Provides for establishment of an index of unapproved new animal drugs for minor species, and allows marketing of such drugs that evidence no human food safety concern.
Authorizes: (1) designation of new animal drugs for minor use or minor species; and (2) grants or contracts for development (and exclusivity) of designated new animal drugs. Modifies new animal drug approval requirements.
Amends the Internal Revenue Code to allow a business research tax credit (not applicable to grant or contract funds) for minor use qualified safety and effectiveness testing expenses.
Directs the Secretary of Health and Human Services to establish within the Food and Drug Administration an Office of Minor Use and Minor Species Animal Drug Development.
[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 1346 Introduced in Senate (IS)]
107th CONGRESS
1st Session
S. 1346
To amend the Federal Food, Drug, and Cosmetic Act with regard to new
animal drugs, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
August 2, 2001
Mr. Sessions (for himself, Mr. Bingaman, Mr. Allard, and Ms. Collins)
introduced the following bill; which was read twice and referred to the
Committee on Finance
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with regard to new
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.
This Act may be cited as the ``Minor Use and Minor Species Animal
Health Act of 2001''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) There is a severe shortage of approved new animal drugs
for use in minor species.
(2) There is a severe shortage of approved new animal drugs
for treating animal diseases and conditions that occur
infrequently or in limited geographic areas.
(3) Because of the small market shares, low-profit margins
involved, and capital investment required, it is generally not
economically feasible for new animal drug sponsors to pursue
approvals for these species, diseases, and conditions.
(4) Because the populations for which such new animal drugs
are intended may be small and conditions of animal management
may vary widely, it is often difficult to design and conduct
studies to establish drug safety and effectiveness under
traditional new animal drug approval processes.
(5) It is in the public interest and in the interest of
animal welfare to provide for special procedures to allow the
lawful use and marketing of certain new animal drugs for minor
species and minor uses that take into account these special
circumstances and that ensure that such drugs do not endanger
animal or public health.
(6) Exclusive marketing rights and tax credits for clinical
testing expenses have helped encourage the development of
`orphan' drugs for human use, and comparable incentives should
encourage the development of new animal drugs for minor species
and minor uses.
SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) Definitions.--Section 201 of the Federal, Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the
following:
``(kk) The term `major species' means cattle, horses, swine,
chickens, turkeys, dogs, and cats, except that the Secretary may revise
this definition by regulation.
``(ll) The term `minor species' means animals other than humans
that are not major species.
``(mm) The term `minor use' means the intended use of a drug in a
major species for an indication that occurs infrequently or in limited
geographical areas.''.
(b) Three-Year Exclusivity for Minor Use and Minor Species
Approvals.--Section 512(c)(2)(F) (ii), (iii), and (v) of the Federal
Food, Drug, and Cosmetic Act is amended by striking ``(other than
bioequivalence or residue studies)'' and inserting ``(other than
bioequivalence studies or final residue depletion studies, except final
residue depletion studies for minor uses or minor species)'' every
place it appears.
(c) Scope of Review for Minor Use and Minor Species Applications.--
Section 512(d) of the Federal Food, Drug, and Cosmetic Act is amended
by adding at the end the following new paragraph:
``(5) In reviewing an application that proposes a change to
add an intended use for a minor use or a minor species to an
approved new animal drug application, the Secretary shall
reevaluate only the relevant information in the approved
application to determine whether the application for the minor
use or minor species can be approved. A decision to approve the
application for the minor use or minor species is not,
implicitly or explicitly, a reaffirmation of the approval of
the original application.''.
(d) Minor Use and Minor Species New Animal Drugs.--Chapter V of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended
by adding at the end the following:
``Subchapter F--New Animal Drugs For Minor Use And Minor Species
``SEC. 571. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS FOR MINOR USE AND
MINOR SPECIES.
``(a)(1) Except as provided in paragraph (3) of this section, any
person may file with the Secretary an application for conditional
approval of a new animal drug intended for a minor use or a minor
species. Such an application may not be a supplement to an application
approved under section 512. Such application must comply in all
respects with the provisions of section 512 of this Act except
512(b)(2), 512(c)(1), 512(c)(2), 512(c)(3), 512(d)(1), 512(e), 512(h),
and 512(n) unless otherwise stated in this section, and any additional
provisions of this section.
``(2) The applicant shall submit to the Secretary as part of an
application for the conditional approval of a new animal drug--
``(A) all information necessary to meet the requirements of
section 512(b)(1) except 512(b)(1)(A);
``(B) full reports of investigations which have been made
to show whether or not such drug is safe and there is a
reasonable expectation of effectiveness for use;
``(C) data for establishing a conditional dose;
``(D) projections of expected need and the justification
for that expectation based on the best information available;
``(E) information regarding the quantity of drug expected
to be distributed on an annual basis to meet the expected need;
and
``(F) a commitment that the applicant will conduct
additional investigations to meet the requirements for the full
demonstration of effectiveness under section 512(d)(1)(E)
within 5 years.
``(3) A person may not file an application under paragraph (1) if
without adequate justification--
``(A) the person has previously filed an application for
conditional approval under paragraph (1) for the same drug,
conditions of use, and dosage form whether or not subsequently
conditionally approved by the Secretary under subsection (b),
or
``(B) the person obtained the application, or data or other
information contained therein, directly or indirectly from the
person who filed for conditional approval under paragraph (1)
for the same drug and conditions of use whether or not
subsequently conditionally approved by the Secretary under
subsection (b).
``(b) Within 180 days after the filing of an application pursuant
to subsection (a), or such additional period as may be agreed upon by
the Secretary and the applicant, the Secretary shall either--
``(1) issue an order, effective for one year, conditionally
approving the application if the Secretary finds that none of
the grounds for denying conditional approval, specified in
subsection (c) of this section applies, or
``(2) give the applicant notice of an opportunity for an
informal hearing on the question whether such application can
be conditionally approved.
``(c) If the Secretary finds, after giving the applicant notice and
an opportunity for an informal hearing, that--
``(1) any of the provisions of section 512(d)(1)(A) through
(D) or (F) through (I) are applicable;
``(2) the information submitted to the Secretary as part of
the application and any other information before the Secretary
with respect to such drug, is insufficient to show that there
is a reasonable expectation that the drug will have the effect
it purports or is represented to have under the conditions of
use prescribed, recommended, or suggested in the proposed
labeling thereof; or
``(3) another person has received approval under section
512 for a drug with the same active ingredient or ingredients,
the same conditions of use, and the same dosage form and that
person is able to assure the availability of sufficient
quantities of the drug to meet the needs for which the drug is
intended;
the Secretary shall issue an order refusing to conditionally approve
the application. If, after such notice and opportunity for an informal
hearing, the Secretary finds that subparagraphs (1) through (3) do not
apply, the Secretary shall issue an order conditionally approving the
application effective for one year. Any order issued under this
subsection refusing to conditionally approve an application shall state
the findings upon which it is based.
``(d) A conditional approval under this section is effective for a
1-year period and is thereafter renewable by the Secretary annually for
up to 4 additional 1-year terms. A conditional approval shall be in
effect for no more than 5 years from the date of approval under
subsections (b)(1) or (c) of this section unless extended as provided
for in subsection (h) of this section. The following shall also apply:
``(1) No later than 90 days from the end of the 1-year
period for which the original or renewed conditional approval
is effective, the applicant may submit a request to renew a
conditional approval for an additional 1-year term.
``(2) If the renewal request is submitted no later than 90-
days from the end of the 1-year period, a conditional approval
shall be deemed renewed at the end of the 1-year period, or at
the end of an additional 90-day extension when deemed necessary
to complete review of an application, unless the Secretary
makes a written determination before the expiration of the 1-
year period or the 90-day extension that--
``(A) the request fails to contain sufficient
information to show that--
``(i) the applicant is making sufficient
progress toward meeting approval requirements
under section 512(d)(1)(E), and is likely to be
able to fulfill those requirements and obtain
an approval under section 512 before the
expiration of the 5-year maximum term of the
conditional approval;
``(ii) the quantity of the drug that has
been distributed is consistent with the
intended use, unless there is adequate
explanation that ensures that the drug is only
used for its intended purpose; or
``(iii) no other drug with the same active
ingredient or ingredients, for the same
conditions of use, and dosage form has received
approval under section 512, or if such a drug
has been approved, that the holder of the
approved application is unable to assure the
availability of sufficient quantities of the
drug to meet the needs for which the drug is
intended; or
``(B) 1 or more of the conditions of subsection
512(e)(1)(A) through (B) and (D) through (F) are met.
``(3) If the Secretary makes a timely written determination
that a conditional approval should not be renewed, or the
applicant fails to submit a timely renewal request, the
Secretary shall issue an order refusing to renew the
conditional approval, and such conditional approval shall be
deemed withdrawn and no longer in effect. The Secretary shall
thereafter provide an opportunity for an informal hearing to
the applicant on the issue whether the conditional approval
shall be reinstated.
``(e)(1) The Secretary shall issue an order withdrawing conditional
approval of an application filed pursuant to subsection (a) if the
Secretary finds that another person has received approval under section
512 for a drug with the same active ingredient or ingredients, the same
conditions of use, and dosage form, and that person is able to assure
the availability of sufficient quantities of the drug to meet the needs
for which the drug is intended.
``(2) The Secretary shall, after due notice and opportunity for an
informal hearing to the applicant, issue an order withdrawing
conditional approval of an application filed pursuant to subsection (a)
if the Secretary finds that--
``(A) any of the provisions of section 512(e)(1)(A) through
(B) or (D) through (F) are applicable; or
``(B) on the basis of new information before the Secretary
with respect to such drug, evaluated together with the evidence
available to the Secretary when the application was
conditionally approved, that there is not a reasonable
expectation that such drug will have the effect it purports or
is represented to have under the conditions of use prescribed,
recommended, or suggested in the labeling thereof;
``(3) The Secretary may also, after due notice and opportunity for
an informal hearing to the applicant, issue an order withdrawing
conditional approval of an application filed pursuant to subsection (a)
if the Secretary finds that any of the provisions of section 512(e)(2)
are applicable.
``(f)(1) The label and labeling of a new animal drug with a
conditional approval under this section shall--
``(A) bear the statement, ``conditionally approved by FDA
pending a full demonstration of effectiveness under application
number''; and
``(B) contain such other information as prescribed by the
Secretary.
``(2) An intended use that is the subject of a conditional approval
under this section shall not be included in the same product label with
any intended use approved under section 512.
``(g) A conditionally-approved new animal drug application may not
be amended or supplemented to add indications for use.
``(h) 180 days prior to the termination date established under
subsection (d)(1) of this section, a sponsor shall have submitted all
the information necessary to support a complete new animal drug
application in accordance with section 512(b)(1) or the conditional
approval issued under this section is no longer in effect. Upon receipt
of this information, the Secretary shall either--
``(1) issue an order approving the application if the
Secretary finds that none of the grounds for denying approval
specified in 512(d)(1) applies, or
``(2) give the sponsor an opportunity for a hearing before
the Secretary under 512(d) on the question whether such
application can be approved. Upon issuance of an order
approving the application, product labeling and administrative
records of approval shall be modified accordingly. If the
Secretary has not issued an order under section 512(c)
approving such application prior to the termination date
established under subsection (d)(1) of this section, the
conditional approval issued under this section is no longer in
effect unless the Secretary grants an extension of an
additional 180-day period so that the Secretary can complete
review of the application. The decision to grant an extension
is committed to Agency discretion and not subject to judicial
review.
``(i) The decision of the Secretary under subsections (c), (d), or
(e) of this section, refusing or withdrawing conditional approval of an
application shall constitute final agency action subject to judicial
review.
``SEC. 572. INDEX OF LEGALLY-MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR
MINOR SPECIES.
``(a) The Secretary shall establish an index of unapproved minor
species new animal drugs that may be lawfully marketed for use in minor
species. The index shall be limited to--
``(1) new animal drugs intended for use in a minor species
for which there is a reasonable certainty that the animal or
edible products from the animal will not be consumed by humans,
and
``(2) new animal drugs intended for use in an early life
stage of a food-producing minor species where human food safety
can be demonstrated in accordance with the standard of section
512(d) by showing that--
``(A) there is no significant likelihood that
harmful residues will be present in the animal
presented as food for humans as a result of treatment
at the early life stage;
``(B) there is no significant likelihood that
harmful residues will be present in the animal
presented as food for food-producing animals as a
result of treatment at the early life stage; and
``(C) there are no concerns about the use of the
drug at later life stages because a tolerance and
regulatory method to test for the drug at later life
stages are available or there is no practical use for
the drug in later life stages.
``(b) Any person intending to file a request under this section
shall be entitled to one or more conferences to discuss the
requirements for indexing a new animal drug.
``(c)(1) Any person may submit a request to the Secretary for a
determination whether a new animal drug may be eligible for inclusion
in the index. Such a request shall include--
``(A) information regarding the need for the new animal
drug, the species for which the new animal drug is intended,
the proposed intended use and conditions of use, and
anticipated annual distribution;
``(B) information to support the conclusion that the
proposed use meets the conditions of subsections (a)(1) or
(a)(2) of this section;
``(C) information regarding the components and composition
of the new animal drug;
``(D) a description of the methods used in, and the
facilities and controls used for, the manufacture, processing,
and packing of such new animal drug;
``(E) an environmental assessment or information to support
a categorical exclusion from the requirement to prepare an
environmental assessment;
``(F) information sufficient to support the conclusion that
the proposed use of the new animal drug does not present a
threat to the safety of individuals exposed to the new animal
drug through its manufacture or use; and
``(G) such other information as the Secretary may deem
necessary to make this eligibility determination.
``(2) Within 90 days after the submission of a request for a
determination of eligibility for indexing based on paragraph (a)(1) of
this section, or 180 days for a request submitted based on paragraph
(a)(2) of this section, the Secretary shall grant or deny the request,
and notify the person who requested such determination of the
Secretary's decision. The Secretary shall grant the request if the
Secretary finds that--
``(A) no new animal drug, including the same active
ingredient or any salt or ester thereof is approved or
conditionally approved in the same dosage form for the same
intended use;
``(B) the proposed use does not raise concerns related to
safety; and
``(C) the person requesting the determination has
established appropriate specifications for the manufacture and
control of the new animal drug and has demonstrated an
understanding of the requirements of current good manufacturing
practices.
If the Secretary denies the request, the Secretary shall thereafter
provide due notice and an opportunity for an informal conference. The
decision of the Secretary following an informal conference shall
constitute final agency action subject to judicial review.
``(d)(1) With respect to a new animal drug for which the Secretary
has made a determination of eligibility under subsection (b), the
person who made such a request may ask that the Secretary add the new
animal drug to the index established under subsection (a). The request
for addition to the index shall include--
``(A) a copy of the Secretary's determination of
eligibility issued under subsection (b);
``(B) a written report that meets the requirements in
subparagraph (d)(2) of this section;
``(C) a proposed index entry;
``(D) facsimile labeling;
``(E) anticipated annual distribution of the new animal
drug;
``(F) a written commitment to manufacture the new animal
drug according to current good manufacturing practices;
``(G) a written commitment to label, distribute, and
promote the new animal drug only in accordance with the index
entry;
``(H) upon specific request of the Secretary, information
submitted to the expert panel described in subparagraph (3);
and
``(I) any additional requirements that the Secretary may
prescribe by general regulation or specific order.
``(2) The report required in subparagraph (1) shall:
``(A) be authored by a qualified expert panel;
``(B) include an evaluation of all available target animal
safety and effectiveness information, including anecdotal
information;
``(C) State the expert panel's opinion regarding whether
the benefits of using the new animal drug for the proposed use
in a minor species outweigh its risks, taking into account the
harm being caused by the absence of an approved or
conditionally-approved new animal drug for the minor species in
question;
``(D) include information upon which labeling can be
written; and
``(E) include a recommendation regarding whether the new
animal drug should be limited to use under the professional
supervision of a licensed veterinarian.
``(3) A qualified expert panel, as used in this section, is a panel
that--
``(A) is composed of experts qualified by scientific
training and experience to evaluate the target animal safety
and effectiveness of the new animal drug under consideration;
``(B) operates external to FDA; and
``(C) is not subject to the Federal Advisory Committee Act,
5 U.S.C. App. 2.
The Secretary shall define the criteria for selection of a qualified
expert panel and the procedures for the operation of the panel by
regulation.
``(4) Within 180 days after the receipt of a request for listing a
new animal drug in the index, the Secretary shall grant or deny the
request. The Secretary shall grant the request if the request for
indexing continues to meet the eligibility criteria in subsection (a)
and the Secretary finds, on the basis of the report of the qualified
expert panel and other information available to the Secretary, that the
benefits of using the new animal drug for the proposed use in a minor
species outweigh its risks, taking into account the harm caused by the
absence of an approved or conditionally-approved new animal drug for
the minor species in question. If the Secretary denies the request, the
Secretary shall thereafter provide due notice and the opportunity for
an informal conference. The decision of the Secretary following an
informal conference shall constitute final agency action subject to
judicial review.
``(e)(1) The index established under subsection (a) shall include
the following information for each listed drug--
``(A) the name and address of the person who holds the
index listing;
``(B) the name of the drug and the intended use and
conditions of use for which it is being indexed;
``(C) product labeling; and
``(D) conditions and any limitations that the Secretary
deems necessary regarding use of the drug.
``(2) The Secretary shall publish the index, and revise it
periodically.
``(3) The Secretary may establish by regulation a process for
reporting changes in the conditions of manufacturing or labeling of
indexed products.
``(f)(1) If the Secretary finds, after due notice to the person who
requested the index listing and an opportunity for an informal
conference, that--
``(A) the expert panel failed to meet the requirements as
set forth by the Secretary by regulation;
``(B) on the basis of new information before the Secretary,
evaluated together with the evidence available to the
Secretary when the new animal drug was listed in the index, the
benefits of using the new animal drug for the indexed use do not
outweigh its risks;
``(C) the conditions of subsection (c)(2) of this section
are no longer satisfied;
``(D) the manufacture of the new animal drug is not in
accordance with current good manufacturing practices;
``(E) the labeling, distribution, or promotion of the new
animal drug is not in accordance with the index entry;
``(F) the conditions and limitations of use associated with
the index listing have not been followed; or
``(G) the request for indexing contains any untrue
statement of material fact;
the Secretary shall remove the new animal drug from the index. The
decision of the Secretary following an informal conference shall
constitute final agency action subject to judicial review.
``(2) If the Secretary finds that there is a reasonable probability
that the use of the drug would adversely affect the health of humans or
other animals, the Secretary may:
``(A) suspend the listing of such drug immediately;
``(B) give the person listed in the index prompt notice of
the Secretary's action; and
``(C) afford that person the opportunity for an informal
conference.
The decision of the Secretary following an informal conference shall
constitute final agency action subject to judicial review.
``(g) For purposes of indexing new animal drugs under this section,
to the extent consistent with the public health, the Secretary shall
promulgate regulations for exempting from the operation of section 512
minor species new animal drugs and animal feeds bearing or containing
new animal drugs intended solely for investigational use by experts
qualified by scientific training and experience to investigate the
safety and effectiveness of minor species animal drugs. Such
regulations may, at the discretion of the Secretary, among other
conditions relating to the protection of the public health, provide for
conditioning such exemption upon the establishment and maintenance of
such records, and the making of such reports to the Secretary, by the
manufacturer or the sponsor of the investigation of such article, of
data (including but not limited to analytical reports by investigators)
obtained as a result of such investigational use of such article, as
the Secretary finds will enable the Secretary to evaluate the safety
and effectiveness of such article in the event of the filing of a
request for an index listing pursuant to this section.
``(h) The labeling of a new animal drug that is the subject of an
index listing shall state, prominently and conspicuously--
``(1) Not approved by FDA.--Legally marketed as an FDA
indexed product. Extra-label use is prohibited.'';
``(2) except in the case of new animal drugs indexed for
use in an early life stage of a food producing animal, ``This
product is not to be used in animals intended for use as food
for humans or other animals.''; and
``(3) such other information as may be prescribed by the
Secretary in the index listing.
``(i)(1) In the case of any new animal drug for which an index
listing pursuant to subsection (a) is in effect, the person who has an
index listing shall establish and maintain such records, and make such
reports to the Secretary, of data relating to experience, and other
data or information, received or otherwise obtained by such person with
respect to such drug, or with respect to animal feeds bearing or
containing such drug, as the Secretary may by general regulation, or by
order with respect to such listing, prescribe on the basis of a finding
that such records and reports are necessary in order to enable the
Secretary to determine, or facilitate a determination, whether there is
or may be ground for invoking subsection (f). Such regulation or order
shall provide, where the Secretary deems it to be appropriate, for the
examination, upon request, by the persons to whom such regulation or
order is applicable, of similar information received or otherwise
obtained by the Secretary.
``(2) Every person required under this subsection to maintain
records, and every person in charge or custody thereof, shall, upon
request of an officer or employee designated by the Secretary, permit
such officer or employee at all reasonable times to have access to and
copy and verify such records.
``(j)(1) Safety and effectiveness data and information which has
been submitted in support of a request for a new animal drug to be
indexed under this section and which has not been previously disclosed
to the public shall be made available to the public, upon request,
unless extraordinary circumstances are shown--
``(A) if no work is being or will be undertaken to have the
drug indexed in accordance with the request,
``(B) if the Secretary has determined that such drug cannot
be indexed and all legal appeals have been exhausted,
``(C) if the indexing of such drug is terminated and all
legal appeals have been exhausted, or
``(D) if the Secretary has determined that such drug is not
a new animal drug.
``(2) Any request for data and information pursuant to paragraph
(1) shall include a verified statement by the person making the request
that any data or information received under such paragraph shall not be
disclosed by such person to any other person--
``(A) for the purpose of, or as part of a plan, scheme, or
device for, obtaining the right to make, use, or market, or
making, using, or marketing, outside the United States, the
drug identified in the request for indexing; and
``(B) without obtaining from any person to whom the data
and information are disclosed an identical verified statement,
a copy of which is to be provided by such person to the
Secretary, which meets the requirements of this paragraph.
``SEC. 573. DESIGNATED NEW ANIMAL DRUGS FOR MINOR USE OR MINOR SPECIES.
``(a) Designation.--
``(1) The manufacturer or the sponsor of a new animal drug
for a minor use or use in a minor species may request that the
Secretary declare that drug a `designated new animal drug'. A
request for designation of a new animal drug shall be made
before the submission of an application under section 512(b) or
section 571 for the new animal drug.
``(2) The Secretary may declare a new animal drug a
`designated new animal drug' for an intended use if--
``(A) it is intended for a minor use or use in a
minor species; and
``(B) a new animal drug containing the same active
ingredient, including any salt or ester of the active
ingredient, for the same intended use, in the same
species, and in the same dosage form is not approved
under section 512 or section 571 or designated for the
intended use at the time the request is made.
``(3) Regarding the termination of a designation--
``(A) the sponsor of a new animal drug shall notify
the Secretary of any decision to discontinue active
pursuit of approval under sections 512 or 571 of an
application for a designated new animal drug. The
Secretary shall terminate the designation upon such
notification;
``(B) the Secretary may also terminate designation
if the Secretary independently determines that the
sponsor is not actively pursuing approval under
sections 512 or 571 with due diligence;
``(C) the sponsor of an approved designated new
animal drug shall notify the Secretary of any
discontinuance of the manufacture of such new animal
drug at least one year before discontinuance. The
Secretary shall terminate the designation upon such
notification; and
``(D) the designation shall terminate upon the
expiration of any applicable exclusivity period under
subsection (c).
``(4) Notice respecting the designation or termination of
designation of a new animal drug shall be made available to the
public.
``(b) Grants and Contracts for Development of Designated New Animal
Drugs.--
``(1) The Secretary may make grants to and enter into
contracts with public and private entities and individuals to
assist in defraying the costs of qualified safety and
effectiveness testing expenses and manufacturing expenses
incurred in connection with the development of designated new
animal drugs.
``(2) For purposes of subsection (1) of this section--
``(A) The term ``qualified safety and effectiveness
testing'' means testing--
``(i) which occurs after the date such new
animal drug is designated under this section
and before the date on which an application
with respect to such drug is submitted under
section 512 or 571; and
``(ii) which is carried out under an
investigational exemption under section 512(j).
``(B) The term ``manufacturing expenses'' means
expenses incurred in developing processes and
procedures associated with manufacture of the
designated new animal drug which occur after the new
animal drug is designated under this section and before
the date on which an application with respect to such
new animal drug is submitted under section 512 or
section 571.
``(3) There is authorized to be appropriated to carry out
this subsection $1,000,000 for the fiscal year following
publication of final implementing regulations, $2,000,000 for
the subsequent fiscal year and such sums as may be necessary
for each fiscal year thereafter.
``(c) Exclusivity for Designated New Animal Drugs.--
``(1) Except as provided in subsection (c)(2), if the
Secretary--
``(A) approves or conditionally approves an
application for a designated new animal drug, and no
active ingredient (including any salt or ester of the
active ingredient) of that designated new animal drug
has been approved or conditionally approved previously,
the Secretary may not approve or conditionally approve
another application submitted for a new animal drug
with the same active ingredient and intended use as the
designated new animal drug for another applicant before
the expiration of ten years from the date of the
approval or conditional approval of the application.
``(B) approves or conditionally approves an
application for a designated new animal drug, and an
active ingredient (including an ester or salt of the
active ingredient) of that designated new animal drug
has been approved or conditionally approved previously,
the Secretary may not approve or conditionally approve
another application submitted for a new animal drug
with the same active ingredient and intended use as the
designated new animal drug for another applicant before
the expiration of seven years from the date of approval
or conditional approval of the application.
``(2) If an application filed pursuant to section 512 or
section 571 is approved for a designated new animal drug, the
Secretary may, during the 10-year or 7-year exclusivity period
beginning on the date of the application approval or
conditional approval, approve or conditionally approve another
application under section 512 or section 571 for such drug for
such minor use or minor species for another applicant if--
``(A) the Secretary finds, after providing the
holder of such an approved application notice and
opportunity for the submission of views, that in the
granted exclusivity period the holder of the approved application
cannot assure the availability of sufficient quantities of the drug to
meet the needs for which the drug was designated; or
``(B) such holder provides written consent to the
Secretary for the approval or conditional approval of
other applications before the expiration of such
exclusivity period.''.
(e) Conforming Amendments.--
(1) Section 201(u) of the Federal Food, Drug, and Cosmetic
Act is amended by striking ``512'' and inserting ``512, 571''.
(2) Section 201(v) of the Federal Food, Drug, and Cosmetic
Act is amended by inserting the following after paragraph (2):
``Provided that any drug intended for minor use or use in a
minor species that is not the subject of a final regulation
published by the Secretary through notice and comment
rulemaking finding that the criteria of paragraphs (1) and (2)
or of section 108 of Public Law 90-399 have been met is a new
animal drug.''
(3) Section 301(e) of the Federal Food, Drug, and Cosmetic
Act is amended by striking ``512(a)(4)(C), 512(j), (l) or (m)''
and inserting ``512(a)(4)(C), 512(j), (l) or (m), 572(i).''
(4) Section 301(j) of the Federal Food, Drug, and Cosmetic
Act is amended by deleting ``520'' and inserting ``520, 571,
572, 573.''
(5) Section 502 of the Federal Food, Drug, and Cosmetic Act
is amended by adding at the end the following new subsection:
``(u) If it is a new animal drug--
``(1) that is conditionally approved under section 571 and
its labeling does not conform with the approved application or
section 571(f), or that is not conditionally approved under
section 571 and its label bears the statement set forth in
section 571(f)(1)(A); or
``(2) that is indexed under section 572 and its labeling
does not conform with the index listing under section 572(e) or
572(h), or that has not been indexed under section 572 and its
label bears the statement set forth in section 572(h).''.
(6) Section 503(f) of the Federal Food, Drug, and Cosmetic
Act is amended by--
(A) in paragraph (1)(A)(ii) by striking ``512'' and
inserting ``512, a conditionally-approved application
under section 571, or an index listing under section
572''; and
(B) in paragraph (3) by striking ``section 512''
and inserting ``sections 512, 571, or 572''.
(7) Section 504(a)(1) of the Federal Food, Drug, and
Cosmetic Act is amended by striking ``512(b)'' and inserting
``512(b), a conditionally-approved application filed pursuant
to section 571, or an index listing pursuant to section 572''.
(8) Sections 504(a)(2)(B) and 504(b) of the Federal Food,
Drug, and Cosmetic Act are amended by striking ``512(i)'' each
place it appears and inserting ``512(i), or the index listing
pursuant to section 572(e)''.
(9) Section 512(a) of the Federal Food, Drug, and Cosmetic
Act is amended by striking paragraphs (1) and (2) and inserting
the following:
``(1) A new animal drug shall, with respect to any particular use
or intended use of such drug, be deemed unsafe for purposes of section
501(a)(5) and section 402(a)(2)(C)(ii) unless--
``(A) there is in effect an approval of an application
filed pursuant to subsection (b) with respect to such use or
intended use of such drug, and such drug, its labeling, and
such use conform to such approved application;
``(B) there is in effect a conditional approval of an
application filed pursuant to section 571 with respect to such
use or intended use of such drug, and such drug, its labeling,
and such use conform to such conditionally-approved
application; or
``(C) there is in effect an index listing pursuant to
section 572 with respect to such use or intended use of such
drug in a minor species, and such drug, its labeling, and such
use conform to such index listing.''
A new animal drug shall also be deemed unsafe for such purposes in the
event of removal from the establishment of a manufacturer, packer, or
distributor of such drug for use in the manufacture of animal feed in
any State unless at the time of such removal such manufacturer, packer,
or distributor has an unrevoked written statement from the consignee of
such drug, or notice from the Secretary, to the effect that, with
respect to the use of such drug in animal feed, such consignee (i)
holds a license issued under subsection (m) and has in its possession
current approved labeling for such drug in animal feed; or (ii) will,
if the consignee is not a user of the drug, ship such drug only to a
holder of a license issued under subsection (m).
``(2) An animal feed bearing or containing a new animal drug shall,
with respect to any particular use or intended use of such animal feed
be deemed unsafe for purposes of section 501(a)(6) unless--
``(A) there is in effect--
``(i) an approval of an application filed pursuant
to subsection (b) with respect to such drug, as used in
such animal feed, and such animal feed and its
labeling, distribution, holding, and use conform to
such approved application;
``(ii) a conditional approval of an application
filed pursuant to section 571 with respect to such
drug, as used in such animal feed, and such animal feed
and its labeling, distribution, holding, and use
conform to such conditionally-approved application; or
``(iii) an index listing pursuant to section 572
with respect to such drug, as used in such animal feed,
and such animal feed and its labeling, distribution,
holding, and use conform to such index listing; and
``(B) such animal feed is manufactured at a site for which
there is in effect a license issued pursuant to subsection
(m)(1) to manufacture such animal feed.''.
(10) Section 512(b)(3) of the Federal Food, Drug, and
Cosmetic Act is amended by striking ``under paragraph (1) or a
request for an investigational exemption under subsection (j)''
and inserting ``under paragraph (1), section 571, or a request
for an investigational exemption under subsection (j)''.
(11) Section 512(d)(4) of the Federal Food, Drug, and
Cosmetic Act is amended by striking ``have previously been
separately approved'' and inserting ``have previously been
separately approved pursuant to an application submitted under
section 512(b)(1)''.
(12) Section 512(f) of the Federal Food, Drug, and Cosmetic
Act is amended by striking ``subsection (d), (e), or (m)'' and
inserting ``subsection (d), (e), or (m), or section 571(c),
(d), or (e)''.
(13) Section 512(g) of the Federal Food, Drug, and Cosmetic
Act is amended by striking ``this section'' and inserting
``this section, or section 571''.
(14) Section 512(i) of the Federal Food, Drug, and Cosmetic
Act is amended by striking ``subsection (b)'' and inserting
``subsection (b) or section 571'' and by inserting ``or upon
failure to renew a conditional approval under section 571''
after ``or upon its suspension''.
(15) Section 512(l)(1) of the Federal Food, Drug, and
Cosmetic Act is amended by striking ``subsection (b)'' and
inserting ``subsection (b) or section 571''.
(16) Section 512(m)(1)(C) of the Federal Food, Drug, and
Cosmetic Act is amended by striking ``applicable regulations
published pursuant to subsection (i)'' and inserting
``applicable regulations published pursuant to subsection (i)
or for indexed new animal drugs in accordance with the index
listing published pursuant to section 572(e)(2) and the
labeling requirements set forth in section 572(h)''.
(17) Section 512(m)(3) of the Federal Food, Drug, and
Cosmetic Act is amended by inserting ``or an index listing
pursuant to section 572(e)'' after ``subsection (i)''.
(18) Section 512(p)(1) of the Federal Food, Drug, and
Cosmetic Act is amended by striking ``subsection (b)(1)'' and
inserting ``subsection (b)(1) or section 571(a)''.
(19) Section 512(p)(2) of the Federal Food, Drug, and
Cosmetic Act is amended by striking ``subsection (b)(1)'' and
inserting ``subsection (b)(1) or section 571(a)''.
SEC. 4. INTERNAL REVENUE CODE AMENDMENTS.
(a) The Internal Revenue Code of 1986 is amended by adding the
following new section after section 45C:
``SEC. 45D. SAFETY AND EFFECTIVENESS TESTING EXPENSES FOR DESIGNATED
NEW ANIMAL DRUGS FOR MINOR USES AND MINOR SPECIES.
``(a) For purposes of section 38, the credit determined under this
section for the taxable year is an amount equal to 50 percent of the
qualified safety and effectiveness testing expenses for the designated
new animal drug for the taxable year.
``(b) For purposes of this section--
``(1) Qualified safety and effectiveness testing expenses--
``(A) Except as otherwise provided in this
paragraph, the term `qualified safety and effectiveness
testing expenses' means the amounts which are paid or
incurred by the taxpayer during the taxable year which
would be described in subsection (b) of section 41 if
such subsection were applied with the modifications set
forth in subparagraph (B).
``(B) For purposes of subparagraph (A), subsection
(b) of section 41 shall be applied--
``(i) by substituting `safety and
effectiveness testing' for `qualified research'
each place it appears in paragraphs (2) and (3)
of such subsection; and
``(ii) by substituting `100 percent' for
`65 percent' in paragraph (3)(A) of such
subsection.
``(C) The term `qualified safety and effectiveness
testing expenses' shall not include any amount to the
extent such amount is funded by any grant, contract, or
otherwise by another person (or any governmental
entity).
``(D) For purposes of this paragraph--
``(i) section 41 shall be deemed to remain
in effect for periods after June 30, 2001; and
``(ii) the `trade or business of the
taxpayer' requirement of section 41(b)(1) shall
be deemed to be satisfied in the case of a
taxpayer that owns animals that are the subject
of safety and effectiveness testing.
``(2)(A) The term `safety and effectiveness testing' means
any safety and effectiveness testing--
``(i) which is carried out under an exemption for a
new animal drug being tested for minor use or a minor
species under section 512(j) of the Federal Food, Drug,
and Cosmetic Act (or regulations issued under such
section);
``(ii) which occurs--
``(I) after the date such new animal drug
request is filed for designation under section
573 of such Act, and
``(II) before the date on which an
application with respect to such drug is
approved under section 512(c) of such Act; and
``(iii) which is conducted by or on behalf of--
``(I) the taxpayer who applied for the
designation under section 573; or
``(II) the owner of the animals that are
the subject of safety and effectiveness
testing.
``(B) Safety and effectiveness testing shall be taken into
account under subparagraph (A) only to the extent such testing
is related to the use of a new animal drug for the minor use or minor
species for which it was designated under section 573 of the Federal
Food, Drug, and Cosmetic Act.
``(c)(1) Except as provided in paragraph (2), any qualified safety
and effectiveness testing expenses for a taxable year to which an
election under this section applies shall not be taken into account for
purposes of determining the credit allowable under section 41 for such
taxable year.
``(2) Any qualified safety and effectiveness testing expenses for
any taxable year which are qualified research expenses (within the
meaning of section 41(b)) shall be taken into account in determining
base period research expenses for purposes of applying section 41 to
subsequent taxable years.
``(d)(1) For purposes of this section, the term `minor use' is
defined in section 201(mm) of the Federal Food, Drug, and Cosmetic Act
and `minor species' is defined in section 201(ll). Determinations under
the preceding sentence with respect to any new animal drug shall be
made on the basis of the facts and circumstances as of the date such
new animal drug is designated under section 573 of the Federal Food,
Drug, and Cosmetic Act.
``(2) No credit shall be allowed under this section with respect to
any safety and effectiveness testing conducted by a corporation to
which an election under section 936 applies.
``(3) Rules similar to the rules of paragraphs (1) and (2) of
section 41(f) shall apply for purposes of this section.
``(4) This section shall apply to any taxpayer for any taxable year
only if such taxpayer elects (at such time and in such manner as the
Secretary may by regulations prescribe) to have this section apply for
such taxable year.''.
(b) Conforming Amendments.--
(1) Section 38(b) of the Internal Revenue Code is amended--
(A) By deleting ``plus'' at end of paragraph (11);
(B) By deleting the period at the end of paragraph
(12) and replacing it with the following: ``, plus'';
and
(C) By adding the following new paragraph at the
end: ``the minor use and minor species new animal drug
credit determined under section 45D(a)''.
(2) Section 280C(b) of the Internal Revenue Code is
amended--
(A) in paragraph (1), by deleting ``section
45C(b)'' and substituting the following: ``section
45C(b) or 45D(b)''; and
(B) in paragraphs (1) and (2), by deleting
``section 45C'' wherever it appears and substituting
the following: ``section 45C or 45D''.
(c) Regulations.--The Secretary of the Treasury shall publish
proposed regulations to implement amendments to the Internal Revenue
Code made by this Act within 6 months of the date of enactment, and
final regulations within 24 months of the date of enactment.
SEC. 5. REGULATIONS.
Not later than 18 months after the date of enactment of this Act,
the Secretary of Health and Human Services shall issue proposed
regulations to implement section 572 of the Federal Food, Drug, and
Cosmetic Act (as added by this Act), and not later than 36 months after
the date of enactment of this Act, the Secretary shall issue final
regulations implementing such amendments. Not later than 12 months
after the date of enactment of this Act, the Secretary of Health and
Human Services shall issue proposed regulations to implement section
573 of the Federal Food, Drug, and Cosmetic Act (as added by this Act),
and not later than 24 months after the date of enactment of this Act,
the Secretary shall issue final regulations implementing such
amendments; provided that these timeframes shall be extended by 12
months for each fiscal year in which the funds authorized to be
appropriated by this Act are not in fact appropriated. The Secretary
shall implement section 571 of the Federal Food, Drug, and Cosmetic Act
(as added by this Act) on the date of enactment of this Act and
subsequently publish any needed implementing regulations.
SEC. 6. OFFICE OF MINOR USE AND MINOR SPECIES ANIMAL DRUG DEVELOPMENT.
The Secretary of Health and Human Services shall establish within
the Center of Veterinary Medicine (of the Food and Drug
Administration), an Office of Minor Use and Minor Species Animal Drug
Development that reports directly to the Director of the Center for
Veterinary Medicine. This office shall be responsible for overseeing
the development and legal marketing of new animal drugs for minor uses
and minor species. There is authorized to be appropriated to carry out
this subsection $1,200,000 for fiscal year 2002 and such sums as may be
necessary for each fiscal year thereafter.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR 8/3/2001 S8768)
Read twice and referred to the Committee on Finance.
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