[Federal Register: September 8, 2005 (Volume 70, Number 173)]
[Notices]
[Page 53369-53371]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08se05-61]
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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 (404) 371-5983
and send comments to Seleda Perryman, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
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. 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).
Background and Brief Description
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 (HHS) shall provide for the establishment and
enforcement of standards and procedures governing the possession, use,
and transfer of select 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) Request to Transfer Select Agent
or Toxin; (3) Report of Theft, Loss, or Release of Select Agent and
Toxin; (4) Report of Identification of Select Agent or Toxin; 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. 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 CDC. 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 Request to Transfer 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 receiving the agent. CDC revised
the Request to Transfer 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 Report of Theft, Loss, or Release of Select Agent and Toxin
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. Estimated
average time to complete this form is 1 hour.
The Report of Identification of Select Agent or Toxin form 42 CFR
73.5(a)(b) and 73.6(a)(b)) will be used by clinical and diagnostic
laboratories to notify CDC that select agents or toxins identified as
the result of diagnostic or proficiency testing have been disposed
[[Page 53370]]
of in a proper manner. In addition, the form will be used by Federal
law enforcement agencies to report the seizure and final disposition of
select agents and toxins. 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 an investigational product that
are, bear, or contain select agents or toxins or in cases of public
health emergency. 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 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 duties 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 individual or entity may request administrative review of a
decision denying or revoking certification of registration or an
individual may appeal a denial of access approval (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(b)). 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.
Estimate of Annualized Burden Hours
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Total annual
CFR reference Data collection Number of Responses per Average burden (in
respondents respondent hourly burden hours)
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73.7(d)......................................... Registration Application.............. 350 1 3.75 1,313
73.7(d)......................................... Additional Investigators.............. 245 2 45/60 368
73.7(d)......................................... Additional Investigators.............. 53 4 45/60 159
73.7(d)......................................... Additional Investigators.............. 52 9 45/60 351
73.7(h)(1)...................................... Amendment to Registration Application. 350 2 1 700
73.19(a)(b)..................................... Notification of Theft, Loss, or 12 1 1 12
Release form.
73.5 & 73.6 (d-e)/73.3 & 73.4(e)(1)............. Request for Exemption/Exclusion....... 17 1 1 17
73.16........................................... Request to Transfer Select Agent or 350 2 1.50 1,050
Toxin.
73.5 & 73.6(a)(b)............................... Report of Identification of Select 325 4 1 1,300
Agent or Toxin form.
73.10(e)........................................ Request expedited review.............. 10 1 0.5 5
73.9(a)(5)...................................... Documentation of self-inspection...... 350 1 1 350
73.15(c)........................................ Documentation of training............. 350 1 2 700
73.20........................................... Administrative Review................. 15 1 4 60
73.17(b)........................................ Ensure secure recordkeeping system.... 350 1 4 1,400
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Total................................ .............. .............. .............. 7,785
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[[Page 53371]]
Dated: August 30, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 05-17765 Filed 9-7-05; 8:45 am]
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