[Congressional Record (Bound Edition), Volume 150 (2004), Part 3]
[Senate]
[Pages 3640-3650]
[From the U.S. Government Publishing Office, www.gpo.gov]




         MINOR USE AND MINOR SPECIES ANIMAL HEALTH ACT OF 2003

  Mr. NICKLES. Mr. President, I ask unanimous consent that the Senate 
proceed to the immediate consideration of Calendar No. 431, S. 741.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill (S. 741) to amend the Federal Food, Drug and 
     Cosmetic Act with regard to new animal drugs, and for other 
     purposes.

  There being no objection, the Senate proceeded to consider the bill 
which had been reported from the Committee on Health, Education, Labor 
and Pensions, with an amendment to strike all after the enacting clause 
and inserting in lieu thereof the following:
  (Strike the part shown in black brackets and insert the part shown in 
italic.)

                                 S. 741

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     [SECTION 1. SHORT TITLE.

       [This Act may be cited as the ``Minor Use and Minor Species 
     Animal Health Act of 2003''.

     [SEC. 2. FINDINGS.

       [Congress makes the following findings:
       [(1) There is a severe shortage of approved new animal 
     drugs for use in minor species.
       [(2) There is a severe shortage of approved new animal 
     drugs for treating animal diseases and conditions that occur 
     infrequently or in limited geographic areas.
       [(3) Because of the small market shares, low-profit margins 
     involved, and capital investment required, it is generally 
     not economically feasible for new animal drug applicants to 
     pursue approvals for these species, diseases, and conditions.
       [(4) Because the populations for which such new animal 
     drugs are intended may be small and conditions of animal 
     management may vary widely, it is often difficult to design 
     and conduct studies to establish drug safety and 
     effectiveness under traditional new animal drug approval 
     processes.
       [(5) It is in the public interest and in the interest of 
     animal welfare to provide for special procedures to allow the 
     lawful use and marketing of certain new animal drugs for 
     minor species and minor uses that take into account these 
     special circumstances and that ensure that such drugs do not 
     endanger animal or public health.
       [(6) Exclusive marketing rights and tax credits for 
     clinical testing expenses have helped encourage the 
     development of ``orphan'' drugs for human use, and comparable 
     incentives should encourage the development of new animal 
     drugs for minor species and minor uses.

     [SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC 
                   ACT.

       [(a) Definitions.--Section 201 of the Federal, Food, Drug, 
     and Cosmetic Act (21 U.S.C. 321) is amended by adding at the 
     end the following:
       [``(kk) The term `major species' means cattle, horses, 
     swine, chickens, turkeys, dogs, and cats, except that the 
     Secretary may revise this definition by regulation.
       [``(ll) The term `minor species' means animals other than 
     humans that are not major species.
       [``(mm) The term `minor use' means the intended use of a 
     drug in a major species for an indication that occurs 
     infrequently or in limited geographical areas.''.
       [(b) Three-Year Exclusivity for Minor Use and Minor Species 
     Approvals.--Section 512(c)(2)(F) (ii), (iii), and (v) of the 
     Federal Food, Drug, and Cosmetic Act is amended by striking 
     ``(other than bioequivalence or residue studies)'' and 
     inserting ``(other than bioequivalence studies or residue 
     depletion studies, except residue depletion studies for minor 
     uses or minor species)'' every place it appears.
       [(c) Scope of Review for Minor Use and Minor Species 
     Applications.--Section 512(d) of the Federal Food, Drug, and 
     Cosmetic Act is amended by adding at the end the following 
     new paragraph:
       [``(5) In reviewing an application that proposes a change 
     to add an intended use for a minor use or a minor species to 
     an approved new animal drug application, the Secretary shall 
     reevaluate only the relevant information in the approved 
     application to determine whether the application for the 
     minor use or minor species can be approved. A decision to 
     approve the application for the minor use or minor species is 
     not, implicitly or explicitly, a reaffirmation of the 
     approval of the original application.''.
       [(d) Minor Use and Minor Species New Animal Drugs.--Chapter 
     V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
     et seq.) is amended by adding at the end the following:

   [``Subchapter F--New Animal Drugs for Minor Use and Minor Species

     [``SEC. 571. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS FOR 
                   MINOR USE AND MINOR SPECIES.

       [``(a)(1) Except as provided in paragraph (3) of this 
     section, any person may file with the Secretary an 
     application for conditional approval of a new animal drug 
     intended for a minor use or a minor species. Such an 
     application may not be a supplement to an application 
     approved under section 512. Such application must comply in 
     all respects with the provisions of section 512 of this Act 
     except sections 512(a)(4), 512(b)(2), 512(c)(1),

[[Page 3641]]

     512(c)(2), 512(c)(3), 512(d)(1), 512(e), 512(h), and 512(n) 
     unless otherwise stated in this section, and any additional 
     provisions of this section.
       [``(2) The applicant shall submit to the Secretary as part 
     of an application for the conditional approval of a new 
     animal drug--
       [``(A) all information necessary to meet the requirements 
     of section 512(b)(1) except section 512(b)(1)(A);
       [``(B) full reports of investigations which have been made 
     to show whether or not such drug is safe and there is a 
     reasonable expectation of effectiveness for use;
       [``(C) data for establishing a conditional dose;
       [``(D) projections of expected need and the justification 
     for that expectation based on the best information available;
       [``(E) information regarding the quantity of drug expected 
     to be distributed on an annual basis to meet the expected 
     need; and
       [``(F) a commitment that the applicant will conduct 
     additional investigations to meet the requirements for the 
     full demonstration of effectiveness under section 
     512(d)(1)(E) within 5 years.
       [``(3) A person may not file an application under paragraph 
     (1) if--
       [``(A) the person has previously filed an application for 
     conditional approval under paragraph (1) for the same drug in 
     the same dosage form for the same intended use whether or not 
     subsequently conditionally approved by the Secretary under 
     subsection (b), or
       [``(B) the person obtained the application, or data or 
     other information contained therein, directly or indirectly 
     from the person who filed for conditional approval under 
     paragraph (1) for the same drug in the same dosage form for 
     the same intended use whether or not subsequently 
     conditionally approved by the Secretary under subsection (b).
       [``(b) Within 180 days after the filing of an application 
     pursuant to subsection (a), or such additional period as may 
     be agreed upon by the Secretary and the applicant, the 
     Secretary shall either--
       [``(1) issue an order, effective for one year, 
     conditionally approving the application if the Secretary 
     finds that none of the grounds for denying conditional 
     approval, specified in subsection (c) of this section 
     applies, or
       [``(2) give the applicant notice of an opportunity for an 
     informal hearing on the question whether such application can 
     be conditionally approved.
       [``(c) If the Secretary finds, after giving the applicant 
     notice and an opportunity for an informal hearing, that--
       [``(1) any of the provisions of section 512(d)(1) (A) 
     through (D) or (F) through (I) are applicable;
       [``(2) the information submitted to the Secretary as part 
     of the application and any other information before the 
     Secretary with respect to such drug, is insufficient to show 
     that there is a reasonable expectation that the drug will 
     have the effect it purports or is represented to have under 
     the conditions of use prescribed, recommended, or suggested 
     in the proposed labeling thereof; or
       [``(3) another person has received approval under section 
     512 for the same drug in the same dosage form for the same 
     intended use, and that person is able to assure the 
     availability of sufficient quantities of the drug to meet the 
     needs for which the drug is intended;
     [the Secretary shall issue an order refusing to conditionally 
     approve the application. If, after such notice and 
     opportunity for an informal hearing, the Secretary finds that 
     paragraphs (1) through (3) do not apply, the Secretary shall 
     issue an order conditionally approving the application 
     effective for one year. Any order issued under this 
     subsection refusing to conditionally approve an application 
     shall state the findings upon which it is based.
       [``(d) A conditional approval under this section is 
     effective for a 1-year period and is thereafter renewable by 
     the Secretary annually for up to 4 additional 1-year terms. A 
     conditional approval shall be in effect for no more than 5 
     years from the date of approval under subsection (b)(1) or 
     (c) of this section unless extended as provided for in 
     subsection (h) of this section. The following shall also 
     apply:
       [``(1) No later than 90 days from the end of the 1-year 
     period for which the original or renewed conditional approval 
     is effective, the applicant may submit a request to renew a 
     conditional approval for an additional 1-year term.
       [``(2) A conditional approval shall be deemed renewed at 
     the end of the 1-year period, or at the end of a 90-day 
     extension that the Secretary may, at the Secretary's 
     discretion, grant by letter in order to complete review of 
     the renewal request, unless the Secretary determines before 
     the expiration of the 1-year period or the 90-day extension 
     that--
       [``(A) the applicant failed to submit a timely renewal 
     request;
       [``(B) the request fails to contain sufficient information 
     to show that--
       [``(i) the applicant is making sufficient progress toward 
     meeting approval requirements under section 512(d)(1)(E), and 
     is likely to be able to fulfill those requirements and obtain 
     an approval under section 512 before the expiration of the 5-
     year maximum term of the conditional approval;
       [``(ii) the quantity of the drug that has been distributed 
     is consistent with the conditionally approved intended use 
     and conditions of use, unless there is adequate explanation 
     that ensures that the drug is only used for its intended 
     purpose; or
       [``(iii) the same drug in the same dosage form for the same 
     intended use has not received approval under section 512, or 
     if such a drug has been approved, that the holder of the 
     approved application is unable to assure the availability of 
     sufficient quantities of the drug to meet the needs for which 
     the drug is intended; or
       [``(C) any of the provisions of section 512(e)(1) (A) 
     through (B) or (D) through (F) are applicable.
       [``(3) If the Secretary determines before the end of the 1-
     year period or the 90-day extension, if granted, that a 
     conditional approval should not be renewed, the Secretary 
     shall issue an order refusing to renew the conditional 
     approval, and such conditional approval shall be deemed 
     withdrawn and no longer in effect. The Secretary shall 
     thereafter provide an opportunity for an informal hearing to 
     the applicant on the issue whether the conditional approval 
     shall be reinstated.
       [``(e)(1) The Secretary shall issue an order withdrawing 
     conditional approval of an application filed pursuant to 
     subsection (a) if the Secretary finds that another person has 
     received approval under section 512 for the same drug in the 
     same dosage form for the same intended use and that person is 
     able to assure the availability of sufficient quantities of 
     the drug to meet the needs for which the drug is intended.
       [``(2) The Secretary shall, after due notice and 
     opportunity for an informal hearing to the applicant, issue 
     an order withdrawing conditional approval of an application 
     filed pursuant to subsection (a) if the Secretary finds 
     that--
       [``(A) any of the provisions of section 512(e)(1) (A) 
     through (B) or (D) through (F) are applicable; or
       [``(B) on the basis of new information before the Secretary 
     with respect to such drug, evaluated together with the 
     evidence available to the Secretary when the application was 
     conditionally approved, that there is not a reasonable 
     expectation that such drug will have the effect it purports 
     or is represented to have under the conditions of use 
     prescribed, recommended, or suggested in the labeling 
     thereof.
       [``(3) The Secretary may also, after due notice and 
     opportunity for an informal hearing to the applicant, issue 
     an order withdrawing conditional approval of an application 
     filed pursuant to subsection (a) if the Secretary finds that 
     any of the provisions of section 512(e)(2) are applicable.
       [``(f)(1) The label and labeling of a new animal drug with 
     a conditional approval under this section shall--
       [``(A) bear the statement, `conditionally approved by FDA 
     pending a full demonstration of effectiveness under 
     application number'; and
       [``(B) contain such other information as prescribed by the 
     Secretary.
       [``(2) An intended use that is the subject of a conditional 
     approval under this section shall not be included in the same 
     product label with any intended use approved under section 
     512.
       [``(g) A conditionally approved new animal drug application 
     may not be amended or supplemented to add indications for 
     use.
       [``(h) 180 days prior to the termination date established 
     under subsection (d)(1) of this section, an applicant shall 
     have submitted all the information necessary to support a 
     complete new animal drug application in accordance with 
     section 512(b)(1) or the conditional approval issued under 
     this section is no longer in effect. Following review of this 
     information, the Secretary shall either--
       [``(1) issue an order approving the application under 
     section 512(c) if the Secretary finds that none of the 
     grounds for denying approval specified in section 512(d)(1) 
     applies, or
       [``(2) give the applicant an opportunity for a hearing 
     before the Secretary under section 512(d) on the question 
     whether such application can be approved.
     [Upon issuance of an order approving the application, product 
     labeling and administrative records of approval shall be 
     modified accordingly. If the Secretary has not issued an 
     order under section 512(c) approving such application prior 
     to the termination date established under subsection (d)(1) 
     of this section, the conditional approval issued under this 
     section is no longer in effect unless the Secretary grants an 
     extension of an additional 180-day period so that the 
     Secretary can complete review of the application. The 
     decision to grant an extension is committed to the discretion 
     of the Secretary and not subject to judicial review.
       [``(i) The decision of the Secretary under subsection (c), 
     (d), or (e) of this section refusing or withdrawing 
     conditional approval of an application shall constitute final 
     agency action subject to judicial review.

     [``SEC. 572. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL 
                   DRUGS FOR MINOR SPECIES.

       [``(a) The Secretary shall establish an index of unapproved 
     minor species new animal drugs that may be lawfully marketed 
     for

[[Page 3642]]

     use in minor species. The index shall be limited to--
       [``(1) new animal drugs intended for use in a minor species 
     for which there is a reasonable certainty that the animal or 
     edible products from the animal will not be consumed by 
     humans or food-producing animals, and
       [``(2) new animal drugs intended for use in an early life 
     stage of a food-producing minor species where human food 
     safety can be demonstrated in accordance with the standard of 
     section 512(d) by showing that--
       [``(A) there is no significant likelihood that harmful 
     residues will be present in the animal or edible products 
     from the animal presented as food for humans as a result of 
     treatment at the early life stage;
       [``(B) there is no significant likelihood that harmful 
     residues will be present in the animal or edible products 
     from the animal presented as food for food-producing animals 
     as a result of treatment at the early life stage; and
       [``(C) there are no concerns about the use of the drug at 
     later life stages because a tolerance and regulatory method 
     to test for the drug at later life stages are available or 
     there is no practical use for the drug in later life stages.
       [``(b) Any person intending to file a request under this 
     section shall be entitled to one or more conferences to 
     discuss the requirements for indexing a new animal drug.
       [``(c)(1) Any person may submit a request to the Secretary 
     for a determination whether a new animal drug may be eligible 
     for inclusion in the index. Such a request shall include--
       [``(A) information regarding the need for the new animal 
     drug, the species for which the new animal drug is intended, 
     the proposed intended use and conditions of use, and 
     anticipated annual distribution;
       [``(B) information to support the conclusion that the 
     proposed use meets the conditions of subsection (a)(1) or 
     (a)(2) of this section;
       [``(C) information regarding the components and composition 
     of the new animal drug;
       [``(D) a description of the methods used in, and the 
     facilities and controls used for, the manufacture, 
     processing, and packing of such new animal drug;
       [``(E) an environmental assessment or information to 
     support a categorical exclusion from the requirement to 
     prepare an environmental assessment;
       [``(F) information sufficient to support the conclusion 
     that the proposed use of the new animal drug does not present 
     a threat to the safety of individuals exposed to the new 
     animal drug through its manufacture or use; and
       [``(G) such other information as the Secretary may deem 
     necessary to make this eligibility determination.
       [``(2) Within 90 days after the submission of a request for 
     a determination of eligibility for indexing based on 
     subsection (a)(1) of this section, or 180 days for a request 
     submitted based on subsection (a)(2) of this section, the 
     Secretary shall grant or deny the request, and notify the 
     person who requested such determination of the Secretary's 
     decision. The Secretary shall grant the request if the 
     Secretary finds that--
       [``(A) the same drug in the same dosage form for the same 
     intended use is not approved or conditionally approved;
       [``(B) the proposed use does not raise concerns related to 
     safety; and
       [``(C) the person requesting the determination has 
     established appropriate specifications for the manufacture 
     and control of the new animal drug and has demonstrated an 
     understanding of the requirements of current good 
     manufacturing practices.
     [If the Secretary denies the request, the Secretary shall 
     thereafter provide due notice and an opportunity for an 
     informal conference. A decision of the Secretary to deny an 
     eligibility request following an informal conference shall 
     constitute final agency action subject to judicial review.
       [``(d)(1) With respect to a new animal drug for which the 
     Secretary has made a determination of eligibility under 
     subsection (b), the person who made such a request may ask 
     that the Secretary add the new animal drug to the index 
     established under subsection (a). The request for addition to 
     the index shall include--
       [``(A) a copy of the Secretary's determination of 
     eligibility issued under subsection (b);
       [``(B) a written report that meets the requirements in 
     subsection (d)(2) of this section;
       [``(C) a proposed index entry;
       [``(D) facsimile labeling;
       [``(E) anticipated annual distribution of the new animal 
     drug;
       [``(F) a written commitment to manufacture the new animal 
     drug and animal feeds bearing or containing such new animal 
     drug according to current good manufacturing practices;
       [``(G) a written commitment to label, distribute, and 
     promote the new animal drug only in accordance with the index 
     entry;
       [``(H) upon specific request of the Secretary, information 
     submitted to the expert panel described in paragraph (3); and
       [``(I) any additional requirements that the Secretary may 
     prescribe by general regulation or specific order.
       [``(2) The report required in paragraph (1) shall--
       [``(A) be authored by a qualified expert panel;
       [``(B) include an evaluation of all available target animal 
     safety and effectiveness information, including anecdotal 
     information;
       [``(C) state the expert panel's opinion regarding whether 
     the benefits of using the new animal drug for the proposed 
     use in a minor species outweigh its risks, taking into 
     account the harm being caused by the absence of an approved 
     or conditionally approved new animal drug for the minor 
     species in question;
       [``(D) include information from which labeling can be 
     written; and
       [``(E) include a recommendation regarding whether the new 
     animal drug should be limited to use under the professional 
     supervision of a licensed veterinarian.
       [``(3) A qualified expert panel, as used in this section, 
     is a panel that--
       [``(A) is composed of experts qualified by scientific 
     training and experience to evaluate the target animal safety 
     and effectiveness of the new animal drug under consideration;
       [``(B) operates external to FDA; and
       [``(C) is not subject to the Federal Advisory Committee 
     Act, 5 U.S.C. App. 2.
     [The Secretary shall define the criteria for selection of a 
     qualified expert panel and the procedures for the operation 
     of the panel by regulation.
       [``(4) Within 180 days after the receipt of a request for 
     listing a new animal drug in the index, the Secretary shall 
     grant or deny the request. The Secretary shall grant the 
     request if the request for indexing continues to meet the 
     eligibility criteria in subsection (a) and the Secretary 
     finds, on the basis of the report of the qualified expert 
     panel and other information available to the Secretary, that 
     the benefits of using the new animal drug for the proposed 
     use in a minor species outweigh its risks, taking into 
     account the harm caused by the absence of an approved or 
     conditionally-approved new animal drug for the minor species 
     in question. If the Secretary denies the request, the 
     Secretary shall thereafter provide due notice and the 
     opportunity for an informal conference. The decision of the 
     Secretary following an informal conference shall constitute 
     final agency action subject to judicial review.
       [``(e)(1) The index established under subsection (a) shall 
     include the following information for each listed drug--
       [``(A) the name and address of the person who holds the 
     index listing;
       [``(B) the name of the drug and the intended use and 
     conditions of use for which it is being indexed;
       [``(C) product labeling; and
       [``(D) conditions and any limitations that the Secretary 
     deems necessary regarding use of the drug.
       [``(2) The Secretary shall publish the index, and revise it 
     periodically.
       [``(3) The Secretary may establish by regulation a process 
     for reporting changes in the conditions of manufacturing or 
     labeling of indexed products.
       [``(f)(1) If the Secretary finds, after due notice to the 
     person who requested the index listing and an opportunity for 
     an informal conference, that--
       [``(A) the expert panel failed to meet the requirements as 
     set forth by the Secretary by regulation;
       [``(B) on the basis of new information before the 
     Secretary, evaluated together with the evidence available to 
     the Secretary when the new animal drug was listed in the 
     index, the benefits of using the new animal drug for the 
     indexed use do not outweigh its risks;
       [``(C) the conditions of subsection (c)(2) of this section 
     are no longer satisfied;
       [``(D) the manufacture of the new animal drug is not in 
     accordance with current good manufacturing practices;
       [``(E) the labeling, distribution, or promotion of the new 
     animal drug is not in accordance with the index entry;
       [``(F) the conditions and limitations of use associated 
     with the index listing have not been followed; or
       [``(G) the request for indexing contains any untrue 
     statement of material fact,
     the Secretary shall remove the new animal drug from the 
     index. The decision of the Secretary following an informal 
     conference shall constitute final agency action subject to 
     judicial review.
       [``(2) If the Secretary finds that there is a reasonable 
     probability that the use of the drug would present a risk to 
     the health of humans or other animals, the Secretary may--
       [``(A) suspend the listing of such drug immediately;
       [``(B) give the person listed in the index prompt notice of 
     the Secretary's action; and
       [``(C) afford that person the opportunity for an informal 
     conference.
     [The decision of the Secretary following an informal 
     conference shall constitute final agency action subject to 
     judicial review.
       [``(g) For purposes of indexing new animal drugs under this 
     section, to the extent consistent with the public health, the 
     Secretary shall promulgate regulations for exempting from the 
     operation of section 512 minor species new animal drugs and 
     animal feeds bearing or containing new animal drugs intended

[[Page 3643]]

     solely for investigational use by experts qualified by 
     scientific training and experience to investigate the safety 
     and effectiveness of minor species animal drugs. Such 
     regulations may, at the discretion of the Secretary, among 
     other conditions relating to the protection of the public 
     health, provide for conditioning such exemption upon the 
     establishment and maintenance of such records, and the making 
     of such reports to the Secretary, by the manufacturer or the 
     sponsor of the investigation of such article, of data 
     (including but not limited to analytical reports by 
     investigators) obtained as a result of such investigational 
     use of such article, as the Secretary finds will enable the 
     Secretary to evaluate the safety and effectiveness of such 
     article in the event of the filing of a request for an index 
     listing pursuant to this section.
       [``(h) The labeling of a new animal drug that is the 
     subject of an index listing shall state, prominently and 
     conspicuously--
       [``(1) `Not approved by fda.--Legally marketed as an FDA 
     indexed product. Extra-label use is prohibited.';
       [``(2) except in the case of new animal drugs indexed for 
     use in an early life stage of a food-producing animal, `This 
     product is not to be used in animals intended for use as food 
     for humans or other animals.'; and
       [``(3) such other information as may be prescribed by the 
     Secretary in the index listing.
       [``(i)(1) In the case of any new animal drug for which an 
     index listing pursuant to subsection (a) is in effect, the 
     person who has an index listing shall establish and maintain 
     such records, and make such reports to the Secretary, of data 
     relating to experience, and other data or information, 
     received or otherwise obtained by such person with respect to 
     such drug, or with respect to animal feeds bearing or 
     containing such drug, as the Secretary may by general 
     regulation, or by order with respect to such listing, 
     prescribe on the basis of a finding that such records and 
     reports are necessary in order to enable the Secretary to 
     determine, or facilitate a determination, whether there is or 
     may be ground for invoking subsection (f). Such regulation or 
     order shall provide, where the Secretary deems it to be 
     appropriate, for the examination, upon request, by the 
     persons to whom such regulation or order is applicable, of 
     similar information received or otherwise obtained by the 
     Secretary.
       [``(2) Every person required under this subsection to 
     maintain records, and every person in charge or custody 
     thereof, shall, upon request of an officer or employee 
     designated by the Secretary, permit such officer or employee 
     at all reasonable times to have access to and copy and verify 
     such records.
       [``(j)(1) Safety and effectiveness data and information 
     which has been submitted in support of a request for a new 
     animal drug to be indexed under this section and which has 
     not been previously disclosed to the public shall be made 
     available to the public, upon request, unless extraordinary 
     circumstances are shown--
       [``(A) if no work is being or will be undertaken to have 
     the drug indexed in accordance with the request,
       [``(B) if the Secretary has determined that such drug 
     cannot be indexed and all legal appeals have been exhausted,
       [``(C) if the indexing of such drug is terminated and all 
     legal appeals have been exhausted, or
       [``(D) if the Secretary has determined that such drug is 
     not a new animal drug.
       [``(2) Any request for data and information pursuant to 
     paragraph (1) shall include a verified statement by the 
     person making the request that any data or information 
     received under such paragraph shall not be disclosed by such 
     person to any other person--
       [``(A) for the purpose of, or as part of a plan, scheme, or 
     device for, obtaining the right to make, use, or market, or 
     making, using, or marketing, outside the United States, the 
     drug identified in the request for indexing; and
       [``(B) without obtaining from any person to whom the data 
     and information are disclosed an identical verified 
     statement, a copy of which is to be provided by such person 
     to the Secretary, which meets the requirements of this 
     paragraph.

     [``SEC. 573. DESIGNATED NEW ANIMAL DRUGS FOR MINOR USE OR 
                   MINOR SPECIES.

       [``(a) Designation.--
       [``(1) The manufacturer or the sponsor of a new animal drug 
     for a minor use or use in a minor species may request that 
     the Secretary declare that drug a `designated new animal 
     drug'. A request for designation of a new animal drug shall 
     be made before the submission of an application under section 
     512(b) or section 571 for the new animal drug.
       [``(2) The Secretary may declare a new animal drug a 
     `designated new animal drug' for an intended use if--
       [``(A) it is intended for a minor use or use in a minor 
     species; and
       [``(B) the same drug in the same dosage form for the same 
     intended use is not approved under section 512 or 571 or 
     designated under this section at the time the request is 
     made.
       [``(3) Regarding the termination of a designation--
       [``(A) the sponsor of a new animal drug shall notify the 
     Secretary of any decision to discontinue active pursuit of 
     approval under section 512 or 571 of an application for a 
     designated new animal drug. The Secretary shall terminate the 
     designation upon such notification;
       [``(B) the Secretary may also terminate designation if the 
     Secretary independently determines that the sponsor is not 
     actively pursuing approval under section 512 or 571 with due 
     diligence;
       [``(C) the sponsor of an approved designated new animal 
     drug shall notify the Secretary of any discontinuance of the 
     manufacture of such new animal drug at least one year before 
     discontinuance. The Secretary shall terminate the designation 
     upon such notification; and
       [``(D) the designation shall terminate upon the expiration 
     of any applicable exclusivity period under subsection (c).
       [``(4) Notice respecting the designation or termination of 
     designation of a new animal drug shall be made available to 
     the public.
       [``(b) Grants and Contracts for Development of Designated 
     New Animal Drugs.--
       [``(1) The Secretary may make grants to and enter into 
     contracts with public and private entities and individuals to 
     assist in defraying the costs of qualified safety and 
     effectiveness testing expenses and manufacturing expenses 
     incurred in connection with the development of designated new 
     animal drugs.
       [``(2) For purposes of paragraph (1) of this section--
       [``(A) The term `qualified safety and effectiveness 
     testing' means testing--
       [``(i) which occurs after the date such new animal drug is 
     designated under this section and before the date on which an 
     application with respect to such drug is submitted under 
     section 512; and
       [``(ii) which is carried out under an investigational 
     exemption under section 512(j).
       [``(B) The term `manufacturing expenses' means expenses 
     incurred in developing processes and procedures associated 
     with manufacture of the designated new animal drug which 
     occur after the new animal drug is designated under this 
     section and before the date on which an application with 
     respect to such new animal drug is submitted under section 
     512 or 571.
       [``(c) Exclusivity for Designated New Animal Drugs.--
       [``(1) Except as provided in subsection (c)(2), if the 
     Secretary--
       [``(A) approves or conditionally approves an application 
     for a designated new animal drug, and no active ingredient 
     (including any salt or ester of the active ingredient) of 
     that designated new animal drug has been approved or 
     conditionally approved previously, the Secretary may not 
     approve or conditionally approve another application 
     submitted for a new animal drug with the same active 
     ingredient and intended use as the designated new animal drug 
     for another applicant before the expiration of ten years from 
     the date of the approval or conditional approval of the 
     application.
       [``(B) approves or conditionally approves an application 
     for a designated new animal drug, and an active ingredient 
     (including an ester or salt of the active ingredient) of that 
     designated new animal drug has been approved or conditionally 
     approved previously, the Secretary may not approve or 
     conditionally approve another application submitted for a new 
     animal drug with the same active ingredient and intended use 
     as the designated new animal drug for another applicant 
     before the expiration of seven years from the date of 
     approval or conditional approval of the application.
       [``(2) If an application filed pursuant to section 512 or 
     section 571 is approved for a designated new animal drug, the 
     Secretary may, during the 10-year or 7-year exclusivity 
     period beginning on the date of the application approval or 
     conditional approval, approve or conditionally approve 
     another application under section 512 or section 571 for such 
     drug for such minor use or minor species for another 
     applicant if--
       [``(A) the Secretary finds, after providing the holder of 
     such an approved application notice and opportunity for the 
     submission of views, that in the granted exclusivity period 
     the holder of the approved application cannot assure the 
     availability of sufficient quantities of the drug to meet the 
     needs for which the drug was designated; or
       [``(B) such holder provides written consent to the 
     Secretary for the approval or conditional approval of other 
     applications before the expiration of such exclusivity 
     period.''.
       [(e) Conforming Amendments.--
       [(1) Section 201(u) of the Federal Food, Drug, and Cosmetic 
     Act is amended by striking ``512'' and inserting ``512, 
     571''.
       [(2) Section 201(v) of the Federal Food, Drug, and Cosmetic 
     Act is amended by inserting the following after paragraph 
     (2): ``Provided that any drug intended for minor use or use 
     in a minor species that is not the subject of a final 
     regulation published by the Secretary through notice and 
     comment rulemaking finding that the criteria of paragraphs 
     (1) and (2) have not been met (or that the exception to the 
     criterion in paragraph (1) has been met) is a new animal 
     drug.''.
       [(3) Section 301(e) of the Federal Food, Drug, and Cosmetic 
     Act is amended by striking ``512(a)(4)(C), 512(j), (l) or 
     (m)'' and inserting ``512(a)(4)(C), 512 (j), (l) or (m), 
     572(i).''
       [(4) Section 301(j) of the Federal Food, Drug, and Cosmetic 
     Act is amended by deleting ``520'' and inserting ``520, 571, 
     572, 573.''

[[Page 3644]]

       [(5) Section 502 of the Federal Food, Drug, and Cosmetic 
     Act is amended by adding at the end the following new 
     subsection:
       [``(u) If it is a new animal drug--
       [``(1) that is conditionally approved under section 571 and 
     its labeling does not conform with the approved application 
     or section 571(f), or that is not conditionally approved 
     under section 571 and its label bears the statement set forth 
     in section 571(f)(1)(A); or
       [``(2) that is indexed under section 572 and its labeling 
     does not conform with the index listing under section 572(e) 
     or 572(h), or that has not been indexed under section 572 and 
     its label bears the statement set forth in section 572(h).''.
       [(6) Section 503(f) of the Federal Food, Drug, and Cosmetic 
     Act is amended by--
       [(A) in paragraph (1)(A)(ii) by striking ``512'' and 
     inserting ``512, a conditionally-approved application under 
     section 571, or an index listing under section 572''; and
       [(B) in paragraph (3) by striking ``section 512'' and 
     inserting ``section 512, 571, or 572''.
       [(7) Section 504(a)(1) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``512(b)'' and inserting 
     ``512(b), a conditionally-approved application filed pursuant 
     to section 571, or an index listing pursuant to section 
     572''.
       [(8) Sections 504(a)(2)(B) and 504(b) of the Federal Food, 
     Drug, and Cosmetic Act are amended by striking ``512(i)'' 
     each place it appears and inserting ``512(i), or the index 
     listing pursuant to section 572(e)''.
       [(9) Section 512(a) of the Federal Food, Drug, and Cosmetic 
     Act is amended by striking paragraphs (1) and (2) and 
     inserting the following:
       [``(1) A new animal drug shall, with respect to any 
     particular use or intended use of such drug, be deemed unsafe 
     for purposes of section 501(a)(5) and section 
     402(a)(2)(C)(ii) unless--
       [``(A) there is in effect an approval of an application 
     filed pursuant to subsection (b) with respect to such use or 
     intended use of such drug, and such drug, its labeling, and 
     such use conform to such approved application;
       [``(B) there is in effect a conditional approval of an 
     application filed pursuant to section 571 with respect to 
     such use or intended use of such drug, and such drug, its 
     labeling, and such use conform to such conditionally approved 
     application; or
       [``(C) there is in effect an index listing pursuant to 
     section 572 with respect to such use or intended use of such 
     drug in a minor species, and such drug, its labeling, and 
     such use conform to such index listing.
     [A new animal drug shall also be deemed unsafe for such 
     purposes in the event of removal from the establishment of a 
     manufacturer, packer, or distributor of such drug for use in 
     the manufacture of animal feed in any State unless at the 
     time of such removal such manufacturer, packer, or 
     distributor has an unrevoked written statement from the 
     consignee of such drug, or notice from the Secretary, to the 
     effect that, with respect to the use of such drug in animal 
     feed, such consignee (i) holds a license issued under 
     subsection (m) and has in its possession current approved 
     labeling for such drug in animal feed; or (ii) will, if the 
     consignee is not a user of the drug, ship such drug only to a 
     holder of a license issued under subsection (m).
       [``(2) An animal feed bearing or containing a new animal 
     drug shall, with respect to any particular use or intended 
     use of such animal feed be deemed unsafe for purposes of 
     section 501(a)(6) unless--
       [``(A) there is in effect--
       [``(i) an approval of an application filed pursuant to 
     subsection (b) with respect to such drug, as used in such 
     animal feed, and such animal feed and its labeling, 
     distribution, holding, and use conform to such approved 
     application;
       [``(ii) a conditional approval of an application filed 
     pursuant to section 571 with respect to such drug, as used in 
     such animal feed, and such animal feed and its labeling, 
     distribution, holding, and use conform to such conditionally 
     approved application; or
       [``(iii) an index listing pursuant to section 572 with 
     respect to such drug, as used in such animal feed, and such 
     animal feed and its labeling, distribution, holding, and use 
     conform to such index listing; and
       [``(B) such animal feed is manufactured at a site for which 
     there is in effect a license issued pursuant to subsection 
     (m)(1) to manufacture such animal feed.''.
       [(10) Section 512(b)(3) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``under paragraph (1) or 
     a request for an investigational exemption under subsection 
     (j)'' and inserting ``under paragraph (1), section 571, or a 
     request for an investigational exemption under subsection 
     (j)''.
       [(11) Section 512(d)(4) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``have previously been 
     separately approved'' and inserting ``have previously been 
     separately approved pursuant to an application submitted 
     under section 512(b)(1)''.
       [(12) Section 512(f) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``subsection (d), (e), or 
     (m)'' and inserting ``subsection (d), (e), or (m), or section 
     571 (c), (d), or (e)''.
       [(13) Section 512(g) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``this section'' and 
     inserting ``this section, or section 571''.
       [(14) Section 512(i) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``subsection (b)'' and 
     inserting ``subsection (b) or section 571'' and by inserting 
     ``or upon failure to renew a conditional approval under 
     section 571'' after ``or upon its suspension''.
       [(15) Section 512(l)(1) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``subsection (b)'' and 
     inserting ``subsection (b) or section 571''.
       [(16) Section 512(m)(1)(C) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``applicable regulations 
     published pursuant to subsection (i)'' and inserting 
     ``applicable regulations published pursuant to subsection (i) 
     or for indexed new animal drugs in accordance with the index 
     listing published pursuant to section 572(e)(2) and the 
     labeling requirements set forth in section 572(h)''.
       [(17) Section 512(m)(3) of the Federal Food, Drug, and 
     Cosmetic Act is amended by inserting ``or an index listing 
     pursuant to section 572(e)'' after ``subsection (i)'' each 
     place it appears.
       [(18) Section 512(p)(1) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``subsection (b)(1)'' and 
     inserting ``subsection (b)(1) or section 571(a)''.
       [(19) Section 512(p)(2) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``subsection (b)(1)'' and 
     inserting ``subsection (b)(1) or section 571(a)''.
       [(20) Section 108(b)(3) of Public Law 90-399 is amended by 
     striking ``section 201(w) as added by this Act'' and 
     inserting ``section 201(v) as added by the Minor Use and 
     Minor Species Animal Health Act of 2003''.
       [(f) Regulations.--The Secretary of Health and Human 
     Services shall implement sections 571 and 573 of the Federal 
     Food, Drug, and Cosmetic Act and subsequently publish 
     implementing regulations. Not later than 12 months after the 
     date of enactment of this Act, the Secretary shall issue 
     proposed regulations to implement section 573 of the Federal 
     Food, Drug, and Cosmetic Act (as added by this Act), and not 
     later than 24 months after the date of enactment of this Act, 
     the Secretary shall issue final regulations implementing 
     section 573 of the Federal Food, Drug, and Cosmetic Act. Not 
     later than 18 months after the date of enactment of this Act, 
     the Secretary shall issue proposed regulations to implement 
     section 572 of the Federal Food, Drug, and Cosmetic Act (as 
     added by this Act), and not later than 36 months after the 
     date of enactment of this Act, the Secretary shall issue 
     final regulations implementing section 572 of the Federal 
     Food, Drug, and Cosmetic Act. Not later than 30 months after 
     the date of enactment of this Act, the Secretary shall issue 
     proposed regulations to implement section 571 of the Federal 
     Food, Drug, and Cosmetic Act (as added by this Act), and not 
     later than 42 months after the date of enactment of this Act, 
     the Secretary shall issue final regulations implementing 
     section 571 of the Federal Food, Drug, and Cosmetic Act. 
     These timeframes shall be extended by 12 months for each 
     fiscal year, in which the funds authorized to be appropriated 
     under subsection (i) are not in fact appropriated.
       [(g) Office.--The Secretary of Health and Human Services 
     shall establish within the Center for Veterinary Medicine (of 
     the Food and Drug Administration), an Office of Minor Use and 
     Minor Species Animal Drug Development that reports directly 
     to the Director of the Center for Veterinary Medicine. This 
     office shall be responsible for overseeing the development 
     and legal marketing of new animal drugs for minor uses and 
     minor species. There is authorized to be appropriated to 
     carry out this subsection $1,200,000 for fiscal year 2003 and 
     such sums as may be necessary for each fiscal year 
     thereafter.
       [(h) Authorization of Appropriations.--There is authorized 
     to be appropriated to carry out section 573(b) of the Federal 
     Food, Drug, and Cosmetic Act (as added by this Act) 
     $1,000,000 for the fiscal year following publication of final 
     implementing regulations, $2,000,000 for the subsequent 
     fiscal year, and such sums as may be necessary for each 
     fiscal year thereafter.]

              TITLE I--MINOR USE AND MINOR SPECIES HEALTH

     SECTION 101. SHORT TITLE.

       This title may be cited as the ``Minor Use and Minor 
     Species Animal Health Act of 2003''.

     SEC. 102. MINOR USE AND MINOR SPECIES ANIMAL HEALTH.

       (a) Findings.--Congress makes the following findings:
       (1) There is a severe shortage of approved new animal drugs 
     for use in minor species.
       (2) There is a severe shortage of approved new animal drugs 
     for treating animal diseases and conditions that occur 
     infrequently or in limited geographic areas.
       (3) Because of the small market shares, low-profit margins 
     involved, and capital investment required, it is generally 
     not economically feasible for new animal drug applicants to 
     pursue approvals for these species, diseases, and conditions.
       (4) Because the populations for which such new animal drugs 
     are intended may be small and conditions of animal management 
     may vary widely, it is often difficult to design and conduct 
     studies to establish drug safety and effectiveness under 
     traditional new animal drug approval processes.

[[Page 3645]]

       (5) It is in the public interest and in the interest of 
     animal welfare to provide for special procedures to allow the 
     lawful use and marketing of certain new animal drugs for 
     minor species and minor uses that take into account these 
     special circumstances and that ensure that such drugs do not 
     endanger animal or public health.
       (6) Exclusive marketing rights for clinical testing 
     expenses have helped encourage the development of ``orphan'' 
     drugs for human use, and comparable incentives should 
     encourage the development of new animal drugs for minor 
     species and minor uses.
       (b) Amendments to the Federal Food, Drug, and Cosmetic 
     Act.--
       (1) Definitions.--Section 201 of the Federal, Food, Drug, 
     and Cosmetic Act (21 U.S.C. 321) is amended by adding at the 
     end the following:
       ``(nn) The term `major species' means cattle, horses, 
     swine, chickens, turkeys, dogs, and cats, except that the 
     Secretary may add species to this definition by regulation.
       ``(oo) The term `minor species' means animals other than 
     humans that are not major species.
       ``(pp) The term `minor use' means the intended use of a 
     drug in a major species for an indication that occurs 
     infrequently and in only a small number of animals or in 
     limited geographical areas and in only a small number of 
     animals annually.''.
       (2) Three-year exclusivity for minor use and minor species 
     approvals.--Section 512(c)(2)(F) (ii), (iii), and (v) of the 
     Federal Food, Drug, and Cosmetic Act is amended by striking 
     ``(other than bioequivalence or residue studies)'' and 
     inserting ``(other than bioequivalence studies or residue 
     depletion studies, except residue depletion studies for minor 
     uses or minor species)'' every place it appears.
       (3) Scope of review for minor use and minor species 
     applications.--Section 512(d) of the Federal Food, Drug, and 
     Cosmetic Act is amended by adding at the end the following 
     new paragraph:
       ``(5) In reviewing an application that proposes a change to 
     add an intended use for a minor use or a minor species to an 
     approved new animal drug application, the Secretary shall 
     reevaluate only the relevant information in the approved 
     application to determine whether the application for the 
     minor use or minor species can be approved. A decision to 
     approve the application for the minor use or minor species is 
     not, implicitly or explicitly, a reaffirmation of the 
     approval of the original application.''.
       (4) Minor use and minor species new animal drugs.--Chapter 
     V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
     et seq.) is amended by adding at the end the following:

    ``Subchapter F--New Animal Drugs for Minor Use and Minor Species

     ``SEC. 571. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS FOR 
                   MINOR USE AND MINOR SPECIES.

       ``(a)(1) Except as provided in paragraph (3) of this 
     section, any person may file with the Secretary an 
     application for conditional approval of a new animal drug 
     intended for a minor use or a minor species. Such an 
     application may not be a supplement to an application 
     approved under section 512. Such application must comply in 
     all respects with the provisions of section 512 of this Act 
     except sections 512(a)(4), 512(b)(2), 512(c)(1), 512(c)(2), 
     512(c)(3), 512(d)(1), 512(e), 512(h), and 512(n) unless 
     otherwise stated in this section, and any additional 
     provisions of this section. New animal drugs are subject to 
     application of the same safety standards that would be 
     applied to such drugs under section 512(d) (including, for 
     antimicrobial new animal drugs, with respect to antimicrobial 
     resistance).
       ``(2) The applicant shall submit to the Secretary as part 
     of an application for the conditional approval of a new 
     animal drug--
       ``(A) all information necessary to meet the requirements of 
     section 512(b)(1) except section 512(b)(1)(A);
       ``(B) full reports of investigations which have been made 
     to show whether or not such drug is safe under section 512(d) 
     (including, for an antimicrobial new animal drug, with 
     respect to antimicrobial resistance) and there is a 
     reasonable expectation of effectiveness for use;
       ``(C) data for establishing a conditional dose;
       ``(D) projections of expected need and the justification 
     for that expectation based on the best information available;
       ``(E) information regarding the quantity of drug expected 
     to be distributed on an annual basis to meet the expected 
     need; and
       ``(F) a commitment that the applicant will conduct 
     additional investigations to meet the requirements for the 
     full demonstration of effectiveness under section 
     512(d)(1)(E) within 5 years.
       ``(3) A person may not file an application under paragraph 
     (1) if--
       ``(A) the application seeks conditional approval of a new 
     animal drug that is contained in, or is a product of, a 
     transgenic animal.
       ``(B) the person has previously filed an application for 
     conditional approval under paragraph (1) for the same drug in 
     the same dosage form for the same intended use whether or not 
     subsequently conditionally approved by the Secretary under 
     subsection (b), or
       ``(C) the person obtained the application, or data or other 
     information contained therein, directly or indirectly from 
     the person who filed for conditional approval under paragraph 
     (1) for the same drug in the same dosage form for the same 
     intended use whether or not subsequently conditionally 
     approved by the Secretary under subsection (b).
       ``(b) Within 180 days after the filing of an application 
     pursuant to subsection (a), or such additional period as may 
     be agreed upon by the Secretary and the applicant, the 
     Secretary shall either--
       ``(1) issue an order, effective for one year, conditionally 
     approving the application if the Secretary finds that none of 
     the grounds for denying conditional approval, specified in 
     subsection (c) of this section applies and publish a Federal 
     Register notice of the conditional approval, or
       ``(2) give the applicant notice of an opportunity for an 
     informal hearing on the question whether such application can 
     be conditionally approved.
       ``(c) If the Secretary finds, after giving the applicant 
     notice and an opportunity for an informal hearing, that--
       ``(1) any of the provisions of section 512(d)(1) (A) 
     through (D) or (F) through (I) are applicable;
       ``(2) the information submitted to the Secretary as part of 
     the application and any other information before the 
     Secretary with respect to such drug, is insufficient to show 
     that there is a reasonable expectation that the drug will 
     have the effect it purports or is represented to have under 
     the conditions of use prescribed, recommended, or suggested 
     in the proposed labeling thereof; or
       ``(3) another person has received approval under section 
     512 for the same drug in the same dosage form for the same 
     intended use, and that person is able to assure the 
     availability of sufficient quantities of the drug to meet the 
     needs for which the drug is intended;

     the Secretary shall issue an order refusing to conditionally 
     approve the application. If, after such notice and 
     opportunity for an informal hearing, the Secretary finds that 
     paragraphs (1) through (3) do not apply, the Secretary shall 
     issue an order conditionally approving the application 
     effective for one year and publish a Federal Register notice 
     of the conditional approval. Any order issued under this 
     subsection refusing to conditionally approve an application 
     shall state the findings upon which it is based.
       ``(d) A conditional approval under this section is 
     effective for a 1-year period and is thereafter renewable by 
     the Secretary annually for up to 4 additional 1-year terms. A 
     conditional approval shall be in effect for no more than 5 
     years from the date of approval under subsection (b)(1) or 
     (c) of this section unless extended as provided for in 
     subsection (h) of this section. The following shall also 
     apply:
       ``(1) No later than 90 days from the end of the 1-year 
     period for which the original or renewed conditional approval 
     is effective, the applicant may submit a request to renew a 
     conditional approval for an additional 1-year term.
       ``(2) A conditional approval shall be deemed renewed at the 
     end of the 1-year period, or at the end of a 90-day extension 
     that the Secretary may, at the Secretary's discretion, grant 
     by letter in order to complete review of the renewal request, 
     unless the Secretary determines before the expiration of the 
     1-year period or the 90-day extension that--
       ``(A) the applicant failed to submit a timely renewal 
     request;
       ``(B) the request fails to contain sufficient information 
     to show that--
       ``(i) the applicant is making sufficient progress toward 
     meeting approval requirements under section 512(d)(1)(E), and 
     is likely to be able to fulfill those requirements and obtain 
     an approval under section 512 before the expiration of the 5-
     year maximum term of the conditional approval;
       ``(ii) the quantity of the drug that has been distributed 
     is consistent with the conditionally approved intended use 
     and conditions of use, unless there is adequate explanation 
     that ensures that the drug is only used for its intended 
     purpose; or
       ``(iii) the same drug in the same dosage form for the same 
     intended use has not received approval under section 512, or 
     if such a drug has been approved, that the holder of the 
     approved application is unable to assure the availability of 
     sufficient quantities of the drug to meet the needs for which 
     the drug is intended; or
       ``(C) any of the provisions of section 512(e)(1) (A) 
     through (B) or (D) through (F) are applicable.
       ``(3) If the Secretary determines before the end of the 1-
     year period or the 90-day extension, if granted, that a 
     conditional approval should not be renewed, the Secretary 
     shall issue an order refusing to renew the conditional 
     approval, and such conditional approval shall be deemed 
     withdrawn and no longer in effect. The Secretary shall 
     thereafter provide an opportunity for an informal hearing to 
     the applicant on the issue whether the conditional approval 
     shall be reinstated.
       ``(e)(1) The Secretary shall issue an order withdrawing 
     conditional approval of an application filed pursuant to 
     subsection (a) if the Secretary finds that another person has 
     received approval under section 512 for the same drug in the 
     same dosage form for the same intended use and that person is 
     able to assure the availability of sufficient quantities of 
     the drug to meet the needs for which the drug is intended.
       ``(2) The Secretary shall, after due notice and opportunity 
     for an informal hearing to the applicant, issue an order 
     withdrawing conditional approval of an application filed 
     pursuant to subsection (a) if the Secretary finds that--
       ``(A) any of the provisions of section 512(e)(1) (A) 
     through (B) or (D) through (F) are applicable; or
       ``(B) on the basis of new information before the Secretary 
     with respect to such drug, evaluated together with the 
     evidence available to the

[[Page 3646]]

     Secretary when the application was conditionally approved, 
     that there is not a reasonable expectation that such drug 
     will have the effect it purports or is represented to have 
     under the conditions of use prescribed, recommended, or 
     suggested in the labeling thereof.
       ``(3) The Secretary may also, after due notice and 
     opportunity for an informal hearing to the applicant, issue 
     an order withdrawing conditional approval of an application 
     filed pursuant to subsection (a) if the Secretary finds that 
     any of the provisions of section 512(e)(2) are applicable.
       ``(f)(1) The label and labeling of a new animal drug with a 
     conditional approval under this section shall--
       ``(A) bear the statement, `conditionally approved by FDA 
     pending a full demonstration of effectiveness under 
     application number'; and
       ``(B) contain such other information as prescribed by the 
     Secretary.
       ``(2) An intended use that is the subject of a conditional 
     approval under this section shall not be included in the same 
     product label with any intended use approved under section 
     512.
       ``(g) A conditionally approved new animal drug application 
     may not be amended or supplemented to add indications for 
     use.
       ``(h) 180 days prior to the termination date established 
     under subsection (d) of this section, an applicant shall have 
     submitted all the information necessary to support a complete 
     new animal drug application in accordance with section 
     512(b)(1) or the conditional approval issued under this 
     section is no longer in effect. Following review of this 
     information, the Secretary shall either--
       ``(1) issue an order approving the application under 
     section 512(c) if the Secretary finds that none of the 
     grounds for denying approval specified in section 512(d)(1) 
     applies, or
       ``(2) give the applicant an opportunity for a hearing 
     before the Secretary under section 512(d) on the question 
     whether such application can be approved.

     Upon issuance of an order approving the application, product 
     labeling and administrative records of approval shall be 
     modified accordingly. If the Secretary has not issued an 
     order under section 512(c) approving such application prior 
     to the termination date established under subsection (d) of 
     this section, the conditional approval issued under this 
     section is no longer in effect unless the Secretary grants an 
     extension of an additional 180-day period so that the 
     Secretary can complete review of the application. The 
     decision to grant an extension is committed to the discretion 
     of the Secretary and not subject to judicial review.
       ``(i) The decision of the Secretary under subsection (c), 
     (d), or (e) of this section refusing or withdrawing 
     conditional approval of an application shall constitute final 
     agency action subject to judicial review.
       ``(j) In this section and section 572, the term `transgenic 
     animal' means an animal whose genome contains a nucleotide 
     sequence that has been intentionally modified in vitro, and 
     the progeny of such an animal; Provided that the term 
     `transgenic animal' does not include an animal of which the 
     nucleotide sequence of the genome has been modified solely by 
     selective breeding.

     ``SEC. 572. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL 
                   DRUGS FOR MINOR SPECIES.

       ``(a)(1) The Secretary shall establish an index limited 
     to--
       ``(A) new animal drugs intended for use in a minor species 
     for which there is a reasonable certainty that the animal or 
     edible products from the animal will not be consumed by 
     humans or food-producing animals; and
       ``(B) new animal drugs intended for use only in a hatchery, 
     tank, pond, or other similar contained man-made structure in 
     an early, non-food life stage of a food-producing minor 
     species, where safety for humans is demonstrated in 
     accordance with the standard of section 512(d) (including, 
     for an antimicrobial new animal drug, with respect to 
     antimicrobial resistance).
       ``(2) The index shall not include a new animal drug that is 
     contained in or a product of a transgenic animal.
       ``(b) Any person intending to file a request under this 
     section shall be entitled to one or more conferences to 
     discuss the requirements for indexing a new animal drug.
       ``(c)(1) Any person may submit a request to the Secretary 
     for a determination whether a new animal drug may be eligible 
     for inclusion in the index. Such a request shall include--
       ``(A) information regarding the need for the new animal 
     drug, the species for which the new animal drug is intended, 
     the proposed intended use and conditions of use, and 
     anticipated annual distribution;
       ``(B) information to support the conclusion that the 
     proposed use meets the conditions of subparagraph (A) or (B) 
     of subsection (a)(1) of this section;
       ``(C) information regarding the components and composition 
     of the new animal drug;
       ``(D) a description of the methods used in, and the 
     facilities and controls used for, the manufacture, 
     processing, and packing of such new animal drug;
       ``(E) an environmental assessment that meets the 
     requirements of the National Environmental Policy Act of 
     1969, as amended, and as defined in 21 CFR Part 25, as it 
     appears on the date of enactment of this provision and 
     amended thereafter or information to support a categorical 
     exclusion from the requirement to prepare an environmental 
     assessment;
       ``(F) information sufficient to support the conclusion that 
     the proposed use of the new animal drug is safe under section 
     512(d) with respect to individuals exposed to the new animal 
     drug through its manufacture or use; and
       ``(G) such other information as the Secretary may deem 
     necessary to make this eligibility determination.
       ``(2) Within 90 days after the submission of a request for 
     a determination of eligibility for indexing based on 
     subsection (a)(1)(A) of this section, or 180 days for a 
     request submitted based on subsection (a)(1)(B) of this 
     section, the Secretary shall grant or deny the request, and 
     notify the person who requested such determination of the 
     Secretary's decision. The Secretary shall grant the request 
     if the Secretary finds that--
       ``(A) the same drug in the same dosage form for the same 
     intended use is not approved or conditionally approved;
       ``(B) the proposed use of the drug meets the conditions of 
     subparagraph (A) or (B) of subsection (a)(1), as appropriate;
       ``(C) the person requesting the determination has 
     established appropriate specifications for the manufacture 
     and control of the new animal drug and has demonstrated an 
     understanding of the requirements of current good 
     manufacturing practices;
       ``(D) the new animal drug will not significantly affect the 
     human environment; and
       ``(E) the new animal drug is safe with respect to 
     individuals exposed to the new animal drug through its 
     manufacture or use.

     If the Secretary denies the request, the Secretary shall 
     thereafter provide due notice and an opportunity for an 
     informal conference. A decision of the Secretary to deny an 
     eligibility request following an informal conference shall 
     constitute final agency action subject to judicial review.
       ``(d)(1) With respect to a new animal drug for which the 
     Secretary has made a determination of eligibility under 
     subsection (c), the person who made such a request may ask 
     that the Secretary add the new animal drug to the index 
     established under subsection (a). The request for addition to 
     the index shall include--
       ``(A) a copy of the Secretary's determination of 
     eligibility issued under subsection (c);
       ``(B) a written report that meets the requirements in 
     subsection (d)(2) of this section;
       ``(C) a proposed index entry;
       ``(D) facsimile labeling;
       ``(E) anticipated annual distribution of the new animal 
     drug;
       ``(F) a written commitment to manufacture the new animal 
     drug and animal feeds bearing or containing such new animal 
     drug according to current good manufacturing practices;
       ``(G) a written commitment to label, distribute, and 
     promote the new animal drug only in accordance with the index 
     entry;
       ``(H) upon specific request of the Secretary, information 
     submitted to the expert panel described in paragraph (3); and
       ``(I) any additional requirements that the Secretary may 
     prescribe by general regulation or specific order.
       ``(2) The report required in paragraph (1) shall--
       ``(A) be authored by a qualified expert panel;
       ``(B) include an evaluation of all available target animal 
     safety and effectiveness information, including anecdotal 
     information;
       ``(C) state the expert panel's opinion regarding whether 
     the benefits of using the new animal drug for the proposed 
     use in a minor species outweigh its risks to the target 
     animal, taking into account the harm being caused by the 
     absence of an approved or conditionally approved new animal 
     drug for the minor species in question;
       ``(D) include information from which labeling can be 
     written; and
       ``(E) include a recommendation regarding whether the new 
     animal drug should be limited to use under the professional 
     supervision of a licensed veterinarian.
       ``(3) A qualified expert panel, as used in this section, is 
     a panel that--
       ``(A) is composed of experts qualified by scientific 
     training and experience to evaluate the target animal safety 
     and effectiveness of the new animal drug under consideration;
       ``(B) operates external to FDA; and
       ``(C) is not subject to the Federal Advisory Committee Act, 
     5 U.S.C. App. 2.

     The Secretary shall define the criteria for selection of a 
     qualified expert panel and the procedures for the operation 
     of the panel by regulation.
       ``(4) Within 180 days after the receipt of a request for 
     listing a new animal drug in the index, the Secretary shall 
     grant or deny the request. The Secretary shall grant the 
     request if the request for indexing continues to meet the 
     eligibility criteria in subsection (a) and the Secretary 
     finds, on the basis of the report of the qualified expert 
     panel and other information available to the Secretary, that 
     the benefits of using the new animal drug for the proposed 
     use in a minor species outweigh its risks to the target 
     animal, taking into account the harm caused by the absence of 
     an approved or conditionally-approved new animal drug for the 
     minor species in question. If the Secretary denies the 
     request, the Secretary shall thereafter provide due notice 
     and the opportunity for an informal conference. The decision 
     of the Secretary following an informal conference shall 
     constitute final agency action subject to judicial review.
       ``(e)(1) The index established under subsection (a) shall 
     include the following information for each listed drug--
       ``(A) the name and address of the person who holds the 
     index listing;

[[Page 3647]]

       ``(B) the name of the drug and the intended use and 
     conditions of use for which it is being indexed;
       ``(C) product labeling; and
       ``(D) conditions and any limitations that the Secretary 
     deems necessary regarding use of the drug.
       ``(2) The Secretary shall publish the index, and revise it 
     periodically.
       ``(3) The Secretary may establish by regulation a process 
     for reporting changes in the conditions of manufacturing or 
     labeling of indexed products.
       ``(f)(1) If the Secretary finds, after due notice to the 
     person who requested the index listing and an opportunity for 
     an informal conference, that--
       ``(A) the expert panel failed to meet the requirements as 
     set forth by the Secretary by regulation;
       ``(B) on the basis of new information before the Secretary, 
     evaluated together with the evidence available to the 
     Secretary when the new animal drug was listed in the index, 
     the benefits of using the new animal drug for the indexed use 
     do not outweigh its risks to the target animal;
       ``(C) the conditions of subsection (c)(2) of this section 
     are no longer satisfied;
       ``(D) the manufacture of the new animal drug is not in 
     accordance with current good manufacturing practices;
       ``(E) the labeling, distribution, or promotion of the new 
     animal drug is not in accordance with the index entry;
       ``(F) the conditions and limitations of use associated with 
     the index listing have not been followed; or
       ``(G) the request for indexing contains any untrue 
     statement of material fact,

     the Secretary shall remove the new animal drug from the 
     index. The decision of the Secretary following an informal 
     conference shall constitute final agency action subject to 
     judicial review.
       ``(2) If the Secretary finds that there is a reasonable 
     probability that the use of the drug would present a risk to 
     the health of humans or other animals, the Secretary may--
       ``(A) suspend the listing of such drug immediately;
       ``(B) give the person listed in the index prompt notice of 
     the Secretary's action; and
       ``(C) afford that person the opportunity for an informal 
     conference.

     The decision of the Secretary following an informal 
     conference shall constitute final agency action subject to 
     judicial review.
       ``(g) For purposes of indexing new animal drugs under this 
     section, to the extent consistent with the public health, the 
     Secretary shall promulgate regulations for exempting from the 
     operation of section 512 minor species new animal drugs and 
     animal feeds bearing or containing new animal drugs intended 
     solely for investigational use by experts qualified by 
     scientific training and experience to investigate the safety 
     and effectiveness of minor species animal drugs. Such 
     regulations may, at the discretion of the Secretary, among 
     other conditions relating to the protection of the public 
     health, provide for conditioning such exemption upon the 
     establishment and maintenance of such records, and the making 
     of such reports to the Secretary, by the manufacturer or the 
     sponsor of the investigation of such article, of data 
     (including but not limited to analytical reports by 
     investigators) obtained as a result of such investigational 
     use of such article, as the Secretary finds will enable the 
     Secretary to evaluate the safety and effectiveness of such 
     article in the event of the filing of a request for an index 
     listing pursuant to this section.
       ``(h) The labeling of a new animal drug that is the subject 
     of an index listing shall state, prominently and 
     conspicuously--
       ``(1) `Not approved by fda.--Legally marketed as an FDA 
     indexed product. Extra-label use is prohibited.';
       ``(2) except in the case of new animal drugs indexed for 
     use in an early life stage of a food-producing animal, `This 
     product is not to be used in animals intended for use as food 
     for humans or other animals.'; and
       ``(3) such other information as may be prescribed by the 
     Secretary in the index listing.
       ``(i)(1) In the case of any new animal drug for which an 
     index listing pursuant to subsection (a) is in effect, the 
     person who has an index listing shall establish and maintain 
     such records, and make such reports to the Secretary, of data 
     relating to experience, and other data or information, 
     received or otherwise obtained by such person with respect to 
     such drug, or with respect to animal feeds bearing or 
     containing such drug, as the Secretary may by general 
     regulation, or by order with respect to such listing, 
     prescribe on the basis of a finding that such records and 
     reports are necessary in order to enable the Secretary to 
     determine, or facilitate a determination, whether there is or 
     may be ground for invoking subsection (f). Such regulation or 
     order shall provide, where the Secretary deems it to be 
     appropriate, for the examination, upon request, by the 
     persons to whom such regulation or order is applicable, of 
     similar information received or otherwise obtained by the 
     Secretary.
       ``(2) Every person required under this subsection to 
     maintain records, and every person in charge or custody 
     thereof, shall, upon request of an officer or employee 
     designated by the Secretary, permit such officer or employee 
     at all reasonable times to have access to and copy and verify 
     such records.
       ``(j)(1) Safety and effectiveness data and information 
     which has been submitted in support of a request for a new 
     animal drug to be indexed under this section and which has 
     not been previously disclosed to the public shall be made 
     available to the public, upon request, unless extraordinary 
     circumstances are shown--
       ``(A) if no work is being or will be undertaken to have the 
     drug indexed in accordance with the request,
       ``(B) if the Secretary has determined that such drug cannot 
     be indexed and all legal appeals have been exhausted,
       ``(C) if the indexing of such drug is terminated and all 
     legal appeals have been exhausted, or
       ``(D) if the Secretary has determined that such drug is not 
     a new animal drug.
       ``(2) Any request for data and information pursuant to 
     paragraph (1) shall include a verified statement by the 
     person making the request that any data or information 
     received under such paragraph shall not be disclosed by such 
     person to any other person--
       ``(A) for the purpose of, or as part of a plan, scheme, or 
     device for, obtaining the right to make, use, or market, or 
     making, using, or marketing, outside the United States, the 
     drug identified in the request for indexing; and
       ``(B) without obtaining from any person to whom the data 
     and information are disclosed an identical verified 
     statement, a copy of which is to be provided by such person 
     to the Secretary, which meets the requirements of this 
     paragraph.

     ``SEC. 573. DESIGNATED NEW ANIMAL DRUGS FOR MINOR USE OR 
                   MINOR SPECIES.

       ``(a) Designation.--
       ``(1) The manufacturer or the sponsor of a new animal drug 
     for a minor use or use in a minor species may request that 
     the Secretary declare that drug a `designated new animal 
     drug'. A request for designation of a new animal drug shall 
     be made before the submission of an application under section 
     512(b) or section 571 for the new animal drug.
       ``(2) The Secretary may declare a new animal drug a 
     `designated new animal drug' if--
       ``(A) it is intended for a minor use or use in a minor 
     species; and
       ``(B) the same drug in the same dosage form for the same 
     intended use is not approved under section 512 or 571 or 
     designated under this section at the time the request is 
     made.
       ``(3) Regarding the termination of a designation--
       ``(A) the sponsor of a new animal drug shall notify the 
     Secretary of any decision to discontinue active pursuit of 
     approval under section 512 or 571 of an application for a 
     designated new animal drug. The Secretary shall terminate the 
     designation upon such notification;
       ``(B) the Secretary may also terminate designation if the 
     Secretary independently determines that the sponsor is not 
     actively pursuing approval under section 512 or 571 with due 
     diligence;
       ``(C) the sponsor of an approved designated new animal drug 
     shall notify the Secretary of any discontinuance of the 
     manufacture of such new animal drug at least one year before 
     discontinuance. The Secretary shall terminate the designation 
     upon such notification; and
       ``(D) the designation shall terminate upon the expiration 
     of any applicable exclusivity period under subsection (c).
       ``(4) Notice respecting the designation or termination of 
     designation of a new animal drug shall be made available to 
     the public.
       ``(b) Grants and Contracts for Development of Designated 
     New Animal Drugs.--
       ``(1) The Secretary may make grants to and enter into 
     contracts with public and private entities and individuals to 
     assist in defraying the costs of qualified safety and 
     effectiveness testing expenses and manufacturing expenses 
     incurred in connection with the development of designated new 
     animal drugs.
       ``(2) For purposes of paragraph (1) of this section--
       ``(A) The term `qualified safety and effectiveness testing' 
     means testing--
       ``(i) which occurs after the date such new animal drug is 
     designated under this section and before the date on which an 
     application with respect to such drug is submitted under 
     section 512; and
       ``(ii) which is carried out under an investigational 
     exemption under section 512(j).
       ``(B) The term `manufacturing expenses' means expenses 
     incurred in developing processes and procedures associated 
     with manufacture of the designated new animal drug which 
     occur after the new animal drug is designated under this 
     section and before the date on which an application with 
     respect to such new animal drug is submitted under section 
     512 or 571.
       ``(c) Exclusivity for Designated New Animal Drugs.--
       ``(1) Except as provided in subsection (c)(2), if the 
     Secretary approves or conditionally approves an application 
     for a designated new animal drug, the Secretary may not 
     approve or conditionally approve another application 
     submitted for such new animal drug with the same intended use 
     as the designated new animal drug for another applicant 
     before the expiration of seven years from the date of 
     approval or conditional approval of the application.
       ``(2) If an application filed pursuant to section 512 or 
     section 571 is approved for a designated new animal drug, the 
     Secretary may, during the 7-year exclusivity period beginning 
     on the date of the application approval or conditional 
     approval, approve or conditionally approve another 
     application under section 512 or section 571 for such drug 
     for such minor use or minor species for another applicant 
     if--
       ``(A) the Secretary finds, after providing the holder of 
     such an approved application notice and opportunity for the 
     submission of views,

[[Page 3648]]

     that in the granted exclusivity period the holder of the 
     approved application cannot assure the availability of 
     sufficient quantities of the drug to meet the needs for which 
     the drug was designated; or
       ``(B) such holder provides written consent to the Secretary 
     for the approval or conditional approval of other 
     applications before the expiration of such exclusivity 
     period.''.
       (5) Conforming amendments.--
       (A) Section 201(u) of the Federal Food, Drug, and Cosmetic 
     Act is amended by striking ``512'' and inserting ``512, 
     571''.
       (B) Section 201(v) of the Federal Food, Drug, and Cosmetic 
     Act is amended by inserting the following after paragraph 
     (2): ``Provided that any drug intended for minor use or use 
     in a minor species that is not the subject of a final 
     regulation published by the Secretary through notice and 
     comment rulemaking finding that the criteria of paragraphs 
     (1) and (2) have not been met (or that the exception to the 
     criterion in paragraph (1) has been met) is a new animal 
     drug.''.
       (C) Section 301(e) of the Federal Food, Drug, and Cosmetic 
     Act is amended by striking ``512(a)(4)(C), 512(j), (l) or 
     (m)'' and inserting ``512(a)(4)(C), 512 (j), (l) or (m), 
     572(i).''
       (D) Section 301(j) of the Federal Food, Drug, and Cosmetic 
     Act is amended by striking ``520'' and inserting ``520, 571, 
     572, 573.''
       (E) Section 502 of the Federal Food, Drug, and Cosmetic Act 
     is amended by adding at the end the following new subsection:
       ``(w) If it is a new animal drug--
       ``(1) that is conditionally approved under section 571 and 
     its labeling does not conform with the approved application 
     or section 571(f), or that is not conditionally approved 
     under section 571 and its label bears the statement set forth 
     in section 571(f)(1)(A); or
       ``(2) that is indexed under section 572 and its labeling 
     does not conform with the index listing under section 572(e) 
     or 572(h), or that has not been indexed under section 572 and 
     its label bears the statement set forth in section 572(h).''.
       (F) Section 503(f) of the Federal Food, Drug, and Cosmetic 
     Act is amended--
       (i) in paragraph (1)(A)(ii) by striking ``512'' and 
     inserting ``512, a conditionally-approved application under 
     section 571, or an index listing under section 572''; and
       (ii) in paragraph (3) by striking ``section 512'' and 
     inserting ``section 512, 571, or 572''.
       (G) Section 504(a)(1) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``512(b)'' and inserting 
     ``512(b), a conditionally-approved application filed pursuant 
     to section 571, or an index listing pursuant to section 
     572''.
       (H) Sections 504(a)(2)(B) and 504(b) of the Federal Food, 
     Drug, and Cosmetic Act are amended by striking ``512(i)'' 
     each place it appears and inserting ``512(i), or the index 
     listing pursuant to section 572(e)''.
       (I) Section 512(a) of the Federal Food, Drug, and Cosmetic 
     Act is amended by striking paragraphs (1) and (2) and 
     inserting the following:
       ``(1) A new animal drug shall, with respect to any 
     particular use or intended use of such drug, be deemed unsafe 
     for purposes of section 501(a)(5) and section 
     402(a)(2)(C)(ii) unless--
       ``(A) there is in effect an approval of an application 
     filed pursuant to subsection (b) with respect to such use or 
     intended use of such drug, and such drug, its labeling, and 
     such use conform to such approved application;
       ``(B) there is in effect a conditional approval of an 
     application filed pursuant to section 571 with respect to 
     such use or intended use of such drug, and such drug, its 
     labeling, and such use conform to such conditionally approved 
     application; or
       ``(C) there is in effect an index listing pursuant to 
     section 572 with respect to such use or intended use of such 
     drug in a minor species, and such drug, its labeling, and 
     such use conform to such index listing.

     A new animal drug shall also be deemed unsafe for such 
     purposes in the event of removal from the establishment of a 
     manufacturer, packer, or distributor of such drug for use in 
     the manufacture of animal feed in any State unless at the 
     time of such removal such manufacturer, packer, or 
     distributor has an unrevoked written statement from the 
     consignee of such drug, or notice from the Secretary, to the 
     effect that, with respect to the use of such drug in animal 
     feed, such consignee (i) holds a license issued under 
     subsection (m) and has in its possession current approved 
     labeling for such drug in animal feed; or (ii) will, if the 
     consignee is not a user of the drug, ship such drug only to a 
     holder of a license issued under subsection (m).
       ``(2) An animal feed bearing or containing a new animal 
     drug shall, with respect to any particular use or intended 
     use of such animal feed be deemed unsafe for purposes of 
     section 501(a)(6) unless--
       ``(A) there is in effect--
       ``(i) an approval of an application filed pursuant to 
     subsection (b) with respect to such drug, as used in such 
     animal feed, and such animal feed and its labeling, 
     distribution, holding, and use conform to such approved 
     application;
       ``(ii) a conditional approval of an application filed 
     pursuant to section 571 with respect to such drug, as used in 
     such animal feed, and such animal feed and its labeling, 
     distribution, holding, and use conform to such conditionally 
     approved application; or
       ``(iii) an index listing pursuant to section 572 with 
     respect to such drug, as used in such animal feed, and such 
     animal feed and its labeling, distribution, holding, and use 
     conform to such index listing; and
       ``(B) such animal feed is manufactured at a site for which 
     there is in effect a license issued pursuant to subsection 
     (m)(1) to manufacture such animal feed.''.
       (J) Section 512(b)(3) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``under paragraph (1) or 
     a request for an investigational exemption under subsection 
     (j)'' and inserting ``under paragraph (1), section 571, or a 
     request for an investigational exemption under subsection 
     (j)''.
       (K) Section 512(d)(4) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``have previously been 
     separately approved'' and inserting ``have previously been 
     separately approved pursuant to an application submitted 
     under section 512(b)(1)''.
       (L) Section 512(f) of the Federal Food, Drug, and Cosmetic 
     Act is amended by striking ``subsection (d), (e), or (m)'' 
     and inserting ``subsection (d), (e), or (m), or section 571 
     (c), (d), or (e)''.
       (M) Section 512(g) of the Federal Food, Drug, and Cosmetic 
     Act is amended by striking ``this section'' and inserting 
     ``this section, or section 571''.
       (N) Section 512(i) of the Federal Food, Drug, and Cosmetic 
     Act is amended by striking ``subsection (b)'' and inserting 
     ``subsection (b) or section 571'' and by inserting ``or upon 
     failure to renew a conditional approval under section 571'' 
     after ``or upon its suspension''.
       (O) Section 512(l)(1) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``subsection (b)'' and 
     inserting ``subsection (b) or section 571''.
       (P) Section 512(m)(1)(C) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``applicable regulations 
     published pursuant to subsection (i)'' and inserting 
     ``applicable regulations published pursuant to subsection (i) 
     or for indexed new animal drugs in accordance with the index 
     listing published pursuant to section 572(e)(2) and the 
     labeling requirements set forth in section 572(h)''.
       (Q) Section 512(m)(3) of the Federal Food, Drug, and 
     Cosmetic Act is amended by inserting ``or an index listing 
     pursuant to section 572(e)'' after ``subsection (i)'' each 
     place it appears.
       (R) Section 512(p)(1) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``subsection (b)(1)'' and 
     inserting ``subsection (b)(1) or section 571(a)''.
       (S) Section 512(p)(2) of the Federal Food, Drug, and 
     Cosmetic Act is amended by striking ``subsection (b)(1)'' and 
     inserting ``subsection (b)(1) or section 571(a)''.
       (T) Section 108(b)(3) of Public Law 90-399 is amended by 
     striking ``section 201(w) as added by this Act'' and 
     inserting ``section 201(v)''.
       (6) Regulations.--On the date of enactment of this Act, the 
     Secretary of Health and Human Services shall implement 
     sections 571 and 573 of the Federal Food, Drug, and Cosmetic 
     Act and subsequently publish implementing regulations. Not 
     later than 12 months after the date of enactment of this Act, 
     the Secretary shall issue proposed regulations to implement 
     section 573 of the Federal Food, Drug, and Cosmetic Act (as 
     added by this Act), and not later than 24 months after the 
     date of enactment of this Act, the Secretary shall issue 
     final regulations implementing section 573 of the Federal 
     Food, Drug, and Cosmetic Act. Not later than 18 months after 
     the date of enactment of this Act, the Secretary shall issue 
     proposed regulations to implement section 572 of the Federal 
     Food, Drug, and Cosmetic Act (as added by this Act), and not 
     later than 36 months after the date of enactment of this Act, 
     the Secretary shall issue final regulations implementing 
     section 572 of the Federal Food, Drug, and Cosmetic Act. Not 
     later than 30 months after the date of enactment of this Act, 
     the Secretary shall issue proposed regulations to implement 
     section 571 of the Federal Food, Drug, and Cosmetic Act (as 
     added by this Act), and not later than 42 months after the 
     date of enactment of this Act, the Secretary shall issue 
     final regulations implementing section 571 of the Federal 
     Food, Drug, and Cosmetic Act. These timeframes shall be 
     extended by 12 months for each fiscal year, in which the 
     funds authorized to be appropriated under subsection (i) are 
     not in fact appropriated.
       (7) Office.--The Secretary of Health and Human Services 
     shall establish within the Center for Veterinary Medicine (of 
     the Food and Drug Administration), an Office of Minor Use and 
     Minor Species Animal Drug Development that reports directly 
     to the Director of the Center for Veterinary Medicine. This 
     office shall be responsible for overseeing the development 
     and legal marketing of new animal drugs for minor uses and 
     minor species. There is authorized to be appropriated to 
     carry out this subsection $1,200,000 for fiscal year 2004 and 
     such sums as may be necessary for each fiscal year 
     thereafter.
       (8) Authorization of Appropriations.--There is authorized 
     to be appropriated to carry out section 573(b) of the Federal 
     Food, Drug, and Cosmetic Act (as added by this section) 
     $1,000,000 for the fiscal year following publication of final 
     implementing regulations, $2,000,000 for the subsequent 
     fiscal year, and such sums as may be necessary for each 
     fiscal year thereafter.

        TITLE II--FOOD ALLERGEN LABELING AND CONSUMER PROTECTION

     SEC. 201. SHORT TITLE.

       This title may be cited as the ``Food Allergen Labeling and 
     Consumer Protection Act of 2003''.

     SEC. 202. FINDINGS.

       Congress finds that--
       (1) it is estimated that--
       (A) approximately 2 percent of adults and about 5 percent 
     of infants and young children in the United States suffer 
     from food allergies; and

[[Page 3649]]

       (B) each year, roughly 30,000 individuals require emergency 
     room treatment and 150 individuals die because of allergic 
     reactions to food;
       (2)(A) eight major foods or food groups--milk, eggs, fish, 
     Crustacean shellfish, tree nuts, peanuts, wheat, and 
     soybeans--account for 90 percent of food allergies;
       (B) at present, there is no cure for food allergies; and
       (C) a food allergic consumer must avoid the food to which 
     the consumer is allergic;
       (3)(A) in a review of the foods of randomly selected 
     manufacturers of baked goods, ice cream, and candy in 
     Minnesota and Wisconsin in 1999, the Food and Drug 
     Administration found that 25 percent of sampled foods failed 
     to list peanuts or eggs as ingredients on the food labels; 
     and
       (B) nationally, the number of recalls because of unlabeled 
     allergens rose to 121 in 2000 from about 35 a decade earlier;
       (4) a recent study shows that many parents of children with 
     a food allergy were unable to correctly identify in each of 
     several food labels the ingredients derived from major food 
     allergens;
       (5)(A) ingredients in foods must be listed by their 
     ``common or usual name'';
       (B) in some cases, the common or usual name of an 
     ingredient may be unfamiliar to consumers, and many consumers 
     may not realize the ingredient is derived from, or contains, 
     a major food allergen; and
       (C) in other cases, the ingredients may be declared as a 
     class, including spices, flavorings, and certain colorings, 
     or are exempt from the ingredient labeling requirements, such 
     as incidental additives; and
       (6)(A) celiac disease is an immune-mediated disease that 
     causes damage to the gastrointestinal tract, central nervous 
     system, and other organs;
       (B) the current recommended treatment is avoidance of 
     glutens in foods that are associated with celiac disease; and
       (C) a multicenter, multiyear study estimated that the 
     prevalence of celiac disease in the United States is 0.5 to 1 
     percent of the general population.

     SEC. 203. FOOD LABELING; REQUIREMENT OF INFORMATION REGARDING 
                   ALLERGENIC SUBSTANCES.

       (a) In General.--Section 403 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 343) is amended by adding at the end 
     the following:
       ``(w)(1) If it is not a raw agricultural commodity and it 
     is, or it contains an ingredient that bears or contains, a 
     major food allergen, unless either--
       ``(A) the word `Contains', followed by the name of the food 
     source from which the major food allergen is derived, is 
     printed immediately after or is adjacent to the list of 
     ingredients (in a type size no smaller than the type size 
     used in the list of ingredients) required under subsections 
     (g) and (i); or
       ``(B) the common or usual name of the major food allergen 
     in the list of ingredients required under subsections (g) and 
     (i) is followed in parentheses by the name of the food source 
     from which the major food allergen is derived, except that 
     the name of the food source is not required when--
       ``(i) the common or usual name of the ingredient uses the 
     name of the food source from which the major food allergen is 
     derived; or
       ``(ii) the name of the food source from which the major 
     food allergen is derived appears elsewhere in the ingredient 
     list, unless the name of the food source that appears 
     elsewhere in the ingredient list appears as part of the name 
     of a food ingredient that is not a major food allergen under 
     section 201(qq)(2)(A) or (B).
       ``(2) As used in this subsection, the term `name of the 
     food source from which the major food allergen is derived' 
     means the name described in section 201(qq)(1); provided that 
     in the case of a tree nut, fish, or Crustacean shellfish, the 
     term `name of the food source from which the major food 
     allergen is derived' means the name of the specific type of 
     nut or species of fish or Crustacean shellfish.
       ``(3) The information required under this subsection may 
     appear in labeling in lieu of appearing on the label only if 
     the Secretary finds that such other labeling is sufficient to 
     protect the public health. A finding by the Secretary under 
     this paragraph (including any change in an earlier finding 
     under this paragraph) is effective upon publication in the 
     Federal Register as a notice.
       ``(4) Notwithstanding subsection (g), (i), or (k), or any 
     other law, a flavoring, coloring, or incidental additive that 
     is, or that bears or contains, a major food allergen shall be 
     subject to the labeling requirements of this subsection.
       ``(5) The Secretary may by regulation modify the 
     requirements of subparagraph (A) or (B) of paragraph (1), or 
     eliminate either the requirement of subparagraph (A) or the 
     requirements of subparagraph (B) of paragraph (1), if the 
     Secretary determines that the modification or elimination of 
     the requirement of subparagraph (A) or the requirements of 
     subparagraph (B) is necessary to protect the public health.
       ``(6)(A) Any person may petition the Secretary to exempt a 
     food ingredient described in section 201(qq)(2) from the 
     allergen labeling requirements of this subsection.
       ``(B) The Secretary shall approve or deny such petition 
     within 180 days of receipt of the petition or the petition 
     shall be deemed denied, unless an extension of time is 
     mutually agreed upon by the Secretary and the petitioner.
       ``(C) The burden shall be on the petitioner to provide 
     scientific evidence (including the analytical method used to 
     produce the evidence) that demonstrates that such food 
     ingredient, as derived by the method specified in the 
     petition, does not cause an allergic response that poses a 
     risk to human health.
       ``(D) A determination regarding a petition under this 
     paragraph shall constitute final agency action.
       ``(E) The Secretary shall promptly post to a public site 
     all petitions received under this paragraph within 14 days of 
     receipt and the Secretary shall promptly post the Secretary's 
     response to each.
       ``(7)(A) A person need not file a petition under paragraph 
     (6) to exempt a food ingredient described in section 
     201(qq)(2) from the allergen labeling requirements of this 
     subsection, if the person files with the Secretary a 
     notification containing--
       ``(i) scientific evidence (including the analytical method 
     used) that demonstrates that the food ingredient (as derived 
     by the method specified in the notification, where 
     applicable) does not contain allergenic protein; or
       ``(ii) a determination by the Secretary that the ingredient 
     does not cause an allergic response that poses a risk to 
     human health under a premarket approval or notification 
     program under section 409.
       ``(B) The food ingredient may be introduced or delivered 
     for introduction into interstate commerce as a food 
     ingredient that is not a major food allergen 90 days after 
     the date of receipt of the notification by the Secretary, 
     unless the Secretary determines within the 90-day period that 
     the notification does not meet the requirements of this 
     paragraph, or there is insufficient scientific evidence to 
     determine that the food ingredient does not contain 
     allergenic protein or does not cause an allergenic response 
     that poses a risk to human health.
       ``(C) The Secretary shall promptly post to a public site 
     all notifications received under this subparagraph within 14 
     days of receipt and promptly post any objections thereto by 
     the Secretary.
       ``(x) Notwithstanding subsection (g), (i), or (k), or any 
     other law, a spice, flavoring, coloring, or incidental 
     additive that is, or that bears or contains, a food allergen 
     (other than a major food allergen), as determined by the 
     Secretary by regulation, shall be disclosed in a manner 
     specified by the Secretary by regulation.''.
       (b) Effect on Other Authority.--The amendments made by this 
     section that require a label or labeling for major food 
     allergens do not alter the authority of the Secretary of 
     Health and Human Services under the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 301 et seq.) to require a label or 
     labeling for other food allergens.
       (c) Conforming Amendments.--
       (1) Section 201 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321) (as amended by section 102(b)) is amended by 
     adding at the end the following:
       ``(qq) The term `major food allergen' means any of the 
     following:
       ``(1) Milk, egg, fish (e.g., bass, flounder, or cod), 
     Crustacean shellfish (e.g., crab, lobster, or shrimp), tree 
     nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and 
     soybeans.
       ``(2) A food ingredient that contains protein derived from 
     a food specified in paragraph (1), except the following:
       ``(A) Any highly refined oil derived from a food specified 
     in paragraph (1) and any ingredient derived from such highly 
     refined oil.
       ``(B) A food ingredient that is exempt under paragraph (6) 
     or (7) of section 403(w).''.
       (2) Section 403A(a)(2) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 343-1(a)(2)) is amended by striking 
     ``or 403(i)(2)'' and inserting ``403(i)(2), 403(w), or 
     403(x)''.
       (d) Effective Date.--The amendments made by this section 
     shall apply to any food that is labeled on or after January 
     1, 2006.

     SEC. 204. REPORT ON FOOD ALLERGENS.

       Not later than 18 months after the date of enactment of 
     this Act, the Secretary of Health and Human Services (in this 
     section referred to as the ``Secretary'') shall submit to the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Committee on Energy and Commerce of the House 
     of Representatives a report that--
       (1)(A) analyzes--
       (i) the ways in which foods, during manufacturing and 
     processing, are unintentionally contaminated with major food 
     allergens, including contamination caused by the use by 
     manufacturers of the same production line to produce both 
     products for which major food allergens are intentional 
     ingredients and products for which major food allergens are 
     not intentional ingredients; and
       (ii) the ways in which foods produced on dedicated 
     production lines are unintentionally contaminated with major 
     food allergens; and
       (B) estimates how common the practices described in 
     subparagraph (A) are in the food industry, with breakdowns by 
     food type as appropriate;
       (2) advises whether good manufacturing practices or other 
     methods can be used to reduce or eliminate cross-contact of 
     foods with the major food allergens;
       (3) describes--
       (A) the various types of advisory labeling (such as 
     labeling that uses the words ``may contain'') used by food 
     producers;
       (B) the conditions of manufacture of food that are 
     associated with the various types of advisory labeling; and
       (C) the extent to which advisory labels are being used on 
     food products;
       (4) describes how consumers with food allergies or the 
     caretakers of consumers would prefer

[[Page 3650]]

     that information about the risk of cross-contact be 
     communicated on food labels as determined by using 
     appropriate survey mechanisms;
       (5) states the number of inspections of food manufacturing 
     and processing facilities conducted in the previous 2 years 
     and describes--
       (A) the number of facilities and food labels that were 
     found to be in compliance or out of compliance with respect 
     to cross-contact of foods with residues of major food 
     allergens and the proper labeling of major food allergens;
       (B) the nature of the violations found; and
       (C) the number of voluntary recalls, and their 
     classifications, of foods containing undeclared major food 
     allergens; and
       (6) assesses the extent to which the Secretary and the food 
     industry have effectively addressed cross-contact issues.

     SEC. 205. INSPECTIONS RELATING TO FOOD ALLERGENS.

       The Secretary of Health and Human Services shall conduct 
     inspections consistent with the authority under section 704 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) 
     of facilities in which foods are manufactured, processed, 
     packed, or held--
       (1) to ensure that the entities operating the facilities 
     comply with practices to reduce or eliminate cross-contact of 
     a food with residues of major food allergens that are not 
     intentional ingredients of the food; and
       (2) to ensure that major food allergens are properly 
     labeled on foods.

     SEC. 206. GLUTEN LABELING.

       Not later than 2 years after the date of enactment of this 
     Act, the Secretary of Health and Human Services, in 
     consultation with appropriate experts and stakeholders, shall 
     issue a proposed rule to define, and permit use of, the term 
     ``gluten-free'' on the labeling of foods. Not later than 4 
     years after the date of enactment of this Act, the Secretary 
     shall issue a final rule to define, and permit use of, the 
     term ``gluten-free'' on the labeling of foods.

     SEC. 207. IMPROVEMENT AND PUBLICATION OF DATA ON FOOD-RELATED 
                   ALLERGIC RESPONSES.

       (a) In General.--The Secretary of Health and Human 
     Services, acting through the Director of the Centers for 
     Disease Control and Prevention and in consultation with the 
     Commissioner of Food and Drugs, shall improve (including by 
     educating physicians and other health care providers) the 
     collection of, and publish as it becomes available, national 
     data on--
       (1) the prevalence of food allergies;
       (2) the incidence of clinically significant or serious 
     adverse events related to food allergies; and
       (3) the use of different modes of treatment for and 
     prevention of allergic responses to foods.
       (b) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated such sums as may be necessary.

     SEC. 208. FOOD ALLERGIES RESEARCH.

       (a) In General.--The Secretary of Health and Human 
     Services, acting through the Director of the National 
     Institutes of Health, shall convene an ad hoc panel of 
     nationally recognized experts in allergy and immunology to 
     review current basic and clinical research efforts related to 
     food allergies.
       (b) Recommendations.--Not later than 1 year after the date 
     of enactment of this Act, the panel shall make 
     recommendations to the Secretary for enhancing and 
     coordinating research activities concerning food allergies, 
     which the Secretary shall make public.

     SEC. 209. FOOD ALLERGENS IN THE FOOD CODE.

       The Secretary of Health and Human Services shall, in the 
     Conference for Food Protection, as part of its efforts to 
     encourage cooperative activities between the States under 
     section 311 of the Public Health Service Act (42 U.S.C. 243), 
     pursue revision of the Food Code to provide guidelines for 
     preparing allergen-free foods in food establishments, 
     including in restaurants, grocery store delicatessens and 
     bakeries, and elementary and secondary school cafeterias. The 
     Secretary shall consider guidelines and recommendations 
     developed by public and private entities for public and 
     private food establishments for preparing allergen-free foods 
     in pursuing this revision.

     SEC. 210. RECOMMENDATIONS REGARDING RESPONDING TO FOOD-
                   RELATED ALLERGIC RESPONSES.

       The Secretary of Health and Human Services shall, in 
     providing technical assistance relating to trauma care and 
     emergency medical services to State and local agencies under 
     section 1202(b)(3) of the Public Health Service Act (42 
     U.S.C. 300d-2(b)(3)), include technical assistance relating 
     to the use of different modes of treatment for and prevention 
     of allergic responses to foods.

  Mr. KENNEDY. Mr. President, I support both of the important 
provisions in this legislation, the Minor Use and Minor Species Animal 
Health Act and the Food Allergen Labeling and Consumer Protection Act.
  Veterinarians now treat many animals with drugs approved for other 
animals or even for humans. Such use is sometimes illegal, and it is 
not always guided by the best evidence available on the safe and 
effective use of the drug in particular species. The animal health 
legislation will provide new ways for drugs for minor uses and minor 
species to become available to treat animals for which very few drugs 
are now approved.
  The bill allows conditional approval by the Food and Drug 
Administration of all minor use drugs and minor species drugs. It also 
permits the use of unapproved drugs, if they are for use in nonfood 
producing minor species, and in certain circumstances, even in the 
early life stages of food-producing minor species. Safeguards are 
included so that these drugs will be safe for humans, just as any other 
animal drug must be safe for humans, and will not lead to antibiotic 
resistance in humans.
  The legislation also allows new animal drugs to become ``designated 
new animal drugs,'' for which research grants and 7 years of market 
exclusivity will be available if they are approved or conditionally 
approved by the Food and Drug Administration.
  Overall, this title of the bill will help to improve the health of 
family pets, zoo animals, and farm animals, and I commend Senator Gregg 
and Senator Sessions for their leadership in developing this 
legislation and enabling the Senate to consider it today.
  The second title of the bill will give families greater confidence 
that the food they eat is safe. Under the Food Allergen Labeling and 
Consumer Protection Act, 7 million Americans with food allergies will 
be able to identify a product's ingredients more easily and avoid foods 
that may harm them. One-hundred and fifty Americans die each year from 
food allergies, and this legislation will greatly reduce that number.
  It requires the labels on food packages to identify ingredients 
related to one of the eight main food allergens, and to do so in easily 
understood words. The FDA is required to provide for ``gluten-free'' 
labels on foods, to help people with celiac disease avoid the glutens 
that cause their disease.
  The bill also requires the Centers for Disease Control and Prevention 
to monitor deaths related to food allergies, and directs the National 
Institutes of Health to develop a plan for research on food alleries.
  I commend Senator Gregg and my colleagues on the HELP Committee for 
their leadership on this title as well, and I urge the Senate to 
approve this legislation.
  Mr. NICKLES. Mr. President, I ask unanimous consent that the 
committee substitute amendment be agreed to, the bill, as amended, be 
read a third time and passed, the motion to reconsider be laid upon the 
table, and that any statements relating to the bill be printed in the 
Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The committee amendment in the nature of a substitute was agreed to.
  The bill (S. 741), as amended, was read the third time and passed.

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