[Federal Register Volume 70, Number 52 (Friday, March 18, 2005)]
[Notices]
[Pages 13159-13160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5065]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 02-088-5]


Notice of Request for Emergency Approval of an Information 
Collection

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Emergency approval of an information collection; comment 
request.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this 
notice announces the Animal and Plant Health Inspection Service's 
intention to request emergency approval of an information collection in 
support of a final rule published in today's issue of the Federal 
Register regarding the possession, use, and transfer of select agents 
and toxins.

DATES: We will consider all comments that we receive on or before March 
25, 2005.

ADDRESSES: You may submit comments by any of the following methods:
     EDOCKET: Go to http://www.epa.gov/feddocket to submit or 
view public comments, access the index listing of the contents of the 
official public docket, and to access those documents in the public 
docket that are available electronically. Once you have entered 
EDOCKET, click on the ``View Open APHIS Dockets'' link to locate this 
document.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. 02-088-5, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your 
comment refers to Docket No. 02-088-5.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room is located in room 1141 of 
the USDA South Building, 14th Street and Independence Avenue SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    Other Information: You may view APHIS documents published in the 
Federal Register and related information on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: For information concerning the 
regulations in 7 CFR part 331, contact Dr. Charles L. Divan, Senior 
Agricultural Microbiologist, Pest Permit Evaluations, Biological and 
Technical Services, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 
20737-1236; (301) 734-8758.
    For information concerning the regulations in 9 CFR part 121, 
contact Dr. Lee Ann Thomas, Director, Animals, Organisms and Vectors, 
and Select Agents, VS, APHIS, 4700 River Road Unit 2, Riverdale, MD 
20737-1231; (301) 734-5960.
    For copies of more detailed information on the information 
collection, contact Mrs. Celeste Sickles, APHIS' Information Collection 
Coordinator, at (301) 734-7477.

SUPPLEMENTARY INFORMATION: In an interim rule published in the Federal 
Register on December 13, 2002 (67 FR 76908-76938, Docket No. 02-088-1) 
and effective on February 11, 2003, the Animal and Plant Health 
Inspection

[[Page 13160]]

Service (APHIS) established regulations in 7 CFR part 331 and 9 CFR 
part 121 governing the possession, use, and transfer of biological 
agents and toxins that have been determined to have the potential to 
pose a severe threat to public health and safety, to animal health, to 
plant health, or to animal or plant products. In a final rule published 
in today's issue of the Federal Register, APHIS is adopting, with 
changes, the December 2002 interim rule.
    The final rule includes certain regulatory provisions that differ 
from those included in the December 2002 interim rule. Some of those 
provisions involve changes from the information collection requirements 
set out in the December 2002 interim rule, which were approved by the 
Office of Management and Budget (OMB) under OMB control number 0579-
0213 (expires May 31, 2005). These changes include the following:
     As a condition of exemption, an entity must report any 
theft, loss, or release of a select agent or toxin during the period 
between identification of the agent or toxin and transfer or 
destruction of such agent or toxin. This is a new requirement in the 
final rule.
     As a condition of exemption, an entity must immediately 
report the identification of specified select agents and toxins; 
identification of the other select agents and toxins must be reported 
within 7 calendar days after identification. This is a change from the 
requirement in the December 2002 interim rule that identifications of 
any select agent or toxin be immediately reported.
     The responsible official must report the identification 
and final disposition of any select agent or toxin contained in a 
specimen presented for diagnosis or verification. This is a change from 
the requirement in the December 2002 interim rule that the responsible 
official immediately report the identification of a select agent or 
toxin contained in a specimen presented for diagnosis.
     The responsible official must report the identification 
and final disposition of any select agent or toxin contained in a 
specimen presented for proficiency testing. This is a new requirement 
in the final rule.
     A select agent or toxin that is contained in a specimen 
for proficiency testing may be transferred without prior authorization 
from APHIS or the Centers for Disease Control and Prevention (CDC) 
provided that, at least 7 calendar days prior to the transfer, the 
sender reports to APHIS or CDC the select agent or toxin to be 
transferred and the name and address of the recipient. This is a change 
from the requirement in the December 2002 interim rule that the 
transfer of a select agent or toxin be authorized by APHIS or CDC prior 
to the transfer.
     An individual or entity must report the theft, loss, or 
release of a select agent or toxin. This is a change from the December 
2002 interim rule that required such reporting for registered entities 
only.
     The responsible official is no longer required to notify 
APHIS 5 business days prior to the planned inactivation of a select 
agent or toxin if he/she wishes to discontinue possessing, using, or 
transferring a particular agent or toxin. In addition, the responsible 
official is no longer required to submit information about an 
individual's training and skills. These requirements have been deleted 
in the final rule.
    In addition, there are a number of nonsubstantive changes, 
including changes in terminology and changes to form numbers.
    In accordance with section 3507(j) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection and 
recordkeeping requirements included in the final rule have been 
submitted for emergency approval to the Office of Management and Budget 
(OMB). The purpose of this notice is to solicit comments from the 
public (as well as affected agencies) concerning our information 
collection. These comments will help us:
    (1) Evaluate whether the collection of information is necessary for 
the proper performance of the functions of the Agency, including 
whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
collection of information, including the validity of the methodology 
and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the collection of information on those 
who are to respond, through use, as appropriate, of automated, 
electronic, mechanical, and other collection technologies; e.g., 
permitting electronic submission of responses.
    Estimate of burden: The public reporting burden for this collection 
of information is estimated to average 2.8495857 hours per response.
    Respondents: Researchers, universities, research and development 
organizations, diagnostic laboratories and other interested parties who 
possess, use, or transfers select agents or toxins.
    Estimated annual number of respondents: 915.
    Estimated annual number of responses per respondent: 5.1442622.
    Estimated annual number of responses: 4,707.
    Estimated total annual burden on respondents: 13,413. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    APHIS will provide OMB with a copy of all comments received on this 
notice. All comments will also become a matter of public record.
    When OMB notifies us of its decision, we will publish a document in 
the Federal Register providing notice of the assigned OMB control 
number or, if approval is denied, providing notice of what action we 
plan to take.

    Done in Washington, DC, this 10th day of March 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-5065 Filed 3-17-05; 8:45 am]
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