[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR511.1]

[Page 52-56]
 
                        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--Table of Contents
 
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,

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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:

    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.

[[Page 54]]

    (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 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.

[[Page 55]]

    (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 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.

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    (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 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]