; (II) each facility in which the human tissue specimens of the applicant are donated, recovered, processed, packed, or held meets standards designed to ensure that the human tissue specimens do not pose a communicable disease risk to the general public; and (III) the applicant creates, compiles, and maintains a complete record on each donor from which it recovers a human body or human tissue specimen for educational or research purposes, which record shall include, at a minimum— (aa) documentation demonstrating that the donor or the agent making the donation on the donor’s behalf has knowingly consented to the anatomical donation for educational or research purposes; (bb) documentation showing that the donor or the agent making the donation on the donor’s behalf has been informed as to whether the body or human tissue specimens shall be returned to a relative or personal representative or whether the applicant shall arrange and carry out the disposition of the human body or human tissue specimens; (cc) documentation of the identity and address of each entity which has been in possession of the human body or human tissue specimen before the applicant took possession, such as a funeral home, coroner, hospital, organ procurement organization, or tissue bank; and (dd) documentation on the use and disposition of each human body or human tissue specimen, including the name and address of each person or entity that receives the human body or human tissue specimen directly from the applicant; and (ii) only if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c). (3) Requirements for exemption The Secretary shall prescribe requirements under which a human tissue specimen shall be exempt from the requirements of paragraph (1). (b) Falsely labeling or marking package or container