[Code of Federal Regulations] [Title 42, Volume 1] [Revised as of October 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR73.7] [Page 449-451] TITLE 42--PUBLIC HEALTH CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 73--SELECT AGENTS AND TOXINS--Table of Contents Sec. 73.7 Registration. (a) An entity may not possess or use in the United States, receive from outside the United States, or transfer within the United States, any select agent or toxin unless the entity has [[Page 450]] been granted a certificate of registration by the HHS Secretary or the USDA Secretary. (b) To apply for a certificate of registration an entity must: (1) Obtain a registration application number from the HHS Secretary and then apply for approval under Sec. 73.8 for the entity, the Responsible Official, and any individual who owns or controls the entity; and (2) In accordance with Sec. 73.21, submit the information requested to the HHS Secretary or the USDA Secretary as specified in the registration application package [CDC Form 0.1319]. Information submitted will be used to determine whether the applicant would be eligible to conduct activities under this part. Minimum information required includes: (i) Identification information (e.g., name, address, contact numbers, identification number assigned by the Attorney General for compliance with Sec. 73.8); (ii) The name, source, and characterization information on select agents and toxins included in the registration, and quantities held at the time of the application; (iii) The location, including building and room and floor plans for each building and room, where each select agent or toxin will be stored or used; (iv) Information addressing safety, security, emergency response plans, and training, including descriptions of any equivalent measures adopted pursuant to Sec. 73.11(d); (v) The name, position, and identification information regarding the Responsible Official, including the identification number assigned by the Attorney General for compliance with Sec. 73.8; (vi) A list of individuals who will need access to select agents and toxins; (vii) A certification statement signed by the Responsible Official attesting to the accuracy of the information submitted; and (viii) Any other information necessary for the determination. (c) An application that covers any HHS select agents or toxins (regardless of whether it also covers overlap select agents or toxins) must be submitted to the HHS Secretary in accordance with Sec. 73.21. An application that covers only overlap select agents or toxins may be submitted to either the HHS Secretary or the USDA Secretary. (d) A certificate of registration will be valid only for the specific select agents and toxins, and the specified activities and locations that are consistent with the information provided by the entity upon which the certificate of registration or amendment was granted. The Responsible Official must promptly notify the HHS Secretary in writing in accordance with Sec. 73.21, if a change occurs in any information submitted to the HHS Secretary in the application for the certificate of registration or amendments. This includes modifications to the list of individuals approved under Sec. 73.8, changes in area of work, or changes in protocols or objectives of studies. To apply for an amendment to a certificate of registration to add select agents or toxins or to change specified activities or locations, an entity must obtain the relevant portion of the registration application package and submit the information requested in the package to the agency that issued the certificate of registration. The package must be submitted to the appropriate address specified in the package. (e) In response to an application to the HHS Secretary for a certificate of registration or amendment for select agents and toxins, the HHS Secretary will issue a certificate of registration or amendment if it is determined that the stated activities would be lawful (based on information submitted by the applicant or otherwise obtained by the HHS Secretary) and meet the requirements of this part. Otherwise, the application for a certificate of registration or amendment will be denied. The HHS Secretary will issue a certificate of registration or amendment for an overlap select agent or toxin only if the USDA Secretary concurs that the requirements for obtaining a certificate of registration or amendment under 9 CFR part 121 have been met. The determination of whether a certificate of registration or amendment will be granted may be contingent upon inspection or submission of additional information. (f) A certificate of registration will cover activities at only one general [[Page 451]] physical location (a building or a complex of buildings at a single mailing address). (g) Unless terminated sooner in accordance with this paragraph, a certificate of registration will be valid for up to three years. To obtain a new certificate of registration an entity must submit a new application. (Note: To help ensure timely processing of an application for a certificate of registration or amendment, the applicant should submit the application at least eight weeks prior to the expiration date.) (1) The HHS Secretary will terminate a certificate of registration based on a determination that the recipient no longer conducts activities covered by the certificate. (2) Also, the HHS Secretary may terminate a certificate of registration based on a security risk assessment under Sec. 73.8 or failure to comply with the provisions of this part, and may take such action immediately if necessary to protect the public health or safety. Upon such termination, any select agent or toxin in the possession of the entity must be destroyed or transferred as directed by the HHS Secretary. (h) An entity must provide notice in writing to the HHS Secretary in accordance with Sec. 73.21 at least five business days before destroying a select agent or toxin, if the destruction would be for the purpose of discontinuing activities with a select agent or toxin covered by a certificate of registration. This will allow the HHS Secretary to observe the destruction or take other action as appropriate.