[Federal Register: September 2, 2003 (Volume 68, Number 169)]
[Notices]
[Page 52212-52213]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02se03-86]
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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.)
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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]
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