[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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