21 CFR 511: New Animal Drugs for Investigational Use

21 CFR Part 511 (up to date as of 2/09/2023)
New Animal Drugs for Investigational Use

21 CFR Part 511

This content is from the eCFR and is authoritative but unofficial.

Title 21 - Food and Drugs
Chapter I - Food and Drug Administration, Department of Health and Human Services
Subchapter E - Animal Drugs, Feeds, and Related Products
Part 511 New Animal Drugs for Investigational Use
§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal Food,
Drug, and Cosmetic Act.
§ 511.3 Definitions.

PART 511 - NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
Authority: 21 U.S.C. 321, 351, 352, 353, 360b, 371.

§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal Food,
Drug, and Cosmetic 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.

21 CFR 511.1(a)(4) (enhanced display)

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21 CFR Part 511 (up to date as of 2/09/2023)
New Animal Drugs for Investigational Use

21 CFR 511.1(b)

(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 FDA 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.
21 CFR 511.1(b)(4)(v)(b) (enhanced display)

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21 CFR Part 511 (up to date as of 2/09/2023)
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21 CFR 511.1(b)(4)(v)(c)

(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 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 FDA
pursuant to part 16 of this chapter.
(6) On written request of FDA, 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.

21 CFR 511.1(b)(7)(iii) (enhanced display)

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New Animal Drugs for Investigational Use

21 CFR 511.1(b)(8)

(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 FDA 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 FDA 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 § 25.30 or § 25.33 of this
chapter or an environmental assessment under § 25.40 of this chapter.
(c) Disqualification of a clinical investigator.
(1) If FDA has information indicating that an investigator (including a sponsor-investigator) has
repeatedly or deliberately failed to comply with the conditions of these exempting regulations or has
repeatedly or deliberately submitted to FDA or to the sponsor false information in any required
report, the Center for Veterinary Medicine will furnish the investigator written notice of the matter
complained of and offer the investigator an opportunity to explain the matter in writing, or, at the
option of the investigator, in an informal conference. If an explanation is offered and accepted by the
Center for Veterinary Medicine, the Center will discontinue the disqualification proceeding. If an
explanation is offered but not accepted by the Center for Veterinary Medicine, the investigator will be
given an opportunity for a regulatory hearing under part 16 of this chapter on the question of
whether the investigator is eligible to receive test articles under this part and eligible to conduct:
(i)

Any clinical investigation that supports an application for a research or marketing permit for
products regulated by FDA; and

21 CFR 511.1(c)(1)(i) (enhanced display)

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21 CFR 511.1(c)(1)(ii)

(ii) Any nonclinical laboratory study intended to support an application for a research or marketing
permit for a new animal drug.
(2) After evaluating all available information, including any explanation presented by the investigator, if
the Commissioner determines that the investigator has repeatedly or deliberately failed to comply
with the conditions of the exempting regulations in this subchapter, or has repeatedly or deliberately
submitted to FDA or to the sponsor false information in any required report, the Commissioner will
notify the investigator and the sponsor of any investigation in which the investigator has been
named as a participant that the investigator is not eligible to receive test articles under this part. The
notification to the investigator and sponsor will provide a statement of the basis for such
determination. The notification also will explain that an investigator determined to be ineligible to
receive test articles under this part will be ineligible to conduct:
(i)

Any clinical investigation that supports an application for a research or marketing permit for
products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods,
including dietary supplements, that bear a nutrient content claim or a health claim, infant
formulas, food and color additives, and tobacco products; and

(ii) Any nonclinical laboratory study intended to support an application for a research or marketing
permit for a new animal drug.
(3) Each application or submission to FDA under the provisions of this chapter containing data reported
by an investigator who has been determined to be ineligible to receive FDA-regulated test articles is
subject to examination to determine whether the investigator has submitted unreliable data that are
essential to the continuation of an investigation or essential to the approval of a marketing
application, or essential to the continued marketing of an FDA-regulated product.
(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, the Commissioner will notify the sponsor, who shall
have an opportunity for a regulatory hearing under part 16 of this chapter. If a danger to the public
health exists, however, the Commissioner shall terminate the exemption immediately and notify the
sponsor of the termination. In such case, the sponsor shall have an opportunity for a regulatory
hearing before FDA under part 16 on the question of whether the exemption should be reinstated.
The determination that an investigation may not be considered in support of a research or marketing
application or a notification or petition submission does not, however, relieve the sponsor of any
obligation under any other applicable regulation to submit to FDA the results of the investigation.
(5) If the Commissioner determines, after the unreliable data submitted by the investigator are
eliminated from consideration, that the continued approval of the product for which the data were
submitted cannot be justified, the Commissioner will proceed to withdraw approval of the product in
accordance with the applicable provisions of the relevant statutes.
(6) An investigator who has been determined to be ineligible under paragraph (c)(2) of this section may
be reinstated as eligible when the Commissioner determines that the investigator has presented
adequate assurances that the investigator will employ all test articles, and will conduct any clinical
investigation that supports an application for a research or marketing permit for products regulated
by FDA and any nonclinical laboratory study intended to support an application for a research or
marketing permit for a new animal drug, solely in compliance with the applicable provisions of this
chapter.
(d) Termination of exemption. If the Commissioner finds that:
21 CFR 511.1(d) (enhanced display)

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21 CFR Part 511 (up to date as of 2/09/2023)
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21 CFR 511.1(d)(1)

(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 FDA 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 FDA.
(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.
(g) Index of legally marketed unapproved new animal drugs for minor species. All provisions of part 511 apply
to new animal drugs for investigational use in support of indexing, as described in section 572 of the act,
subject to the provisions of § 516.125 of this chapter.
[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; 72 FR 69121, Dec. 6, 2007; 77 FR 25359, Apr. 30, 2012; 82 FR 61446, Dec. 28, 2017]

§ 511.3 Definitions.
As used in this part:
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.
21 CFR 511.3 “Contract research organization” (enhanced display)

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New Animal Drugs for Investigational Use

21 CFR 511.3 “Investigator”

Investigator means an individual who actually conducts a clinical investigation (i.e., under whose immediate
direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by
a team of individuals, the investigator is the responsible leader of the team. “Subinvestigator” includes
any other individual member of that team.
Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be
an individual or pharmaceutical company, governmental agency, academic institution, private
organization, or other organization. The sponsor does not actually conduct the investigation unless the
sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own
employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and
the employees are investigators.
Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose
immediate direction the investigational drug is administered or dispensed. The term does not include any
person other than an individual. The requirements applicable to a sponsor-investigator under this part
include both those applicable to an investigator and a sponsor.
[77 FR 25359, Apr. 30, 2012]

21 CFR 511.3 “Sponsor-Investigator” (enhanced display)

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