[Congressional Record Volume 142, Number 133 (Tuesday, September 24, 1996)]
[Senate]
[Pages S11204-S11209]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                      ANIMAL DRUG AVAILABILITY ACT

  Mr. FRIST. Mr. President, I ask unanimous consent the Labor Committee 
be discharged from further consideration of S. 773, and the Senate 
immediately proceed to its consideration.
  The PRESIDING OFFICER. Without objection, it is so ordered. The clerk 
will report.
  The assistant legislative clerk read as follows:

       A 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.

  The PRESIDING OFFICER. Is there objection to the immediate 
consideration of the bill?
  There being no objection, the Senate proceeded to consider the bill.

                           Amendment No. 5401

            (Purpose: To provide for a substitute amendment)

  Mr. FRIST. Mr. President, Senator Kassebaum has a substitute at the 
desk. I ask for its consideration.
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from Tennessee [Mr. Frist], for Mrs. Kassebaum, 
     proposes an amendment numbered 5401.

  (The text of the amendment is printed in today's Record under 
``Amendments Submitted.'')
  Mrs. KASSEBAUM. Mr. President, I wish to thank my colleagues for 
agreeing to the passage of S. 773, the Animal Drug Availability Act. 
This legislation is designed to address the severe shortage of new 
drugs for the treatment of animals. The bill will modernize clinical 
testing requirements and make them more predictable and will improve 
the efficiency and timeliness of the Food and Drug Administration's 
[FDA] review of new animal drug applications, while at the same time 
ensuring that new animal drugs are safe for animals and humans and are 
effective.
  The Senate's passage of this legislation is a testament to what can 
be accomplished when the FDA, the regulated industry, and Congress 
recognize a problem--in this case, the lack of new drugs for treating 
animals--and work together in good faith to craft and enact creative, 
reasonable solutions to that problem. Dr. Steve Sundlof, the director 
of the FDA's Center for Veterinary Medicine, and his staff deserve 
great credit for their dedication to meaningful animal drug law and 
regulation reform in this Congress.
  I wish especially to thank each of the Members who has cosponsored 
and worked with me for the passage of this legislation. Without their 
effort and dedication to seeing this bill through the legislative 
process, we would not have succeeded in passing this bill today. Our 
former majority leader, Senator Dole, and Senators Lugar, Pryor, 
Pressler, Gregg, Gorton, Coats, Jeffords, Frist, Harkin, Craig, Inhofe, 
Grassley, McConnell, Kyl, Santorum, Heflin, Bond, Kerrey, Bennett, 
Helms, Hutchison, Lott, Bumpers, Mack, Ashcroft, Cochran, Roth, Warner, 
Ford, Kempthorne, Robb, Nickles, Stevens, Abraham, Daschle, Grams, 
Conrad, Burns, Moseley-Braun, Dorgan, Baucus, and Hatch each deserve 
great credit for their active support for this legislation.

[[Page S11205]]

  I ask unanimous consent a summary of the bill be printed in the 
Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

           S. 773, The Animal Drug Availability Act--Summary

       The Animal Drug Availability Act, S. 773, was introduced on 
     May 5, 1995, by Senator Kassebaum. It was approved by the 
     Senate Committee on Labor and Human Resources on March 28, 
     1996, as part of S. 1744, the FDA Performance and 
     Accountability Act, and now has a total of 43 bipartisan 
     Senate cosponsors. Subsequently, S. 773 was refined in close 
     collaboration with the Food and Drug Administration (FDA), 
     and the amendment in the nature to S. 773 reflects these 
     refinements.
       S. 773 is designed to address the serious lack of drugs for 
     treating animals by modernizing and making more predictable 
     the FDA's requirements for new animal drug testing and 
     improving the efficiency and timeliness of FDA's review of 
     new animal drug applications, without compromising either 
     human or animal safety or product effectiveness.
       These reforms include:
       1. Determination of effectiveness: The legislation would 
     clarify the discretionary authority of the FDA to rely on one 
     adequate and well-controlled investigation for the 
     determination of the effectiveness of an animal drug. The 
     study or studies could, but would no longer automatically be 
     presumed to, require field investigation(s).
       2. Combination drugs: The legislation clarifies that when 
     an already approved animal drugs are used in combination with 
     one another, the FDA may approve the combination drug as long 
     as none of the drugs in combination exceeds its established 
     tolerance or none of the drugs interferes with the working of 
     another of the drugs.
       3. Collaborative protocol design: The legislation provides 
     for a collaborative protocol design process. The FDA is 
     required to meet with individuals intending to investigate or 
     investigating new animal drugs to mutually decide on the 
     appropriate protocol for the clinical investigation. If the 
     FDA decides that more than one field investigation will be 
     necessary, the FDA must set forth its scientific 
     justification for that decision.
       4. Drugs for minor uses and species: The legislation 
     directs the Secretary to propose legislative or regulatory 
     options for facilitating the approval of animal drugs for 
     minor species and minor uses.
       5. Drug tolerance setting: The legislation clarifies that 
     the FDA may approve animal drugs which will not exceed the 
     tolerance set for that drug, as opposed to requiring the 
     manufacturer to determine an optimal dose for the drug.
       6. Tolerance for unapproved drugs: The legislation provides 
     the Secretary new authority to set tolerances for new animal 
     drugs that are not approved in the U.S. but are used in 
     animals imported for consumption in this country.
       7. Veterainary feed directive drugs: The legislation 
     establishes a new category of animal drugs--``veterinary feed 
     directive drugs.'' This is a category of drugs between 
     prescription drugs and over-the-counter drugs. The bill 
     establishes a number of requirements to ensure that these 
     drugs can be tracked and that they are used appropriately.
       8. Feed mill licensing: The legislation establishes a new 
     requirement for the licensing of feed mills that are 
     manufacturing feeds containing animal drugs to ensure 
     conformity with good manufacturing practices and for other 
     reasons.

  Mr. LUGAR. Mr. President, I am pleased that the Animal Drug 
Availability Act (S. 773) is before the full Senate for consideration 
today.
  As an original cosponsor of this legislation, I recognize the need 
for reform of the Food and Drug Administration [FDA] animal drug 
approval process. Producers and manufactures of animal drugs have been 
concerned with the lengthy time required to gain FDA approval of animal 
drugs as well as the lack of new drug options available to treat 
livestock and poultry.
  The legislation before us today is a consensus bill that is 
acceptable to FDA, agricultural procedures, pharmaceutical and animal 
health organizations and has garnered bipartisan support in the Senate. 
I had written to Senator Kassebaum recently urging prompt action on 
this legislation and thank her for her efforts to move this bill 
forward.
  The bill before us today will provide FDA with greater flexibility to 
determine when animal drugs are effective for intended uses; streamline 
approval of combination animal drugs when the drugs have been 
previously approved separately for the same species and conditions of 
use; provide FDA with greater flexibility in whether field 
investigations are necessary to prove efficacy; and require 
presubmission conferences to help FDA and drug manufacturers to reach 
agreement on testing requirements before a drug application is 
submitted to FDA. In addition, the bill streamlines the drug 
application licenses for feed mills, permits FDA to set import 
tolerances for drugs used in other countries, and includes a veterinary 
feed directive provision which will make new therapeutic animal drugs 
accessible in feed form.
  I urge my colleagues to support this important bill.
  Mr. GREGG. Mr. President, I rise today to talk about the demise of 
one very important piece of legislation--the 1996 FDA reform bill--and 
what I hope will be the success of another--the animal drug 
availability reform bill. These bills represent important Republican 
priorities: American patients and consumers, innovation in medicine and 
consumer products, and a smaller role for the Federal Government.
  Republicans put forth an FDA reform bill, supported in the Labor 
Committee by three of our Democratic colleagues, that puts the needs of 
our citizens first. Our goal in developing this legislation was clearly 
to expedite the bureaucratic review process at the Food and Drug 
Administration, while still recognizing their role in ensuring the 
safety of products such as pharmaceuticals, medical devices, and food 
additives being introduced into domestic and international commerce.
  In the Labor Committee, our discussions focused on the 
reprioritization of Agency resources and attitudes in order to achieve 
this goal. And while some have characterized these provisions as 
extreme, I believe that it is important to recognize that a number of 
provisions in the bill that our chairman, the senior Senator from 
Kansas [Mrs. Kassebaum] assembled simply recodify current law--albeit 
not current practice--by the FDA.
  In addition, this legislation contained a number of incremental 
improvements to the Food, Drug and Cosmetic Act. While I will freely 
admit that many of these provisions do not go as far as the changes 
that I advocate, I recognize the balance that Senator Kassebaum was 
attempting to strike; that is why I voted in favor of this legislation 
in Committee. I also would like to mention the spirit of the 
negotiations that I observed Senator Kassebaum engaged in with our 
Democratic colleagues and the administration. I thought her approach to 
this important issue was eminently fair, balanced, and accommodating.
  Mr. President, FDA reform is not a new idea. Like so many of the 
issues we take on, discussion and debate about FDA reform has been 
going on for many years. For example, the Edwards Commission was 
established by charter in 1989 and authorized by then Secretary of 
Health and Human Service Dr. Louis Sullivan. This task force was formed 
in response to a growing perception that FDA was in crisis. Serious 
questions had been raised about the agency's ability to do its job.
  After a year of public testimony and study, they published a report 
in May, 1991--a detailed analysis of the FDA's inner workings. The 
report concluded that the FDA was an agency in crisis. A large part of 
the report focused on internal structure, organization and management; 
the report recommended individual center adopt mission statements and 
that paper work flow studies be conducted agencywide. As a result of 
the report, Congress gave FDA substantially more money and staff--but I 
think that we all now understand that simply providing the FDA more 
resources does not solve the problems they have at the Agency.
  Mr. President, I originally had high hopes for FDA reform this 
Congress. On March 16, 1995, in a speech at an environmental facility 
in Virginia announcing phase II of the Reinventing Government 
initiative, the President even acknowledged that FDA reform was a vital 
issue. In RE-GO II, the administration issued specific recommendations 
for the reform of the FDA to be achieved through legislative and 
regulatory changes. However, I was concerned by the quotation used from 
the President's rhetoric on the first page of the follow up white 
paper: ``The Food and Drug Administration has made American drugs and 
medical devices the envy of the world and in demaind all over the 
world.''
  I believe that it is this sort of perception that has gotten us to 
the point where we are today: a regulatory system that no longer has 
clear boundaries or delineated goals, is anticompetitive, and has an 
attitude that we must function as ``the FDA to the

[[Page S11206]]

world.'' Former Commissioner Dr. Charles Edwards put it more 
appropriately when he said that, ``The mission of the FDA is consumer 
protection. Unfortunately, the FDA has tended to confuse its mission 
with the power to promote what it deems to be appropriate personal and 
professional behavior.'' No matter--the administration's white paper of 
reforms proved to be more of a red herring than anything else.
  The FDA has demonstrated a lack of investment on their part in the 
private sectors' efforts to bring cutting edge medicine to American 
patients. Businesses do not engage in activities lightly, especially 
small business making substantial investments in their own future. The 
FDA has also indicated an unwillingness to let scientists determine the 
standard of science, to let doctors freely practice medicine, and to 
allow patients to be informed about their range of options.
  To the FDA, it all seems to be about money. The authorized user 
fees--or taxes placed on the backs of companies working to provide 
innovative health care solutions--in the Administration's budget 
request continue to grow. The Administration also continues to annually 
request two unauthorized user fees: one would levy a new tax on medical 
device manufacturers and another would be an important inspection fee. 
Increasing taxes will not solve the problems that persist at the Food 
and Drug Administration.
  Peter Barton Hutt, former FDA General Counsel, summed this up well in 
a speech before the Utah International Medical Device Congress in 1993. 
He stated, ``User fees is a false issue. If we do not change the 
philosophy of the FDA reviewers about the criteria for approving either 
Section 510(k) notifications or PMA applications, we can triple the 
number of people in the FDA and not get one additional application 
approved.'' It is these sort of changes in philosophy, as well as 
corrections to the fiscal priorities, that we are seeking at the FDA 
through our reform efforts. But, unfortunately, Congress cannot 
legislate attitude.
  I also remain unconvinced that new user fees would ever be sunset, 
even if the application backlog is cleared. I think the discussion we 
will soon begin in regard to the renegotiation of PDUFA will be 
revealing on this count. I also have yet to see any proposal that would 
refund user fees to any company if the product review was not completed 
within the statutory timeline--this is an agency that wants to function 
like a business without regard to the rules of business--``Get what you 
pay for.'' I don't see why businesses should be expected to tolerate 
this.
  In recent years, there also seems to have been a marked shift from 
product approval to enforcement at FDA. While there is no clear cut 
cause for this sea change, the intimidation that has resulted from 
these actions is great. There is, of course, no way to accurately 
measure the chilling effect this may be having on relevant industries. 
But this police state mentality has spilled over into the appropriate 
regulation of product safety.
  Companies are terrified that they will be made the victim of a public 
campaign in the media. The FDA is reputed for its role in propagating 
widespread fear of retaliation against any company that would cooperate 
with Congress in its examination of the FDA's mission and regulatory 
practices. We have found that a number of individuals and companies 
fear retribution in the form of delayed FDA product reviews and 
regulatory discrimination if they should criticize the agency. This 
fear has led to hesitancy on the part of potential witnesses to provide 
committees with the testimony that they need in order to make an 
informed judgment on the policies and practices of the agency.
  Commissioner Kessler has argued that the industry perceives issues to 
be something other than what they actually are, such as the Reference 
List being viewed as a ``black list.'' While we appreciated the 
assurances made to the Labor Committee by the Commissioner that such 
fears are unfounded, I have yet to learn what affirmative steps the FDA 
has taken to reassure those regulated by the agency that they may feel 
completely comfortable exercising their right to speak freely to the 
Congress, without threat of retribution or retaliation from the agency. 
I have to wonder how many stories continue to go untold, how many 
problems go unexplored, how many questions remain unanswered.
  However, Mr. President, I am pleased to note that a couple of FDA-
related problems have been resolved this Congress. One dealt with the 
untenable restrictions placed on U.S. manufacturers regarding their 
ability to export products approved for use in other countries, but not 
yet approved for domestic commerce. Working closely with my colleague 
from Utah, Senator Hatch, we engaged in a lengthy dialog with ranking 
minority member of the Labor Committee, Mr. Kennedy. The result was 
passage of reform of sections 801 and 802 of the Federal Food, Drug and 
Cosmetic Act, provisions which govern the import and export of FDA-
regulated products. Subsequently, these provisions were signed into 
law, a major victory for U.S. manufacturers who are no longer obligated 
to build factories and send jobs and investment capital overseas.
  A second major issue that was partially resolved dealt with the 
ridiculously unscientific Delaney Clause. Countless experts and 
virtually every former Commissioner have stated the fact that a ``zero 
risk'' standard is not only unscientific, but virtually immeasurable. 
As analytical examinations have improved, science has been able to 
detect ever-shrinking amounts of trace chemicals in our food supply--
excellent science means that minute, formerly undetectable amounts of 
pesticides and chemicals can be detected, and even though they pose no 
threat over a human lifetime, would be banned under the unrealistic 
Delaney scheme. Fortunately, this Congress had the bipartisan wisdom to 
institute a realistic, scientifically based standard in place of the 
Delaney Clause as it related to the regulation of pesticides. Congress 
recognized that in this day and age ``zero risk'' would come close to 
meaning ``zero food.'' The Delaney reform signed into law takes us out 
of the realm of the theory of a health treat, and into a food safety 
realm that balances health considerations with an abundant, affordable 
food supply.

  And, Mr. President, I am hopeful that we will add this animal drug 
reform compromise to the list of items we have accomplished this 
Congress. I understand from my colleague from Kansas that this 
legislation is the result of a real effort on the part of the FDA, the 
relevant industry, and her staff. I also understand that the House has 
taken action on this matter, so there is a realistic chance for these 
provisions to become law--the type of all that we can all feel good 
about, a law that balances consumer safety with an appropriate level of 
Federal regulation.
  I also hope that we will have an opportunity to clear the way for one 
other related measure before Congress adjourns--the biomaterials bill 
that Senators Gorton, Lieberman, and McCain have been championing for 
many months. This legislation, which provides reasonable relief to the 
suppliers of critical raw materials. This relief is necessary to ensure 
that life-sustaining and life-enhancing devices will remain readily 
available to American patients.
  Mr. President, let me just conclude by saying that the discussion of 
FDA reform will continue into the next Congress. This is a high 
priority for many of us, as it is such a high priority for American 
patients and consumers on a daily basis. We will continue to work hard 
to define an appropriate role for the Federal Government--for the FDA--
in the lives of our citizens.
  Mr. HARKIN. Mr. President, I am pleased to that we are today seeing 
Senate passage of this important legislation. I especially want to 
thank Senator Kassebaum for her efforts in working out the details of 
this consensus bill and in arranging for its passage as a freestanding 
measure. I also want to thank Senator Kennedy for his cooperation and 
efforts in clearing the bill for passage.
  I am proud to be an original cosponsor of the legislation. It has 
been very gratifying to have been a part of the process of reaching 
agreement on the provisions of this bill among representatives of the 
animal drug industry, livestock and poultry producer organizations, 
consumers and the Food and Drug Administration. In particular, I would 
like to commend Dr. Stephen Sundlof, Director of the Center for 
Veterinary Medicine at FDA for his hard

[[Page S11207]]

work and cooperation in reaching consensus on this bill. This has been 
an exemplary effort in reaching a common-sense balance between the need 
for adequate regulation and the practical realities of livestock and 
poultry production.
  The bill does not in any way weaken the protections for human health 
contained in current law pertaining to animal drugs. The bill does, 
however, streamline the animal drug approval process, primarily by 
removing unnecessary and duplicative testing and investigation 
requirements found in current law. By reducing unnecessary requirements 
in the approval process, the approval of new animal drugs will become 
less costly and time consuming. That is very important, since the 
livestock and poultry industries are facing a near crisis caused by the 
lack of approved new drugs. For example, there has been only one new 
drug approved for use in swine since 1990, and that drug cannot be 
marketed as a practical matter until this legislation passes.
  The bill also contains a much needed resolution of the problems 
associated with veterinary oversight in dispensing of drugs for use in 
livestock and poultry feeds.
  This legislation is a huge step forward in improving FDA's animal 
drug approval process and a real victory for livestock and poultry 
producers, consumers and producers of animal drugs.
  Mr. FRIST. Mr. President, I ask unanimous consent the amendment be 
agreed to, the bill be deemed read a third time and passed, the motion 
to reconsider be laid upon the table, and that any statement relating 
to the bill appear at this point in the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 5401) was agreed to.
  The bill (S. 773), as amended, was deemed read for a third time and 
passed, as follows:

                                 S. 773

       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

[[Page S11208]]

     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 US.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

[[Page S11209]]

     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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