[Federal Register Volume 68, Number 169 (Tuesday, September 2, 2003)]
[Notices]
[Pages 52212-52213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22254]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-67-03]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    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) 498-1210. Send written 
comments to CDC, Desk Officer, Human Resources and Housing Branch, New 
Executive Office Building, Room 10235, Washington, DC 20503 or by fax 
to (202) 395-6974. Written comments should be received within 30 days 
of this notice.
    Proposed Project: Possession, Use, and Transfer of Select Agents 
and Toxins (42 CFR part 73) (OMB Control No. 0920-0576)--Revision--
Office of the Director (OD), Centers for Disease Control and Prevention 
(CDC). The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (Public Law 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. This request 
reflects revisions to the forms approved in February, 2003 as a result 
of public comments to the Interim Final Rules that CDC and USDA/APHIS 
published in February, 2003. 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 revisions to the forms are 
primarily changes to the Guidance documents to clarify instructions and 
the inclusion of a supplemental form to the Application form for 
Biosafety Level 4 (BSL4) laboratories. CDC is requesting a 3-year 
approval for this data collection.
    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. 
BSL4 laboratories will also complete and submit Section 6 of the 
Application for Registration. CDC is requesting OMB approval to add 
this section to the Application for Registration because of the unique 
data required for these facilities. We identified the need for this 
section during the registration process following the February, 2003 
approval of the Application form. Although there are less than 10 
respondents for this form, CDC has decided to voluntarily comply with 
the Paperwork Reduction Act and seek OMB approval for this form. 
Estimated time to complete and submit Section 6 is 2 hours.
    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. 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. 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. Estimated average time to complete 
this form is 1 hour, 45 minutes.
    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. 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. Total annualized burden for this data collection is 
17,905 hours.

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                                                                                                      Avg burden
                                                                                No. of     Responses      per
              CFR reference                         Data collection          respondents      per      response
                                                                                          respondent   (in hrs.)
----------------------------------------------------------------------------------------------------------------
73.7(b)..................................  Registration Application........          575           1        3.75
73.7(b)..................................  BSL4 Supplement.................            4           1           2
73.7(e)..................................  Amendment to Registration                 575           2           1
                                            Application.
73.17(a)(e)..............................  Notification Form...............           10           1           1
73.6(c-e)................................  Request for Exemption...........           17           1        1.16
73.14....................................  Transfer of Select Agent........          575           5        1.75
73.6(a)(2)...............................  Clinical and Diagnostic                 1,000           4           1
                                            Laboratory Exemption Report.
73.7(i)..................................  Notification of Inactivation....            6           1       30/60
73.8(g)..................................  Request Expedited Review........            6           1       30/60
73.10(b).................................  Documentation of Self-inspection          575           1           1
73.13(f).................................  Documentation of Training.......          575           1           2
73.18....................................  Administrative Review...........           14           1           4
73.15(d).................................  Ensure Secure Record keeping              575           1       30/60
                                            System.
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    Dated: August 25, 2003.
Nancy Cheal,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 03-22254 Filed 8-29-03; 8:45 am]
BILLING CODE 4163-18-P