[Federal Register: February 4, 2005 (Volume 70, Number 23)]
[Notices]
[Page 6009-6011]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04fe05-89]
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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 the CDC Reports
Clearance Officer on (404) 371-5976. CDC is requesting an emergency
clearance from OMB regarding this data collection with a 10 day public
comment period. The emergency clearance is based on a revision of this
data collection as a result of a final rule.
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. To request a copy of these requests,
call the CDC Reports Clearance Officer at (404) 371-5976 or send an e-
mail to omb@cdc.gov. Written comments can be sent to Seleda M.
Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road,
MS-D74, Atlanta, GA 30333 or sent via e-mail to omb@cdc.gov. Written
comments can also be faxed to the CDC Desk Officer, Human Resources and
Housing Branch, Office of Management and Budget at (202) 395-6974.
Written comments should be received within 10 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
[[Page 6010]]
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 an emergency clearance to allow the continued
collection of this information through the use of five separate forms.
These forms have been revised since the last clearance. This emergency
request will allow CDC to use the revised forms. These forms are: (1)
Application for Registration, (2) Transfer of Select Agent or Toxin
Form, (3) Facility Notification of Theft, Loss, or Release Form, (4)
Clinical and Diagnostic Laboratory Reporting Form, 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. The revisions to this form were administrative
in nature. 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 the HHS 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 1 hour.
The Facility Notification 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. In the revised rules we are now requiring
reporting from exempt entities. 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 select agents or toxins in
investigational new drug testing or in cases of public health
emergency. The revisions to this form were administrative in nature.
Estimated average time to complete this form is 1 hour.
The Transfer of 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 transferring the agent. CDC revised
the Transfer of 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 Clinical and Diagnostic Laboratory Exemption Report (42 CFR
73.5(a), (b) and 73.6(a), (b)) will be used by clinical and diagnostic
laboratories to notify the HHS Secretary that select agents or toxins
identified as the result of diagnostic or proficiency testing have been
disposed of in a proper manner. In the revised form revisions were made
to clarify that the registered entities required to report can now
retain the agent. 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 (e.g. Principal
Investigator) 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 requirements 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 entity or an individual may request administrative review of a
decision denying or revoking certification of registration (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). 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.
Annualized Burden Hours:
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Total annual
CFR reference Data collection Number of Responses per Average hourly burden (in
respondents respondent burden hours)
----------------------------------------------------------------------------------------------------------------
73.7(d)....................... Registration 350 1 3.75 1,313
Application.
73.7(d)....................... Additional 245 2 45/60 368
Investigators.
73.7(d)....................... Additional 53 4 45/60 159
Investigators.
73.7(d)....................... Additional 52 9 45/60 351
Investigators.
[[Page 6011]]
73.7(h)(1).................... Amendment to 350 2 1 700
Registration
Application.
73.19(a)(b)................... Notification 12 1 1 12
Form.
73.5 & 73.6 (d-e)/73.3 & Request for 17 1 1 17
73.4(e)(1). Exemption/
Exclusion.
73.16......................... Transfer of 350 2 90/60 1,050
Select Agent or
Toxin.
73.5 & 73.6(a)(b)............. Clinical and 325 4 1 1,300
Diagnostic
Laboratory
Exemption
Report.
73.10(e)...................... Request 10 1 30/60 5
expedited
review.
73.9(a)(5).................... Documentation of 350 1 1 350
self-inspection.
73.15(c)...................... Documentation of 350 1 2 700
training.
73.20......................... Administrative 15 1 4 60
Review.
73.17......................... Ensure secure 350 1 4 1,400
recordkeeping
system.
-------------------
Total..................... ................ .............. .............. .............. 7,785
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Dated: January 31, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Office of the Chief Science Officer,
Centers for Disease Control and Prevention.
[FR Doc. 05-2144 Filed 2-3-05; 8:45 am]
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