[Federal Register Volume 70, Number 173 (Thursday, September 8, 2005)]
[Notices]
[Pages 53369-53371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17765]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-05-0576]


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 (404) 371-5983 
and send comments to Seleda Perryman, CDC Assistant Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to [email protected].
    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. Written comments should be received 
within 60 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).

Background and Brief Description

    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 (HHS) shall provide for the establishment and 
enforcement of standards and procedures governing the possession, use, 
and transfer of select 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 continued OMB approval to collect this 
information through the use of five separate forms. These 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. 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. 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 CDC. 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 Request to Transfer 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 receiving the agent. CDC revised 
the Request to Transfer 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 Report of Theft, Loss, or Release of Select Agent and Toxin 
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. Estimated 
average time to complete this form is 1 hour.
    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

[[Page 53370]]

of in a proper manner. In addition, the form will be used by Federal 
law enforcement agencies to report the seizure and final disposition of 
select agents and toxins. 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 an investigational product that 
are, bear, or contain select agents or toxins or in cases of public 
health emergency. 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 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 duties 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 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). 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(b)). 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.

                                                           Estimate of Annualized Burden Hours
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                                                                                                                                           Total annual
                  CFR reference                               Data collection                Number of     Responses per      Average       burden  (in
                                                                                            respondents     respondent    hourly  burden      hours)
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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 of Theft, Loss, or                     12               1               1              12
                                                   Release form.
73.5 & 73.6 (d-e)/73.3 & 73.4(e)(1).............  Request for Exemption/Exclusion.......              17               1               1              17
73.16...........................................  Request to Transfer Select Agent or                350               2            1.50           1,050
                                                   Toxin.
73.5 & 73.6(a)(b)...............................  Report of Identification of Select                 325               4               1           1,300
                                                   Agent or Toxin form.
73.10(e)........................................  Request expedited review..............              10               1             0.5               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(b)........................................  Ensure secure recordkeeping system....             350               1               4           1,400
                                                                                         -----------------
                                                   Total................................  ..............  ..............  ..............           7,785
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[[Page 53371]]

    Dated: August 30, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 05-17765 Filed 9-7-05; 8:45 am]
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