[Federal Register: April 14, 2003 (Volume 68, Number 71)]
[Notices]
[Page 17951-17953]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap03-59]
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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
[[Page 17953]]
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
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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]
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