[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR103.2]

[Page 572]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 103_EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF 
BIOLOGICAL PRODUCTS PRIOR TO LICENSING--Table of Contents
 
Sec.  103.2  Disposition of animals administered experimental biological 
products or live organisms.

    Safeguards as herein provided shall be established by the research 
investigator or research sponsor to control disposition of all animals 
administered experimental biological products or live organisms.
    (a) Surviving test animals (including challenged control animals) 
shall not be removed from the premises on which the tests are conducted 
for at least 14 days after administration of an experimental biological 
product or live organisms: Provided, however, That this holding period 
may be increased or decreased as permitted or requested by the 
Administrator following review of all relevant information or data 
available.
    (b) All animals administered experimental biological products which 
are to be slaughtered at establishments subject to the Federal Meat 
Inspection Act, as amended and extended (21 U.S.C. 601 et. seq.) are 
subject to the applicable requirements of Sec.  309.16 of this title 
(Meat Inspection Regulations).
    (c) Except as otherwise provided in this paragraph, the research 
investigator or research sponsor shall maintain adequate records 
relative to the disposition of each animal administered experimental 
biological products. These records shall be maintained for a minimum 
period of two years from the date that an experimental product was 
administered to such animal, and shall show the name and address of the 
owner; number, species, class and location of the animals; and if sold, 
the name and address of the consignee, buyer, commission, firm or 
abattoir: Provided, however, That a research investigator or research 
sponsor may be exempted from these recordkeeping requirements by the 
Administrator on the basis of acceptable data demonstrating that use of 
the experimental biological product will not result in the presence of 
any unwholesome condition in the edible parts of animals subsequently 
presented for slaughter.

(Approved by the Office of Management and Budget under control number 
0579-0059)

[30 FR 11848, Sept. 16, 1965, as amended at 48 FR 57473, Dec. 30, 1983; 
56 FR 66783, Dec. 26, 1991; 66 FR 21063, Apr. 27, 2001]