[Congressional Record Volume 142, Number 133 (Tuesday, September 24, 1996)]
[Senate]
[Pages S11189-S11191]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




[[Page S11189]]



                THE ANIMAL DRUG AVAILABILITY ACT OF 1996

                                 ______
                                 

                      KASSEBAUM AMENDMENT NO. 5401

  Mr. FRIST (for Mrs. Kassebaum) proposed an amendment to the bill (S. 
773) 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 follows:

       Strike all after the enacting clause and insert the 
     following:

     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. 360(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.--
       (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 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;

[[Page S11190]]

       (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 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 animals 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 acknowledgement 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 acknowledgement 
     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 
     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

[[Page S11191]]

     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 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 approval 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 this 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.

                          ____________________