[Federal Register Volume 70, Number 23 (Friday, February 4, 2005)]
[Notices]
[Pages 6009-6011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2144]


-----------------------------------------------------------------------

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 the CDC Reports 
Clearance Officer on (404) 371-5976. 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 (404) 371-5976 or send an e-
mail to [email protected]. 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 [email protected]. Written 
comments can also be faxed to the CDC Desk Officer, Human Resources and 
Housing Branch, Office of Management and Budget at (202) 395-6974. 
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

[[Page 6010]]

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:

----------------------------------------------------------------------------------------------------------------
                                                                                                   Total annual
         CFR reference           Data collection     Number of     Responses per  Average hourly    burden  (in
                                                    respondents     respondent        burden          hours)
----------------------------------------------------------------------------------------------------------------
73.7(d).......................  Registration                 350               1            3.75           1,313
                                 Application.
73.7(d).......................  Additional                   245               2           45/60             368
                                 Investigators.
73.7(d).......................  Additional                    53               4           45/60             159
                                 Investigators.
73.7(d).......................  Additional                    52               9           45/60             351
                                 Investigators.

[[Page 6011]]

 
73.7(h)(1)....................  Amendment to                 350               2               1             700
                                 Registration
                                 Application.
73.19(a)(b)...................  Notification                  12               1               1              12
                                 Form.
73.5 & 73.6 (d-e)/73.3 &        Request for                   17               1               1              17
 73.4(e)(1).                     Exemption/
                                 Exclusion.
73.16.........................  Transfer of                  350               2           90/60           1,050
                                 Select Agent or
                                 Toxin.
73.5 & 73.6(a)(b).............  Clinical and                 325               4               1           1,300
                                 Diagnostic
                                 Laboratory
                                 Exemption
                                 Report.
73.10(e)......................   Request                      10               1           30/60               5
                                 expedited
                                 review.
73.9(a)(5)....................  Documentation of             350               1               1             350
                                 self-inspection.
73.15(c)......................  Documentation of             350               1               2             700
                                 training.
73.20.........................  Administrative                15               1               4              60
                                 Review.
73.17.........................  Ensure secure                350               1               4           1,400
                                 recordkeeping
                                 system.
                               -------------------
    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.
[FR Doc. 05-2144 Filed 2-3-05; 8:45 am]
BILLING CODE 4163-18-P