[Federal Register: March 18, 2005 (Volume 70, Number 52)]
[Notices]
[Page 13159-13160]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18mr05-34]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 3410-34-P