Manual of Standard Operating Procedures and Policies

Regulatory - Review

Processing of Animal Component Information Submitted in Investigational and Marketing Applications / Notifications

 

SOPP 8401.5

Version #1

June 24, 2005
  1. Purpose
    2.

The purpose of this document is to describe the procedure for administrative processing of information related to animal components submitted in investigational and marketing applications / notifications.

  1. Definitions
    2.

Refer to the Animal Component Database User's Guide and Dictionary accessible through the pull-down help menu found on your computer desktop: CBER MENU / Animal Component Database (ACD).

  1. Background
    2.

The Center for Biologics Evaluation and Research (CBER) regulates a wide variety of products for which animal materials are used in the manufacturing process or in product formulation. CBER reviews these products through a variety of submissions, including Investigational New Drugs (IND), Biologic License Applications (BLA), and New Drug Applications (NDAs).

Because of infectious disease issues that may result due to use of animal materials and components, CBER's goal is to minimize these risks. One step in minimizing risks is by knowing what products are made using animal materials in the manufacturing process or as a component. To improve the efficiency of tracking animal components and materials used in the manufacture of products, the Animal Component Database has been developed. Entering information about animal components and materials used in manufacturing into the database as part of the review of an application will enable a rapid identification of products of concern, should the need arise. With state-of-the-art tracking of animal components, public health is efficiently served.

  1. Policy
    2.

In order to support CBER's ability to respond to emerging problems concerning the possible presence of Transmissiable Spongioform Encephalopathies (TSE) and other emerging infectious agents in CBER regulated products, CBER has established and will maintain a database of animal components and materials used in the manufacture of those products. It is CBER's policy that each Office, upon review of regulatory submissions (e.g., INDs, BLAs, ,and NDAs) will enter information on animal materials used in the manufacture of marketing and investigational products into the database.

  1. Responsibilities and Procedures
    2.

    1. The CMC/Product reviewer will review the submission to determine if components of animal origin and other associated information are present in the formulation or are otherwise used in production and/or contact with the product.
    2. The CMC/Product reviewer will, prior to the completion of the first review cycle of the submission, enter the information found in the submission (as outlined Appendix 1) into the Animal Component Database fields (accessed from the CBER Menu).
    3. Steps 1 and 2 are repeated for any additional information applicable to an investigational or marketing application / notification (e.g., new protocols under IND, supplements, amendments).
  1. Appendix
    2.

    Appendix 1: List of fields to be entered into the ACD

    • Reference number, e.g., STN
    • Animal Components
    • Animal Derived Materials
    • Animal Derived Material Suppliers
    • Stage of Manufacture Useage(s)
    • Source of Organism(s)
    • Source Organism SubSource(s)
    • Source Organism Country / State/Province Origin(s)
  1. Effective Date
    2.

June 24, 2005

  1. History
    2.
Written By
Approved By
Approval Date
Version Number
Comment
Tom Maudru
Theresa Finn
Diane Maloney
Len Wilson		 Robert Yetter, PhD
5/18/2005
1
Original; 6/24/2005 device references removed

 

 

 

 

 
Updated: June 27, 2005