I 

108TH CONGRESS 

1ST SESSION H. R. 2079

To amend the Federal Food, Drug, and Cosmetic Act with regard to new 

animal drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 13, 2003

Mr. PICKERING (for himself, Mr. JOHN, Mr. BERRY, Mr. THOMPSON of Mississippi, Mr. TOWNS, Mr. ALEXANDER, Mr. ROSS, Mr. GREENWOOD, Ms. 

BORDALLO, Mr. OTTER, Mr. UPTON, Mr. LIPINSKI, Mr. BOSWELL, Mr. 

GOODE, Mr. BONNER, Mr. ADERHOLT, Mr. BACHUS, Mr. DAVIS of Alabama, Mr. BONILLA, Mr. EVERETT, Mr. PUTNAM, Mr. EDWARDS, and 

Mr. SIMPSON) introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL

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

regard to new animal drugs, and for other purposes.

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

2 This Act may be cited as the ‘‘Minor Use and Minor 

3 Species Animal Health Act of 2003’’. 

4 SEC. 2. FINDINGS. 

5 Congress makes the following findings: 

6 (1) There is a severe shortage of approved new 

7 animal drugs for use in minor species. 

8 (2) There is a severe shortage of approved new 

9 animal drugs for treating animal diseases and condi10 tions that occur infrequently or in limited geographic 

11 areas. 

12 (3) Because of the small market shares, low13 profit margins involved, and capital investment re14 quired, it is generally not economically feasible for 

15 new animal drug applicants to pursue approvals for 

16 these species, diseases, and conditions. 

17 (4) Because the populations for which such new 

18 animal drugs are intended may be small and condi19 tions of animal management may vary widely, it is 

20 often difficult to design and conduct studies to es21 tablish drug safety and effectiveness under tradi22 tional new animal drug approval processes. 

23 (5) It is in the public interest and in the inter24 est of animal welfare to provide for special proce25 dures to allow the lawful use and marketing of cer26 tain new animal drugs for minor species and minor 
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1 uses that take into account these special cir2 cumstances and that ensure that such drugs do not 

3 endanger animal or public health. 

4 (6) Exclusive marketing rights and tax credits 

5 for clinical testing expenses have helped encourage 

6 the development of ‘‘orphan’’ drugs for human use, 

7 and comparable incentives should encourage the de8 velopment of new animal drugs for minor species 

9 and minor uses. 

10 SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 

11 COSMETIC ACT. 

12 (a) DEFINITIONS.—Section 201 of the Federal, Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 

14 adding at the end the following: 

15 ‘‘(kk) The term ‘major species’ means cattle, horses, 

16 swine, chickens, turkeys, dogs, and cats, except that the 

17 Secretary may revise this definition by regulation. 

18 ‘‘(ll) The term ‘minor species’ means animals other 

19 than humans that are not major species. 

20 ‘‘(mm) The term ‘minor use’ means the intended use 

21 of a drug in a major species for an indication that occurs 

22 infrequently or in limited geographical areas.’’. 

23 (b) THREE-YEAR EXCLUSIVITY FOR MINOR USE AND

24 MINOR SPECIES APPROVALS.—Section 512(c)(2)(F) (ii), 

25 (iii), and (v) of the Federal Food, Drug, and Cosmetic 
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1 Act is amended by striking ‘‘(other than bioequivalence or 

2 residue studies)’’ and inserting ‘‘(other than bioequiva3 lence studies or residue depletion studies, except residue 

4 depletion studies for minor uses or minor species)’’ every 

5 place it appears. 

6 (c) SCOPE OF REVIEW FOR MINOR USE AND MINOR

7 SPECIES APPLICATIONS.— Section 512(d) of the Federal 

8 Food, Drug, and Cosmetic Act is amended by adding at 

9 the end the following new paragraph: 

10 ‘‘(5) In reviewing an application that proposes 

11 a change to add an intended use for a minor use or 

12 a minor species to an approved new animal drug ap13 plication, the Secretary shall reevaluate only the rel14 evant information in the approved application to de15 termine whether the application for the minor use or 

16 minor species can be approved. A decision to ap17 prove the application for the minor use or minor 

18 species is not, implicitly or explicitly, a reaffirmation 

19 of the approval of the original application.’’. 

20 (d) MINOR USE AND MINOR SPECIES NEW ANIMAL

21 DRUGS.—Chapter V of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 351 et seq.) is amended by adding 

23 at the end the following: 
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1 ‘‘Subchapter F—New Animal Drugs for Minor 

2 Use and Minor Species 

3 ‘‘SEC. 571. CONDITIONAL APPROVAL OF NEW ANIMAL 

4 DRUGS FOR MINOR USE AND MINOR SPECIES. 

5 ‘‘(a)(1) Except as provided in paragraph (3) of this 

6 section, any person may file with the Secretary an applica7 tion for conditional approval of a new animal drug in8 tended for a minor use or a minor species. Such an appli9 cation may not be a supplement to an application ap10 proved under section 512. Such application must comply 

11 in all respects with the provisions of section 512 of this 

12 Act except sections 512(a)(4), 512(b)(2), 512(c)(1), 

13 512(c)(2), 512(c)(3), 512(d)(1), 512(e), 512(h), and 

14 512(n) unless otherwise stated in this section, and any ad15 ditional provisions of this section. 

16 ‘‘(2) The applicant shall submit to the Secretary as 

17 part of an application for the conditional approval of a 

18 new animal drug—

19 ‘‘(A) all information necessary to meet the re20 quirements of section 512(b)(1) except section 

21 512(b)(1)(A); 

22 ‘‘(B) full reports of investigations which have 

23 been made to show whether or not such drug is safe 

24 and there is a reasonable expectation of effectiveness 

25 for use;
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1 ‘‘(C) data for establishing a conditional dose; 

2 ‘‘(D) projections of expected need and the jus3 tification for that expectation based on the best in4 formation available; 

5 ‘‘(E) information regarding the quantity of 

6 drug expected to be distributed on an annual basis 

7 to meet the expected need; and 

8 ‘‘(F) a commitment that the applicant will con9 duct additional investigations to meet the require10 ments for the full demonstration of effectiveness 

11 under section 512(d)(1)(E) within 5 years. 

12 ‘‘(3) A person may not file an application under para13 graph (1) if—

14 ‘‘(A) the person has previously filed an applica15 tion for conditional approval under paragraph (1) 

16 for the same drug in the same dosage form for the 

17 same intended use whether or not subsequently con18 ditionally approved by the Secretary under sub19 section (b), or 

20 ‘‘(B) the person obtained the application, or 

21 data or other information contained therein, directly 

22 or indirectly from the person who filed for condi23 tional approval under paragraph (1) for the same 

24 drug in the same dosage form for the same intended 
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1 use whether or not subsequently conditionally ap2 proved by the Secretary under subsection (b). 

3 ‘‘(b) Within 180 days after the filing of an applica4 tion pursuant to subsection (a), or such additional period 

5 as may be agreed upon by the Secretary and the applicant, 

6 the Secretary shall either—

7 ‘‘(1) issue an order, effective for one year, con8 ditionally approving the application if the Secretary 

9 finds that none of the grounds for denying condi10 tional approval, specified in subsection (c) of this 

11 section applies, or 

12 ‘‘(2) give the applicant notice of an opportunity 

13 for an informal hearing on the question whether 

14 such application can be conditionally approved. 

15 ‘‘(c) If the Secretary finds, after giving the applicant 

16 notice and an opportunity for an informal hearing, that—

17 ‘‘(1) any of the provisions of section 512(d)(1) 

18 (A) through (D) or (F) through (I) are applicable; 

19 ‘‘(2) the information submitted to the Secretary 

20 as part of the application and any other information 

21 before the Secretary with respect to such drug, is in22 sufficient to show that there is a reasonable expecta23 tion that the drug will have the effect it purports or 

24 is represented to have under the conditions of use 
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1 prescribed, recommended, or suggested in the pro2 posed labeling thereof; or 

3 ‘‘(3) another person has received approval 

4 under section 512 for the same drug in the same 

5 dosage form for the same intended use, and that 

6 person is able to assure the availability of sufficient 

7 quantities of the drug to meet the needs for which 

8 the drug is intended; 

9 the Secretary shall issue an order refusing to conditionally 

10 approve the application. 

11 If, after such notice and opportunity for an informal 

12 hearing, the Secretary finds that paragraphs (1) through 

13 (3) do not apply, the Secretary shall issue an order condi14 tionally approving the application effective for one year. 

15 Any order issued under this subsection refusing to condi16 tionally approve an application shall state the findings 

17 upon which it is based. 

18 ‘‘(d) A conditional approval under this section is ef19 fective for a 1-year period and is thereafter renewable by 

20 the Secretary annually for up to 4 additional 1-year terms. 

21 A conditional approval shall be in effect for no more than 

22 5 years from the date of approval under subsection (b)(1) 

23 or (c) of this section unless extended as provided for in 

24 subsection (h) of this section. The following shall also 

25 apply: 
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1 ‘‘(1) No later than 90 days from the end of the 

2 1-year period for which the original or renewed con3 ditional approval is effective, the applicant may sub4 mit a request to renew a conditional approval for an 

5 additional 1-year term. 

6 ‘‘(2) A conditional approval shall be deemed re7 newed at the end of the 1-year period, or at the end 

8 of a 90-day extension that the Secretary may, at the 

9 Secretary’s discretion, grant by letter in order to 

10 complete review of the renewal request, unless the 

11 Secretary determines before the expiration of the 1-

12 year period or the 90-day extension that—

13 ‘‘(A) the applicant failed to submit a time14 ly renewal request; 

15 ‘‘(B) the request fails to contain sufficient 

16 information to show that—

17 ‘‘(i) the applicant is making sufficient 

18 progress toward meeting approval require19 ments under section 512(d)(1)(E), and is 

20 likely to be able to fulfill those require21 ments and obtain an approval under sec22 tion 512 before the expiration of the 5-year 

23 maximum term of the conditional approval; 

24 ‘‘(ii) the quantity of the drug that has 

25 been distributed is consistent with the con-
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1 ditionally approved intended use and condi2 tions of use, unless there is adequate ex3 planation that ensures that the drug is 

4 only used for its intended purpose; or 

5 ‘‘(iii) the same drug in the same dos6 age form for the same intended use has 

7 not received approval under section 512, or 

8 if such a drug has been approved, that the 

9 holder of the approved application is un10 able to assure the availability of sufficient 

11 quantities of the drug to meet the needs 

12 for which the drug is intended; or 

13 ‘‘(C) any of the provisions of section 

14 512(e)(1) (A) through (B) or (D) through (F) 

15 are applicable. 

16 ‘‘(3) If the Secretary determines before the end 

17 of the 1-year period or the 90-day extension, if 

18 granted, that a conditional approval should not be 

19 renewed, the Secretary shall issue an order refusing 

20 to renew the conditional approval, and such condi21 tional approval shall be deemed withdrawn and no 

22 longer in effect. The Secretary shall thereafter pro23 vide an opportunity for an informal hearing to the 

24 applicant on the issue whether the conditional ap25 proval shall be reinstated.
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1 ‘‘(e)(1) The Secretary shall issue an order with2 drawing conditional approval of an application filed pursu3 ant to subsection (a) if the Secretary finds that another 

4 person has received approval under section 512 for the 

5 same drug in the same dosage form for the same intended 

6 use and that person is able to assure the availability of 

7 sufficient quantities of the drug to meet the needs for 

8 which the drug is intended. 

9 ‘‘(2) The Secretary shall, after due notice and oppor10 tunity for an informal hearing to the applicant, issue an 

11 order withdrawing conditional approval of an application 

12 filed pursuant to subsection (a) if the Secretary finds 

13 that—

14 ‘‘(A) any of the provisions of section 512(e)(1) 

15 (A) through (B) or (D) through (F) are applicable; 

16 or 

17 ‘‘(B) on the basis of new information before the 

18 Secretary with respect to such drug, evaluated to19 gether with the evidence available to the Secretary 

20 when the application was conditionally approved, 

21 that there is not a reasonable expectation that such 

22 drug will have the effect it purports or is rep23 resented to have under the conditions of use pre24 scribed, recommended, or suggested in the labeling 

25 thereof. 
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1 ‘‘(3) The Secretary may also, after due notice and 

2 opportunity for an informal hearing to the applicant, issue 

3 an order withdrawing conditional approval of an applica4 tion filed pursuant to subsection (a) if the Secretary finds 

5 that any of the provisions of section 512(e)(2) are applica6 ble. 

7 ‘‘(f)(1) The label and labeling of a new animal drug 

8 with a conditional approval under this section shall—

9 ‘‘(A) bear the statement, ‘conditionally ap10 proved by FDA pending a full demonstration of ef11 fectiveness under application [number]’; and 

12 ‘‘(B) contain such other information as pre13 scribed by the Secretary. 

14 ‘‘(2) An intended use that is the subject of a condi15 tional approval under this section shall not be included 

16 in the same product label with any intended use approved 

17 under section 512. 

18 ‘‘(g) A conditionally approved new animal drug appli19 cation may not be amended or supplemented to add indi20 cations for use. 

21 ‘‘(h) 180 days prior to the termination date estab22 lished under subsection (d)(1) of this section, an applicant 

23 shall have submitted all the information necessary to sup24 port a complete new animal drug application in accordance 

25 with section 512(b)(1) or the conditional approval issued 
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1 under this section is no longer in effect. Following review 

2 of this information, the Secretary shall either—

3 ‘‘(1) issue an order approving the application 

4 under section 512(c) if the Secretary finds that none 

5 of the grounds for denying approval specified in sec6 tion 512(d)(1) applies, or 

7 ‘‘(2) give the applicant an opportunity for a 

8 hearing before the Secretary under section 512(d) 

9 on the question whether such application can be ap10 proved. 

11 Upon issuance of an order approving the application, 

12 product labeling and administrative records of approval 

13 shall be modified accordingly. If the Secretary has not 

14 issued an order under section 512(c) approving such appli15 cation prior to the termination date established under sub16 section (d)(1) of this section, the conditional approval 

17 issued under this section is no longer in effect unless the 

18 Secretary grants an extension of an additional 180-day pe19 riod so that the Secretary can complete review of the ap20 plication. The decision to grant an extension is committed 

21 to the discretion of the Secretary and not subject to judi22 cial review. 

23 ‘‘(i) The decision of the Secretary under subsection 

24 (c), (d), or (e) of this section refusing or withdrawing con-
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1 ditional approval of an application shall constitute final 

2 agency action subject to judicial review. 

3 ‘‘SEC. 572. INDEX OF LEGALLY MARKETED UNAPPROVED 

4 NEW ANIMAL DRUGS FOR MINOR SPECIES. 

5 ‘‘(a) The Secretary shall establish an index of unap6 proved minor species new animal drugs that may be law7 fully marketed for use in minor species. The index shall 

8 be limited to—

9 ‘‘(1) new animal drugs intended for use in a 

10 minor species for which there is a reasonable cer11 tainty that the animal or edible products from the 

12 animal will not be consumed by humans or food-pro13 ducing animals, and 

14 ‘‘(2) new animal drugs intended for use in an 

15 early life stage of a food-producing minor species 

16 where human food safety can be demonstrated in ac17 cordance with the standard of section 512(d) by 

18 showing that—

19 ‘‘(A) there is no significant likelihood that 

20 harmful residues will be present in the animal 

21 or edible products from the animal presented as 

22 food for humans as a result of treatment at the 

23 early life stage; 

24 ‘‘(B) there is no significant likelihood that 

25 harmful residues will be present in the animal 
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1 or edible products from the animal presented as 

2 food for food-producing animals as a result of 

3 treatment at the early life stage; and 

4 ‘‘(C) there are no concerns about the use 

5 of the drug at later life stages because a toler6 ance and regulatory method to test for the drug 

7 at later life stages are available or there is no 

8 practical use for the drug in later life stages. 

9 ‘‘(b) Any person intending to file a request under this 

10 section shall be entitled to one or more conferences to dis11 cuss the requirements for indexing a new animal drug. 

12 ‘‘(c)(1) Any person may submit a request to the Sec13 retary for a determination whether a new animal drug 

14 may be eligible for inclusion in the index. Such a request 

15 shall include—

16 ‘‘(A) information regarding the need for the 

17 new animal drug, the species for which the new ani18 mal drug is intended, the proposed intended use and 

19 conditions of use, and anticipated annual distribu20 tion; 

21 ‘‘(B) information to support the conclusion that 

22 the proposed use meets the conditions of subsection 

23 (a)(1) or (a)(2) of this section; 

24 ‘‘(C) information regarding the components and 

25 composition of the new animal drug;
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1 ‘‘(D) a description of the methods used in, and 

2 the facilities and controls used for, the manufacture, 

3 processing, and packing of such new animal drug; 

4 ‘‘(E) an environmental assessment or informa5 tion to support a categorical exclusion from the re6 quirement to prepare an environmental assessment; 

7 ‘‘(F) information sufficient to support the con8 clusion that the proposed use of the new animal 

9 drug does not present a threat to the safety of indi10 viduals exposed to the new animal drug through its 

11 manufacture or use; and 

12 ‘‘(G) such other information as the Secretary 

13 may deem necessary to make this eligibility deter14 mination. 

15 ‘‘(2) Within 90 days after the submission of a request 

16 for a determination of eligibility for indexing based on sub17 section (a)(1) of this section, or 180 days for a request 

18 submitted based on subsection (a)(2) of this section, the 

19 Secretary shall grant or deny the request, and notify the 

20 person who requested such determination of the Sec21 retary’s decision. The Secretary shall grant the request if 

22 the Secretary finds that—

23 ‘‘(A) the same drug in the same dosage form 

24 for the same intended use is not approved or condi25 tionally approved; 
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1 ‘‘(B) the proposed use does not raise concerns 

2 related to safety; and 

3 ‘‘(C) the person requesting the determination 

4 has established appropriate specifications for the 

5 manufacture and control of the new animal drug 

6 and has demonstrated an understanding of the re7 quirements of current good manufacturing practices. 

8 If the Secretary denies the request, the Secretary shall 

9 thereafter provide due notice and an opportunity for an 

10 informal conference. A decision of the Secretary to deny 

11 an eligibility request following an informal conference shall 

12 constitute final agency action subject to judicial review. 

13 ‘‘(d)(1) With respect to a new animal drug for which 

14 the Secretary has made a determination of eligibility 

15 under subsection (b), the person who made such a request 

16 may ask that the Secretary add the new animal drug to 

17 the index established under subsection (a). The request 

18 for addition to the index shall include—

19 ‘‘(A) a copy of the Secretary’s determination of 

20 eligibility issued under subsection (b); 

21 ‘‘(B) a written report that meets the require22 ments in subsection (d)(2) of this section; 

23 ‘‘(C) a proposed index entry; 

24 ‘‘(D) facsimile labeling; 
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1 ‘‘(E) anticipated annual distribution of the new 

2 animal drug; 

3 ‘‘(F) a written commitment to manufacture the 

4 new animal drug and animal feeds bearing or con5 taining such new animal drug according to current 

6 good manufacturing practices; 

7 ‘‘(G) a written commitment to label, distribute, 

8 and promote the new animal drug only in accordance 

9 with the index entry; 

10 ‘‘(H) upon specific request of the Secretary, in11 formation submitted to the expert panel described in 

12 paragraph (3); and 

13 ‘‘(I) any additional requirements that the Sec14 retary may prescribe by general regulation or spe15 cific order. 

16 ‘‘(2) The report required in paragraph (1) shall—

17 ‘‘(A) be authored by a qualified expert panel; 

18 ‘‘(B) include an evaluation of all available tar19 get animal safety and effectiveness information, in20 cluding anecdotal information; 

21 ‘‘(C) state the expert panel’s opinion regarding 

22 whether the benefits of using the new animal drug 

23 for the proposed use in a minor species outweigh its 

24 risks, taking into account the harm being caused by 
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1 the absence of an approved or conditionally approved 

2 new animal drug for the minor species in question; 

3 ‘‘(D) include information from which labeling 

4 can be written; and 

5 ‘‘(E) include a recommendation regarding 

6 whether the new animal drug should be limited to 

7 use under the professional supervision of a licensed 

8 veterinarian. 

9 ‘‘(3) A qualified expert panel, as used in this section, 

10 is a panel that—

11 ‘‘(A) is composed of experts qualified by sci12 entific training and experience to evaluate the target 

13 animal safety and effectiveness of the new animal 

14 drug under consideration; 

15 ‘‘(B) operates external to FDA; and 

16 ‘‘(C) is not subject to the Federal Advisory 

17 Committee Act, 5 U.S.C. App.2. 

18 The Secretary shall define the criteria for selection of a 

19 qualified expert panel and the procedures for the operation 

20 of the panel by regulation. 

21 ‘‘(4) Within 180 days after the receipt of a request 

22 for listing a new animal drug in the index, the Secretary 

23 shall grant or deny the request. The Secretary shall grant 

24 the request if the request for indexing continues to meet 

25 the eligibility criteria in subsection (a) and the Secretary 
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1 finds, on the basis of the report of the qualified expert 

2 panel and other information available to the Secretary, 

3 that the benefits of using the new animal drug for the 

4 proposed use in a minor species outweigh its risks, taking 

5 into account the harm caused by the absence of an ap6 proved or conditionally-approved new animal drug for the 

7 minor species in question. If the Secretary denies the re8 quest, the Secretary shall thereafter provide due notice 

9 and the opportunity for an informal conference. The deci10 sion of the Secretary following an informal conference 

11 shall constitute final agency action subject to judicial re12 view. 

13 ‘‘(e)(1) The index established under subsection (a) 

14 shall include the following information for each listed 

15 drug—

16 ‘‘(A) the name and address of the person who 

17 holds the index listing; 

18 ‘‘(B) the name of the drug and the intended 

19 use and conditions of use for which it is being in20 dexed; 

21 ‘‘(C) product labeling; and 

22 ‘‘(D) conditions and any limitations that the 

23 Secretary deems necessary regarding use of the 

24 drug.
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1 ‘‘(2) The Secretary shall publish the index, and revise 

2 it periodically. 

3 ‘‘(3) The Secretary may establish by regulation a 

4 process for reporting changes in the conditions of manu5 facturing or labeling of indexed products. 

6 ‘‘(f)(1) If the Secretary finds, after due notice to the 

7 person who requested the index listing and an opportunity 

8 for an informal conference, that—

9 ‘‘(A) the expert panel failed to meet the re10 quirements as set forth by the Secretary by regula11 tion; 

12 ‘‘(B) on the basis of new information before the 

13 Secretary, evaluated together with the evidence 

14 available to the Secretary when the new animal drug 

15 was listed in the index, the benefits of using the new 

16 animal drug for the indexed use do not outweigh its 

17 risks; 

18 ‘‘(C) the conditions of subsection (c)(2) of this 

19 section are no longer satisfied; 

20 ‘‘(D) the manufacture of the new animal drug 

21 is not in accordance with current good manufac22 turing practices; 

23 ‘‘(E) the labeling, distribution, or promotion of 

24 the new animal drug is not in accordance with the 

25 index entry; 
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1 ‘‘(F) the conditions and limitations of use asso2 ciated with the index listing have not been followed; 

3 or 

4 ‘‘(G) the request for indexing contains any un5 true statement of material fact, 

6 the Secretary shall remove the new animal drug from the 

7 index. The decision of the Secretary following an informal 

8 conference shall constitute final agency action subject to 

9 judicial review. 

10 ‘‘(2) If the Secretary finds that there is a reasonable 

11 probability that the use of the drug would present a risk 

12 to the health of humans or other animals, the Secretary 

13 may—

14 ‘‘(A) suspend the listing of such drug imme15 diately; 

16 ‘‘(B) give the person listed in the index prompt 

17 notice of the Secretary’s action; and 

18 ‘‘(C) afford that person the opportunity for an 

19 informal conference. 

20 The decision of the Secretary following an informal con21 ference shall constitute final agency action subject to judi22 cial review. 

23 ‘‘(g) For purposes of indexing new animal drugs 

24 under this section, to the extent consistent with the public 

25 health, the Secretary shall promulgate regulations for ex-
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1 empting from the operation of section 512 minor species 

2 new animal drugs and animal feeds bearing or containing 

3 new animal drugs intended solely for investigational use 

4 by experts qualified by scientific training and experience 

5 to investigate the safety and effectiveness of minor species 

6 animal drugs. Such regulations may, at the discretion of 

7 the Secretary, among other conditions relating to the pro8 tection of the public health, provide for conditioning such 

9 exemption upon the establishment and maintenance of 

10 such records, and the making of such reports to the Sec11 retary, by the manufacturer or the sponsor of the inves12 tigation of such article, of data (including but not limited 

13 to analytical reports by investigators) obtained as a result 

14 of such investigational use of such article, as the Secretary 

15 finds will enable the Secretary to evaluate the safety and 

16 effectiveness of such article in the event of the filing of 

17 a request for an index listing pursuant to this section. 

18 ‘‘(h) The labeling of a new animal drug that is the 

19 subject of an index listing shall state, prominently and 

20 conspicuously—

21 ‘‘(1) ‘NOT APPROVED BY FDA.—Legally mar22 keted as an FDA indexed product. Extra-label use 

23 is prohibited.’; 

24 ‘‘(2) except in the case of new animal drugs in25 dexed for use in an early life stage of a food-pro-
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1 ducing animal, ‘This product is not to be used in 

2 animals intended for use as food for humans or 

3 other animals.’; and 

4 ‘‘(3) such other information as may be pre5 scribed by the Secretary in the index listing. 

6 ‘‘(i)(1) In the case of any new animal drug for which 

7 an index listing pursuant to subsection (a) is in effect, 

8 the person who has an index listing shall establish and 

9 maintain such records, and make such reports to the Sec10 retary, of data relating to experience, and other data or 

11 information, received or otherwise obtained by such person 

12 with respect to such drug, or with respect to animal feeds 

13 bearing or containing such drug, as the Secretary may by 

14 general regulation, or by order with respect to such listing, 

15 prescribe on the basis of a finding that such records and 

16 reports are necessary in order to enable the Secretary to 

17 determine, or facilitate a determination, whether there is 

18 or may be ground for invoking subsection (f). Such regula19 tion or order shall provide, where the Secretary deems it 

20 to be appropriate, for the examination, upon request, by 

21 the persons to whom such regulation or order is applica22 ble, of similar information received or otherwise obtained 

23 by the Secretary. 

24 ‘‘(2) Every person required under this subsection to 

25 maintain records, and every person in charge or custody 
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1 thereof, shall, upon request of an officer or employee des2 ignated by the Secretary, permit such officer or employee 

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

4 verify such records. 

5 ‘‘(j)(1) Safety and effectiveness data and information 

6 which has been submitted in support of a request for a 

7 new animal drug to be indexed under this section and 

8 which has not been previously disclosed to the public shall 

9 be made available to the public, upon request, unless ex10 traordinary circumstances are shown—

11 ‘‘(A) if no work is being or will be undertaken 

12 to have the drug indexed in accordance with the re13 quest, 

14 ‘‘(B) if the Secretary has determined that such 

15 drug cannot be indexed and all legal appeals have 

16 been exhausted, 

17 ‘‘(C) if the indexing of such drug is terminated 

18 and all legal appeals have been exhausted, or 

19 ‘‘(D) if the Secretary has determined that such 

20 drug is not a new animal drug. 

21 ‘‘(2) Any request for data and information pursuant 

22 to paragraph (1) shall include a verified statement by the 

23 person making the request that any data or information 

24 received under such paragraph shall not be disclosed by 

25 such person to any other person—
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1 ‘‘(A) for the purpose of, or as part of a plan, 

2 scheme, or device for, obtaining the right to make, 

3 use, or market, or making, using, or marketing, out4 side the United States, the drug identified in the re5 quest for indexing; and 

6 ‘‘(B) without obtaining from any person to 

7 whom the data and information are disclosed an 

8 identical verified statement, a copy of which is to be 

9 provided by such person to the Secretary, which 

10 meets the requirements of this paragraph. 

11 ‘‘SEC. 573. DESIGNATED NEW ANIMAL DRUGS FOR MINOR 

12 USE OR MINOR SPECIES. 

13 ‘‘(a) DESIGNATION.—

14 ‘‘(1) The manufacturer or the sponsor of a new 

15 animal drug for a minor use or use in a minor spe16 cies may request that the Secretary declare that 

17 drug a ‘designated new animal drug’. A request for 

18 designation of a new animal drug shall be made be19 fore the submission of an application under section 

20 512(b) or section 571 for the new animal drug. 

21 ‘‘(2) The Secretary may declare a new animal 

22 drug a ‘designated new animal drug’ for an intended 

23 use if—

24 ‘‘(A) it is intended for a minor use or use 

25 in a minor species; and 
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1 ‘‘(B) the same drug in the same dosage 

2 form for the same intended use is not approved 

3 under section 512 or 571 or designated under 

4 this section at the time the request is made. 

5 ‘‘(3) Regarding the termination of a designa6 tion—

7 ‘‘(A) the sponsor of a new animal drug 

8 shall notify the Secretary of any decision to dis9 continue active pursuit of approval under sec10 tion 512 or 571 of an application for a des11 ignated new animal drug. The Secretary shall 

12 terminate the designation upon such notifica13 tion; 

14 ‘‘(B) the Secretary may also terminate des15 ignation if the Secretary independently deter16 mines that the sponsor is not actively pursuing 

17 approval under section 512 or 571 with due 

18 diligence; 

19 ‘‘(C) the sponsor of an approved des20 ignated new animal drug shall notify the Sec21 retary of any discontinuance of the manufac22 ture of such new animal drug at least one year 

23 before discontinuance. The Secretary shall ter24 minate the designation upon such notification; 

25 and 
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1 ‘‘(D) the designation shall terminate upon 

2 the expiration of any applicable exclusivity pe3 riod under subsection (c). 

4 ‘‘(4) Notice respecting the designation or termi5 nation of designation of a new animal drug shall be 

6 made available to the public. 

7 ‘‘(b) GRANTS AND CONTRACTS FOR DEVELOPMENT

8 OF DESIGNATED NEW ANIMAL DRUGS.—

9 ‘‘(1) The Secretary may make grants to and 

10 enter into contracts with public and private entities 

11 and individuals to assist in defraying the costs of 

12 qualified safety and effectiveness testing expenses 

13 and manufacturing expenses incurred in connection 

14 with the development of designated new animal 

15 drugs. 

16 ‘‘(2) For purposes of paragraph (1) of this sec17 tion—

18 ‘‘(A) The term ‘qualified safety and effec19 tiveness testing’ means testing—

20 ‘‘(i) which occurs after the date such 

21 new animal drug is designated under this 

22 section and before the date on which an 

23 application with respect to such drug is 

24 submitted under section 512; and 
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1 ‘‘(ii) which is carried out under an in2 vestigational exemption under section 

3 512(j). 

4 ‘‘(B) The term ‘manufacturing expenses’ 

5 means expenses incurred in developing proc6 esses and procedures associated with manufac7 ture of the designated new animal drug which 

8 occur after the new animal drug is designated 

9 under this section and before the date on which 

10 an application with respect to such new animal 

11 drug is submitted under section 512 or 571. 

12 ‘‘(c) EXCLUSIVITY FOR DESIGNATED NEW ANIMAL

13 DRUGS.—

14 ‘‘(1) Except as provided in subsection (c)(2), if 

15 the Secretary—

16 ‘‘(A) approves or conditionally approves an 

17 application for a designated new animal drug, 

18 and no active ingredient (including any salt or 

19 ester of the active ingredient) of that des20 ignated new animal drug has been approved or 

21 conditionally approved previously, the Secretary 

22 may not approve or conditionally approve an23 other application submitted for a new animal 

24 drug with the same active ingredient and in25 tended use as the designated new animal drug 
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1 for another applicant before the expiration of 

2 ten years from the date of the approval or con3 ditional approval of the application. 

4 ‘‘(B) approves or conditionally approves an 

5 application for a designated new animal drug, 

6 and an active ingredient (including an ester or 

7 salt of the active ingredient) of that designated 

8 new animal drug has been approved or condi9 tionally approved previously, the Secretary may 

10 not approve or conditionally approve another 

11 application submitted for a new animal drug 

12 with the same active ingredient and intended 

13 use as the designated new animal drug for an14 other applicant before the expiration of seven 

15 years from the date of approval or conditional 

16 approval of the application. 

17 ‘‘(2) If an application filed pursuant to section 

18 512 or section 571 is approved for a designated new 

19 animal drug, the Secretary may, during the 10-year 

20 or 7-year exclusivity period beginning on the date of 

21 the application approval or conditional approval, ap22 prove or conditionally approve another application 

23 under section 512 or section 571 for such drug for 

24 such minor use or minor species for another appli25 cant if—
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1 ‘‘(A) the Secretary finds, after providing 

2 the holder of such an approved application no3 tice and opportunity for the submission of 

4 views, that in the granted exclusivity period the 

5 holder of the approved application cannot as6 sure the availability of sufficient quantities of 

7 the drug to meet the needs for which the drug 

8 was designated; or 

9 ‘‘(B) such holder provides written consent 

10 to the Secretary for the approval or conditional 

11 approval of other applications before the expira12 tion of such exclusivity period.’’. 

13 (g) CONFORMING AMENDMENTS.—

14 (1) Section 201(u) of the Federal Food, Drug, 

15 and Cosmetic Act is amended by striking ‘‘512’’ and 

16 inserting ‘‘512, 571’’. 

17 (2) Section 201(v) of the Federal Food, Drug, 

18 and Cosmetic Act is amended by inserting the fol19 lowing after paragraph (2): ‘‘Provided that any drug 

20 intended for minor use or use in a minor species 

21 that is not the subject of a final regulation published 

22 by the Secretary through notice and comment rule23 making finding that the criteria of paragraphs (1) 

24 and (2) have not been met (or that the exception to 
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1 the criterion in paragraph (1) has been met) is a 

2 new animal drug.’’. 

3 (3) Section 301(e) of the Federal Food, Drug, 

4 and Cosmetic Act is amended by striking 

5 ‘‘512(a)(4)(C), 512(j), (l) or (m)’’ and inserting 

6 ‘‘512(a)(4)(C), 512 (j), (l) or (m), 572(i).’’

7 (4) Section 301(j) of the Federal Food, Drug, 

8 and Cosmetic Act is amended by deleting ‘‘520’’ and 

9 inserting ‘‘520, 571, 572, 573.’’

10 (5) Section 502 of the Federal Food, Drug, and 

11 Cosmetic Act is amended by adding at the end the 

12 following new subsection: 

13 ‘‘(u) If it is a new animal drug—

14 ‘‘(1) that is conditionally approved under sec15 tion 571 and its labeling does not conform with the 

16 approved application or section 571(f), or that is not 

17 conditionally approved under section 571 and its 

18 label bears the statement set forth in section 

19 571(f)(1)(A); or 

20 ‘‘(2) that is indexed under section 572 and its 

21 labeling does not conform with the index listing 

22 under section 572(e) or 572(h), or that has not been 

23 indexed under section 572 and its label bears the 

24 statement set forth in section 572(h).’’. 
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1 (6) Section 503(f) of the Federal Food, Drug, 

2 and Cosmetic Act is amended by—

3 (A) in paragraph (1)(A)(ii) by striking 

4 ‘‘512’’ and inserting ‘‘512, a conditionally-ap5 proved application under section 571, or an 

6 index listing under section 572’’; and 

7 (B) in paragraph (3) by striking ‘‘section 

8 512’’ and inserting ‘‘section 512, 571, or 572’’. 

9 (7) Section 504(a)(1) of the Federal Food, 

10 Drug, and Cosmetic Act is amended by striking 

11 ‘‘512(b)’’ and inserting ‘‘512(b), a conditionally-ap12 proved application filed pursuant to section 571, or 

13 an index listing pursuant to section 572’’. 

14 (8) Sections 504(a)(2)(B) and 504(b) of the 

15 Federal Food, Drug, and Cosmetic Act are amended 

16 by striking ‘‘512(i)’’ each place it appears and in17 serting ‘‘512(i), or the index listing pursuant to sec18 tion 572(e)’’. 

19 (9) Section 512(a) of the Federal Food, Drug, 

20 and Cosmetic Act is amended by striking paragraphs 

21 (1) and (2) and inserting the following: 

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

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

24 unsafe for purposes of section 501(a)(5) and section 

25 402(a)(2)(C)(ii) unless—
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1 ‘‘(A) there is in effect an approval of an appli2 cation filed pursuant to subsection (b) with respect 

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

4 drug, its labeling, and such use conform to such ap5 proved application; 

6 ‘‘(B) there is in effect a conditional approval of 

7 an application filed pursuant to section 571 with re8 spect to such use or intended use of such drug, and 

9 such drug, its labeling, and such use conform to 

10 such conditionally approved application; or 

11 ‘‘(C) there is in effect an index listing pursuant 

12 to section 572 with respect to such use or intended 

13 use of such drug in a minor species, and such drug, 

14 its labeling, and such use conform to such index list15 ing. 

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

17 purposes in the event of removal from the establishment 

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

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

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

21 or distributor has an unrevoked written statement from 

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

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

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

25 under subsection (m) and has in its possession current ap-
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1 proved labeling for such drug in animal feed; or (ii) will, 

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

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

4 ‘‘(2) An animal feed bearing or containing a new ani5 mal drug shall, with respect to any particular use or in6 tended use of such animal feed be deemed unsafe for pur7 poses of section 501(a)(6) unless—

8 ‘‘(A) there is in effect—

9 ‘‘(i) an approval of an application filed 

10 pursuant to subsection (b) with respect to such 

11 drug, as used in such animal feed, and such 

12 animal feed and its labeling, distribution, hold13 ing, and use conform to such approved applica14 tion; 

15 ‘‘(ii) a conditional approval of an applica16 tion filed pursuant to section 571 with respect 

17 to such drug, as used in such animal feed, and 

18 such animal feed and its labeling, distribution, 

19 holding, and use conform to such conditionally 

20 approved application; or 

21 ‘‘(iii) an index listing pursuant to section 

22 572 with respect to such drug, as used in such 

23 animal feed, and such animal feed and its label24 ing, distribution, holding, and use conform to 

25 such index listing; and
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1 ‘‘(B) such animal feed is manufactured at a site 

2 for which there is in effect a license issued pursuant 

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

4 feed.’’. 

5 (10) Section 512(b)(3) of the Federal Food, 

6 Drug, and Cosmetic Act is amended by striking 

7 ‘‘under paragraph (1) or a request for an investiga8 tional exemption under subsection (j)’’ and inserting 

9 ‘‘under paragraph (1), section 571, or a request for 

10 an investigational exemption under subsection (j)’’. 

11 (11) Section 512(d)(4) of the Federal Food, 

12 Drug, and Cosmetic Act is amended by striking 

13 ‘‘have previously been separately approved’’ and in14 serting ‘‘have previously been separately approved 

15 pursuant to an application submitted under section 

16 512(b)(1)’’. 

17 (12) Section 512(f) of the Federal Food, Drug, 

18 and Cosmetic Act is amended by striking ‘‘sub19 section (d), (e), or (m)’’ and inserting ‘‘subsection 

20 (d), (e), or (m), or section 571 (c), (d), or (e)’’. 

21 (13) Section 512(g) of the Federal Food, Drug, 

22 and Cosmetic Act is amended by striking ‘‘this sec23 tion’’ and inserting ‘‘this section, or section 571’’. 

24 (14) Section 512(i) of the Federal Food, Drug, 

25 and Cosmetic Act is amended by striking ‘‘sub-
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1 section (b)’’ and inserting ‘‘subsection (b) or section 

2 571’’ and by inserting ‘‘or upon failure to renew a 

3 conditional approval under section 571’’ after ‘‘or 

4 upon its suspension’’. 

5 (15) Section 512(l)(1) of the Federal Food, 

6 Drug, and Cosmetic Act is amended by striking 

7 ‘‘subsection (b)’’ and inserting ‘‘subsection (b) or 

8 section 571’’. 

9 (16) Section 512(m)(1)(C) of the Federal Food, 

10 Drug, and Cosmetic Act is amended by striking ‘‘ap11 plicable regulations published pursuant to subsection 

12 (i)’’ and inserting ‘‘applicable regulations published 

13 pursuant to subsection (i) or for indexed new animal 

14 drugs in accordance with the index listing published 

15 pursuant to section 572(e)(2) and the labeling re16 quirements set forth in section 572(h)’’. 

17 (17) Section 512(m)(3) of the Federal Food, 

18 Drug, and Cosmetic Act is amended by inserting ‘‘or 

19 an index listing pursuant to section 572(e)’’ after 

20 ‘‘subsection (i)’’ each place it appears. 

21 (18) Section 512(p)(1) of the Federal Food, 

22 Drug, and Cosmetic Act is amended by striking 

23 ‘‘subsection (b)(1)’’ and inserting ‘‘subsection (b)(1) 

24 or section 571(a)’’. 
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1 (19) Section 512(p)(2) of the Federal Food, 

2 Drug, and Cosmetic Act is amended by striking 

3 ‘‘subsection (b)(1)’’ and inserting ‘‘subsection (b)(1) 

4 or section 571(a)’’. 

5 (20) Section 108(b)(3) of Public Law 90–399 is 

6 amended by striking ‘‘section 201(w) as added by 

7 this Act’’ and inserting ‘‘section 201(v) as added by 

8 the Minor Use and Minor Species Animal Health 

9 Act of 2003’’. 

10 (h) REGULATIONS.—The Secretary of Health and 

11 Human Services shall implement sections 571 and 573 of 

12 the Federal Food, Drug, and Cosmetic Act and subse13 quently publish implementing regulations. Not later than 

14 12 months after the date of enactment of this Act, the 

15 Secretary shall issue proposed regulations to implement 

16 section 573 of the Federal Food, Drug, and Cosmetic Act 

17 (as added by this Act), and not later than 24 months after 

18 the date of enactment of this Act, the Secretary shall issue 

19 final regulations implementing section 573 of the Federal 

20 Food, Drug, and Cosmetic Act. Not later than 18 months 

21 after the date of enactment of this Act, the Secretary shall 

22 issue proposed regulations to implement section 572 of the 

23 Federal Food, Drug, and Cosmetic Act (as added by this 

24 Act), and not later than 36 months after the date of enact25 ment of this Act, the Secretary shall issue final regulations 
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1 implementing section 572 of the Federal Food, Drug, and 

2 Cosmetic Act. Not later than 30 months after the date 

3 of enactment of this Act, the Secretary shall issue pro4 posed regulations to implement section 571 of the Federal 

5 Food, Drug, and Cosmetic Act (as added by this Act), and 

6 not later than 42 months after the date of enactment of 

7 this Act, the Secretary shall issue final regulations imple8 menting section 571 of the Federal Food, Drug, and Cos9 metic Act. These timeframes shall be extended by 12 

10 months for each fiscal year, in which the funds authorized 

11 to be appropriated under subsection (i) are not in fact ap12 propriated. 

13 (i) OFFICE.—The Secretary of Health and Human 

14 Services shall establish within the Center for Veterinary 

15 Medicine (of the Food and Drug Administration), an Of16 fice of Minor Use and Minor Species Animal Drug Devel17 opment that reports directly to the Director of the Center 

18 for Veterinary Medicine. This office shall be responsible 

19 for overseeing the development and legal marketing of new 

20 animal drugs for minor uses and minor species. There is 

21 authorized to be appropriated to carry out this subsection 

22 $1,200,000 for fiscal year 2003 and such sums as may 

23 be necessary for each fiscal year thereafter. 

24 (j) AUTHORIZATION OF APPROPRIATIONS.—There is 

25 authorized to be appropriated to carry out section 573(b) 
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1 of the Federal Food, Drug, and Cosmetic Act (as added 

2 by this Act) $1,000,000 for the fiscal year following publi3 cation of final implementing regulations, $2,000,000 for 

4 the subsequent fiscal year, and such sums as may be nec5 essary for each fiscal year thereafter.

Æ