[Federal Register Volume 73, Number 52 (Monday, March 17, 2008)]
[Notices]
[Pages 14252-14253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-5256]
[[Page 14252]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-08-0576]
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 404-639-5960
and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to [email protected].
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--Division of Select Agents and Toxins
(DSAT), Coordinating Office for Terrorism Preparedness and Emergency
Response (COTPER), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, Subtitle A of Public Law 107-188 (42 U.S.C.
262a), requires the United States Department of Health and Human
Services (HHS) to regulate the possession, use, and transfer of
biological agents or toxins (i.e., select agents and toxins) that could
pose a severe threat to public health and safety. The Agricultural
Bioterrorism Protection Act of 2002, Subtitle B of Public Law 107-188
(7 U.S.C. 8401), requires the United States Department of Agriculture
(USDA) to regulate the possession, use, and transfer of biological
agents or toxins (i.e., select agents and toxins) that could pose a
severe threat to animal or plant health, or animal or plant products.
In accordance with these Acts, HHS and USDA promulgated regulations
requiring entities to register with the CDC or the Animal and Plant
Health Inspection Service (APHIS) if they possess, use, or transfer a
select agent or toxin (42 CFR part 73, 7 CFR part 331, and 9 CFR part
121). CDC and APHIS coordinate regulatory activities for those agents
that would be regulated by both agencies (``overlap'' select agents).
Accordingly, CDC and APHIS adopted an identical system to collect
information for the possession, use, and transfer of select agents and
toxins.
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 the select agent or toxin.
Based on the data obtained from the 264 entities registered with CDC
(this number excludes registered federal government entities), there
are approximately 2 principal investigators for each registered entity.
For new applications submitted to the CDC since the last submission,
CDC estimates based on the information obtained from the database that
5 applications will be submitted from entities wishing to register with
CDC to possess, use or transfer select agents and toxins on an annual
basis. We have used these figures to calculate the burden for this
section. Estimated burden for the Application for Registration is 375
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. Based on the data regarding amendments received from
registered entities since the last submission, CDC estimates 5
amendment request to entity's certificate of registration will be
received on an annual basis.
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. CDC in conjunction with APHIS has revised the
Request to Transfer Select Agent or Toxin form by requiring the
recipient to submit the initial request, be notified by the sender of
the expected shipment date, and verify if the shipment did not occur.
Estimated average time to complete this form is 1 hour, 30 minutes.
Based on data regarding the transfer requests received since the last
submission, CDC estimates 4 transfer requests submitted per registered
entity on an annual basis.
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. Based on data regarding
the reports received since the last submission, CDC estimates that 60
reports per respondent will be received on an annual basis.
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 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. CDC in conjunction with APHIS has revised the
Report of Identification of Select Agent or Toxin form to ensure
duplicate reports are not submitted by requesting the entity that makes
the final identification report the select agents or toxins identified
as the result of diagnostic or verification testing. Estimated average
time to complete this form is 1 hour. Based on data regarding the
reports received since the last submission, CDC estimates that 10
reports per respondent will be received on an annual basis.
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
[[Page 14253]]
cases of public health emergency. Estimated average time to complete
this form is 1 hour. Based on data regarding the requests received
since the last submission, CDC estimates that 5 requests per respondent
will be received on an annual basis.
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 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.
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.
Prior to issuance of a certificate of registration, CDC inspects
entities to ensure compliance with this regulation (42 CFR 73.18). As
part of the inspection process, the entity may need to respond to
written requests from CDC. CDC estimates the time to prepare and submit
a response for the inspection is 8 hours. To estimate the burden, we
use the total number of registered entities since each entity will be
inspected at least once during the course of their registration.
Estimated Annualized Burden Hours
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Average burden
CFR reference Form Number of Responses per per response (in Total annual
respondents respondent hours) burden (in hours)
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73.7(d).................................. Registration Application......... 5 1 5 25
73.7(h)(1)............................... Amendment to Registration 264 5 1 1,320
Application.
73.19(a)(b).............................. Notification of Theft, Loss, or 60 1 1 60
Release form.
73.5 & 73.6(d-e)/73.3 & 73.4(e)(1)....... Request for Exemption/Exclusion.. 5 1 1 5
73.16.................................... Request to Transfer Select Agent 264 4 2 2,112
or Toxin.
73.5 & 73.6(a)(b)........................ Report of Identification of 264 10 1 2,640
Select Agent or Toxin form.
73.10(e)................................. Request expedited review......... 10 1 1 10
73.9(a)(5)............................... Documentation of self-inspection. 264 1 1 264
73.15(c)................................. Documentation of training........ 264 1 2 528
73.20.................................... Administrative Review............ 15 1 4 60
73.17.................................... Ensure secure recordkeeping 264 1 4 1,056
system.
73.18.................................... Inspections...................... 264 1 8 2,112
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Total................................ ................................. ................. ................. ................. 9,657
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Dated: March 4, 2008.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E8-5256 Filed 3-14-08; 8:45 am]
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