I

107TH CONGRESS

1ST SESSION H. R. 1956

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 23, 2001

Mr. PICKERING (for himself, Mr. COMBEST, Mr. SIMPSON, Mr. OTTER, Mrs.

THURMAN, and Mr. HAYES) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to

the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions

as fall within the jurisdiction of the committee concerned

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,

3 SECTION 1. SHORT TITLE.

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

5 Species Animal Health Act of 2001’’.

6 SEC. 2. FINDINGS.

7 Congress makes the following findings:
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1 (1) There is a severe shortage of approved new

2 animal drugs for use in minor species.

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

4 animal drugs for treating animal diseases and condi5 tions that occur infrequently or in limited geographic

6 areas.

7 (3) Because of the small market shares, low8 profit margins involved, and capital investment re9 quired, it is generally not economically feasible for

10 new animal drug sponsors to pursue approvals for

11 these species, diseases, and conditions.

12 (4) Because the populations for which such new

13 animal drugs are intended may be small and condi14 tions of animal management may vary widely, it is

15 often difficult to design and conduct studies to es16 tablish drug safety and effectiveness under tradi17 tional new animal drug approval processes.

18 (5) It is in the public interest and in the inter19 est of animal welfare to provide for special proce20 dures to allow the lawful use and marketing of cer21 tain new animal drugs for minor species and minor

22 uses that take into account these special cir23 cumstances and that ensure that such drugs do not

24 endanger animal or public health.
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1 (6) Exclusive marketing rights and tax credits

2 for clinical testing expenses have helped encourage

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

4 and comparable incentives should encourage the de5 velopment of new animal drugs for minor species

6 and minor uses.

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

8 COSMETIC ACT.

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

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

11 adding at the end the following:

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

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

14 Secretary may revise this definition by regulation.

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

16 than humans that are not major species.

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

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

19 infrequently or in limited geographical areas.’’.

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

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

22 (iii), and (v) of the Federal Food, Drug, and Cosmetic

23 Act is amended by striking ‘‘(other than bioequivalence or

24 residue studies)’’ and inserting ‘‘(other than bioequiva25 lence studies or final residue depletion studies, except final
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1 residue depletion studies for minor uses or minor species)’’

2 every place it appears.

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

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

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

6 the end the following new paragraph:

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

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

9 a minor species to an approved new animal drug ap10 plication, the Secretary shall reevaluate only the rel11 evant information in the approved application to de12 termine whether the application for the minor use or

13 minor species can be approved. A decision to ap14 prove the application for the minor use or minor

15 species is not, implicitly or explicitly, a reaffirmation

16 of the approval of the original application.’’.

17 (d) MINOR USE AND MINOR SPECIES NEW ANIMAL

18 DRUGS.—Chapter V of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 351 et seq.) is amended by adding

20 at the end the following:
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1 ‘‘Subchapter F—New Animal Drugs

2 For Minor 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 512(b)(2), 512(c)(1), 512(c)(2), 512(c)(3),

13 512(d)(1), 512(e), 512(h), and 512(n) unless otherwise

14 stated in this section, and any additional provisions of this

15 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 512(b)(1)(A);

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

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

23 and there is a reasonable expectation of effectiveness

24 for use;

25 ‘‘(C) data for establishing a conditional dose;
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1 ‘‘(D) projections of expected need and the jus2 tification for that expectation based on the best in3 formation available;

4 ‘‘(E) information regarding the quantity of

5 drug expected to be distributed on an annual basis

6 to meet the expected need; and

7 ‘‘(F) a commitment that the applicant will con8 duct additional investigations to meet the require9 ments for the full demonstration of effectiveness

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

11 ‘‘(3) A person may not file an application under para12 graph (1) if without adequate justification—

13 ‘‘(A) the person has previously filed an applica14 tion for conditional approval under paragraph (1)

15 for the same drug, conditions of use, and dosage

16 form whether or not subsequently conditionally ap17 proved by the Secretary under subsection (b), or

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

19 data or other information contained therein, directly

20 or indirectly from the person who filed for condi21 tional approval under paragraph (1) for the same

22 drug and conditions of use whether or not subse23 quently conditionally approved by the Secretary

24 under subsection (b).
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1 ‘‘(b) Within 180 days after the filing of an applica2 tion pursuant to subsection (a), or such additional period

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

4 the Secretary shall either—

5 ‘‘(1) issue an order, effective for one year, con6 ditionally approving the application if the Secretary

7 finds that none of the grounds for denying condi8 tional approval, specified in subsection (c) of this

9 section applies, or

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

11 for an informal hearing on the question whether

12 such application can be conditionally approved.

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

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

15 ‘‘(1) any of the provisions of section

16 512(d)(1)(A) through (D) or (F) through (I) are ap17 plicable;

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

19 as part of the application and any other information

20 before the Secretary with respect to such drug, is in21 sufficient to show that there is a reasonable expecta22 tion that the drug will have the effect it purports or

23 is represented to have under the conditions of use

24 prescribed, recommended, or suggested in the pro25 posed labeling thereof; or
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1 ‘‘(3) another person has received approval

2 under section 512 for a drug with the same active

3 ingredient or ingredients, the same conditions of use,

4 and the same dosage form and that person is able

5 to assure the availability of sufficient quantities of

6 the drug to meet the needs for which the drug is in7 tended;

8 the Secretary shall issue an order refusing to conditionally

9 approve the application.

10 ‘‘If, after such notice and opportunity for an informal

11 hearing, the Secretary finds that subparagraphs (1)

12 through (3) do not apply, the Secretary shall issue an

13 order conditionally approving the application effective for

14 one year. Any order issued under this subsection refusing

15 to conditionally approve an application shall state the find16 ings upon which it is based.

17 ‘‘(d) A conditional approval under this section is ef18 fective for a 1-year period and is thereafter renewable by

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

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

21 5 years from the date of approval under subsections (b)(1)

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

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

24 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) If the renewal request is submitted no

7 later than 90-days from the end of the 1-year pe8 riod, a conditional approval shall be deemed renewed

9 at the end of the 1-year period, or at the end of an

10 additional 90-day extension when deemed necessary

11 to complete review of an application, unless the Sec12 retary makes a written determination before the ex13 piration of the 1-year period or the 90-day extension

14 that—

15 ‘‘(A) 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 in-
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1 tended use, unless there is adequate expla2 nation that ensures that the drug is only

3 used for its intended purpose; or

4 ‘‘(iii) no other drug with the same ac5 tive ingredient or ingredients, for the same

6 conditions of use, and dosage form has re7 ceived approval under section 512, or if

8 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 ‘‘(B) 1 or more of the conditions of sub14 section 512(e)(1)(A) through (B) and (D)

15 through (F) are met.

16 ‘‘(3) If the Secretary makes a timely written

17 determination that a conditional approval should not

18 be renewed, or the applicant fails to submit a timely

19 renewal request, the Secretary shall issue an order

20 refusing to renew the conditional approval, and such

21 conditional approval shall be deemed withdrawn and

22 no longer in effect. The Secretary shall thereafter

23 provide an opportunity for an informal hearing to

24 the applicant on the issue whether the conditional

25 approval 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 a drug

5 with the same active ingredient or ingredients, the same

6 conditions of use, and dosage form, and that person is able

7 to assure the availability of sufficient quantities of the

8 drug to meet the needs for 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

15 512(e)(1)(A) through (B) or (D) through (F) are

16 applicable; 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, a sponsor

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. Upon receipt of

2 this information, the Secretary shall either—

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

4 the Secretary finds that none of the grounds for de5 nying approval specified in 512(d)(1) applies, or

6 ‘‘(2) give the sponsor an opportunity for a hear7 ing before the Secretary under 512(d) on the ques8 tion whether such application can be approved. Upon

9 issuance of an order approving the application, prod10 uct labeling and administrative records of approval

11 shall be modified accordingly. If the Secretary has

12 not issued an order under section 512(c) approving

13 such application prior to the termination date estab14 lished under subsection (d)(1) of this section, the

15 conditional approval issued under this section is no

16 longer in effect unless the Secretary grants an ex17 tension of an additional 180-day period so that the

18 Secretary can complete review of the application.

19 The decision to grant an extension is committed to

20 Agency discretion and not subject to judicial review.

21 ‘‘(i) The decision of the Secretary under subsections

22 (c), (d), or (e) of this section, refusing or withdrawing con23 ditional approval of an application shall constitute final

24 agency action subject to judicial review.
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1 ‘‘SEC. 572. INDEX OF LEGALLY-MARKETED UNAPPROVED

2 NEW ANIMAL DRUGS FOR MINOR SPECIES.

3 ‘‘(a) The Secretary shall establish an index of unap4 proved minor species new animal drugs that may be law5 fully marketed for use in minor species. The index shall

6 be limited to—

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

8 minor species for which there is a reasonable cer9 tainty that the animal or edible products from the

10 animal will not be consumed by humans, and

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

12 early life stage of a food-producing minor species

13 where human food safety can be demonstrated in ac14 cordance with the standard of section 512(d) by

15 showing that—

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

17 harmful residues will be present in the animal

18 presented as food for humans as a result of

19 treatment at the early life stage;

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

21 harmful residues will be present in the animal

22 presented as food for food-producing animals as

23 a result of treatment at the early life stage; and

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

25 of the drug at later life stages because a toler26 ance and regulatory method to test for the drug
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1 at later life stages are available or there is no

2 practical use for the drug in later life stages.

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

4 section shall be entitled to one or more conferences to dis5 cuss the requirements for indexing a new animal drug.

6 ‘‘(c)(1) Any person may submit a request to the Sec7 retary for a determination whether a new animal drug

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

9 shall include—

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

11 new animal drug, the species for which the new ani12 mal drug is intended, the proposed intended use and

13 conditions of use, and anticipated annual distribu14 tion;

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

16 the proposed use meets the conditions of subsections

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

18 ‘‘(C) information regarding the components and

19 composition of the new animal drug;

20 ‘‘(D) a description of the methods used in, and

21 the facilities and controls used for, the manufacture,

22 processing, and packing of such new animal drug;

23 ‘‘(E) an environmental assessment or informa24 tion to support a categorical exclusion from the re25 quirement to prepare an environmental assessment;
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1 ‘‘(F) information sufficient to support the con2 clusion that the proposed use of the new animal

3 drug does not present a threat to the safety of indi4 viduals exposed to the new animal drug through its

5 manufacture or use; and

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

7 may deem necessary to make this eligibility deter8 mination.

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

10 for a determination of eligibility for indexing based on

11 paragraph (a)(1) of this section, or 180 days for a request

12 submitted based on paragraph (a)(2) of this section, the

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

14 person who requested such determination of the Sec15 retary’s decision. The Secretary shall grant the request if

16 the Secretary finds that—

17 ‘‘(A) no new animal drug, including the same

18 active ingredient or any salt or ester thereof is ap19 proved or conditionally approved in the same dosage

20 form for the same intended use;

21 ‘‘(B) the proposed use does not raise concerns

22 related to safety; and

23 ‘‘(C) the person requesting the determination

24 has established appropriate specifications for the

25 manufacture and control of the new animal drug
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1 and has demonstrated an understanding of the re2 quirements of current good manufacturing practices.

3 If the Secretary denies the request, the Secretary shall

4 thereafter provide due notice and an opportunity for an

5 informal conference. The decision of the Secretary fol6 lowing an informal conference shall constitute final agency

7 action subject to judicial review.

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

9 the Secretary has made a determination of eligibility

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

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

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

13 for addition to the index shall include—

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

15 eligibility issued under subsection (b);

16 ‘‘(B) a written report that meets the require17 ments in subparagraph (d)(2) of this section;

18 ‘‘(C) a proposed index entry;

19 ‘‘(D) facsimile labeling;

20 ‘‘(E) anticipated annual distribution of the new

21 animal drug;

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

23 new animal drug according to current good manu24 facturing practices;
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1 ‘‘(G) a written commitment to label, distribute,

2 and promote the new animal drug only in accordance

3 with the index entry;

4 ‘‘(H) upon specific request of the Secretary, in5 formation submitted to the expert panel described in

6 subparagraph (3); and

7 ‘‘(I) any additional requirements that the Sec8 retary may prescribe by general regulation or spe9 cific order.

10 ‘‘(2) The report required in subparagraph (1) shall:

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

12 ‘‘(B) include an evaluation of all available tar13 get animal safety and effectiveness information, in14 cluding anecdotal information;

15 ‘‘(C) State the expert panel’s opinion regarding

16 whether the benefits of using the new animal drug

17 for the proposed use in a minor species outweigh its

18 risks, taking into account the harm being caused by

19 the absence of an approved or conditionally-approved

20 new animal drug for the minor species in question;

21 ‘‘(D) include information upon which labeling

22 can be written; and

23 ‘‘(E) include a recommendation regarding

24 whether the new animal drug should be limited to
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1 use under the professional supervision of a licensed

2 veterinarian.

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

4 is a panel that—

5 ‘‘(A) is composed of experts qualified by sci6 entific training and experience to evaluate the target

7 animal safety and effectiveness of the new animal

8 drug under consideration;

9 ‘‘(B) operates external to FDA; and

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

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

12 The Secretary shall define the criteria for selection of a

13 qualified expert panel and the procedures for the operation

14 of the panel by regulation.

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

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

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

18 the request if the request for indexing continues to meet

19 the eligibility criteria in subsection (a) and the Secretary

20 finds, on the basis of the report of the qualified expert

21 panel and other information available to the Secretary,

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

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

24 into account the harm caused by the absence of an ap25 proved or conditionally-approved new animal drug for the
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1 minor species in question. If the Secretary denies the re2 quest, the Secretary shall thereafter provide due notice

3 and the opportunity for an informal conference. The deci4 sion of the Secretary following an informal conference

5 shall constitute final agency action subject to judicial re6 view.

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

8 shall include the following information for each listed

9 drug—

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

11 holds the index listing;

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

13 use and conditions of use for which it is being in14 dexed;

15 ‘‘(C) product labeling; and

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

17 Secretary deems necessary regarding use of the

18 drug.

19 ‘‘(2) The Secretary shall publish the index, and revise

20 it periodically.

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

22 process for reporting changes in the conditions of manu23 facturing or labeling of indexed products.
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1 ‘‘(f)(1) If the Secretary finds, after due notice to the

2 person who requested the index listing and an opportunity

3 for an informal conference, that—

4 ‘‘(A) the expert panel failed to meet the re5 quirements as set forth by the Secretary by regula6 tion;

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

8 Secretary, evaluated together with the evidence

9 available to the Secretary when the new animal drug

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

11 animal drug for the indexed use do not outweigh its

12 risks;

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

14 section are no longer satisfied;

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

16 is not in accordance with current good manufac17 turing practices;

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

19 the new animal drug is not in accordance with the

20 index entry;

21 ‘‘(F) the conditions and limitations of use asso22 ciated with the index listing have not been followed;

23 or

24 ‘‘(G) the request for indexing contains any un25 true statement of material fact;
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1 the Secretary shall remove the new animal drug from the

2 index. The decision of the Secretary following an informal

3 conference shall constitute final agency action subject to

4 judicial review.

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

6 probability that the use of the drug would adversely affect

7 the health of humans or other animals, the Secretary may:

8 ‘‘(A) suspend the listing of such drug imme9 diately;

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

11 notice of the Secretary’s action; and

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

13 informal conference.

14 The decision of the Secretary following an informal con15 ference shall constitute final agency action subject to judi16 cial review.

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

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

19 health, the Secretary shall promulgate regulations for ex20 empting from the operation of section 512 minor species

21 new animal drugs and animal feeds bearing or containing

22 new animal drugs intended solely for investigational use

23 by experts qualified by scientific training and experience

24 to investigate the safety and effectiveness of minor species

25 animal drugs. Such regulations may, at the discretion of
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1 the Secretary, among other conditions relating to the pro2 tection of the public health, provide for conditioning such

3 exemption upon the establishment and maintenance of

4 such records, and the making of such reports to the Sec5 retary, by the manufacturer or the sponsor of the inves6 tigation of such article, of data (including but not limited

7 to analytical reports by investigators) obtained as a result

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

9 finds will enable the Secretary to evaluate the safety and

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

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

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

13 subject of an index listing shall state, prominently and

14 conspicuously—

15 ‘‘(1) ‘NOT APPROVED BY FDA.—Legally mar16 keted as an FDA indexed product. Extra-label use

17 is prohibited.’;

18 ‘‘(2) except in the case of new animal drugs in19 dexed for use in an early life stage of a food pro20 ducing animal, ‘This product is not to be used in

21 animals intended for use as food for humans or

22 other animals.’; and

23 ‘‘(3) such other information as may be pre24 scribed by the Secretary in the index listing.
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1 ‘‘(i)(1) In the case of any new animal drug for which

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

3 the person who has an index listing shall establish and

4 maintain such records, and make such reports to the Sec5 retary, of data relating to experience, and other data or

6 information, received or otherwise obtained by such person

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

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

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

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

11 reports are necessary in order to enable the Secretary to

12 determine, or facilitate a determination, whether there is

13 or may be ground for invoking subsection (f). Such regula14 tion or order shall provide, where the Secretary deems it

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

16 the persons to whom such regulation or order is applica17 ble, of similar information received or otherwise obtained

18 by the Secretary.

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

20 maintain records, and every person in charge or custody

21 thereof, shall, upon request of an officer or employee des22 ignated by the Secretary, permit such officer or employee

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

24 verify such records.
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1 ‘‘(j)(1) Safety and effectiveness data and information

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

3 new animal drug to be indexed under this section and

4 which has not been previously disclosed to the public shall

5 be made available to the public, upon request, unless ex6 traordinary circumstances are shown—

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

8 to have the drug indexed in accordance with the re9 quest,

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

11 drug cannot be indexed and all legal appeals have

12 been exhausted,

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

14 and all legal appeals have been exhausted, or

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

16 drug is not a new animal drug.

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

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

19 person making the request that any data or information

20 received under such paragraph shall not be disclosed by

21 such person to any other person—

22 ‘‘(A) for the purpose of, or as part of a plan,

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

24 use, or market, or making, using, or marketing, out-
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1 side the United States, the drug identified in the re2 quest for indexing; and

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

4 whom the data and information are disclosed an

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

6 provided by such person to the Secretary, which

7 meets the requirements of this paragraph.

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

9 USE OR MINOR SPECIES.

10 ‘‘(a) DESIGNATION.—

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

12 animal drug for a minor use or use in a minor spe13 cies may request that the Secretary declare that

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

15 designation of a new animal drug shall be made be16 fore the submission of an application under section

17 512(b) or section 571 for the new animal drug.

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

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

20 use if—

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

22 in a minor species; and

23 ‘‘(B) a new animal drug containing the

24 same active ingredient, including any salt or

25 ester of the active ingredient, for the same in-
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•HR 1956 IH

1 tended use, in the same species, and in the

2 same dosage form is not approved under section

3 512 or section 571 or designated for the in4 tended use at the time the request is made.

5 ‘‘(3) Regarding the termination of a

6 designation—

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 tions 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 sections 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 subsection (1) of this

17 section—

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 or 571; and
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•HR 1956 IH

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 section

12 571.

13 ‘‘(3) There is authorized to be appropriated to

14 carry out this subsection $1,000,000 for the fiscal

15 year following publication of final implementing reg16 ulations, $2,000,000 for the subsequent fiscal year

17 and such sums as may be necessary for each fiscal

18 year thereafter.

19 ‘‘(c) EXCLUSIVITY FOR DESIGNATED NEW ANIMAL

20 DRUGS.—

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

22 the Secretary—

23 ‘‘(A) approves or conditionally approves an

24 application for a designated new animal drug,

25 and no active ingredient (including any salt or
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•HR 1956 IH

1 ester of the active ingredient) of that des2 ignated new animal drug has been approved or

3 conditionally approved previously, the Secretary

4 may not approve or conditionally approve an5 other application submitted for a new animal

6 drug with the same active ingredient and in7 tended use as the designated new animal drug

8 for another applicant before the expiration of

9 ten years from the date of the approval or con10 ditional approval of the application.

11 ‘‘(B) approves or conditionally approves an

12 application for a designated new animal drug,

13 and an active ingredient (including an ester or

14 salt of the active ingredient) of that designated

15 new animal drug has been approved or condi16 tionally approved previously, the Secretary may

17 not approve or conditionally approve another

18 application submitted for a new animal drug

19 with the same active ingredient and intended

20 use as the designated new animal drug for an21 other applicant before the expiration of seven

22 years from the date of approval or conditional

23 approval of the application.

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

25 512 or section 571 is approved for a designated new
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•HR 1956 IH

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

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

3 the application approval or conditional approval, ap4 prove or conditionally approve another application

5 under section 512 or section 571 for such drug for

6 such minor use or minor species for another appli7 cant if—

8 ‘‘(A) the Secretary finds, after providing

9 the holder of such an approved application no10 tice and opportunity for the submission of

11 views, that in the granted exclusivity period the

12 holder of the approved application cannot as13 sure the availability of sufficient quantities of

14 the drug to meet the needs for which the drug

15 was designated; or

16 ‘‘(B) such holder provides written consent

17 to the Secretary for the approval or conditional

18 approval of other applications before the expira19 tion of such exclusivity period.’’.

20 (e) CONFORMING AMENDMENTS.—

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

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

23 inserting ‘‘512, 571’’.

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

25 and Cosmetic Act is amended by inserting the fol-
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•HR 1956 IH

1 lowing after paragraph (2): ‘‘Provided that any drug

2 intended for minor use or use in a minor species

3 that is not the subject of a final regulation published

4 by the Secretary through notice and comment rule5 making finding that the criteria of paragraphs (1)

6 and (2) or of section 108 of Public Law 90–399

7 have been met is a new animal drug.’’

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

9 and Cosmetic Act is amended by striking

10 ‘‘512(a)(4)(C), 512(j), (l) or (m)’’ and inserting

11 ‘‘512(a)(4)(C), 512(j), (l) or (m), 572(i).’’

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

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

14 inserting ‘‘520, 571, 572, 573.’’

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

16 Cosmetic Act is amended by adding at the end the

17 following new subsection:

18 ‘‘(u) If it is a new animal drug—

19 ‘‘(1) that is conditionally approved under sec20 tion 571 and its labeling does not conform with the

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

22 conditionally approved under section 571 and its

23 label bears the statement set forth in section

24 571(f)(1)(A); or
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•HR 1956 IH

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

2 labeling does not conform with the index listing

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

4 indexed under section 572 and its label bears the

5 statement set forth in section 572(h).’’

6 (6) Section 503(f) of the Federal Food, Drug,

7 and Cosmetic Act is amended by—

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

9 ‘‘512’’ and inserting ‘‘512, a conditionally-ap10 proved application under section 571, or an

11 index listing under section 572’’; and

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

13 512’’ and inserting ‘‘sections 512, 571, or

14 572’’.

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

16 Drug, and Cosmetic Act is amended by striking

17 ‘‘512(b)’’ and inserting ‘‘512(b), a conditionally-ap18 proved application filed pursuant to section 571, or

19 an index listing pursuant to section 572’’.

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

21 Federal Food, Drug, and Cosmetic Act are amended

22 by striking ‘‘512(i)’’ each place it appears and in23 serting ‘‘512(i), or the index listing pursuant to sec24 tion 572(e)’’.
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•HR 1956 IH

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

2 and Cosmetic Act is amended by striking paragraphs

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

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

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

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

7 402(a)(2)(C)(ii) unless—

8 ‘‘(A) there is in effect an approval of an appli9 cation filed pursuant to subsection (b) with respect

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

11 drug, its labeling, and such use conform to such ap12 proved application;

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

14 an application filed pursuant to section 571 with re15 spect to such use or intended use of such drug, and

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

17 such conditionally-approved application; or

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

19 to section 572 with respect to such use or intended

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

21 its labeling, and such use conform to such index list22 ing.

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

24 purposes in the event of removal from the establishment

25 of a manufacturer, packer, or distributor of such drug for
35

•HR 1956 IH

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

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

3 or distributor has an unrevoked written statement from

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

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

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

7 under subsection (m) and has in its possession current ap8 proved labeling for such drug in animal feed; or (ii) will,

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

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

11 ‘‘(2) An animal feed bearing or containing a new ani12 mal drug shall, with respect to any particular use or in13 tended use of such animal feed be deemed unsafe for pur14 poses of section 501(a)(6) unless—

15 ‘‘(A) there is in effect—

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

17 pursuant to subsection (b) with respect to such

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

19 animal feed and its labeling, distribution, hold20 ing, and use conform to such approved applica21 tion;

22 ‘‘(ii) a conditional approval of an applica23 tion filed pursuant to section 571 with respect

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

25 such animal feed and its labeling, distribution,
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•HR 1956 IH

1 holding, and use conform to such conditionally2 approved application; or

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

4 572 with respect to such drug, as used in such

5 animal feed, and such animal feed and its label6 ing, distribution, holding, and use conform to

7 such index listing; and

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.’’.

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

13 Drug, and Cosmetic Act is amended by striking

14 ‘‘under paragraph (1) or a request for an investiga15 tional exemption under subsection (j)’’ and inserting

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

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

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

19 Drug, and Cosmetic Act is amended by striking

20 ‘‘have previously been separately approved’’ and in21 serting ‘‘have previously been separately approved

22 pursuant to an application submitted under section

23 512(b)(1)’’.

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

25 and Cosmetic Act is amended by striking ‘‘sub-
37

•HR 1956 IH

1 section (d), (e), or (m)’’ and inserting ‘‘subsection

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

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

4 and Cosmetic Act is amended by striking ‘‘this sec5 tion’’ and inserting ‘‘this section, or section 571’’.

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

7 and Cosmetic Act is amended by striking ‘‘sub8 section (b)’’ and inserting ‘‘subsection (b) or section

9 571’’ and by inserting ‘‘or upon failure to renew a

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

11 upon its suspension’’.

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

13 Drug, and Cosmetic Act is amended by striking

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

15 section 571’’.

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

17 Drug, and Cosmetic Act is amended by striking ‘‘ap18 plicable regulations published pursuant to subsection

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

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

21 drugs in accordance with the index listing published

22 pursuant to section 572(e)(2) and the labeling re23 quirements set forth in section 572(h)’’.

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

25 Drug, and Cosmetic Act is amended by inserting ‘‘or
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•HR 1956 IH

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

2 ‘‘subsection (i)’’.

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

4 Drug, and Cosmetic Act is amended by striking

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

6 or section 571(a)’’.

7 (19) Section 512(p)(2) of the Federal Food,

8 Drug, and Cosmetic Act is amended by striking

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

10 or section 571(a)’’.

11 SEC. 4. INTERNAL REVENUE CODE AMENDMENTS.

12 The Internal Revenue Code of 1986 is amended by

13 adding the following new section after section 45C:

14 ‘‘SEC. 45D. SAFETY AND EFFECTIVENESS TESTING EX15 PENSES FOR DESIGNATED NEW ANIMAL

16 DRUGS FOR MINOR USES AND MINOR SPE17 CIES.

18 ‘‘(a) For purposes of section 38, the credit deter19 mined under this section for the taxable year is an amount

20 equal to 50 percent of the qualified safety and effective21 ness testing expenses for the designated new animal drug

22 for the taxable year.

23 ‘‘(b) For purposes of this section—

24 ‘‘(1) Qualified safety and effectiveness testing

25 expenses—
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•HR 1956 IH

1 ‘‘(A) Except as otherwise provided in this

2 paragraph, the term ‘qualified safety and effec3 tiveness testing expenses’ means the amounts

4 which are paid or incurred by the taxpayer dur5 ing the taxable year which would be described

6 in subsection (b) of section 41 if such sub7 section were applied with the modifications set

8 forth in subparagraph (B).

9 ‘‘(B) For purposes of subparagraph (A),

10 subsection (b) of section 41 shall be applied—

11 ‘‘(i) by substituting ‘safety and effec12 tiveness testing’ for ‘qualified research’

13 each place it appears in paragraphs (2)

14 and (3) of such subsection; and

15 ‘‘(ii) by substituting ‘100 percent’ for

16 ‘65 percent’ in paragraph (3)(A) of such

17 subsection.

18 ‘‘(C) The term ‘qualified safety and effec19 tiveness testing expenses’ shall not include any

20 amount to the extent such amount is funded by

21 any grant, contract, or otherwise by another

22 person (or any governmental entity).

23 ‘‘(D) For purposes of this paragraph—
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•HR 1956 IH

1 ‘‘(i) section 41 shall be deemed to re2 main in effect for periods after June 30,

3 2001; and

4 ‘‘(ii) the ‘trade or business of the tax5 payer’ requirement of section 41(b)(1)

6 shall be deemed to be satisfied in the case

7 of a taxpayer that owns animals that are

8 the subject of safety and effectiveness test9 ing.

10 ‘‘(2)(A) The term ‘safety and effectiveness test11 ing’ means any safety and effectiveness testing—

12 ‘‘(i) which is carried out under an exemp13 tion for a new animal drug being tested for

14 minor use or a minor species under section

15 512(j) of the Federal Food, Drug, and Cos16 metic Act (or regulations issued under such sec17 tion);

18 ‘‘(ii) which occurs—

19 ‘‘(I) after the date such new animal

20 drug request is filed for designation under

21 section 573 of such Act, and

22 ‘‘(II) before the date on which an ap23 plication with respect to such drug is ap24 proved under section 512(c) of such Act;

25 and
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•HR 1956 IH

1 ‘‘(iii) which is conducted by or on behalf

2 of—

3 ‘‘(I) the taxpayer who applied for the

4 designation under section 573; or

5 ‘‘(II) the owner of the animals that

6 are the subject of safety and effectiveness

7 testing.

8 ‘‘(B) Safety and effectiveness testing shall be

9 taken into account under subparagraph (A) only to

10 the extent such testing is related to the use of a new

11 animal drug for the minor use or minor species for

12 which it was designated under section 573 of the

13 Federal Food, Drug, and Cosmetic Act.

14 ‘‘(c)(1) Except as provided in paragraph (2), any

15 qualified safety and effectiveness testing expenses for a

16 taxable year to which an election under this section applies

17 shall not be taken into account for purposes of deter18 mining the credit allowable under section 41 for such tax19 able year.

20 ‘‘(2) Any qualified safety and effectiveness testing ex21 penses for any taxable year which are qualified research

22 expenses (within the meaning of section 41(b)) shall be

23 taken into account in determining base period research ex24 penses for purposes of applying section 41 to subsequent

25 taxable years.
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•HR 1956 IH

1 ‘‘(d)(1) For purposes of this section, the term ‘minor

2 use’ is defined in section 201(mm) of the Federal Food,

3 Drug, and Cosmetic Act and ‘minor species’ is defined in

4 section 201(ll). Determinations under the preceding sen5 tence with respect to any new animal drug shall be made

6 on the basis of the facts and circumstances as of the date

7 such new animal drug is designated under section 573 of

8 the Federal Food, Drug, and Cosmetic Act.

9 ‘‘(2) No credit shall be allowed under this section

10 with respect to any safety and effectiveness testing con11 ducted by a corporation to which an election under section

12 936 applies.

13 ‘‘(3) Rules similar to the rules of paragraphs (1) and

14 (2) of section 41(f) shall apply for purposes of this section.

15 ‘‘(4) This section shall apply to any taxpayer for any

16 taxable year only if such taxpayer elects (at such time and

17 in such manner as the Secretary may by regulations pre18 scribe) to have this section apply for such taxable year.’’.

19 (b) CONFORMING AMENDMENTS.—

20 (1) Section 38(b) of the Internal Revenue Code

21 is amended—

22 (A) by deleting ‘‘plus’’ at end of paragraph

23 (11);
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•HR 1956 IH

1 (B) by deleting the period at the end of

2 paragraph (12) and replacing it with the fol3 lowing: ‘‘, plus’’; and

4 (C) by adding the following new paragraph

5 at the end: ‘‘the minor use and minor species

6 new animal drug credit determined under sec7 tion 45D(a)’’.

8 (2) Section 280C(b) of the Internal Revenue

9 Code is amended—

10 (A) in paragraph (1), by deleting ‘‘section

11 45C(b)’’ and substituting the following: ‘‘section

12 45C(b) or 45D(b)’’; and

13 (B) in paragraphs (1) and (2), by deleting

14 ‘‘section 45C’’ wherever it appears and sub15 stituting the following: ‘‘section 45C or 45D’’.

16 (c) REGULATIONS.—The Secretary of the Treasury

17 shall publish proposed regulations to implement amend18 ments to the Internal Revenue Code made by this Act

19 within 6 months of the date of enactment, and final regu20 lations within 24 months of the date of enactment.

21 SEC. 5. REGULATIONS.

22 Not later than 18 months after the date of enactment

23 of this Act, the Secretary of Health and Human Services

24 shall issue proposed regulations to implement section 572

25 of the Federal Food, Drug, and Cosmetic Act (as added
44

•HR 1956 IH

1 by this Act), and not later than 36 months after the date

2 of enactment of this Act, the Secretary shall issue final

3 regulations implementing such amendments. Not later

4 than 12 months after the date of enactment of this Act,

5 the Secretary of Health and Human Services shall issue

6 proposed regulations to implement section 573 of the Fed7 eral Food, Drug, and Cosmetic Act (as added by this Act),

8 and not later than 24 months after the date of enactment

9 of this Act, the Secretary shall issue final regulations im10 plementing such amendments; provided that these time11 frames shall be extended by 12 months for each fiscal year

12 in which the funds authorized to be appropriated by this

13 Act are not in fact appropriated. The Secretary shall im14 plement section 571 of the Federal Food, Drug, and Cos15 metic Act (as added by this Act) on the date of enactment

16 of this Act and subsequently publish any needed imple17 menting regulations.

18 SEC. 6. OFFICE OF MINOR USE AND MINOR SPECIES ANI19 MAL DRUG DEVELOPMENT.

20 The Secretary of Health and Human Services shall

21 establish within the Center of Veterinary Medicine (of the

22 Food and Drug Administration), an Office of Minor Use

23 and Minor Species Animal Drug Development that reports

24 directly to the Director of the Center for Veterinary Medi25 cine. This office shall be responsible for overseeing the de-
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•HR 1956 IH

1 velopment and legal marketing of new animal drugs for

2 minor uses and minor species. There is authorized to be

3 appropriated to carry out this subsection $1,200,000 for

4 fiscal year 2002 and such sums as may be necessary for

5 each fiscal year thereafter.

Æ