[Congressional Record Volume 142, Number 133 (Tuesday, September 24, 1996)]
[House]
[Pages H10835-H10841]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  ANIMAL DRUG AVAILABILITY ACT OF 1996

  Mr. BILIRAKIS. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 2508) to amend the Federal Food, Drug, and Cosmetic Act to 
provide for improvements in the process of approving and using animal 
drugs, and for other purposes, as amended.
  The Clerk read as follows:

                               H.R. 2508

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

     SECTION 1. SHORT TITLE; REFERENCE.

       (a) Short Title.--This Act may be cited as the ``Animal 
     Drug Availability Act of 1996''.
       (b) Reference.--Whenever in this Act an amendment or repeal 
     is expressed in terms of an amendment to, or repeal of, a 
     section or other provision, the reference shall be considered 
     to be made to a section or other provision of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.).

     SEC. 2. EVIDENCE OF EFFECTIVENESS.

       (a) Original Applications.--Paragraph (3) of section 512(d) 
     (21 U.S.C. 360b(d)) is amended to read as follows:
       ``(3) As used in this section, the term `substantial 
     evidence' means evidence consisting of one or more adequate 
     and well controlled investigations, such as--
       ``(A) a study in a target species;
       ``(B) a study in laboratory animals;
       ``(C) any field investigation that may be required under 
     this section and that meets the requirements of subsection 
     (b)(3) if a presubmission conference is requested by the 
     applicant;
       ``(D) a bioequivalence study; or
       ``(E) an in vitro study;

      by experts qualified by scientific training and experience 
     to evaluate the effectiveness of the drug involved, on the 
     basis of which it could fairly and reasonably be concluded by 
     such experts 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 labeling or 
     proposed labeling thereof.''.
       (b) Conforming Amendments.--

[[Page H10836]]

       (1) Clauses (ii) and (iii) of section 512(c)(2)(F) (21 
     U.S.C. 360b(c)(2)(F)) are each amended--
       (A) by striking ``reports of new clinical or field 
     investigations (other than bioequivalence or residue studies) 
     and,'' and inserting ``substantial evidence of the 
     effectiveness of the drug involved, any studies of animal 
     safety, or,''; and
       (B) by striking ``essential to'' and inserting ``required 
     for''.
       (2) Section 512(c)(2)(F)(v) (21 U.S.C. 360b(c)(2)(F)(v)) is 
     amended--
       (A) by striking ``subparagraph (B)(iv)'' each place it 
     appears and inserting ``clause (iv)'';
       (B) by striking ``reports of clinical or field 
     investigations'' and inserting ``substantial evidence of the 
     effectiveness of the drug involved, any studies of animal 
     safety,''; and
       (C) by striking ``essential to'' and inserting ``required 
     for''.
       (c) Combination Drugs.--Section 512(d) (21 U.S.C. 360b(d)), 
     as amended by subsection (a) is amended by adding at the end 
     the following:
       ``(4) In a case in which an animal drug contains more than 
     one active ingredient, or the labeling of the drug 
     prescribes, recommends, or suggests use of the drug in 
     combination with one or more other animal drugs, and the 
     active ingredients or drugs intended for use in the 
     combination have previously been separately approved for 
     particular uses and conditions of use for which they are 
     intended for use in the combination--
       ``(A) the Secretary shall not issue an order under 
     paragraph (1)(A), (1)(B), or (1)(D) refusing to approve the 
     application for such combination on human food safety grounds 
     unless the Secretary finds that the application fails to 
     establish that--
       ``(i) none of the active ingredients or drugs intended for 
     use in the combination, respectively, at the longest 
     withdrawal time of any of the active ingredients or drugs in 
     the combination, respectively, exceeds its established 
     tolerance; or
       ``(ii) none of the active ingredients or drugs in the 
     combination interferes with the methods of analysis for 
     another of the active ingredients or drugs in the 
     combination, respectively;
       ``(B) the Secretary shall not issue an order under 
     paragraph (1)(A), (1)(B), or (1)(D) refusing to approve the 
     application for such combination on target animal safety 
     grounds unless the Secretary finds that--
       ``(i)(I) there is a substantiated scientific issue, 
     specific to one or more of the active ingredients or animal 
     drugs in the combination, that cannot adequately be evaluated 
     based on information contained in the application for the 
     combination (including any investigations, studies, or tests 
     for which the applicant has a right of reference or use from 
     the person by or for whom the investigations, studies, or 
     tests were conducted); or
       ``(II) there is a scientific issue raised by target animal 
     observations contained in studies submitted to the Secretary 
     as part of the application; and
       ``(ii) based on the Secretary's evaluation of the 
     information contained in the application with respect to the 
     issues identified in clauses (i)(I) and (II), paragraph 
     (1)(A), (B), or (D) apply;
       ``(C) except in the case of a combination that contains a 
     nontopical antibacterial ingredient or animal drug, the 
     Secretary shall not issue an order under paragraph (1)(E) 
     refusing to approve an application for a combination animal 
     drug intended for use other than in animal feed or drinking 
     water unless the Secretary finds that the application fails 
     to demonstrate that--
       ``(i) there is substantial evidence that any active 
     ingredient or animal drug intended only for the same use as 
     another active ingredient or animal drug in the combination 
     makes a contribution to labeled effectiveness;
       ``(ii) each active ingredient or animal drug intended for 
     at least one use that is different from all other active 
     ingredients or animal drugs used in the combination provides 
     appropriate concurrent use for the intended target 
     population; or
       ``(iii) where based on scientific information the Secretary 
     has reason to believe the active ingredients or animal drugs 
     may be physically incompatible or have disparate dosing 
     regimens, such active ingredients or animal drugs are 
     physically compatible or do not have disparate dosing 
     regimens; and
       ``(D) the Secretary shall not issue an order under 
     paragraph (1)(E) refusing to approve an application for a 
     combination animal drug intended for use in animal feed or 
     drinking water unless the Secretary finds that the 
     application fails to demonstrate that--
       ``(i) there is substantial evidence that any active 
     ingredient or animal drug intended only for the same use as 
     another active ingredient or animal drug in the combination 
     makes a contribution to the labeled effectiveness;
       ``(ii) each of the active ingredients or animal drugs 
     intended for at least one use that is different from all 
     other active ingredients or animal drugs used in the 
     combination provides appropriate concurrent use for the 
     intended target population;
       ``(iii) where a combination contains more than one 
     nontopical antibacterial ingredient or animal drug, there is 
     substantial evidence that each of the nontopical 
     antibacterial ingredients or animal drugs makes a 
     contribution to the labeled effectiveness; or
       ``(iv) where based on scientific information the Secretary 
     has reason to believe the active ingredients or animal drugs 
     intended for use in drinking water may be physically 
     incompatible, such active ingredients or animal drugs 
     intended for use in drinking water are physically 
     compatible.''.
       (d) Presubmission Conference.--Section 512(b) (21 U.S.C. 
     360b(b)) is amended by adding at the end the following:
       ``(3) Any person intending to file an application under 
     paragraph (1) or a request for an investigational exemption 
     under subsection (j) shall be entitled to one or more 
     conferences prior to such submission to reach an agreement 
     acceptable to the Secretary establishing a submission or an 
     investigational requirement, which may include a requirement 
     for a field investigation. A decision establishing a 
     submission or an investigational requirement shall bind the 
     Secretary and the applicant or requestor unless (A) the 
     Secretary and the applicant or requestor mutually agree to 
     modify the requirement, or (B) the Secretary by written order 
     determines that a substantiated scientific requirement 
     essential to the determination of safety or effectiveness of 
     the animal drug involved has appeared after the conference. 
     No later than 25 calendar days after each such conference, 
     the Secretary shall provide a written order setting forth a 
     scientific justification specific to the animal drug and 
     intended uses under consideration if the agreement referred 
     to in the first sentence requires more than one field 
     investigation as being essential to provide substantial 
     evidence of effectiveness for the intended uses of the drug. 
     Nothing in this paragraph shall be construed as compelling 
     the Secretary to require a field investigation.''.
       (e) Implementation.--
       (1) In general.--Not later than 6 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall issue proposed regulations implementing the 
     amendments made by this Act as described in paragraph (2)(A) 
     of this subsection, and not later than 18 months after the 
     date of enactment of this Act, the Secretary shall issue 
     final regulations implementing such amendments. Not later 
     than 12 months after the date of enactment of this Act, the 
     Secretary shall issue proposed regulations implementing the 
     other amendments made by this Act as described in paragraphs 
     (2)(B) and (2)(C) of this subsection, and not later than 24 
     months after the date of enactment of this Act, the Secretary 
     shall issue final regulations implementing such amendments.
       (2) Contents.--In issuing regulations implementing the 
     amendments made by this Act, and in taking an action to 
     review an application for approval of a new animal drug under 
     section 512 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360b), or a request for an investigational exemption 
     for a new animal drug under subsection (j) of such section, 
     that is pending or has been submitted prior to the effective 
     date of the regulations, the Secretary shall--
       (A) further define the term ``adequate and well 
     controlled'', as used in subsection (d)(3) of section 512 of 
     such Act, to require that field investigations be designed 
     and conducted in a scientifically sound manner, taking into 
     account practical conditions in the field and differences 
     between field conditions and laboratory conditions;
       (B) further define the term ``substantial evidence'', as 
     defined in subsection (d)(3) of such section, in a manner 
     that encourages the submission of applications and 
     supplemental applications; and
       (C) take into account the proposals contained in the 
     citizen petition (FDA Docket No. 91P-0434/CP) jointly 
     submitted by the American Veterinary Medical Association and 
     the Animal Health Institute, dated October 21, 1991.

     Until the regulations required by subparagraph (A) are 
     issued, nothing in the regulations published at 21 C.F.R. 
     514.111(a)(5) (April 1, 1996) shall be construed to compel 
     the Secretary of Health and Human Services to require a field 
     investigation under section 512(d)(1)(E) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)(E)) or to apply 
     any of its provisions in a manner inconsistent with the 
     considerations for scientifically sound field investigations 
     set forth in subparagraph (A).
       (f) Minor Species and Uses.--The Secretary of Health and 
     Human Services shall consider legislative and regulatory 
     options for facilitating the approval under section 512 of 
     the Federal Food, Drug, and Cosmetic Act of animal drugs 
     intended for minor species and for minor uses and, within 18 
     months after the date of enactment of this Act, announce 
     proposals for legislative or regulatory change to the 
     approval process under such section for animal drugs intended 
     for use in minor species or for minor uses.

     SEC. 3. LIMITATION ON RESIDUES.

       Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is amended 
     to read as follows:
       ``(F) upon the basis of information submitted to the 
     Secretary as part of the application or any other information 
     before the Secretary with respect to such drug, any use 
     prescribed, recommended, or suggested in labeling proposed 
     for such drug will result in a residue of such drug in excess 
     of a tolerance found by the Secretary to be safe for such 
     drug;''.

     SEC. 4. IMPORT TOLERANCES.

       Section 512(a) (21 U.S.C. 360b(a)) is amended by adding the 
     following new paragraph at the end:
       ``(6) For purposes of section 402(a)(2)(D), a use or 
     intended use of a new animal drug

[[Page H10837]]

     shall not be deemed unsafe under this section if the 
     Secretary establishes a tolerance for such drug and any 
     edible portion of any animal imported into the United States 
     does not contain residues exceeding such tolerance. In 
     establishing such tolerance, the Secretary shall rely on data 
     sufficient to demonstrate that a proposed tolerance is safe 
     based on similar food safety criteria used by the Secretary 
     to establish tolerances for applications for new animal drugs 
     filed under subsection (b)(1). The Secretary may consider and 
     rely on data submitted by the drug manufacturer, including 
     data submitted to appropriate regulatory authorities in any 
     country where the new animal drug is lawfully used or data 
     available from a relevant international organization, to the 
     extent such data are not inconsistent with the criteria used 
     by the Secretary to establish a tolerance for applications 
     for new animal drugs filed under subsection (b)(1). For 
     purposes of this paragraph, `relevant international 
     organization' means the Codex Alimenterius Commission or 
     other international organization deemed appropriate by the 
     Secretary. The Secretary may, under procedures specified by 
     regulation, revoke a tolerance established under this 
     paragraph if information demonstrates that the use of the new 
     animal drug under actual use conditions results in food being 
     imported into the United States with residues exceeding the 
     tolerance or if scientific evidence shows the tolerance to be 
     unsafe.''.

     SEC. 5. VETERINARY FEED DIRECTIVES.

       (a) Section 503.--Section 503(f)(1)(A) (21 U.S.C. 
     353(f)(1)(A)) is amended by inserting after ``other than 
     man'' the following: ``, other than a veterinary feed 
     directive drug intended for use in animal feed or an animal 
     feed bearing or containing a veterinary feed directive 
     drug,''.
       (b) Section 504.--The Federal Food, Drug, and Cosmetic Act 
     is amended by inserting after section 503 the following:


                   ``veterinary feed directive drugs

       ``Sec. 504. (a)(1) A drug intended for use in or on animal 
     feed which is limited by an approved application filed 
     pursuant to section 512(b) to use under the professional 
     supervision of a licensed veterinarian is a veterinary feed 
     directive drug. Any animal feed bearing or containing a 
     veterinary feed directive drug shall be fed to animals only 
     by or upon a lawful veterinary feed directive issued by a 
     licensed veterinarian in the course of the veterinarian's 
     professional practice. When labeled, distributed, held, and 
     used in accordance with this section, a veterinary feed 
     directive drug and any animal feed bearing or containing a 
     veterinary feed directive drug shall be exempt from section 
     502(f).
       ``(2) A veterinary feed directive is lawful if it--
       ``(A) contains such information as the Secretary may by 
     general regulation or by order require; and
       ``(B) is in compliance with the conditions and indications 
     for use of the drug set forth in the notice published 
     pursuant to section 512(i).
       ``(3)(A) Any persons involved in the distribution or use of 
     animal feed bearing or containing a veterinary feed directive 
     drug and the licensed veterinarian issuing the veterinary 
     feed directive shall maintain a copy of the veterinary feed 
     directive applicable to each such feed, except in the case of 
     a person distributing such feed to another person for further 
     distribution. Such person distributing the feed shall 
     maintain a written acknowledgment from the person to whom the 
     feed is shipped stating that that person shall not ship or 
     move such feed to an animal production facility without a 
     veterinary feed directive or ship such feed to another person 
     for further distribution unless that person has provided the 
     same written acknowledgment to its immediate supplier.
       ``(B) Every person required under subparagraph (A) 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.
       ``(C) Any person who distributes animal feed bearing or 
     containing a veterinary feed directive drug shall upon first 
     engaging in such distribution notify the Secretary of that 
     person's name and place of business. The failure to provide 
     such notification shall be deemed to be an act which results 
     in the drug being misbranded.
       ``(b) A veterinary feed directive drug and any feed bearing 
     or containing a veterinary feed directive drug shall be 
     deemed to be misbranded if their labeling fails to bear such 
     cautionary statement and such other information as the 
     Secretary may by general regulation or by order prescribe, or 
     their advertising fails to conform to the conditions and 
     indications for use published pursuant to section 512(i) or 
     fails to contain the general cautionary statement prescribed 
     by the Secretary.
       ``(c) Neither a drug subject to this section, nor animal 
     feed bearing or containing such a drug, shall be deemed to be 
     a prescription article under any Federal or State law.''.
       (c) Conforming Amendment.--Section 512 (21 U.S.C. 360b) is 
     amended in subsection (i) by inserting after ``(including 
     special labeling requirements'' the following: ``and any 
     requirement that an animal feed bearing or containing the new 
     animal drug be limited to use under the professional 
     supervision of a licensed veterinarian''.
       (d) Section 301(e).--Section 301(e) (21 U.S.C. 331(e)) is 
     amended by inserting after ``by section 412'' the following: 
     ``, 504,''; and by inserting after ``under section 412,'' the 
     following: ``504,''.

     SEC. 6. FEED MILL LICENSES.

       (a) Section 512(a).--Paragraphs (1) and (2) of section 
     512(a) (21 U.S.C. 360b(a)) are amended to read as follows:
       ``(a)(1) A new animal drug shall, with respect to any 
     particular use or intended use of such drug, be deemed unsafe 
     for the purposes of section 501(a)(5) and section 
     402(a)(2)(D) 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
       ``(B) such drug, its labeling, and such use conform to such 
     approved application.

     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 the purposes of 
     section 501(a)(6) unless--
       ``(A) there is in effect an approval of an application 
     filed pursuant to subsection (b) with respect to such drug, 
     as used in such animal feed,
       ``(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, and
       ``(C) such animal feed and its labeling, distribution, 
     holding, and use conform to the conditions and indications of 
     use published pursuant to subsection (i) .''.
       (b) Section 512(m).--Section 512(m) (21 U.S.C. 360b(m)) is 
     amended to read as follows:
       ``(m)(1) Any person may file with the Secretary an 
     application for a license to manufacture animal feeds bearing 
     or containing new animal drugs. Such person shall submit to 
     the Secretary as part of the application (A) a full statement 
     of the business name and address of the specific facility at 
     which the manufacturing is to take place and the facility's 
     registration number, (B) the name and signature of the 
     responsible individual or individuals for that facility, (C) 
     a certification that the animal feeds bearing or containing 
     new animal drugs are manufactured and labeled in accordance 
     with the applicable regulations published pursuant to 
     subsection (i), and (D) a certification that the methods used 
     in, and the facilities and controls used for, manufacturing, 
     processing, packaging, and holding such animal feeds are in 
     conformity with current good manufacturing practice as 
     described in section 501(a)(2)(B).
       ``(2) Within 90 days after the filing of an application 
     pursuant to paragraph (1), or such additional period as may 
     be agreed upon by the Secretary and the applicant, the 
     Secretary shall (A) issue an order approving the application 
     if the Secretary then finds that none of the grounds for 
     denying approval specified in paragraph (3) applies, or (B) 
     give the applicant notice of an opportunity for a hearing 
     before the Secretary under paragraph (3) on the question 
     whether such application is approvable. The procedure 
     governing such a hearing shall be the procedure set forth in 
     the last two sentences of subsection (c)(1).
       ``(3) If the Secretary, after due notice to the applicant 
     in accordance with paragraph (2) and giving the applicant an 
     opportunity for a hearing in accordance with such paragraph, 
     finds, on the basis of information submitted to the Secretary 
     as part of the application, on the basis of a preapproval 
     inspection, or on the basis of any other information before 
     the Secretary--
       ``(A) that the application is incomplete, false, or 
     misleading in any particular;
       ``(B) that the methods used in, and the facilities and 
     controls used for, the manufacture, processing, and packing 
     of such animal feed are inadequate to preserve the identity, 
     strength, quality, and purity of the new animal drug therein; 
     or
       ``(C) that the facility manufactures animal feeds bearing 
     or containing new animal drugs in a manner that does not 
     accord with the specifications for manufacture or labels 
     animal feeds bearing or containing new animal drugs in a 
     manner that does not accord with the conditions or 
     indications of use that are published pursuant to subsection 
     (i),

     the Secretary shall issue an order refusing to approve the 
     application. If, after such notice and opportunity for 
     hearing, the Secretary finds that subparagraphs (A) through 
     (C) do not apply, the Secretary shall issue an order 
     approving the application. An order under this subsection 
     approving an application for a license to manufacture animal 
     feeds bearing or containing new animal drugs shall permit a 
     facility to manufacture only those animal feeds bearing or 
     containing new animal drugs for which there are in effect 
     regulations pursuant to subsection (i) relating to

[[Page H10838]]

     the use of such drugs in or on such animal feed.
       ``(4)(A) The Secretary shall, after due notice and 
     opportunity for hearing to the applicant, revoke a license to 
     manufacture animal feeds bearing or containing new animal 
     drugs under this subsection if the Secretary finds--
       ``(i) that the application for such license contains any 
     untrue statement of a material fact; or
       ``(ii) that the applicant has made changes that would cause 
     the application to contain any untrue statements of material 
     fact or that would affect the safety or effectiveness of the 
     animal feeds manufactured at the facility unless the 
     applicant has supplemented the application by filing with the 
     Secretary adequate information respecting all such changes 
     and unless there is in effect an approval of the supplemental 
     application.

     If the Secretary (or in the Secretary's absence the officer 
     acting as the Secretary) finds that there is an imminent 
     hazard to the health of humans or of the animals for which 
     such animal feed is intended, the Secretary may suspend the 
     license immediately, and give the applicant prompt notice of 
     the action and afford the applicant the opportunity for an 
     expedited hearing under this subsection; but the authority 
     conferred by this sentence shall not be delegated.
       ``(B) The Secretary may also, after due notice and 
     opportunity for hearing to the applicant, revoke a license to 
     manufacture animal feed under this subsection if the 
     Secretary finds--
       ``(i) that the applicant has failed to establish a system 
     for maintaining required records, or has repeatedly or 
     deliberately failed to maintain such records or to make 
     required reports in accordance with a regulation or order 
     under paragraph (5)(A) of this subsection or section 
     504(a)(3)(A), or the applicant has refused to permit access 
     to, or copying or verification of, such records as required 
     by subparagraph (B) of such paragraph or section 
     504(a)(3)(B);
       ``(ii) that on the basis of new information before the 
     Secretary, evaluated together with the evidence before the 
     Secretary when such license was issued, the methods used in, 
     or the facilities and controls used for, the manufacture, 
     processing, packing, and holding of such animal feed are 
     inadequate to assure and preserve the identity, strength, 
     quality, and purity of the new animal drug therein, and were 
     not made adequate within a reasonable time after receipt of 
     written notice from the Secretary, specifying the matter 
     complained of;
       ``(iii) that on the basis of new information before the 
     Secretary, evaluated together with the evidence before the 
     Secretary when such license was issued, the labeling of any 
     animal feeds, based on a fair evaluation of all material 
     facts, is false or misleading in any particular and was not 
     corrected within a reasonable time after receipt of written 
     notice from the Secretary specifying the matter complained 
     of; or
       ``(iv) that on the basis of new information before the 
     Secretary, evaluated together with the evidence before the 
     Secretary when such license was issued, the facility has 
     manufactured, processed, packed, or held animal feed bearing 
     or containing a new animal drug adulterated under section 
     501(a)(6) and the facility did not discontinue the 
     manufacture, processing, packing, or holding of such animal 
     feed within a reasonable time after receipt of written notice 
     from the Secretary specifying the matter complained of.
       ``(C) The Secretary may also revoke a license to 
     manufacture animal feeds under this subsection if an 
     applicant gives notice to the Secretary of intention to 
     discontinue the manufacture of all animal feed covered under 
     this subsection and waives an opportunity for a hearing on 
     the matter.
       ``(D) Any order under this paragraph shall state the 
     findings upon which it is based.
       ``(5) When a license to manufacture animal feeds bearing or 
     containing new animal drugs has been issued--
       ``(A) the applicant shall establish and maintain such 
     records, and make such reports to the Secretary, or (at the 
     option of the Secretary) to the appropriate person or persons 
     holding an approved application filed under subsection (b), 
     as the Secretary may by general regulation, or by order with 
     respect to such application, 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 (e) or paragraph (4); and
       ``(B) 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.
       ``(6) To the extent consistent with the public health, the 
     Secretary may promulgate regulations for exempting from the 
     operation of this subsection facilities that manufacture, 
     process, pack, or hold animal feeds bearing or containing new 
     animal drugs.''.
       (c) Transitional Provision.--A person engaged in the 
     manufacture of animal feeds bearing or containing new animal 
     drugs who holds at least one approved medicated feed 
     application for an animal feed bearing or containing new 
     animal drugs, the manufacture of which was not otherwise 
     exempt from the requirement for an approved medicated feed 
     application on the date of the enactment of this Act, shall 
     be deemed to hold a license for the manufacturing site 
     identified in the approved medicated feed application. The 
     revocation of license provisions of section 512(m)(4) of the 
     Federal Food, Drug, and Cosmetic Act, as amended by this Act, 
     shall apply to such licenses. Such license shall expire 
     within 18 months from the date of enactment of this Act 
     unless the person submits to the Secretary a completed 
     license application for the manufacturing site accompanied by 
     a copy of an approved medicated feed application for such 
     site, which license application shall be deemed to be 
     approved upon receipt by the Secretary.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Florida [Mr. Bilirakis] and the gentleman from New York [Mr. Manton] 
each will control 20 minutes.
  The Chair recognizes the gentleman from California [Mr. Bilirakis].
  Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may 
consume.
  (Mr. BILIRAKIS asked and was given permission to revise and extend 
his remarks.)
  Mr. BILIRAKIS. Mr. Speaker, I rise in strong support of H.R. 2508, 
The Animal Drug Availability Act of 1996. The bill will better protect 
our animals by streamlining the approval and marketing of new animal 
drugs and medicated feeds.
  A broad bipartisan consensus has enabled us to develop this important 
legislation which will bring needed flexibility to the FDA animal drug 
review processes.
  Among its improvements, the legislation redefines ``substantial 
evidence'' to provide FDA with greater flexibility to determine what 
types of studies, including field investigations, are necessary and 
appropriate for demonstrating the effectiveness of any specific animal 
drug product. The bill requires FDA to issue regulations defining 
substantial evidence and adequate and well-controlled field 
investigations taking into account the practical conditions that exist 
in the field.

  To improve cooperation between FDA and industry, the bill requires 
FDA to hold a presubmission conference at the request of a sponsor 
submitting a new animal drug application or a request for an 
investigational exemption.
  The legislation also streamlines the process for the approval of 
combination animal drug products when the individual active ingredients 
or animal drugs used in combination have been approved previously. In 
addition it authorizes FDA to establish a scientifically based safe 
tolerance for new animal drugs.
  The bill creates a new class of animal drugs, veterinary feed 
directive drugs, intended for use in feed under the professional 
supervision of a licensed veterinarian. The bill streamlines the 
requirements for feed mills that make medicated feeds. Finally, the 
bill authorizes FDA to establish import tolerances for new animal drugs 
not approved in the United States.
  In conclusion, I want to thank Members on both sides of the aisle who 
support the Animal Drug Availability Act of 1996.
  Mr. Speaker, I reserve the balance of my time.
  Mr. MANTON. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, the Animal Drug Availability Act makes important changes 
to the process by which the Food and Drug Administration reviews 
applications for new animal drugs.
  We have heard a great deal in this Congress about reforming 
Government and streamlining regulation. This legislation demonstrates 
that these goals can be accomplished if all of the interested parties 
are willing to negotiate. This amendment to H.R. 2508 is the result of 
compromise between the FDA and the animal drug coalition. It is 
bipartisan, and it achieves reforms responsibly and carefully.
  We are pleased that this legislation incorporates FDA proposals 
included in the Vice President's reinventing Government initiatives, 
one that will reduce unnecessary requirements and paperwork associated 
with feed mill licensing and another that will authorize FDA to 
establish import tolerances for animal drugs not approved for use in 
the United States.
  The provisions of this bill complete a task begun with enactment in 
1994 of the Animal Medicinal Drug Use Clarification Act. When the House 
passed that important legislation, we knew that expanding drug 
availability would require addressing the underlying issue

[[Page H10839]]

that there are not enough new animal drugs available for veterinarians 
to treat all the diseases and conditions that affect animals. That is 
the issue dealt with by H.R. 2508.
  The legislation does this through simplifying the process if 
determining an animal drug's effectiveness; establishing a process by 
which FDA and the animal drug sponsor can agree in advance about what 
the sponsor must provide FDA to facilitate the approval of the new 
product; providing a streamlined process for FDA to review combination 
drugs; and establishing a new category of animal drugs, called 
Veterinary Feed Directive drugs.
  Mr. Speaker, this is good legislation. It will help FDA work more 
efficiently, and it will help get safe and effective new animal drugs 
on the market more quickly. It illustrates that a cooperative effort 
between a regulatory agency, its regulated community, and Congress can 
produce results that all parties find acceptable. This is how 
regulatory reform can and should work.
  I support this legislation, and I urge my colleagues to support it.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BILIRAKIS. Mr. Speaker, I yield 2 minutes to the gentleman from 
Wisconsin [Mr. Klug] who will speak on behalf of himself and a few 
hundred thousand cattle in Wisconsin.
  The SPEAKER pro tempore. Including the dairy farmers of the Chair.
  Mr. KLUG. Mr. Speaker, 319,000 dairy cows, to be more specific.
  Mr. Speaker, I would like to thank my colleague, the gentleman from 
Florida [Mr. Bilirakis], for his terrific work on behalf of this 
legislation, and also the full chairman of committee, the gentleman 
from Virginia [Mr. Bliley], and my colleague, the gentleman from 
Colorado [Mr. Allard], one of the few veterinarians in Congress, who 
has been such a strong advocate for this piece of legislation.
  Mr. Speaker, as you know, for the last year the Committee on Commerce 
has been struggling with the ways to modernize the Food and Drug 
Administration, which now regulates a quarter of this Nation's economy. 
We have high hopes in the next session of Congress we will be able to 
streamline the process to approve prescription drugs and also medical 
devices.
  Part of what we have been able to accomplish this session of Congress 
are two major changes in terms of the FDA's responsibility in food 
content. One of them is the modernization of the Delaney clause, and 
then this piece of legislation we have in front of us today.
  As we know, the current law requires animal drugs to be approved in 6 
months, but it actually takes an average of 58 months. Only 1 in 7,500 
chemicals ever makes it through the current approval process. In the 
past 5 years the FDA has approved only four new drugs for food-
producing animals.
  Realistically, without this bill minor use products would never be 
brought to market, and the time and expense of bringing a new animal 
drug to market is already discouraging drug companies from pursuing 
approval for important medications.
  This legislation today will establish a procedure by which the agency 
and company can sit down ahead of time to discuss the approval 
requirements for a new drug. It would create a new category of drugs 
that can be prescribed by a veterinarian and administered by a farmer 
in the animal's feed and it would refocus the regulation of the use of 
two or more drugs simultaneously on the need to prove the safety to 
humans.
  This piece of legislation has the support of 160 cosponsors in the 
House, the Clinton administration supports it, FDA Commissioner Kessler 
supports it, industry supports the bill, and I strongly support this 
bill and encourage my fellow committee members, as well as my 
colleagues in the House, to approve it as well.
  Mr. BILIRAKIS. Mr. Speaker, I yield 3 minutes to the gentleman from 
Colorado [Mr. Allard], a sponsor of this very much needed legislation.
  Mr. ALLARD. Mr. Speaker, I thank the gentleman for yielding me time.
  Mr. Speaker, first of all, I would like to extend my thanks to other 
members of the committee, the gentleman from Florida [Mr. Bilirakis], 
the gentleman from Virginia [Mr. Bliley], the gentleman from Iowa [Mr. 
Ganske], the gentleman from Wisconsin [Mr. Klug], who we just heard on 
the floor, and then the gentleman from Michigan [Mr. Dingell]. I 
appreciate all of their efforts in making sure that this legislation 
came out of committee in good shape. I know they worked very hard to 
make sure that we ended up with a good piece of legislation.
  Mr. Speaker, this has been a bipartisan effort, both Democrats and 
Republicans working together with the administration to reform the Food 
and Drug Administration as they apply the laws as they apply to animal 
drugs.
  This is the second major reform of the Food and Drug Administration. 
The first was the Delaney reform, and then this is the second step, 
which is the animal Food and Drug Administration reform. Both of these 
provisions are going to be a great help to the agricultural community.
  We are looking at a crisis as far as approval of animal drugs is 
concerned. The drugs are being approved at a very slow rate, and it is 
having an impact on the type of quality and care, not only to the 
livestock, but also to pets.
  To further compound this problem, over the past several years, the 
Food and Drug Administration has taken a number of drugs off of the 
market, and the research has not been moving along at an adequate 
enough rate to replace the loss of these particular products. As a 
consequence of that, we have lost animals to disease and also had an 
increased mortality rate on animals, which also cuts down on 
production.
  When a drug has finally been approved after some time, and I would 
say, again, an internal audit by the FDA shows it takes an average of 
58 months to approve a new drug, this law will take it down to where it 
actually will take only 6 months.

                              {time}  1600

  Because of this, the number of drugs that have been approved over the 
last 23 years have dwindled. We used to have about 60 drugs approved in 
1 year, about two decades ago, in 1973; and now, this last year, we 
have only had 10 approved. This certainly is not keeping up with 
science.
  This is a tremendous disincentive for drug companies to create new 
products when it takes this long extended length of period for 
approval. And now, in order to develop a new product, we are looking at 
a cost of anywhere from $15 to $200 million, and yet most of these 
animal drugs have a very limited market and will generate sales of only 
a million dollars or less.
  I think this legislation is going to help solve this problem. It will 
help make these drugs available for animals, both pets and in the 
livestock industry, and it is going to move forward many of the 
advances that should be moved forward and made available to the public.
  In conclusion, I want to thank again the members of the committee for 
all their hard work on this issue and I hope that we will continue to 
move forward in our efforts to reform the Food and Drug Administration.
  Mr. MANTON. Mr. Speaker, I yield 3 minutes to the gentleman from 
Florida [Mr. Deutsch].
  Mr. DEUTSCH. Mr. Speaker, I too rise today in support of the Animal 
Drug Availability Act. This is Congress at its best, a bipartisan 
effort which is going to really streamline the efforts at the FDA, that 
is going to help really major livestock, poultry producers, commercial 
feed industry, veterinarians, some animal owners, and pharmaceutical 
companies as well.
  Currently it takes the FDA an average of 58 months to a new animal 
drug, and the cost of bringing a drug to the approval stage in some 
instances can approach $200 million.
  If the consensus bill becomes law, it will give the FDA greater 
flexibility in determining the type and number of studies it can accept 
as proof of an animal drug's efficacy.
  It will reduce efficacy testing when a drug company seeks approval to 
use in combination two drugs that are already approved individually.
  It will eliminate the requirement that a time-consuming field 
investigation be used in all instances to prove efficacy.
  It will create a presubmission conference at which the FDA drug 
companies will agree before an application is submitted on the types of 
tests needed to approve a drug's effectiveness.
  And it will increase veterinary oversight in dispensing of certain 
feed drugs.

[[Page H10840]]

  In addition, the bill implements two items from the National 
Performance Review. It would allow FDA to set tolerance for drugs used 
on farm animals whose meat ultimately is imported into the United 
States. It also would reduce significantly the paperwork involved in 
licensing of a feed mill to mix animal drugs with feed.
  The consensus bill maintains all human and animal health protections 
in current law.
  Having spoken to individual veterinarians and pet owners, who have 
unfortunately been denied access to some of the drugs that hopefully 
will be readily accessible as soon as this bill is adopted, I can again 
speak from their personal experiences of how valuable I believe this 
bill will be once it is adopted into law.
  Mr. BILIRAKIS. Mr. Speaker, I yield such time as he may consume to 
the gentleman from Nebraska [Mr. Bereuter], who, if he does not have 
the largest animal drug manufacturer in his district, I understand he 
certainly has one of the largest.
  (Mr. BEREUTER asked and was given permission to revise and extend his 
remarks.)
  Mr. BEREUTER. Mr. Speaker, I thank the distinguished gentleman from 
Florida for yielding me this time.
  I rise in support of H.R. 2508, the Animal Drug Availability Act. As 
original cosponsor of this important legislation, I would like to 
commend the distinguished gentlemen from Florida and New York, and the 
gentleman from Virginia, Mr. Bliley, and the gentleman from Michigan, 
Mr. Dingell, the ranking member, for bringing this work to the floor 
today. Certainly I also commend my distinguished colleague from 
Colorado, Mr. Allard, for his initiative in introducing the bill.
  Mr. Speaker, this legislation is clearly needed to streamline the 
bureaucracy and improve the current, outdated process of approving new 
animal health products. Our Nation's livestock producers deserve to 
have the best new products available in a timely and efficient manner. 
This is commonsense legislation which has strong, bipartisan support in 
Congress and broad support in the agricultural and veterinary science 
communities.
  The need for change is obvious. Although research and development 
costs have increased dramatically in recent decades, the number of new 
animal health products being approved by the Food and Drug 
Administration's Center for Veterinary Medicine has declined. The 
Animal Drug Availability Act modifies requirements for proving 
efficacy, streamlines the bureaucracy involved in approving new claims 
for products used in the treatment of minor species, simplifies 
requirements for combination drugs, and makes other improvements in the 
current process. Mr. Speaker, quite simply, this legislation will 
improve the ability of manufacturers to provide the animal health 
products needed by our Nation's farmers and pet owners, among others. 
Therefore, this Member strongly urges his colleagues to support H.R. 
2508, the Animal Drug Availability Act.
  Mr. BILIRAKIS. Mr. Speaker, I yield 3 minutes to the gentleman from 
Iowa [Mr. Ganske], who, as we know, performed a humanitarian act in 
South America during the break and has come back with a fairly serious 
sickness.
  As I understand it, he came back specifically today to speak on this 
particular piece of legislation because he feels very strongly about 
it.
  The SPEAKER pro tempore (Mr. Gunderson). If the gentleman from Iowa 
would suspend for just a moment, I know the Chair speaks for all 
Members in welcoming him back.
  The gentleman from Iowa is now recognized.
  Mr. GANSKE. Mr. Speaker, first let me thank Members of both sides of 
the aisle for their get-well wishes. I appreciate it very much.
  Earlier this month I was seriously ill and so I want to speak about 
this bill in a little different vein, so to speak.
  There will be a lot of talk about how this bill will economically be 
beneficial to farmers, and that is true, and this will help our 
country, I think, compete internationally in terms of livestock 
production.
  But I want to speak about something else. We have not had new drugs 
to treat animals, have many of them, for a long time, and this bill 
will streamline the process and help us get new ones. There is a term 
called animal husbandry. It is an old term. It has been applied to 
farmers, but I think it is appropriate.
  When a farmer has a herd or has a flock, and they come down with a 
respiratory infection and they are suffering and they are sick, that 
farmer is not thinking just about the economic impact. He is looking at 
his flock and he is looking at his herds and he knows they are sick and 
he knows they are suffering. And if you talk to a family that has had a 
pet and their pet dog or cat becomes sick, they see the suffering in 
that animal.
  I have been the beneficiary recently of modern medicine and some good 
antibiotics and good medicines and I think it is time that we make the 
modern technology that we have had on the human side more available on 
the animal side as well.
  I really think it is the only humanitarian thing to do. It will be 
beneficial economically, but even more importantly, I think it will 
help prevent animals from suffering when they are sick. I urge all of 
my colleagues to vote for this bipartisan bill.
  Mr. MILLER of California. Mr. Speaker, I am pleased to be an original 
cosponsor of H.R. 3217, the National Invasive Species Act, which we 
consider today. This legislation embodies a reasonable approach to 
addressing economic and environmental concerns while maintaining 
sensitivity to the maritime industry. It will establish a national 
voluntary ballast management program for vessels visiting U.S. ports. 
In addition to ballast management, this legislation will provide for 
research, education, and new technology to investigate and prevent 
species introduction in coastal and inland waters. In short, it is a 
major step toward protecting our natural resources.
  Prevention of further species introductions can occur to a great 
extent by ballast exchange as provided in this legislation. I only 
caution that the ballast exchange provisions in this bill are based on 
a large part on a good faith agreement with industry to take 
appropriate responsibility for the consequences of ballast transport. 
Based on industry's support of this bill, I believe that agreement is 
sound. However, I would encourage the Coast Guard to be diligent in 
monitoring compliance and assessing the effectiveness of those 
voluntary guidelines, and, where necessary, make mandatory regulations 
to ensure protection for regions that are critically impacted by 
nonindigenous species.
  Some regions of our country such as the San Francisco Bay-Delta 
Estuary are especially susceptible to species introduction from ballast 
water. There are greater than 200 nonindegenous species identified so 
far in the bay-delta with one new species established every 12 weeks. 
In fact, the bay-delta is recognized as the most invaded aquatic 
ecosystem in North America. These nonindigenous species are having 
serious consequences on California's aquatic ecosystem, water supplies, 
fisheries, and agricultural industry. This legislation will address 
those consequences through prevention as well as research efforts in 
the bay-delta. Understanding the patterns of species introductions and 
reducing the occurrence of those introductions is imperative in 
promoting the economic and ecological health of the bay-delta as well 
as the rest of our coastal regions.
  I thank Mr. LaTourette for his leadership on this bill. I would also 
thank my colleague from California, Mr. Filner, as well as Chairman 
Shuster and Mr. Oberstar, for working with me to include provisions 
which address critical concerns in California.
  Mr. HASTERT. Mr. Speaker, I rise in strong support of H.R. 2508, the 
Animal Drug Availability Act of 1995. I'd like to commend the gentleman 
from Colorado [Mr. Allard] for crafting a bill that enjoys such broad, 
bipartisan support. I know of no opposition to this bill.
  This bill is critical to animal agriculture and is sorely needed to 
improve the animal drug approval process. Currently, it takes the FDA 
an average of 58 months to approve a new animal drug, and the cost of 
bringing a drug to approval in some instances can be as high as $200 
million. This bill will streamline the approval process for animal 
drugs, making safe drugs available more quickly and less expensively.
  Clearly, the pork, cattle, poultry, and wool producers in my district 
in Illinois will benefit tremendously from this legislation, as will 
every pet owner in the country. But the benefits of this bill go far 
beyond making life a little easier for our farmers and for our animals. 
Ultimately, the real benefactors of this legislation will be every 
consumer across America, as safe, cheaper animal products are made more 
available.
  The bill before us today represents a consensus that has been 
negotiated with the

[[Page H10841]]

FDA. It enjoys broad bipartisan congressional support, and the full 
support of the administration. I urge quick passage today of the Animal 
Drug Availability Act. Thank you; I yield back the balance of my time.
  Mr. BLILEY. Mr. Speaker, we now take up a bill that is important to 
protect animal health at home and on the farm. The animal health 
industry keeps our pets healthy--including some 130 million dogs and 
cats--and agricultural animals that are vital to our food supply. The 
animal health industry protects human health by safeguarding the health 
of food and domestic animals.
  I have heard repeated concern from Members on both sides of the aisle 
that our FDA system for reviewing animal drug products needs 
significant improvement. Their concern reflects the frustration of 
diverse groups including agricultural interests, the animal drug 
industry, veterinarians, and animal producer groups.
  Our arsenal of drugs to fight animal disease is not growing.
  The FDA review process for animal drugs is much too slow--instead of 
6 months, the process has averaged up to 5 years.
  Some industry has become discouraged and divested animal drug 
development capability.
  Mr. Allard, Mr. Ganske, Mr. Klug, have been among those who said that 
it's time to take action and make changes. I particularly want to thank 
Mr. Ganske who has come from his hospital bed to be here today to 
demonstrate his support. Even the administration recognized the need to 
reform to streamline animal drug regulation and made its own proposals 
that were consistent with our views.
  The committee considered animal drug regulations as part of a broader 
initiative to streamline FDA regulation. We have made significant 
progress and I am very pleased that today we take up the completed 
animal drug reforms in H.R. 2508.
  The committee efforts have been helped by collaboration from the 
administration, the animal health coalition, veterinarians, and others 
interested in safeguarding our animals. I would like to thank each of 
them and their dedicated staff for their hard work.
  H.R. 2508 will facilitate the approval and marketing of new animal 
drugs and medicated feeds. It builds needed flexibility into the FDA 
animal drug review processes to enable more efficient approval and more 
expeditious marketing of safe and effective animal drugs.
  H.R. 2508 accomplishes streamlines without decreasing FDA's existing 
authority to ensure that animal drug products are safe for the animals 
that use them and for the humans who consume animal food products.
  Our reforms are sensible, pragmatic, and above all else, protective 
of public health. Of this accomplishment, I believe we can rightly be 
proud.
  Mr. STENHOLM. Mr. Speaker, H.R. 2508 is an example of how serious 
reform can and should occur. The Animal Drug Availability Act of 1995 
enjoys broad support from camps that do not always see things from the 
same viewpoint, however, both the FDA and the regulated community agree 
on the reform embodied in H.R. 2508. Additionally, the users of animal 
drugs, the veterinarians, and the various animal agriculture groups 
representing farmers and ranchers that raise beef, pork, and poultry 
all support this bill. The Animal Drug Availability Act represents what 
can be accomplished when all involved, regulators, those regulated, and 
the end users sit down and sincerely listen to each other. 
Unfortunately, the larger issue of FDA reform has been slowed for a 
variety of reasons. Hopefully, this bill should serve as an example of 
how future Congresses can approach larger FDA reform and of the 
progress that can result from bipartisan discussion open to all 
stakeholders.
  H.R. 2508, the Animal Drug Availability Act of 1995, represents 
common sense reform that reduces regulatory hurdles for efficacy 
testing and preserves safety testing. Let me say that again. The Animal 
Drug Availability Act does not reduce evaluation of products on the 
basis of human safety, nor does it reduce the FDA's ability to require 
target animal safety information. Essential safety standards for humans 
and animals would not be weakened in any way. The effect of the reform 
should be a speedier approval process without jeopardizing safety 
confidence.
  Animal health products many times do not command lucrative markets 
and it is difficult to justify investment into research and development 
for a new product or an additional approved use on a label if markets 
are limited or absent. Currently a large commitment in time and money 
is required to prove a product's efficacy claims. This bill would give 
the FDA greater flexibility in determining the type and number of 
studies it can accept as proof of an animal drug's efficacy. 
Streamlining the process and eliminating unnecessary field trials 
should speed the time to an approval decision and hopefully reduce some 
negative economic pressures being applied by the regulatory system.
  Small markets or limited economic incentives, do not mean that drugs 
for animals are not important. Take for instance the cattleman who has 
experienced difficult times with low cattle prices who may be trying to 
diversify and is starting to raise ostriches or pheasants, or a farmer 
who is involved in aquaculture, or even the wildlife or zoo 
veterinarian who deals with very unique patients. These are examples of 
animals that as a species represent few in number and generate very 
little economic incentive for a drug manufacturer to pursue R&D in that 
area . . .the so-called minor use/minor species problem of animal 
drugs. The legislation that legalized extra label drug use in animals 
by veterinarians was sponsored by this Member and others in the last 
Congress--the Animal Medicinal Drug Clarification Act of 1994. Extra 
label drug use will always be necessary, however, this bill will 
potentially help reduce the reliance on using drugs extra label. It can 
offer an opportunity for FDA to evaluate how the Animal Medicinal Drug 
Use Clarification Act and the Animal Drug Availability Act could 
efficiently work together.
  It is with some pride, as sponsor of the legislation that dealt with 
extra label use of animal drugs and now as one of the original 
cosponsors of the Animal Drug Availability Act, that this House is here 
addressing this issue on the Suspension Calendar. I am proud that 
animal drug regulatory reform may very well become an example of how 
larger FDA regulatory reform can be accomplished. I ask my colleagues 
to support H.R. 2508 and encourage the Senate to act quickly so that 
the President can sign this appropriate reform into law.
  Mr. ROBERTS. Mr. Speaker, I rise in strong support of this 
legislation which is vital to the future health of the Nation's 
livestock and poultry industry in rural districts throughout this 
country. H.R. 2508, the Animal Drug Availability Act, is a 
noncontroversial, bipartisan bill that streamlines and significantly 
improves the process by which animal drugs are approved. The bill 
expands the types of studies FDA can accept as proof of a drug's 
efficacy; requires FDA and drug companies to agree to test protocols 
before a company submits a drug application for approval; eliminates 
time-consuming field investigations, unless they are the only way to 
prove a drug's efficacy; eliminates some efficacy testing when a 
company seeks to use two individually approved drugs in combination; 
creates veterinary feed directive drugs which increase veterinarian 
involvement in dispensing animal drugs; and eliminates much of the 
licensing paperwork for feed mills that dispense animal drugs.
  The bottom line: this bill is perhaps the most significant thing this 
Congress can do to help the livestock and poultry industry reduce their 
cost of production and become more competitive.
  The cumbersome and lengthy process of getting animal drug approvals 
from FDA has led to several U.S. animal drug companies setting up 
plants overseas. Passage of this bill will also help stem the flow of 
jobs--well paying jobs--from this country.
  I am pleased to finally get a chance to discuss and vote on this 
important piece of legislation and I would strongly urge my colleagues 
to vote in favor of its passage.
  Mr. MANTON. Mr. Speaker, I have no further requests for time, and I 
yield back the balance of my time.
  Mr. BILIRAKIS. Mr. Speaker, I have no further requests for time, and 
I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Florida [Mr. Bilirakis] that the House suspend the rules 
and pass the bill, H.R. 2508, as amended.
  The question was taken; and (two-thirds having voted in favor 
thereof) the rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

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