[Federal Register Volume 68, Number 71 (Monday, April 14, 2003)]
[Notices]
[Pages 17951-17953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9019]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-03-59]


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) 498-1210.
    Comments are invited on: (a) Whether the proposed collection of 
information

[[Page 17952]]

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. Send comments to Anne O'Connor, CDC 
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, 
Atlanta, GA 30333. 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).
    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 continued OMB approval to collect this 
information through the use of five separate forms. These forms are: 
(1) Application for Registration; (2) Facility Notification Form; (3) 
Request for Exemption; (4) Transfer of Select Agent form; and (5) 
Clinical and Diagnostic Laboratory Reporting Form.
    The Application for Registration will be used by facilities to 
register with CDC. The Application for Registration requests facility 
information, a list of select agents in use, possession, or for 
transfer by the facility, characterization of the select agent, 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. CDC estimates that entities will need an 
additional 45 minutes for each additional investigator or select agent. 
This is an increase of 1 hour, 45 minutes over the previous form due to 
new reporting requirements for security and identification of those 
individuals the entity has designated to have a legitimate need to 
handle or use such agents.
    Facilities may amend their registration if any changes occur in the 
information submitted to the 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 60 
minutes.
    The Facility Notification Form must be completed by facilities 
whenever there is release of a select agent or theft or loss of a 
select agent. This is a new form. Estimated average time to complete 
this form is 60 minutes.
    The Request for Exemption form will be used by facilities that are 
using select agents in investigational new drug testing or in cases of 
public health emergency. This is a new form. Estimated average time to 
complete this form is 70 minutes.
    The Transfer of Select Agent Form will be used by facilities 
requesting transfer of a select agent to their facilities and by the 
facility transferring the agent. This is a modification of an existing 
form approved under OMB Control No. 0920-0199. Estimated average time 
to complete this form is 1 hour, 45 minutes. This is an increase of 75 
minutes due to procedural changes.
    The Clinical and Diagnostic Laboratory Exemption Report will be 
used by clinical and diagnostic laboratories to notify the Secretary 
that select agents identified as the result of diagnosis or proficiency 
testing have been properly disposed of. This is a new form. Estimated 
average time to complete this form is 60 minutes.
    In addition to the standardized forms, this regulation also 
outlines situations in which an entity must notify or make a request of 
the Secretary in writing and CDC is requesting OMB approval to collect 
this information. The regulation states that an entity must notify the 
Secretary in writing at least five business days before destroying all 
select agent or toxin covered by a certificate of registration. The 
estimated time to gather the information and submit this notification 
is 30 minutes.
    An entity may also apply to the Secretary for an expedited review 
of an individual by the Attorney General. To apply for this expedited 
review, an entity must submit a request in writing to the Secretary 
establishing the need for such action. The estimated time to gather the 
information and submit this request is 30 minutes. Entities should be 
aware that CDC is not developing standardized forms to use in these 
situations. Rather, the entity should provide the information as 
requested in the appropriate section of the regulation.
    As part of the safety requirements of this regulation, the 
Responsible Official is required to conduct regular inspections (at 
least annually) of the laboratory where select agents and toxins are 
stored. The results of these inspections must be documented. CDC 
estimates that, on the average, such documentation will take 1 hour.
    Also, as part of the safety 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. 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 either a certification of registration or 
approval based on a security risk assessment. This request must be in 
writing 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. 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.

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                                                                               Number of         Responses per      Avg burden per       Total annual
          CFR reference                       Data collection                 respondents         respondent      response (in hrs.)   burden (in hrs.)
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73.7(b).........................  Registration application..............               1,000                   1                3.75               6,262
73.7(e).........................  Amendment to registration application.               1,000                   2                   1               2,000
73.17 (a)(e)....................  Notification form.....................                  10                   1                   1                  10

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73.6 (c-e)......................  Request for exemption.................                  17                   1               70/60                  20
73.14...........................  Transfer of select agent..............               1,000                   5                1.75               8,750
73.6 (a)(2).....................  Clinical and diagnostic laboratory                   1,000                   4                   1               4,000
                                   exemption report.
73.7(i).........................  Notification of inactivation..........                   6                   1               30/60                   3
73.8(g).........................  Request expedited review..............                   6                   1               30/60                   3
73.10(b)........................  Documentation of self-inspection......               1,000                   1                   1               1,000
73.13(f)........................  Documentation of training.............               1,000                   1                   2               8,700
73.18...........................  Administrative review.................                  14                   1                   4                  56
73.15(d)........................  Ensure secure recordkeeping system....               1,000                   1               30/60               4,000
                                                                         ---------------------
    Total.......................  ......................................               1,000  ..................  ..................              34,804
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    Dated: April 7, 2003.
Thomas Bartenfeld,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 03-9019 Filed 4-11-03; 8:45 am]
BILLING CODE 4163-18-P