I

104TH CONGRESS

2D SESSION H. R. 3200

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

to nutritional information about foods, to increase the availability of

safe food products, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

MARCH 29, 1996

Mr. KLUG (for himself, Mr. GREENWOOD, Mr. TOWNS, Mr. BILIRAKIS, Mr.

RICHARDSON, Mr. BURR, Mr. HALL of Texas, Mr. BARTON of Texas, Mr.

GORDON, Mr. UPTON, Mr. BREWSTER, Mr. BILBRAY, Mr. PAYNE of Virginia, Mr. COBURN, Mr. DOOLEY of California, Mr. GANSKE, Mr.

MCHALE, Mr. OXLEY, Mr. HOLDEN, Mr. FIELDS of Texas, Mr. PAXON,

Mr. WHITFIELD, Mr. SCHAEFER, Mr. TAUZIN, Mr. FOX of Pennsylvania,

Mr. CAMPBELL, Mr. MCINTOSH, Mr. COX of California, Mr. DREIER, Mr.

HEINEMAN, Mr. FUNDERBURK, Mr. WELDON of Florida, Mr. SHAYS, Mr.

HASTERT, Mr. NORWOOD, Mr. FRAZER, Mr. STEARNS, Mr. FRISA, Mr.

RAMSTAD, Mr. MARTINI, and Ms. DUNN of Washington) introduced the

following bill; which was referred to the Committee on Commerce

A BILL

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

increase access to nutritional information about foods,

to increase the availability of safe food products, 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; TABLE OF CON2 TENTS.

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

4 ‘‘Food Amendments and the Animal Drug Availability Act

5 of 1996’’.

6 (b) REFERENCE.—Whenever in this Act (other than

7 in section 111) an amendment or repeal is expressed in

8 terms of an amendment to, or repeal of, a section or other

9 provision, the reference shall be considered to be made to

10 a section or other provision of the Federal Food, Drug,

11 and Cosmetic Act.

12 (c) TABLE OF CONTENTS.—The table of contents is

13 as follows:

Sec. 1. Short title; reference; table of contents.

TITLE I—FOOD AMENDMENTS

Sec. 101. FDA mission and annual report.

Sec. 102. Access to disease prevention information.

Sec. 103. Access to nutrient descriptor information.

Sec. 104. Special labeling to protect public health.

Sec. 105. Accredited person review.

Sec. 106. Accredited persons.

Sec. 107. Improving the delaney clause.

Sec. 108. National uniformity.

Sec. 109. Harmonization.

Sec. 110. Informal agency statements.

Sec. 111. Colored margarine.

TITLE II—ANIMAL DRUGS

Sec. 201. Evidence of effectiveness for animal drugs.

Sec. 202. Timeframe for approval for animal drugs.

Sec. 203. Dispute resolution.

Sec. 204. Limitation on residues.

Sec. 205. Veterinary feed directives.
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1 TITLE I—FOOD AMENDMENTS

2 SEC. 101. FDA MISSION AND ANNUAL REPORT.

3 (a) MISSION.—Section 903 (21 U.S.C. 393) is

4 amended by redesignating subsections (b) and (c) as sub5 sections (c) and (d), respectively, and by adding after sub6 section (a) the following:

7 ‘‘(b) MISSION.—The Food and Drug Administration

8 shall protect the public health and safety and promptly

9 and efficiently review and approve clinical research and

10 marketing of products in a manner that does not unduly

11 impede innovation or product availability. The Food and

12 Drug Administration shall participate with other countries

13 to reduce the burden of regulation, harmonize regulatory

14 requirements, and achieve appropriate reciprocal arrange15 ments.’’

16 (b) ANNUAL REPORT.—Section 903 (21 U.S.C. 393),

17 as amended by subsection (a), is amended by adding at

18 the end the following:

19 ‘‘(e) ANNUAL REPORT.—The Secretary shall, simul20 taneously with the submission each year of the budget for

21 the Food and Drug Administration, submit to the Com22 mittee on Commerce of the House of Representatives and

23 the Committee on Labor and Human Resources of the

24 Senate an annual report which shall—
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1 ‘‘(1) review the performance of the Food and

2 Drug Administration in meeting its mission and the

3 development of Food and Drug Administration poli4 cies to implement such mission;

5 ‘‘(2) review the performance of the Food and

6 Drug Administration in meeting its own perform7 ance standards, including its own outcome measure8 ments and statutory deadlines for the approval of

9 products or for other purposes contained in this Act;

10 ‘‘(3) describe the staffing and resources of the

11 Food and Drug Administration and list those per12 sons and organizations accredited to review petitions

13 under sections 403(r), 409, and 721 and applica14 tions under section 512;

15 ‘‘(4) describe the goals, activities, and accom16 plishments of the Food and Drug Administration in

17 bilateral and multinational meetings that addressed

18 methods and approaches to reduce the burden of

19 regulation, harmonize regulation, and to seek appro20 priate reciprocal arrangements, list each such meet21 ing, and list pending issues specifying those that are

22 not consistent with or are contrary to the provisions

23 of this Act; and

24 ‘‘(5) compare the performance of the Food and

25 Drug Administration in approving innovative prod-
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1 ucts with that of the most successful agencies per2 forming similar functions in other countries and

3 compare the resources used by such agencies.’’.

4 SEC. 102. ACCESS TO DISEASE PREVENTION INFORMATION.

5 Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amend6 ed—

7 (1) in clause (B)(i), by adding at the end ‘‘Sig8 nificant scientific agreement does not require con9 sensus or unanimity.’’; and

10 (2) by adding at the end the following:

11 ‘‘(C) Information in materials prepared or distributed

12 by a Federal health agency or by the National Academy

13 of Sciences or its component organizations shall be deemed

14 to comply with clauses (A)(i) and (B).’’.

15 SEC. 103. ACCESS TO NUTRIENT DESCRIPTOR INFORMA16 TION.

17 Section 403(r)(2)(A)(i) (21 U.S.C. 343(r)(2)(A)(i))

18 is amended by adding at the end the following: ‘‘or terms

19 which are synonyms of such defined terms and are not

20 false or misleading’’.

21 SEC. 104. SPECIAL LABELING TO PROTECT PUBLIC

22 HEALTH.

23 Section 403 (21 U.S.C. 343) is amended by adding

24 at the end the following:
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1 ‘‘(t) No provision of this section or section 409 shall

2 be construed to require on a food a separate disclosure

3 of—

4 ‘‘(1) a method of production, or

5 ‘‘(2) an ingredient other than in the statement

6 of ingredients,

7 unless such disclosure is necessary to protect the public

8 health.’’.

9 SEC. 105. ACCREDITED PERSON REVIEW.

10 (a) HEALTH CLAIMS.—Section 403(r)(4)(A) (21

11 U.S.C. 343(r)(4)(A)) is amended by inserting at the end

12 of the first sentence in subclauses (i), (ii), and (iii) the

13 following: ‘‘or may file such a petition with a person au14 thorized to review it under section 712’’.

15 (b) ACCREDITED PERSON REVIEW.—Section

16 403(r)(4) (21 U.S.C. 434(r)(4)) is amended by adding at

17 the end the following:

18 ‘‘(D)(i) In reviewing a petition submitted under

19 clause (A) to an accredited person such a person shall de20 termine if the petition meets the requirements for peti21 tions to the Secretary. The review of such a petition shall

22 be conducted under the standards and requirements of

23 this Act that are applicable to the review of petitions to

24 the Secretary. After a period of 120 days after such a peti25 tion is submitted, the accredited person shall submit a re-
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1 port of its review of such petition to the Secretary and

2 include its recommendations. Such recommendations to

3 the Secretary shall specify—

4 ‘‘(I) in the case of a petition under subclause

5 (i), whether the claim with respect to which the peti6 tion was made should be approved or denied;

7 ‘‘(II) in the case of a petition under subclause

8 (ii), whether such claim may use the terms specified

9 in the petition, and

10 ‘‘(III) in the case of a petition under subclause

11 (iii), whether such claim may be made in a brand

12 name, and

13 shall state the basis for the recommendation.

14 ‘‘(ii) The recommendation of an accredited person to

15 approve or deny a petition submitted to such person shall

16 be deemed to be the decision of the Secretary unless the

17 Secretary finds that such recommendation is contrary to

18 the findings required in this Act. If the Secretary makes

19 such a finding, the Secretary shall provide a detailed ex20 planation of the basis of the finding.’’.

21 (c) FOOD ADDITIVES.—Section 409 (21 U.S.C. 348)

22 is amended—

23 (1) by inserting at the end of subsection (b)(1)

24 the following: ‘‘Any person may submit such a peti25 tion to a person accredited under section 712.’’;
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1 (2) by inserting at the end of subsection (c)(2)

2 the following: ‘‘This paragraph shall apply to a peti3 tion submitted to an accredited person under sub4 section (b)(1).’’; and

5 (3) by adding at the end of subsection (c) the

6 following:

7 ‘‘(6)(A) An accredited person shall review a petition

8 submitted to it under subsection (b)(1) to determine

9 whether there is reasonable assurance that the food addi10 tive with respect to which the petition was submitted may

11 be safely used under the proposed conditions of use. The

12 review of such a petition shall be conducted under the

13 standards and requirements of this Act that are applicable

14 to the review of petitions to the Secretary. After expiration

15 of the period prescribed by paragraph (2), the accredited

16 person shall submit a report of its review of such petition

17 to the Secretary and include its recommendations. Such

18 recommendations to the Secretary shall specify whether

19 a petition should be approved or denied and shall state

20 the basis for the recommendation.

21 ‘‘(B) The recommendation of an accredited person to

22 approve or deny a petition submitted to such person shall

23 be deemed to be the decision of the Secretary unless the

24 Secretary finds that there is a reasonable probability it

25 is not safe. If the Secretary makes such a finding, the
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1 Secretary shall provide a detailed explanation of the basis

2 of the finding.’’.

3 (d) COLOR ADDITIVES.—Section 721 (21 U.S.C

4 379e) is amended by adding at the end the following:

5 ‘‘(g) PETITION TO ACCREDITED PERSON.—(1) Any

6 person may submit a petition to a person accredited under

7 section 712 for the issuance of a regulation under sub8 section (b) or (c) or for the issuance of an exemption

9 under subsection (f).

10 ‘‘(2) In reviewing a petition submitted under para11 graph (1) to an accredited person, such a person shall de12 termine if the petition meets the requirements for the issu13 ance of a regulation under subsection (b) or (c) or for the

14 issuance of an exemption under subsection (f). The review

15 of such a petition shall be conducted under the standards

16 and requirements of this Act that are applicable to the

17 review of petitions to the Secretary for the issuance of

18 such a regulation or exemption. After a period of 120 days

19 after such a petition is submitted, the accredited person

20 shall submit a report of its review of such petition to the

21 Secretary and include its recommendations. Such rec22 ommendations to the Secretary shall specify if such a reg23 ulation or exemption should be issued and shall state the

24 basis for its recommendation.
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1 ‘‘(3) The recommendation of an accredited person to

2 approve or deny a petition submitted to such person shall

3 be deemed to be the decision of the Secretary unless the

4 Secretary finds that there is a reasonable probability it

5 is not safe. If the Secretary makes such a finding, the

6 Secretary shall provide a detailed explanation of the basis

7 of the finding.’’.

8 SEC. 106. ACCREDITED PERSONS.

9 (a) AMENDMENT.—Subchapter A of chapter VII is

10 amended by adding at the end the following:

11 ‘‘SEC. 712. ACCREDITED PERSONS.

12 ‘‘(a) IN GENERAL.—The Secretary shall, within 180

13 days of the date of the enactment of this section, by regu14 lation establish procedures for the accreditation of third

15 parties for the purposes of—

16 ‘‘(1) reviewing petitions under sections 403(r),

17 409, and 721(g), an application under section 512,

18 providing written reviews to the Secretary for the

19 Secretary’s consideration, and making recommenda20 tions on whether or not such petitions or application

21 should be approved; and

22 ‘‘(2) conducting good manufacturing practice

23 inspections to determine the conformance of a facil24 ity with regulations promulgated under section 402.

25 ‘‘(b) ACCREDITATION.—
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1 ‘‘(1) PROGRAMS.—The Secretary shall provide

2 for such accreditation through programs adminis3 tered by government agencies or by other qualified

4 organizations.

5 ‘‘(2) IMPLEMENTATION.—The Secretary may

6 designate one or more qualified non-government or7 ganizations to implement such programs. Such orga8 nizations shall implement such programs from fees

9 charged to applicants for accreditation.

10 ‘‘(3) QUALIFICATIONS.—An accredited person

11 shall meet the following requirements:

12 ‘‘(A) Such person shall be an independent

13 organization which is not owned or controlled

14 by manufacturer, supplier or vendor of food or

15 animal drugs and which has no organizational,

16 material, or financial affiliation with such a

17 manufacturer, supplier, or vendor.

18 ‘‘(B) Such person shall be a legally con19 stituted entity permitted to conduct the activi20 ties for which it seeks accreditation.

21 ‘‘(C) Such person shall not engage in the

22 design, manufacture, promotion, or sale of food

23 or animal drugs.

24 ‘‘(D) Such person shall be operated in ac25 cordance with generally accepted professional
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1 and ethical business practices and shall agree in

2 writing that as a minimum it will—

3 ‘‘(i) certify that reported information

4 accurately reflects data reviewed;

5 ‘‘(ii) limit work to that for which com6 petence and capacity are available;

7 ‘‘(iii) treat information received,

8 records, reports, and recommendations as

9 proprietary information; and

10 ‘‘(iv) promptly respond and attempt to

11 resolve complaints regarding its activities

12 for which it is accredited.’’.

13 (b) CONFORMING AMENDMENT.—Section 301 (21

14 U.S.C. 321) is amended by redesignating the second para15 graph (u) as paragraph (v) and by adding after that para16 graph the following:

17 ‘‘(w) in the case of a drug, device, or food—

18 ‘‘(A) the submission of a report or rec19 ommendation by a person accredited under section

20 712 that is false or misleading in any material re21 spect;

22 ‘‘(B) the disclosure by a person accredited

23 under section 712 of confidential commercial infor24 mation or any trade secret without the express writ-
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1 ten consent of the person who submitted such infor2 mation or secret to such person; or

3 ‘‘(C) the receipt by a person accredited under

4 section 712 of a bribe in any form or the doing of

5 any corrupt act by such person associated with a re6 sponsibility delegated to such person under this

7 Act.’’.

8 SEC. 107. IMPROVING THE DELANEY CLAUSE.

9 (a) FOOD ADDITIVES.—

10 (1) AMENDMENT.—Section 409(c)(3)(A) (21

11 U.S.C. 348(c)(3)(A)) is amended by striking all

12 after ‘‘substance’’ and inserting ‘‘that presents a

13 negligible or de minimus risk’’.

14 (2) REGULATIONS.— The Secretary shall, with15 in 180 days of the date of the enactment of this Act,

16 issue a proposed regulation to establish criteria to

17 determine a negligible or insignificant risk for pur18 poses of section 409(c)(3)(A) of the Federal Food,

19 Drug, and Cosmetic Act (21 U.S.C. 348(c)(3)(A)).

20 Such proposed regulation shall become final unless

21 the Secretary issues a final regulation before 18

22 months after such date of enactment.

23 (b) ANIMAL DRUGS.—

24 (1) AMENDMENT.—Section 512(d)(1)(I) (21

25 U.S.C 360b(d)(1)(I)) is amended by striking every-
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1 thing after ‘‘if’’ and inserting ‘‘if such drug presents

2 a negligible or insignificant risk to humans or ani3 mals.’’.

4 (2) REGULATIONS.— The Secretary shall, with5 in 180 days of the date of the enactment of this Act,

6 issue a proposed regulation to establish criteria to

7 determine a negligible or insignificant risk for pur8 poses of section 512(d)(1)(I) of the Federal Food,

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

10 Such proposed regulation shall become final unless

11 the Secretary issues a final regulation before 18

12 months after such date of enactment.

13 (c) COLOR ADDITIVE.—

14 (1) AMENDMENT.—Section 721(b)(5)(B) (21

15 U.S.C 379e(b)(5)(B)) is amended by striking all

16 after ‘‘with respect to the use of a color additive’’

17 and inserting ‘‘if such color additive presents a neg18 ligible or insignificant risk to humans or animals.’’.

19 (2) REGULATIONS.— The Secretary shall, with20 in 180 days of the date of the enactment of this Act,

21 issue a proposed regulation to establish criteria to

22 determine a negligible or insignificant risk for pur23 poses of section 721(b)(5)(B) of the Federal Food,

24 Drug, and Cosmetic Act (21 U.S.C. 379e(b)(5)(B)).

25 Such proposed regulation shall become final unless
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1 the Secretary issues a final regulation before 18

2 months after such date of enactment.

3 SEC. 108. NATIONAL UNIFORMITY.

4 Chapter VII is amended by adding at the end the

5 following:

6 ‘‘SUBCHAPTER D—NATIONAL UNIFORMITY

7 ‘‘SEC. 741. (a)(1) Except as provided in paragraph

8 (2) or subsections (b) and (c), no State or political subdivi9 sion of a State may, directly or indirectly, establish or con10 tinue in effect under any authority any requirement (in11 cluding a prohibition) for a—

12 ‘‘(A) food for human use,

13 ‘‘(B) a drug (including a biological product), or

14 ‘‘(C) a cosmetic,

15 which is of the type authorized or required under the adul16 teration, misbranding, or new drug provisions of this Act

17 or any regulation to implement such provisions if such

18 State or political subdivision requirement is not identical

19 to a requirement imposed under this Act.

20 ‘‘(2) Paragraph (1) does not apply to a State or polit21 ical subdivision requirement relating to the practice of

22 pharmacy or the dispensing of a drug for human use only

23 upon prescription of a practitioner licensed by law to ad24 minister such drug.
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1 ‘‘(b)(1) Except as provided in subsection (c), no State

2 or political subdivision of a State may, directly or indi3 rectly, establish or continue in effect under any authority

4 any notification requirement for a food, drug, or cosmetic

5 that provides—

6 ‘‘(A) for disclosure of the constituents, source,

7 or method of production or processing of the food,

8 drug, or cosmetic, or

9 ‘‘(B) for a warning concerning the safety of the

10 food, drug, or cosmetic or any component or package

11 thereof,

12 unless such notification requirement has been prescribed

13 under the authority of this Act and the State or political

14 subdivision notification requirement is identical to the no15 tification requirement prescribed under the authority of

16 this Act.

17 ‘‘(2) For purposes of paragraph (1)—

18 ‘‘(A) the term ‘warning’ with respect to a food,

19 drug, or cosmetic means any statement, vignette, or

20 other representation which indicates, directly or by

21 implication, that the food, drug, or cosmetic presents

22 or may present a hazard to human health or safety;

23 and

24 ‘‘(B) the term ‘notification requirement’ in25 cludes any requirement relating to the dissemination
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1 of information about a food, drug, or cosmetic in

2 any manner, such as labels, labeling, posters, public

3 notices, advertising, or any other means of commu4 nication.

5 ‘‘(c) Upon application of a State, the Secretary may

6 by regulation, after notice and opportunity for written and

7 oral presentation of views, exempt from subsection (a) or

8 (b), under such conditions as the Secretary may impose,

9 a State requirement which—

10 ‘‘(1) is justified by compelling and unique local

11 conditions;

12 ‘‘(2) protects an important public interest that

13 would otherwise by unprotected;

14 ‘‘(3) would not cause any food, drug, or cos15 metic to be in violation of any applicable require16 ment or prohibition under Federal law; and

17 ‘‘(4) would not unduly burden interstate com18 merce.’’.

19 SEC. 109. HARMONIZATION.

20 Section 803 (21 U.S.C. 383) is amended by adding

21 at the end the following:

22 ‘‘(c)(1) The Secretary shall regularly and continu23 ously participate in meetings with other countries to dis24 cuss methods and approaches to reduce the burden of reg25 ulation, harmonize regulatory requirements, and seek ap-
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1 propriate reciprocal arrangements. The Secretary shall,

2 within 180 days of the date of enactment of this sub3 section, make public a plan that establishes a framework

4 for achieving mutual recognition of good manufacturing

5 practices.

6 ‘‘(2) The Secretary shall report to the Committee on

7 Commerce of the House of Representatives and the Com8 mittee on Labor and Human Resources of the Senate at

9 least 60 days before executing any bilateral or multilateral

10 agreement under paragraph (1).’’.

11 SEC. 110. INFORMAL AGENCY STATEMENTS.

12 Section 701 (21 U.S.C. 371) is amended by adding

13 at the end the following:

14 ‘‘(h)(1) The Secretary shall not rely upon informal

15 agency statements, including guidance documents, policy

16 statements, points to consider documents, or any other

17 statements that have not been promulgated in accordance

18 with the rulemaking requirements of chapter V of title 5,

19 United States Code, to require any action be taken to sat20 isfy a requirement of this Act.

21 ‘‘(2) The Secretary shall publish notice in the Federal

22 Register of the availability to the public of each type of

23 statement identified in paragraph (1). Additionally, the

24 Secretary shall undertake to make available all such state25 ments by electronic or other similar means.’’.
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1 SEC. 111. COLORED MARGARINE.

2 (a) SECTION 301(m).—Paragraph (m) of section 301

3 (21 U.S.C. 321) is repealed.

4 (b) SECTION 407.—Section 407 (21 U.S.C. 347) is

5 repealed.

6 (c) ACT OF MARCH 16, 1950.—Sections 3(a) and 6

7 of the Act of March 16, 1950 (21 U.S.C. 347a, 347b)

8 are repealed.

9 (d) FEDERAL TRADE COMMISSION ACT.—Section 15

10 of the Federal Trade Commission Act (15 U.S.C. 55) is

11 amended—

12 (1) in subsection (a), by striking ‘‘(a)(1)’’ and

13 inserting ‘‘(a)’’ and by striking paragraph (2); and

14 (2) by striking subsection (f).

15 TITLE II—ANIMAL DRUGS

16 SEC. 201. EVIDENCE OF EFFECTIVENESS FOR ANIMAL

17 DRUGS.

18 (a) ORIGINAL APPLICATIONS.—Section 512(d) (21

19 U.S.C. 360b(d)) is amended by striking paragraph (3) and

20 by adding at the end the following:

21 ‘‘(4)(A) As used in this subsection and subsections

22 (c)(2)(F)(iii) and (e)(1)(C), the term ‘substantial evi23 dence’ means evidence from 1 or more scientifically sound

24 studies, including as appropriate in vitro studies, studies

25 in laboratory animals (including a target species),

26 bioequivalence studies, and any studies voluntarily under-
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1 taken by or for the applicant, that taken together provide

2 reasonable assurance that the drug will have the claimed

3 or intended effect of the drug.

4 ‘‘(B) For purposes of subparagraph (A), a study shall

5 be considered to be scientifically sound if the study is de6 signed and conducted in a manner that is consistent with

7 generally recognized scientific procedures and principles.’’.

8 (b) SUPPLEMENTAL APPLICATIONS.—Section

9 512(c)(2)(F)(iii) (21 U.S.C. 360b(c)(2)(F)(iii)) is amend10 ed—

11 (1) by striking ‘‘reports of new clinical or field

12 investigations (other than bioequivalence or residue

13 studies) and’’ and inserting ‘‘substantial evidence (as

14 defined in subsection (d)(4)) of the effectiveness of

15 the drug involved, any studies of animal safety, or’’;

16 and

17 (2) by striking ‘‘essential to’’ and inserting ‘‘,

18 required for’’.

19 (c) MINOR SPECIES AND USES.—Section 512(d)(1)

20 (21 U.S.C. 360b(d)(1)) is amended by adding at the end

21 the following new sentence: ‘‘Subparagraph (E) shall not

22 apply to a claim for use of the drug described in subpara23 graph (E) in a minor species, or for a minor use of the

24 drug, as the terms ‘minor species’ and ‘minor use’ are de25 fined in regulations issued by the Secretary, if there is
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1 an application filed under subsection (b) for the drug, and

2 the application is approved, prior to the submission of the

3 claim.’’.

4 (d) COMBINATION DRUGS.—Section 512(d) (21

5 U.S.C. 360b(d)) is amended by inserting before paragraph

6 (4) (as added by subsection (a)) the following new para7 graph:

8 ‘‘(3) In a case in which a new animal drug contains

9 more than 1 active ingredient, or the labeling of the drug

10 prescribes, recommends, or suggests use of the drug in

11 combination with another animal drug, and the active in12 gredients or drugs in the combination have been sepa13 rately approved for particular uses and species prior to

14 the approval of the application for the same uses and spe15 cies in combination (or, in the absence of such approvals,

16 after evaluating the safety and efficacy of the combination

17 itself), the Secretary may only consider with respect to the

18 combination whether any of the active ingredients or any

19 of the drugs in the combination, respectively, at the long20 est withdrawal time of any of the active ingredients or

21 drugs in the combination, respectively, is above its safe

22 concentration, i.e. exceeds its established tolerance (as

23 measured by its marker residue), or interferes with the

24 methods of analysis for another of the active ingredients

25 or drugs in the combination, respectively.’’.
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1 (e) WITHDRAWAL OF APPROVAL.—Section

2 512(e)(1)(C) (21 U.S.C. 360b(e)(1)(C)) is amended by in3 serting after ‘‘substantial evidence’’ the following: ‘‘(as de4 fined in subsection (d)(4))’’.

5 (f) IMPLEMENTATION.—

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

7 after the date of enactment of this Act, the Sec8 retary shall issue proposed regulations implementing

9 the amendments made by this section. Not later

10 than 18 months after the date of enactment of this

11 Act, the Secretary shall issue final regulations imple12 menting the amendments.

13 (2) CONTENTS.—In issuing regulations imple14 menting the amendments made by this section, and

15 in taking an action to review an application for ap16 proval of a new animal drug under section 512 of

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

18 U.S.C. 360b), or a request for an investigational ex19 emption for a new animal drug under subsection (j)

20 of such section, that is pending or has been submit21 ted prior to the effective date of the regulations, the

22 Secretary shall—

23 (A) further define the term ‘‘substantial

24 evidence’’, as defined in subsection (d)(4) of

25 such section, in a manner that encourages the
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1 submission of applications for production drugs

2 that conserve food resources, of applications for

3 veterinary prescription drugs whose use is de4 signed to rely on the experience and training of

5 practitioners in establishing effective doses for

6 such drugs, and of supplemental applications,

7 including applications seeking approval for uses

8 of animal drugs in minor species, for minor

9 uses of such drugs, and for permitted unlabeled

10 uses of such drugs;

11 (B) take into account the proposals con12 tained in the citizen petition (FDA Docket No.

13 91P–0434/CP) jointly submitted by the Amer14 ican Veterinary Medical Association and the

15 Animal Health Institute, dated October 21,

16 1991;

17 (C)(i) provide for the opportunity for a

18 conference prior to the submission of an appli19 cation for approval of a new animal drug under

20 such section, and prior to the submission of a

21 request for an investigational exemption under

22 subsection (j) of such section, to make a deci23 sion establishing a submission or an investiga24 tional requirement (which decision shall bind

25 the Secretary and the applicant or requester
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1 unless the Secretary by order determines that a

2 documented scientific requirement essential to

3 the determination of safety or effectiveness of

4 the animal drug involved has appeared after the

5 conference); and

6 (ii) not later than 10 days after each such

7 conference, by written order, provide a scientific

8 justification specific to the animal drug and in9 tended uses under consideration for requiring

10 studies of types other than the types of studies

11 specified in subsection (d)(4) of such section, as

12 being essential to provide substantial evidence

13 of effectiveness for the intended uses of the

14 drug.

15 SEC. 202. TIMEFRAME FOR APPROVAL FOR ANIMAL DRUGS.

16 The first sentence of section 512(c)(1) (21 U.S.C.

17 360b(c)(1)) is amended by striking ‘‘one hundred and

18 eighty’’ and inserting ‘‘90’’.

19 SEC. 203. DISPUTE RESOLUTION.

20 Section 512(c)(1) (21 U.S.C. 360b(c)(1)) is

21 amended—

22 (1) in the first sentence—

23 (A) by redesignating subparagraphs (A)

24 and (B) as clauses (i) and (ii), respectively; and

25 (B) by inserting ‘‘(A)’’ after ‘‘(1)’’;
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1 (2) in the second sentence, by striking ‘‘If’’ and

2 inserting the following:

3 ‘‘(C) If’’; and

4 (3) by inserting after subparagraph (A) (as des5 ignated by paragraph (1)(B)) the following new sub6 paragraph:

7 ‘‘(B)(i) At any time prior to the issuance of the notice

8 under subparagraph (A)(ii), the applicant may, in writing,

9 notify the Secretary that an impasse exists in the review

10 of the application with respect to a specifically identified

11 issue that is preventing the issuance of an order under

12 subparagraph (A)(i).

13 ‘‘(ii) On receipt of the notification from the applicant,

14 the Secretary shall refer the disputed issue—

15 ‘‘(I) to an existing (as of the date of the notifi16 cation) scientific advisory panel having expertise re17 lated to the issue;

18 ‘‘(II) to a special Government employee, as de19 fined in section 202(a) of title 18, United States

20 Code, or to a nongovernmental person qualified to

21 mediate or arbitrate the substance of such impasse

22 who is acceptable to the Secretary and the applicant.

23 ‘‘(iii) The applicant and representatives of the Sec24 retary may consult with the committee, special Govern25 ment employee, or nongovernmental person on the matter
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1 referred. The committee, special Governmental employee,

2 or nongovernmental person shall submit to the Secretary

3 and the applicant a report containing recommendations

4 (including a statement of reasons for the recommenda5 tions) regarding the matter not later than 60 days after

6 the date of the referral, or not later than 90 days after

7 the date of the referral if the committee, special Govern8 mental employee, or nongovernmental person considers

9 the additional 30 days to be necessary. Not later than 30

10 days after the date of receiving the report, the Secretary

11 shall, in writing, confirm or modify the recommendations

12 received, providing reasons and reference to data before

13 the committee, special Governmental employee, or non14 governmental person for any modification.

15 ‘‘(iv) The Federal Advisory Committee Act shall not

16 apply to any scientific advisory panel acting under this

17 subparagraph.’’.

18 SEC. 204. LIMITATION ON RESIDUES.

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

20 amended to read as follows:

21 ‘‘(F) on the basis of information submitted to

22 the Secretary as part of the application or any other

23 information before the Secretary with respect to

24 such drug, any use prescribed, recommended, or

25 suggested in labeling proposed for such drug will re-
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1 sult in a residue of such drug in excess of a toler2 ance found by the Secretary to be safe for such

3 drug;’’.

4 SEC. 205. VETERINARY FEED DIRECTIVES.

5 (a) Section 503(f)(1)(A) (21 U.S.C. 353(f)(1)(A)) is

6 amended by inserting after ‘‘other than man’’ the follow7 ing: ‘‘, other than a veterinary feed directive drug intended

8 for use in animal feed or an animal feed bearing or con9 taining a veterinary feed directive drug,’’.

10 (b) Chapter V is amended by inserting after section

11 503 the following new section:

12 ‘‘VETERINARY FEED DIRECTIVE DRUGS

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

14 animal feed which is limited by an approved application

15 filed pursuant to section 512(b) to use under the profes16 sional supervision of a licensed veterinarian is a veterinary

17 feed directive drug. Any animal feed bearing or containing

18 a veterinary feed directive drug shall be fed to animals

19 only by or upon the lawful veterinary feed directive issued

20 by a licensed veterinarian in the course of the veterinar21 ian’s professional practice. When labeled, distributed,

22 held, and used in accordance with this section, a veteri23 nary feed directive drug and any animal feed bearing or

24 containing a veterinary feed directive drug shall be exempt

25 from section 502(f).

26 ‘‘(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 acknowledgement 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 acknowledge19 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) Section 512 (21 U.S.C. 360b) is amended—

21 (1) in subsection (i), by inserting after ‘‘includ22 ing special labeling requirements’’ the following:

23 ‘‘and any requirement that an animal feed bearing

24 or containing the new animal drug be limited to use
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1 under the professional supervision of a licensed vet2 erinarian’’;

3 (2) in subsection (a)(2)(C), by inserting after

4 ‘‘its labeling,’’ the following: ‘‘its distribution, its

5 holding,’’; and

6 (3) in subsection (m)(4)(B)(i)—

7 (A) by inserting after ‘‘paragraph (5)(A)’’

8 the following: ‘‘or under section 504(a)(3)(A)’’;

9 and

10 (B) by inserting after ‘‘subparagraph (B)

11 of such paragraph’’ the following: ‘‘or section

12 504(a)(3)(B)’’.

13 (d) Section 301(e) (21 U.S.C. 331(e)) is amended—

14 (1) by inserting after ‘‘by section 412’’ the fol15 lowing: ‘‘, 504,’’; and

16 (2) by inserting after ‘‘under section 412,’’ the

17 following: ‘‘504,’’.

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