[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.300]

[Page 41-43]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 510--NEW ANIMAL DRUGS--Table of Contents
 
                     Subpart D--Records and Reports
 
Sec. 510.300  Records and reports concerning experience with new animal drugs for which an approved application is in effect.


    (a) On receiving notification that an application submitted pursuant 
to Sec. 514.1 of this chapter for a new animal drug is approved, the 
applicant shall establish and maintain such records and make such 
reports as are specified in this section to facilitate a determination 
as to whether there may be grounds for suspending or withdrawing 
approval of the application or whether any applicable regulation should 
be amended or repealed. The applicant shall maintain adequately 
organized and indexed files containing full reports of information 
pertinent to the safety or effectiveness of the new animal drug that 
have not previously been submitted as part of his application for the 
drug and which are received or otherwise obtained by him from any 
source, as follows:

[[Page 42]]

    (1) Unpublished reports of clinical or other animal experience, 
studies, investigations, and tests conducted by the applicant or 
reported to him by any person involving the new animal drug that is the 
subject of the application or any related drugs. An adequate summary and 
bibliography of reports in the scientific literature would ordinarily 
suffice. (The application must identify at the time of each report 
submission, each drug he considers related to the subject drug.)
    (2) Experience, investigations, studies, or tests involving the 
chemical or physical properties or any other properties of the new 
animal drug, such as its behavior or properties in relation to 
microorganisms, including both the effects of the drug on microorganisms 
and the effect of microorganisms on the drug.
    (3) For information required by this section, adequate 
identification of its source, when known, including the name and post 
office address of the person who furnishes such information.
    (4) Copies of all mailing pieces and other labeling, and, if it is a 
prescription new animal drug or a veterinary feed directive drug, all 
advertising other than that contained in the application used in 
promoting the drug, and copies of the currently used package labeling 
that gives full information for use of the drug whether or not such 
labeling is contained in the application.
    (5) Information concerning the quantity of the new animal drug 
distributed in a manner and form that facilitates estimates of the 
incidence of any adverse effects reported to be associated with the use 
of the drug. This does not require disclosure of financial, pricing, or 
sales data.
    (6) Information concerning any previously unreported changes from 
the conditions described in an application conforming to the conditions 
of Sec. 514.8(a)(5) of this chapter.
    (b) The applicant shall submit to the Food and Drug Administration 
copies of the records and reports described in paragraph (a) of this 
section, except routine assay and control records, appropriately 
identified with the new animal drug application(s) to which they relate, 
as follows:
    (1) Immediately upon receipt by the applicant, complete records or 
reports covering information of the following kinds:
    (i) Information concerning a mixup in the new animal drug or its 
labeling with another article.
    (ii) Information concerning any bacteriological or significant 
physical or other change or deterioration in the new animal drug, or any 
failure of one or more distributed batches of the drug to meet the 
specifications established for it in the new animal drug application.
    (2) As soon as possible, and in any event within 15 working days of 
its receipt by the applicant, complete records of reports concerning any 
information of the following kinds:
    (i) Information concerning any unexpected side effects, injury, 
toxicity, or sensitivity reaction or any unexpected incidence or 
severity thereof associated with clinical use, studies, investigations, 
or tests, whether or not determined to be attributable to the new animal 
drug, except that this requirement shall not apply to the submission of 
information described in a written communication to the applicant from 
the Food and Drug Administration as types of information that may be 
submitted at other designated intervals. Unexpected as used in this 
subdivision refers to conditions or developments not previously 
submitted as part of the new animal drug application, or conditions and 
developments occurring at a rate higher than that shown by information 
previously submitted as part of the application.
    (ii) Information concerning any unusual failure of the new animal 
drug to exhibit its expected pharmacological activities.
    (3) When mailing pieces, any other labeling, and advertising are 
devised for promotion of the new animal drug, specimens shall be 
submitted at the time of initial dissemination of such labeling and at 
the time of initial publication of any advertisement for a prescription 
drug. Mailing pieces and labeling designed to contain samples of a drug 
shall be complete except for the omission of the drug.
    (4) All the kinds of information described in paragraph (a) of this 
section,

[[Page 43]]

other than that submitted under the provisions of paragraphs (b) (1), 
(2), and (3) of this section, shall be submitted as follows unless 
otherwise ordered in a written communication from the Commissioner:
    (i) At intervals within 6 months beginning with the date of approval 
of the new animal drug application during the first year following such 
date, and at yearly intervals thereafter.
    (ii) Whenever an applicant is required to submit reports under the 
provisions of paragraph (b)(4)(i) of this section with respect to more 
than one approved application for preparations containing the same new 
animal drug so that the same item(s) of information is (are) required to 
be reported for more than one application, he may elect to submit as a 
part of the report for one such application all the information common 
to such applications in lieu of reporting separately and repetitively on 
each. The applicant shall state when this is done and identify all the 
new animal drug applications for which the reports are submitted.
    (iii) The submitted copies of records and reports shall include all 
the required information that was received or otherwise obtained by the 
applicant during the designated intervals.
    (5) On written order of the Commissioner, within the time stated in 
such order or agreed to by the applicant and the Commissioner, any 
designated records or reports containing the kinds of information 
described in this section shall be submitted.
    (c) The applicant shall, upon request of any properly authorized 
officer or employee of the Department at reasonable times, permit such 
officers to have access to and copy and verify any records and reports 
established and maintained under the provisions of this section.
    (d) If the Food and Drug Administration finds that the applicant has 
failed to establish a system for maintaining required records or has 
repeatedly or deliberately failed to maintain such records or to make 
required reports in accordance with the provisions of this section, or 
that the applicant has refused to permit access to or copying of, or 
verification of such records or reports, the Commissioner shall give the 
applicant notice and opportunity for a hearing on the question of 
whether to withdraw the approval of the application, as provided in 
Sec. 514.200 of this chapter.
    (e) Upon written request of the applicant stating reasonable grounds 
therefor, the Commissioner will make available any information in 
possession of the Food and Drug Administration of the kinds the 
applicant is required to maintain under the provisions of this section, 
except information readily available to the applicant from other sources 
or information which the Commissioner concludes is confidential.
    (f) The applicant required to establish and maintain records and 
make reports required by this section includes any person whose name 
appears on the labeling of the drug as its manufacturer, packer, or 
distributor under an approval or who is engaged in the manufacturing, 
processing, packing, or labeling of the drug under an approval of the 
new animal drug application or any supplement to it; however, to avoid 
unnecessary duplication in the submission of reports, any such 
applicant's obligation to submit a report may be met by its submission 
on his behalf, designated as such, by another person responsible for 
reporting.

[40 FR 13807, Mar. 27, 1975, as amended at 65 FR 76928, Dec. 8, 2000]