Attachment 2 - Federal Register Notice

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Federal Register / Vol. 73, No. 52 / Monday, March 17, 2008 / Notices

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.

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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

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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

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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

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Federal Register / Vol. 73, No. 52 / Monday, March 17, 2008 / Notices
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 selfinspections 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
Number of
respondents

CFR reference

Form

73.7(d) ...................
73.7(h)(1) ..............
73.19(a)(b) ............

Registration Application .......................
Amendment to Registration Application
Notification of Theft, Loss, or Release
form.
Request for Exemption/Exclusion ........

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...............................................................

1
5
1

5
1
1

25
1,320
60

5

1

1

5

264

4

2

2,112

264

10

1

2,640

10
264
264
15
264
264

1
1
1
1
1
1

1
1
2
4
4
8

10
264
528
60
1,056
2,112

..............................

..............................

..............................

9,657

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]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

BILLING CODE 4163–18–P

[60Day–0920–0630]

Centers for Disease Control and
Prevention

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

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16:19 Mar 14, 2008

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Total annual
burden
(in hours)

5
264
60

73.5 & 73.6(d–e)/
73.3 & 73.4(e)(1).
73.16 ..................... Request to Transfer Select Agent or
Toxin.
73.5 & 73.6(a)(b) ... Report of Identification of Select Agent
or Toxin form.
73.10(e) ................. Request expedited review ....................
73.9(a)(5) .............. Documentation of self-inspection .........
73.15(c) ................. Documentation of training ....................
73.20 ..................... Administrative Review ..........................
73.17 ..................... Ensure secure recordkeeping system
73.18 ..................... Inspections ...........................................
Total ...............

Average burden
per response
(in hours)

Responses per
respondent

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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 Dr. Maryam
Daneshvar, CDC Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
Atlanta, GA 30333 or send an email to
[email protected].
Comments are invited on: (a) Whether
the proposed collection of information

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17MRN1