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[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2508 Reported in House (RH)]

                                                 Union Calendar No. 451

104th CONGRESS

  2d Session

                               H. R. 2508

                          [Report No. 104-823]

_______________________________________________________________________

                                 A BILL

   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.

_______________________________________________________________________

                           September 24, 1996

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed

                                                 Union Calendar No. 451
104th CONGRESS
  2d Session
                                H. R. 2508

                          [Report No. 104-823]

   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.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            October 19, 1995

   Mr. Allard (for himself, Mr. Klug, Mr. Stenholm, Mr. Dingell, Mr. 
 Ganske, Mr. Barrett of Nebraska, Mr. Bereuter, Mr. Boehner, Mr. Brown 
 of California, Mr. Bryant of Texas, Mr. Burton of Indiana, Mr. Buyer, 
Mr. Chambliss, Mrs. Chenoweth, Mr. Coble, Mr. Combest, Mr. Condit, Mr. 
Cooley of Oregon, Mr. Costello, Mr. Crapo, Mrs. Cubin, Mr. de la Garza, 
  Mr. Dooley of California, Mr. Ehlers, Mr. Emerson, Mr. Ensign, Mr. 
  Ewing, Mr. Goodlatte, Mr. Gordon, Mr. Gunderson, Mr. Hamilton, Mr. 
 Hefley, Mr. Holden, Mr. Hostettler, Mr. Johnson of South Dakota, Mr. 
Kleczka, Mr. LaHood, Mrs. Lincoln, Mr. Largent, Mr. Latham, Mr. Leach, 
   Mr. Lewis of Kentucky, Mr. Lightfoot, Mr. Lucas of Oklahoma, Mr. 
McInnis, Mr. McIntosh, Ms. McKinney, Mr. Miller of Florida, Mr. Minge, 
Ms. Molinari, Mr. Myers of Indiana, Mr. Norwood, Mr. Pastor, Mr. Paxon, 
  Mr. Peterson of Minnesota, Mr. Pombo, Mr. Pomeroy, Mr. Poshard, Mr. 
Roberts, Mr. Roemer, Mr. Rose, Mr. Schaefer, Mr. Skeen, Mr. Souder, Mr. 
Stump, Mr. Taylor of North Carolina, Mr. Thornberry, Mr. Thornton, Mrs. 
     Thurman, Mr. Walsh, Mr. Watts of Oklahoma, and Mr. Whitfield) 
 introduced the following bill; which was referred to the Committee on 
                                Commerce

                           September 24, 1996

Additional sponsors: Mr. Burr, Mrs. Clayton, Mr. Gillmor, Mr. Roth, Mr. 
    Gutknecht, Mr. Jacobs, Ms. Danner, Mr. Stupak, Mr. Volkmer, Mr. 
Funderburk, Mr. Frazer, Mr. Hinchey, Mr. Barton of Texas, Mr. Deutsch, 
  Mr. Skelton, Mr. Wicker, Mr. Gejdenson, Mr. Durbin, Mr. Rahall, Ms. 
Furse, Mr. Frost, Mr. Hancock, Mr. Smith of Texas, Mr. Hutchinson, Mr. 
 Brewster, Mr. Hansen, Mr. Bonilla, Mr. Montgomery, Mr. Laughlin, Mr. 
  Wamp, Ms. Woolsey, Mr. Manton, Mr. Fields of Texas, Mr. Frisa, Mr. 
Smith of Michigan, Mr. Castle, Mr. Forbes, Mr. Radanovich, Mr. Bilbray, 
 Mr. Christensen, Mr. Farr of California, Mr. Barcia, Mr. Dickey, Mr. 
 Heineman, Mr. Porter, Mr. Ney, Mr. Cramer, Mr. Jones, Mr. Jefferson, 
Mr. Greenwood, Mr. Towns, Ms. Pryce, Mr. Kennedy of Massachusetts, Mr. 
    Chrysler, Mr. Kildee, Mr. Livingston, Mr. Barr of Georgia, Mr. 
 Callahan, Mr. Canady of Florida, Mr. Wise, Mrs. Meyers of Kansas, Mr. 
  Matsui, Mr. Bevill, Mr. Traficant, Mr. Abercrombie, Mr. Bachus, Ms. 
 Dunn of Washington, Mr. Solomon, Mr. Fazio of California, Mr. Upton, 
Mr. Deal of Georgia, Mr. Pallone, Mr. Rohrabacher, Mr. Knollenberg, Mr. 
  Linder, Mr. Bunning of Kentucky, Mr. Cunningham, Mr. Ballenger, Mr. 
   Inglis of South Carolina, Mr. Edwards, Mr. Nussle, Mr. Wynn, Mr. 
 LaFalce, Mr. Collins of Georgia, Ms. Rivers, Mr. Foley, Mr. Hayworth, 
 Ms. McCarthy, Mr. Bryant of Tennessee, Mr. Bishop, Mr. Sensenbrenner, 
 Mrs. Myrick, Mr. Kasich, Mr. Pickett, Mr. Nethercutt, and Mr. Cremeans

                           September 24, 1996

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
[For text of introduced bill, see copy of bill as introduced on October 
                               19, 1995]

_______________________________________________________________________

                                 A BILL

 
   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.

    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.--
            (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 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 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.
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