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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 511--NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
Authority: 21 U.S.C. 321, 351, 352, 353, 360b, 371.
Sec. 511.1 New animal drugs for investigational use exempt from section
512(a) of the act.
(a) New animal drugs for tests in vitro and in laboratory research
animals. (1) A shipment or other delivery of a new animal drug or animal
feed bearing or containing a new animal drug intended solely for tests
in vitro or in animals used only for laboratory research purposes shall
be exempt from section 512 (a) and (m) of the act if it is labeled as
follows:
Caution. Contains a new animal drug for investigational use only in
laboratory research animals or for tests in vitro. Not for use in
humans.
(2) The person distributing or causing the distribution of new
animal drugs for tests in vitro or in animals used only for laboratory
research purposes under this exemption shall use due diligence to assure
that the consignee is regularly engaged in conducting such tests and
that the shipment of the new animal drug will actually be used for tests
in vitro or in animals used only for laboratory research.
(3) The person who introduced such shipment or who delivered the new
animal drug for introduction into interstate commerce shall maintain
adequate records showing the name and post office address of the expert
or expert organization to whom the new animal drug is shipped and the
date, quantity, and batch or code mark of each shipment and delivery for
a period of 2 years after such shipment and delivery. Upon the request
of a properly authorized employee of the Department at reasonable times,
he shall make such records available for inspection and copying.
(4) The exemption allowed in this paragraph shall not apply to any
new animal drug intended for in vitro use in the regular course of
diagnosing or treating disease, including antibacterial sensitivity
discs impregnated with any new animal drug or drugs, which discs are
intended for use in determining susceptibility of microorganisms to the
new animal drug or drugs.
(b) New animal drugs for clinical investigation in animals. A
shipment or other delivery of a new animal drug or an animal feed
containing a new animal drug intended for clinical investigational use
in animals shall be exempt from section 512(a) and (m) of the act if all
the following conditions are met:
(1) The label shall bear the statements:
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Caution. Contains a new animal drug for use only in investigational
animals in clinical trials. Not for use in humans. Edible products of
investigational animals are not to be used for food unless authorization
has been granted by the U.S. Food and Drug Administration or by the U.S.
Department of Agriculture.
In the case of containers too small or otherwise unable to
accommodate a label with sufficient space to bear the caution statements
required by paragraph (a) or (b) of this section, the statements may be
included on the carton label and other labeling on or within the package
from which the new animal drug is to be dispensed.
(2) The person or firm distributing or causing the distribution of
the new animal drug or animal feed containing a new animal drug shall
use due diligence to assure that the new animal drug or animal feed
containing a new animal drug will actually be used for tests in animals
and is not used in humans.
(3) The person who introduced such shipment or who delivered the new
animal drug or animal feed containing a new animal drug for introduction
into interstate commerce shall maintain adequate records showing the
name and post office address of the investigator to whom the new animal
drug or animal feed containing a new animal drug is shipped and the
date, quantity, and batch or code mark of each shipment and delivery for
a period of 2 years after such shipment and delivery. Upon the request
of a properly authorized employee of the Department at reasonable times,
such records shall be made available for inspection and copying.
(4) Prior to shipment of the new animal drug for clinical tests in
animals, the sponsor of the investigation shall submit in triplicate to
the Food and Drug Administration a ``Notice of Claimed Investigational
Exemption for a New Animal Drug'' including a signed statement
containing the following information:
(i) The identity of the new animal drug.
(ii) All labeling and other pertinent information to be supplied to
the investigators. When such pertinent information includes nonclinical
laboratory studies, the information shall include, with respect to each
nonclinical study, either a statement that the study was conducted in
compliance with the requirements set forth in part 58 of this chapter,
or, if the study was not conducted in compliance with such regulations,
a brief statement of the reason for the noncompliance.
(iii) The name and address of each clinical investigator.
(iv) The approximate number of animals to be treated (or if not
available, the amount of new animal drug to be shipped).
(v) If the new animal drug is given to food-producing animals, the
statement shall contain the following additional information:
(a) A commitment that the edible products from such animals shall
not be used for food without prior authorization in accordance with the
provisions prescribed in this section.
(b) Approximate dates of the beginning and end of the experiment or
series of experiments.
(c) The maximum daily dose(s) to be administered to a given species,
the size of animal, maximum duration of administration, method(s) of
administration, and proposed withdrawal time, if any.
(vi) If a sponsor has transferred any obligations for the conduct of
any clinical study to a contract research organization, a statement
containing the name and address of the contract research organization,
identification of the clinical study, and a listing of the obligations
transferred. If all obligations governing the conduct of the study have
been transferred, a general statement of this transfer--in lieu of a
listing of the specific obligations transferred--may be submitted.
(5) Authorization for use of edible products derived from a treated
food-producing animal may be granted under the provisions of this
section and when the following specified conditions are met, except that
in the case of an animal administered any unlicensed experimental
veterinary biological product regulated under the viruses, serums,
toxins statute (21 U.S.C., chapter V, sec. 151 et seq.) the product
shall be exempt from the requirements of this section when U.S.
Department of Agriculture approval has been obtained
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as provided in 9 CFR 103.2. Conditional authorization may be granted in
advance of identification of the name(s) and address(es) of the clinical
investigator(s) as required by paragraph (b)(4)(iii) of this section.
Information required for authorization shall include, in addition to all
other requirements of this section, the following:
(i) Data to show that consumption of food derived from animals
treated at the maximum levels with the minimum withdrawal periods, if
any, specified in accordance with paragraph (b)(4)(v)(c) of this
section, will not be inconsistent with the public health; or
(ii) Data to show that food derived from animals treated at the
maximum levels and with the minimum withdrawal periods, if any,
specified in accordance with paragraph (b)(4)(v)(c) of this section,
does not contain drug residues or metabolites.
(iii) The name and location of the packing plant where the animals
will be processed, except that this requirement may be waived, on
request, by the terms of the authorization.
Authorizations granted under this paragraph do not exempt
investigational animals and their products from compliance with other
applicable inspection requirements. Any person who contests a refusal to
grant such authorization shall have an opportunity for a regulatory
hearing before the Food and Drug Administration pursuant to part 16 of
this chapter.
(6) On written request of the Food and Drug Administration, the
sponsor shall submit any additional information reported to or otherwise
received by him with respect to the investigation deemed necessary to
facilitate a determination whether there are grounds in the interest of
public health for terminating the exemption.
(7) The sponsor shall assure himself that the new animal drug is
shipped only to investigators who:
(i) Are qualified by scientific training and/experience to evaluate
the safety and/or effectiveness of the new animal drug.
(ii) Shall maintain complete records of the investigations,
including complete records of the receipt and disposition of each
shipment or delivery of the new animal drug under investigation. Copies
of all records of the investigation shall be retained by the
investigator for 2 years after the termination of the investigation or
approval of a new animal drug application.
(iii) Shall furnish adequate and timely reports of the investigation
to the sponsor.
(8) The sponsor:
(i) Shall retain all reports received from investigators for 2 years
after the termination of the investigation or approval of a new animal
drug application and make such reports available to a duly authorized
employee of the Department for inspection at all reasonable times.
(ii) Shall provide for current monitoring of the investigation by a
person qualified by scientific training and experience to evaluate
information obtained from the investigation, and shall promptly
investigate and report to the Food and Drug Administration and to all
investigators any findings associated with use of the new animal drug
that may suggest significant hazards pertinent to the safety of the new
animal drug.
(iii) Shall not unduly prolong distribution of the new animal drug
for investigational use.
(iv) Shall not, nor shall any person acting for or on behalf of the
sponsor, represent that the new animal drug is safe or effective for the
purposes for which it is under investigation. This requirement is not
intended to restrict the full exchange of scientific information.
(v) Shall not commercially distribute nor test-market the new animal
drug until a new animal drug application is approved pursuant to section
512(c) of the act.
(9) If the shipment or other delivery of the new animal drug is
imported or offered for importation into the United States for clinical
investigational use in animals, it shall also meet the following
conditions:
(i) The importer of all such shipments or deliveries is an agent of
the foreign exporter residing in the United States or the ultimate
consignee, which person has, prior to such shipments and deliveries,
informed the Food and Drug Administration of his intention to import the
new animal
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drug as sponsor in compliance with the conditions prescribed in this
subdivision; or
(ii) The new animal drug is shipped directly to a scientific
institution with adequate facilities and qualified personnel to conduct
laboratory or clinical investigations and is intended solely for use in
such institutions and which institution has submitted a statement as
sponsor of the investigation.
(10) The sponsor shall submit either a claim for categorical
exclusion under Sec. 25.30 or Sec. 25.33 of this chapter or an
environmental assessment under Sec. 25.40 of this chapter.
(c) Withdrawal of eligibility to receive investigational-use new
animal drugs. (1) Whenever the Food and Drug Administration has
information indicating that an investigator has repeatedly or
deliberately failed to comply with the conditions of these exempting
regulations or has submitted false information either to the sponsor of
the investigation or in any required report, the Center for Veterinary
Medicine will furnish the investigator written notice of the matter
complained of in general terms and offer him an opportunity to explain
the matter in an informal conference and/or in writing. If an
explanation is offered but not accepted by the Center for Veterinary
Medicine, the investigator shall have an opportunity for a regulatory
hearing before the Food and Drug Administration pursuant to part 16 of
this chapter on the question of whether the investigator is entitled to
receive investigational new animal drugs.
(2) If, after evaluating all available information, including any
explanation presented by the investigator, the Commissioner determines
that the investigator has repeatedly or deliberately failed to comply
with the conditions of the exempting regulations in this section or has
repeatedly or deliberately submitted false information to the sponsor of
an investigation, the Commissioner will notify the investigator and the
sponsor of any investigation in which he has been named as a participant
that the investigator is not entitled to receive investigational use new
animal drugs with a statement of the basis for such determination.
(3) Each ``Notice of Claimed Investigational Exemption for a New
Animal Drug'' and each approved new animal drug application containing
data reported by an investigator who has been determined to be
ineligible to receive investigational-use new animal drugs will be
examined to determine whether he has submitted unreliable data that are
essential to the continuation of the investigation or essential to the
approval of any new animal drug application.
(4) If the Commissioner determines, after the unreliable data
submitted by the investigator are eliminated from consideration, that
the data remaining are inadequate to support a conclusion that it is
reasonably safe to continue the investigation, he shall first notify the
sponsor, who shall have an opportunity for a regulatory hearing before
the Food and Drug Administration pursuant to part 16 of this chapter on
whether the exemption should be terminated. If a danger to the public
health exists, however, he shall terminate the exemption forthwith and
notify the sponsor of the termination. In such event the sponsor shall
have an opportunity for a regulatory hearing before the Food and Drug
Administration pursuant to part 16 (see 42 FR 15675, March 22, 1977) of
this chapter on the question of whether the exemption should be
reinstated.
(5) If the Commissioner determines, after the unreliable data
submitted by the investigator are eliminated from consideration, that
the data remaining are such that a new animal drug application would not
have been approved, he will proceed to withdraw approval of the
application in accordance with section 512(e) of the act.
(6) An investigator who has been determined to be ineligible may be
reinstated as eligible to receive investigational-use new animal drugs
when the Commissioner determines that he has presented adequate
assurance that he will employ such new animal drugs solely in compliance
with the exempting regulations in this section for investigational-use
new animal drugs.
(d) Termination of exemption. If the Commissioner finds that:
(1) The sponsor of the investigation has failed to comply with any
of the
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conditions for the exemption established under this section, or
(2) The continuance of the investigation is unsafe or otherwise
contrary to the public interest or the drug is being or has been used
for purposes other than bona fide scientific investigation, he shall
first notify the sponsor and invite his immediate correction. If the
conditions of the exemption are not immediately met, the sponsor shall
have an opportunity for a regulatory hearing before the Food and Drug
Administration pursuant of part 16 of this chapter on whether the
exemption should be terminated. If the exemption is terminated the
sponsor shall recall or have destroyed the unused supplies of the new
animal drug.
(e) Statements and requests. ``Notice(s) of Claimed Investigational
Exemption for a New Animal Drug'' and requests for authorization to use
investigational animals and their products for food should be addressed
to the Department of Health and Human Services, Food and Drug
Administration, Center for Veterinary Medicine, 7500 Standish Pl.,
Rockville, MD 20855.
(f) Contract research organizations. (1) For purposes of this part
and part 514, contract research organization means a person that
assumes, as an independent contractor with the sponsor, one or more of
the obligations of a sponsor, e.g., design of a protocol, selection or
monitoring of investigations, evaluation of reports, and preparation of
materials to be submitted to the Food and Drug Administration.
(2) A sponsor may transfer responsibility for any or all of the
obligations set forth in this part to a contract research organization.
Any such transfer shall be in writing and, if not all obligations are
transferred, shall describe each of the obligations being assumed by the
contract research organization. If all obligations are transferred, a
general statement that all obligations have been transferred is
acceptable. Any obligation not covered by the written description shall
be deemed not to have been transferred.
(3) A contract research organization that assumes any obligation of
a sponsor shall comply with the specific regulations in this chapter
applicable to this obligation and shall be subject to the same
regulatory action as a sponsor for failure to comply with any obligation
assumed under these regulations. Thus, all references to sponsor in this
part apply to a contract research organization to the extent that it
assumes one or more obligations of the sponsor.
[40 FR 13823, Mar. 27, 1975, as amended at 41 FR 48268, Nov. 2, 1976; 42
FR 15675, Mar. 22, 1977; 50 FR 7517, Feb. 22, 1985; 50 FR 16668, Apr.
26, 1985; 52 FR 8847, Mar. 19, 1987; 54 FR 18280, Apr. 28, 1989; 57 FR
6475, Feb. 25, 1992; 62 FR 40599, July 29, 1997]