinary feed directive

3 drug,’’.

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

5 Cosmetic Act is amended by inserting after section 503

6 the following:

7 ‘‘VETERINARY FEED DIRECTIVE DRUGS

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

9 animal feed which is limited by an approved application

10 filed pursuant to section 512(b) to use under the profes11 sional supervision of a licensed veterinarian is a veterinary

12 feed directive drug. Any animal feed bearing or containing

13 a veterinary feed directive drug shall be fed to animals

14 only by or upon a lawful veterinary feed directive issued

15 by a licensed veterinarian in the course of the veterinar16 ian’s professional practice. When labeled, distributed,

17 held, and used in accordance with this section, a veteri18 nary feed directive drug and any animal feed bearing or

19 containing a veterinary feed directive drug shall be exempt

20 from section 502(f).

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

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

23 may by general regulation or by order require; and

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

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

26 published pursuant to section 512(i).
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1 ‘‘(3)(A) Any persons involved in the distribution or

2 use of animal feed bearing or containing a veterinary feed

3 directive drug and the licensed veterinarian issuing the

4 veterinary feed directive shall maintain a copy of the vet5 erinary feed directive applicable to each such feed, except

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

7 person for further distribution. Such person distributing

8 the feed shall maintain a written acknowledgment from

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

10 person shall not ship or move such feed to an animal pro11 duction facility without a veterinary feed directive or ship

12 such feed to another person for further distribution unless

13 that person has provided the same written acknowledg14 ment to its immediate supplier.

15 ‘‘(B) Every person required under subpara16 graph (A) to maintain records, and every person in

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

18 officer or employee designated by the Secretary, per19 mit such officer or employee at all reasonable times

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

21 ‘‘(C) Any person who distributes animal feed

22 bearing or containing a veterinary feed directive

23 drug shall upon first engaging in such distribution

24 notify the Secretary of that person’s name and place

25 of business. The failure to provide such notification
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1 shall be deemed to be an act which results in the

2 drug being misbranded.

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

4 bearing or containing a veterinary feed directive drug shall

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

6 such cautionary statement and such other information as

7 the Secretary may by general regulation or by order pre8 scribe, or their advertising fails to conform to the condi9 tions and indications for use published pursuant to section

10 512(i) or fails to contain the general cautionary statement

11 prescribed by the Secretary.

12 ‘‘(c) Neither a drug subject to this section, nor ani13 mal feed bearing or containing such a drug, shall be

14 deemed to be a prescription article under any Federal or

15 State law.’’.

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

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

18 after ‘‘(including special labeling requirements’’ the follow19 ing: ‘‘and any requirement that an animal feed bearing

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

21 the professional supervision of a licensed veterinarian’’.

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

23 331(e)) is amended by inserting after ‘‘by section 412’’

24 the following: ‘‘, 504,’’; and by inserting after ‘‘under sec25 tion 412,’’ the following: ‘‘504,’’.
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1 SEC. 6. FEED MILL LICENSES.

2 (a) SECTION 512(a).—Paragraphs (1) and (2) of sec3 tion 512(a) (21 U.S.C. 360b(a)) are amended to read as

4 follows:

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

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

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

8 402(a)(2)(D) unless —

9 ‘‘(A) there is in effect an approval of an appli10 cation filed pursuant to subsection (b) with respect

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

12 ‘‘(B) such drug, its labeling, and such use con13 form to such approved application.

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

15 purposes in the event of removal from the establishment

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

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

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

19 or distributor has an unrevoked written statement from

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

21 to the effect that, with respect to the use of such drug

22 in animal feed, such consignee (i) holds a license issued

23 under subsection (m) and has in its possession current ap24 proved labeling for such drug in animal feed; or (ii) will,

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

26 only to a holder of a license issued under subsection (m).
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1 ‘‘(2) An animal feed bearing or containing a new ani2 mal drug shall, with respect to any particular use or in3 tended use of such animal feed be deemed unsafe for the

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

5 ‘‘(A) there is in effect an approval of an appli6 cation filed pursuant to subsection (b) with respect

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

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

9 for which there is in effect a license issued pursuant

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

11 feed, and

12 ‘‘(C) such animal feed and its labeling, distribu13 tion, holding, and use conform to the conditions and

14 indications of use published pursuant to subsection

15 (i).’’.

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

17 360b(m)) is amended to read as follows:

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

19 application for a license to manufacture animal feeds bear20 ing or containing new animal drugs. Such person shall

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

22 full statement of the business name and address of the

23 specific facility at which the manufacturing is to take

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

25 and signature of the responsible individual or individuals
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1 for that facility, (C) a certification that the animal feeds

2 bearing or containing new animal drugs are manufactured

3 and labeled in accordance with the applicable regulations

4 published pursuant to subsection (i), and (D) a certifi5 cation that the methods used in, and the facilities and con6 trols used for, manufacturing, processing, packaging, and

7 holding such animal feeds are in conformity with current

8 good manufacturing practice as described in section

9 501(a)(2)(B).

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

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

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

13 the Secretary shall (A) issue an order approving the appli14 cation if the Secretary then finds that none of the grounds

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

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

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

18 question whether such application is approvable. The pro19 cedure governing such a hearing shall be the procedure

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

21 ‘‘(3) If the Secretary, after due notice to the appli22 cant in accordance with paragraph (2) and giving the ap23 plicant an opportunity for a hearing in accordance with

24 such paragraph, finds, on the basis of information submit25 ted to the Secretary as part of the application, on the basis
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1 of a preapproval inspection, or on the basis of any other

2 information before the Secretary—

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

4 misleading in any particular;

5 ‘‘(B) that the methods used in, and the facili6 ties and controls used for, the manufacture, process7 ing, and packing of such animal feed are inadequate

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

9 of the new animal drug therein; or

10 ‘‘(C) that the facility manufactures animal

11 feeds bearing or containing new animal drugs in a

12 manner that does not accord with the specifications

13 for manufacture or labels animal feeds bearing or

14 containing new animal drugs in a manner that does

15 not accord with the conditions or indications of use

16 that are published pursuant to subsection (i),

17 the Secretary shall issue an order refusing to approve the

18 application. If, after such notice and opportunity for hear19 ing, the Secretary finds that subparagraphs (A) through

20 (C) do not apply, the Secretary shall issue an order ap21 proving the application. An order under this subsection

22 approving an application for a license to manufacture ani23 mal feeds bearing or containing new animal drugs shall

24 permit a facility to manufacture only those animal feeds

25 bearing or containing new animal drugs for which there
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1 are in effect regulations pursuant to subsection (i) relating

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

3 ‘‘(4)(A) The Secretary shall, after due notice and op4 portunity for hearing to the applicant, revoke a license to

5 manufacture animal feeds bearing or containing new ani6 mal drugs under this subsection if the Secretary finds—

7 ‘‘(i) that the application for such license con8 tains any untrue statement of a material fact; or

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

10 would cause the application to contain any untrue

11 statements of material fact or that would affect the

12 safety or effectiveness of the animal feeds manufac13 tured at the facility unless the applicant has supple14 mented the application by filing with the Secretary

15 adequate information respecting all such changes

16 and unless there is in effect an approval of the sup17 plemental application.

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

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

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

21 such animal feed is intended, the Secretary may suspend

22 the license immediately, and give the applicant prompt no23 tice of the action and afford the applicant the opportunity

24 for an expedited hearing under this subsection; but the

25 authority conferred by this sentence shall not be delegated.
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1 ‘‘(B) The Secretary may also, after due notice and

2 opportunity for hearing to the applicant, revoke a license

3 to manufacture animal feed under this subsection if the

4 Secretary finds—

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

6 system for maintaining required records, or has re7 peatedly or deliberately failed to maintain such

8 records or to make required reports in accordance

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

10 of this subsection or section 504(a)(3)(A), or the ap11 plicant has refused to permit access to, or copying

12 or verification of, such records as required by sub13 paragraph (B) of such paragraph or section

14 504(a)(3)(B);

15 ‘‘(ii) that on the basis of new information be16 fore the Secretary, evaluated together with the evi17 dence before the Secretary when such license was is18 sued, the methods used in, or the facilities and con19 trols used for, the manufacture, processing, packing,

20 and holding of such animal feed are inadequate to

21 assure and preserve the identity, strength, quality,

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

23 not made adequate within a reasonable time after

24 receipt of written notice from the Secretary, specify25 ing the matter complained of;
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1 ‘‘(iii) that on the basis of new information be2 fore the Secretary, evaluated together with the evi3 dence before the Secretary when such license was is4 sued, the labeling of any animal feeds, based on a

5 fair evaluation of all material facts, is false or mis6 leading in any particular and was not corrected

7 within a reasonable time after receipt of written no8 tice from the Secretary specifying the matter com9 plained of; or

10 ‘‘(iv) that on the basis of new information be11 fore the Secretary, evaluated together with the evi12 dence before the Secretary when such license was is13 sued, the facility has manufactured, processed,

14 packed, or held animal feed bearing or containing a

15 new animal drug adulterated under section

16 501(a)(6) and the facility did not discontinue the

17 manufacture, processing, packing, or holding of such

18 animal feed within a reasonable time after receipt of

19 written notice from the Secretary specifying the

20 matter complained of.

21 ‘‘(C) The Secretary may also revoke a license to man22 ufacture animal feeds under this subsection if an applicant

23 gives notice to the Secretary of intention to discontinue

24 the manufacture of all animal feed covered under this sub-
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1 section and waives an opportunity for a hearing on the

2 matter.

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

4 findings upon which it is based.

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

6 bearing or containing new animal drugs has been issued—

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

8 such records, and make such reports to the Sec9 retary, or (at the option of the Secretary) to the ap10 propriate person or persons holding an approved ap11 plication filed under subsection (b), as the Secretary

12 may by general regulation, or by order with respect

13 to such application, prescribe on the basis of a find14 ing that such records and reports are necessary in

15 order to enable the Secretary to determine, or facili16 tate a determination, whether there is or may be

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

18 and

19 ‘‘(B) every person required under this sub20 section to maintain records, and every person in

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

22 officer or employee designated by the Secretary, per23 mit such officer or employee at all reasonable times

24 to have access to and copy and verify such records.
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1 ‘‘(6) To the extent consistent with the public health,

2 the Secretary may promulgate regulations for exempting

3 from the operation of this subsection facilities that manu4 facture, process, pack, or hold animal feeds bearing or

5 containing new animal drugs.’’.

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

7 the manufacture of animal feeds bearing or containing

8 new animal drugs who holds at least one approved medi9 cated feed application for an animal feed bearing or con10 taining new animal drugs, the manufacture of which was

11 not otherwise exempt from the requirement for an ap12 proved medicated feed application on the date of the en13 actment of this Act, shall be deemed to hold a license for

14 the manufacturing site identified in the approved medi15 cated feed application. The revocation of license provisions

16 of section 512(m)(4) of the Federal Food, Drug, and Cos17 metic Act, as amended by this Act, shall apply to such

18 licenses. Such license shall expire within 18 months from

19 the date of enactment of this Act unless the person sub20 mits to the Secretary a completed license application for

21 the manufacturing site accompanied by a copy of an ap22 proved medicated feed application for such site, which li-
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1 cense application shall be deemed to be approved upon re2 ceipt by the Secretary.

Passed the Senate September 24, 1996.

Attest:

Secretary.
104TH CONGRESS

2D SESSION S. 773

AN ACT

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
S 773 ES——5

S 773 ES——4S 773 ES——3S 773 ES——2