[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: 21CFR514.106]

[Page 80-81]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 514--NEW ANIMAL DRUG APPLICATIONS--Table of Contents
 
            Subpart B--Administrative Actions on Applications
 
Sec.  514.106  Approval of supplemental applications.

    (a) Within 180 days after a supplement to an approved application is 
filed pursuant to Sec.  514.8, the Commissioner shall approve the 
supplemental application in accordance with procedures set forth in 
Sec.  514.105(a)(1) and (2) if he/she determines that the application 
satisfies the requirements of applicable statutory provisions and 
regulations.
    (b) The Commissioner will assign a supplemental application to its 
proper category to ensure processing of the application.
    (1) Category I. Supplements that ordinarily do not require a 
reevaluation of any of the safety or effectiveness data in the parent 
application. Category I supplements include the following:
    (i) A corporate change that alters the identity or address of the 
sponsor of the new animal drug application (NADA).
    (ii) The sale, purchase, or construction of manufacturing 
facilities.
    (iii) The sale or purchase of an NADA.
    (iv) A change in container, container style, shape, size, or 
components.
    (v) A change in approved labeling (color, style, format, addition, 
deletion, or revision of certain statements, e.g., trade name, storage, 
expiration dates, etc).
    (vi) A change in promotional material for a prescription drug not 
exempted by Sec.  514.8(a)(3)(i) and (a)(3)(ii).
    (vii) Changes in manufacturing processes that do not alter the 
method of manufacture or change the final dosage form.
    (viii) A change in bulk drug shipments.
    (ix) A change in an analytical method or control procedures that do 
not alter the approved standards.
    (x) A change in an expiration date.

[[Page 81]]

    (xi) Addition of an alternate manufacturer, repackager, or relabeler 
of the drug product.
    (xii) Addition of an alternate supplier of the new drug substance.
    (xiii) A change permitted in advance of approval as listed in Sec.  
514.8(d).
    (xiv) Changes not requiring prior approval which are listed under 
Sec.  514.8(a)(5) when submitted as supplemental applications.
    (2) Category II. Supplements that may require a reevaluation of 
certain safety or effectiveness data in the parent application. Category 
II supplements include the following:
    (i) A change in the active ingredient concentration or composition 
of the final product.
    (ii) A change in quality, purity, strength, and identity 
specifications of the active or inactive ingredients.
    (iii) A change in dose (amount of drug administered per dose).
    (iv) A change in the treatment regimen (schedule of dosing).
    (v) Addition of a new therapeutic claim to the approved uses of the 
product.
    (vi) Addition of a new or revised animal production claim.
    (vii) Addition of a new species.
    (viii) A change in the prescription or over-the-counter status of a 
drug product.
    (ix) A change in statements regarding side effects, warnings, 
precautions, and contraindications, except the addition of approved 
statements to container, package, and promotional labeling, and 
prescription drug advertising.
    (x) A change in the drug withdrawal period prior to slaughter or in 
the milk discard time.
    (xi) A change in the tolerance for drug residues.
    (xii) A change in analytical methods for drug residues.
    (xiii) A revised method of synthesis or fermentation of the new drug 
substance.
    (xiv) Updating or changes in the manufacturing process of the new 
drug substance and/or final dosage form (other than a change in 
equipment that does not alter the method of manufacture of a new animal 
drug, or a change from one commercial batch size to another without any 
change in manufacturing procedure), or changes in the methods, 
facilities, or controls used for the manufacture, processing, packaging, 
or holding of the new animal drug (other than use of an establishment 
not covered by the approval that is in effect) that give increased 
assurance that the drug will have the characteristics of identity, 
strength, quality, and purity which it purports or is represented to 
possess.

[55 FR 46052, Nov. 1, 1990; 55 FR 49973, Dec. 3, 1990; 56 FR 12422, Mar. 
25, 1991]