[Federal Register: January 24, 2006 (Volume 71, Number 15)]
[Notices]
[Page 3851-3852]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ja06-69]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-06-0576]
Agency Forms Undergoing Paperwork Reduction Act Review
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) 639-4766 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC 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 (OMB
Control No. 0920-0576)--Revision--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 that have the potential to
pose a severe threat to public health and safety. The Act specifies
that entities that possess, use, and transfer these select agents
register with the HHS Secretary. The HHS 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)) is 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)
is used by entities requesting transfer of a select agent or toxin to
their facility and by the entity transferring 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)) is 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 of
in a proper manner. In addition, the form is 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))
is 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
[[Page 3852]]
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 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. The total estimated annualized burden hours are 7,785.
Estimated Annualized Burden Hours
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Data collection Number of Responses per Average burden
CFR reference instrument respondents respondent per response
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73.7(d)........................... Registration application 350 1 3.75
form.
73.7(d)........................... Additional investigators. 245 2 45/60
73.7(d)........................... Additional investigators. 53 4 45/60
73.7(d)........................... Additional investigators. 52 9 45/60
73.7(h)(1)........................ Amendment to registration 350 2 1
application.
73.19(a)(b)....................... Report of theft, loss, or 12 1 1
release.
73.5 & 73.6 (d-e)/ 73.3 & 73.4 Request for exemption 17 1 1
(e)(1). form/exclusion.
73.16............................. Request to transfer...... 350 2 1.5
73.5 & 73.6 (a)(b)................ Report of identification. 325 4 1
73.10(e).......................... Request expedited review. 10 1 30/60
73.9(a)(5)........................ Documentation of self- 350 1 1
inspection.
73.15(c).......................... Documentation of training 350 1 2
73.20............................. Administrative review.... 15 1 4
73.17............................. Ensure secure 350 1 4
recordkeeping system.
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Dated: January 18, 2006.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E6-808 Filed 1-23-06; 8:45 am]
BILLING CODE 4163-18-P