(a) An application for approval shall be made to the department, which shall include the following items.

1. (1) Complete and detailed description of the methods, equipment, and technics used in relation to each tissue which is to be processed.
2. (2) The name and address of the person owning the place, establishment, or institution, in which the processing is to be carried on.
3. (3) The name and address of the director who shall be a duly licensed physician and surgeon in the State of California.
4. (4) Kinds of tissues to be processed.
5. (5) Such additional information as the department may require in order to determine compliance with these regulations.

(d) Application will be approved only when establishment and the methods used are such that the tissues processed will not be contaminated, dangerous, or harmful.

1. (1) Representative samples shall be provided for the department of each lot of tissues, if requested by the department, for the purpose of checking sterility, quality, or other factor.
2. (2) Any duly authorized representative of the department shall have free access to the establishment and the records thereof at all reasonable hours for the purpose of ascertaining compliance with these regulations.

(f) Renewal of Approval.

1. (1) The department shall issue renewal notices annually prior to the end of each calendar year.
2. (2) Each person on applying for renewal shall review his activities in the field for the preceding year if requested to do so by the department.