[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR114.8]

[Page 718-719]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 114--PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS--Table of Contents
 
Sec. 114.8  Outline of Production required.

    An Outline of Production shall be on file with Animal and Plant 
Health Inspection Service for each licensed biological product or for 
each biological product authorized to be imported into the United States 
for Distribution and Sale. Preparation of a biological product in a 
licensed establishment shall be in accordance with the Outline of 
Production for such product filed with Animal and Plant Health 
Inspection Service as provided in this section, but subject to changes 
as may be required under Sec. 114.8(f).
    (a) The Outline of Production shall be prepared as prescribed in 
Sec. 114.9 and submitted to Animal and Plant Health Inspection Service 
for filing. When objectionable features, if any, are corrected and no 
further exceptions are taken by Animal and Plant Health Inspection 
Service to an Outline of Production for a biological product, such 
Outline of Production shall be approved for filing.
    (b) Each page shall be stamped as filed on the date such action was 
taken in the bottom right hand corner. Although the filed outline may be 
referred to as an approved outline, approval for filing constitutes no 
endorsement by Animal and Plant Health Inspection Service of such 
biological product or the methods and procedures used to prepare such 
biological product.
    (c) The original and two copies shall be retained by Animal and 
Plant Health Inspection Service and the remaining copies returned.
    (d) Each licensee shall review each Outline of Production for 
accuracy and sufficiency not less frequently than once a year. Revisions 
necessary to bring an Outline of Production into compliance with the 
regulations shall be submitted to Animal and Plant Health Inspection 
Service.
    (e) When a list of licensed products to be continued in production 
at a licensed establishment is requested by the Administrator in 
accordance with Sec. 102.5(d) of this subchapter, the licensee shall 
supplement the list with information for each product as follows:
    (1) The Outline of Production currently being used shall be 
identified as to the date when last revised and filed with Animal and 
Plant Health Inspection Service and the date of the last review made by 
the licensee.
    (2) The Outline of Production to be kept in the active file shall be 
designated. If more than one has been filed for a product, only the 
Outline of Production currently being used shall be included.
    (f) The Administrator may, upon the basis of information not 
available to him at the time the current Outline of Production for a 
biological product was filed, object to the methods or procedures being 
used in the preparation of such biological product and notify the 
licensee to modify the filed Outline of Production to eliminate such 
objections. If the licensee does not comply with the notice, the 
Administrator

[[Page 719]]

may, after affording opportunity for a hearing to the licensee, suspend 
the product license for the biological product involved; in which case, 
the licensee shall not prepare such product until subsequent notice of 
withdrawal of the suspension is given to the licensee.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[39 FR 16869, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 56 
FR 66784, Dec. 26, 1991]