The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail to email@example.com. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395-6974. Written comments should be received within 30 days of this notice.
Possession, Use, and Transfer of Select Agents and Toxins (OMB Control No. 0920-0576)—Revision—Division of Select Agents and Toxins (DSAT), Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER), Centers for Disease Control and Prevention (CDC). The revisions to the data collection are primarily changes to the guidance documents and forms to clarify instructions, correct editorial errors from previous submission, and reformat the structure of the forms based on the day-to-day processing of these forms. This request is for approval for three years.
Background and Brief Description
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A of Public Law 107-188 (42 U.S.C. 262a), requires the United States Department of Health and Human Services (HHS) to regulate the possession, use, and transfer of biological agents or toxins (i.e., select agents and toxins) that could pose a severe threat to public health and safety. The Agricultural Bioterrorism Protection Act of 2002, Subtitle B of Public Law 107-188 (7 U.S.C. 8401), Start Printed Page 39703requires the United States Department of Agriculture (USDA) to regulate the possession, use, and transfer of biological agents or toxins (i.e., select agents and toxins) that could pose a severe threat to animal or plant health, or animal or plant products. In accordance with these Acts, HHS and USDA promulgated regulations requiring entities to register with the CDC or the Animal and Plant Health Inspection Service (APHIS) if they possess, use, or transfer a select agent or toxin (42 CFR part 73, 7 CFR part 331, and 9 CFR part 121). CDC and APHIS coordinate regulatory activities for those agents that would be regulated by both agencies (“overlap” select agents). CDC and APHIS adopted an identical system to collect information for the possession, use, and transfer of select agents and toxins.
CDC is requesting continued OMB approval to collect this information through the use of five forms. The forms are: (1) Application for Registration, (2) Request to Transfer Select Agent or Toxin, (3) Report of Theft, Loss, or Release of Select Agent and Toxin, (4) Report of Identification of Select Agent or Toxin, and (5) Request for Exemption. The Application for Registration (42 CFR, 73.7(d)) will be used by entities to register with CDC. Entities may amend their registration (42 CFR, 73.7(h)1)) if any changes occur.
The Request to Transfer Select Agent or Toxin form (42 CFR 73.16) will be used to request transfer of a select agent or toxin to their facility. CDC, with APHIS, has revised the form by requiring the recipient to submit the initial request, be notified by the sender of the expected shipment date, and verify if the shipment did not occur.
The Report of Theft, Loss, or Release of Select Agent and Toxin form (42 CFR 73.19(a)(b)) must be completed by entities if there is theft, loss, or release of a select agent or toxin. The Report of Identification of Select Agent or Toxin form 42 CFR 73.5(a)(b) and 73.6(a)(b)) will be used by clinical and diagnostic laboratories to notify CDC that select agents or toxins identified as the result of diagnostic or proficiency testing have been disposed of in a proper manner. The form will be used by Federal law enforcement agencies to report the seizure and final disposition of select agents and toxins. CDC has revised the Report of Identification of Select Agent or Toxin form to ensure duplicate reports are not submitted by requesting the entity that makes the final identification report the select agents or toxins identified as the result of diagnostic or verification testing.
The Request for Exemption form (42 CFR 73.5(d)(e) and 73.6(d)(e)) will be used by entities that use an investigational product that are, bear, or contain select agents or toxins or in cases of public health emergency. An entity may apply to HHS for an exclusion of an attenuated strain of a select agent or toxin that does not pose a severe threat to public health and safety (42 CFR 73.3(e)(1) and 73.4(e)(1)).
This regulation outlines situations in which an entity must notify or may make a request of HHS in writing. An entity may apply to the HHS Secretary for an expedited review of an individual by the Attorney General (42 CFR 73.10(e)). CDC has not developed standardized forms for these situations. The entity should provide the information in the appropriate section of the regulation.
As part of the requirements of the Responsible Official, the Responsible Official is required to conduct regular inspections (at least annually) of the laboratory where select agents or toxins are stored. Results of these self-inspections must be documented (42 CFR 73.9(a)(5)).
As part of the training requirements of this regulation, the entity is required to record the identity of the individual trained, the date of training, and the means used to verify that the employee understood the training (42 CFR 73.15(c)).
An individual or entity may request administrative review of a decision denying or revoking certification of registration or an individual may appeal a denial of access approval (42 CFR 73.20). An entity must implement a system to ensure certain records and databases are accurate and that the authenticity of records may be verified (42 CFR 73.17(b).
Prior to issuance of a certificate of registration, CDC inspects entities to ensure compliance with this regulation (42 CFR 73.18).
The estimated annual burden is 9,657 hours.
|CFR reference||Data collection||Number of respondents||Responses per respondent||Average burden per response (in hours)|
|73.7(h)(1)||Amendment to Registration Application||264||5||1|
|73.19(a)(b)||Notification of Theft, Loss, or Release form||60||1||1|
|73.5 & 73.6(d-e)/73.3 & 73.4(e)(1)||Request for Exemption/Exclusion||5||1||1|
|73.16||Request to Transfer Select Agent or Toxin||264||4||1.5|
|73.5 & 73.6(a)(b)||Report of Identification of Select Agent or Toxin form||264||10||1|
|73.10(e)||Request expedited review||10||1||30/60|
|73.9(a)(5)||Documentation of self-inspection||264||1||1|
|73.15(c)||Documentation of training||264||1||2|
|73.17||Ensure secure recordkeeping system||264||1||4|
Dated: July 2, 2008.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E8-15749 Filed 7-9-08; 8:45 am]
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