05-2144. Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call the CDC Reports Clearance Officer on [phone]. CDC is requesting an emergency clearance from OMB regarding this data collection with a 10 day public comment period. The emergency clearance is based on a revision of this data collection as a result of a final rule.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. To request a copy of these requests, call the CDC Reports Clearance Officer at [phone] or send an e-mail to [e-mail]. Written comments can be sent to Seleda M. Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or sent via e-mail to [e-mail]. Written comments can also be faxed to the CDC Desk Officer, Human Resources and Housing Branch, Office of Management and Budget at [phone]. Written comments should be received within 10 days of this notice.

Proposed Project

Possession, Use, and Transfer of Select Agents and Toxins (OMB Control No. 0920-0576)—Extension—Office of the Director (OD), Centers for Disease Control and Prevention (CDC).

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188) specifies that the Secretary of Health and Human Services shall provide for the establishment and enforcement of standards and procedures governing the possession, use, and transfer of select biological agents and toxins. The Act specifies that facilities that possess, use, and transfer select agents register with the Secretary. The Secretary has designated CDC as the agency responsible for collecting this information.

CDC is requesting an emergency clearance to allow the continued collection of this information through the use of five separate forms. These forms have been revised since the last clearance. This emergency request will allow CDC to use the revised forms. These forms are: (1) Application for Registration, (2) Transfer of Select Agent or Toxin Form, (3) Facility Notification of Theft, Loss, or Release Form, (4) Clinical and Diagnostic Laboratory Reporting Form, and (5) Request for Exemption.

The Application for Registration (42 CFR 73.7(d)) will be used by entities to register with CDC. The Application for Registration requests facility information; a list of select agents or toxins in use, possession, or for transfer by the entity; characterization of the select agent or toxin; and laboratory information. Estimated average time to complete this form is 3 hours, 45 minutes for an entity with one principal investigator working with one select agent or toxin. CDC estimates that entities will need an additional 45 minutes for each additional investigator or agent. In our regulatory analysis, we have estimated that 70% of the 350 entities have 1-3 principal investigators, 15% have 5 principal investigators, and 15% have 10 principal investigators. We have used these figures to calculate the burden for this section. The revisions to this form were administrative in nature. Estimated burden for the Application for Registration is 2,191 hours.

Entities may amend their registration (42 CFR, 73.7(h)(1)) if any changes occur in the information submitted to the HHS Secretary. To apply for an amendment to a certificate of registration, an entity must obtain the relevant portion of the application package and submit the information requested in the package to CDC. Estimated time to amend a registration package is 1 hour.

The Facility Notification Form (42 CFR 73.19(a), (b)) must be completed by entities whenever there is theft, loss, or release of a select agent or toxin. In the revised rules we are now requiring reporting from exempt entities. Estimated average time to complete this form is 1 hour.

The Request for Exemption form (42 CFR 73.5 (d), (e) and 73.6 (d), (e)) will be used by entities that are using select agents or toxins in investigational new drug testing or in cases of public health emergency. The revisions to this form were administrative in nature. Estimated average time to complete this form is 1 hour.

The Transfer of Select Agent or Toxin Form (42 CFR 73.16) will be used by entities requesting transfer of a select agent or toxin to their facility and by the entity transferring the agent. CDC revised the Transfer of Select Agent or Toxin Form by removing the requirement that entities provide written notice within five business days when select agents or toxins are consumed or destroyed after a transfer. Estimated average time to complete this form is 1 hour, 30 minutes.

The Clinical and Diagnostic Laboratory Exemption Report (42 CFR 73.5(a), (b) and 73.6(a), (b)) will be used by clinical and diagnostic laboratories to notify the HHS Secretary that select agents or toxins identified as the result of diagnostic or proficiency testing have been disposed of in a proper manner. In the revised form revisions were made to clarify that the registered entities required to report can now retain the agent. Estimated average time to complete this form is 1 hour.

In addition to the standardized forms, this regulation also outlines situations in which an entity must notify or may make a request of the HHS Secretary in writing. An entity may apply to the HHS Secretary for an expedited review of an individual (e.g. Principal Investigator) by the Attorney General (42 CFR 73.10(e)). To apply for this expedited review, an entity must submit a request in writing to the HHS Secretary establishing the need for such action. The estimated time to gather the information and submit this request is 30 minutes. CDC has not developed standardized forms to use in the above situations. Rather, the entity should provide the information as requested in the appropriate section of the regulation.

An entity may also apply to the HHS Secretary 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)). The estimated time to gather the information and submit this request is 1 hour.

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)). CDC estimates, that, on average, such documentation will take 1 hour.

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)). Estimated time for this documentation is 2 hours per principal investigator.

An entity or an individual may request administrative review of a decision denying or revoking certification of registration (42 CFR 73.20). This request must be made in writing and within 30 calendar days after the adverse decision. This request should include a statement of the factual basis for the review. CDC estimates the time to prepare and submit such a request is 4 hours.

Finally, an entity must implement a system to ensure that certain records and databases are accurate and that the authenticity of records may be verified (42 CFR 73.17). The time to implement such a system is estimated to average 4 hours.

The cost to respondents is their time to complete the forms and comply with the reporting and recordkeeping components of the Act plus a one-time purchase of a file cabinet (estimated cost $400) to maintain records.

Annualized Burden Hours:

CFR reference	Data collection	Number of respondents	Responses per respondent	Average hourly burden	Total annual burden (in hours)
73.7(d)	Registration Application	350	1	3.75	1,313
73.7(d)	Additional Investigators	245	2	45/60	368
73.7(d)	Additional Investigators	53	4	45/60	159
73.7(d)	Additional Investigators	52	9	45/60	351
73.7(h)(1)	Amendment to Registration Application	350	2	1	700
73.19(a)(b)	Notification Form	12	1	1	12
73.5 & 73.6 (d-e)/73.3 & 73.4(e)(1)	Request for Exemption/Exclusion	17	1	1	17
73.16	Transfer of Select Agent or Toxin	350	2	90/60	1,050
73.5 & 73.6(a)(b)	Clinical and Diagnostic Laboratory Exemption Report	325	4	1	1,300
73.10(e)	Request expedited review	10	1	30/60	5
73.9(a)(5)	Documentation of self-inspection	350	1	1	350
73.15(c)	Documentation of training	350	1	2	700
73.20	Administrative Review	15	1	4	60
73.17	Ensure secure recordkeeping system	350	1	4	1,400
Total					7,785

Dated: January 31, 2005.

Betsey Dunaway,

Acting Reports Clearance Officer, Office of the Chief Science Officer, Centers for Disease Control and Prevention.