[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Notices]
[Pages 30092-30093]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12753]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2011-0024]


Notice of Request for Extension of Approval of an Information 
Collection; Select Agent Registration

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Extension of 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 extension of approval of an information collection 
associated with regulations for the possession, use, and transfer of 
biological agents and toxins that have the potential to pose a severe 
threat to human and animal health, to animal health, to plant health, 
or to animal products and plant products.

DATES: We will consider all comments that we receive on or before July 
25, 2011.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2011&-0024 to submit or view comments 
and to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send one copy of 
your comment to Docket No. APHIS-2011-0024, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2011-0024.
    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: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: For information regarding the select 
agent registration process associated with the possession, use, or 
transfer of biological agents and toxins in 7 CFR part 331, contact Dr. 
Charles Divan, Branch Chief, Agriculture Select Agent Program, RIPPS, 
PPQ, APHIS, 4700 River Road, Unit 2, Riverdale, MD 20737; (301) 734-
8758.
    For information regarding the select agent registration process 
associated with the possession, use, or transfer of biological agents 
and toxins in 9 CFR part 121, contact Mr. Robert Rice, Security 
Manager, Agriculture Select Agent Program, Technical Trade Services 
Team, NCIE, VS, APHIS, 4700 River Road, Unit 2, Riverdale, MD 20737; 
(301) 734-5557.
    For copies of more detailed information on the information 
collection, contact Mrs. Celeste Sickles, APHIS' Information Collection 
Coordinator, at (301) 851-2908.

SUPPLEMENTARY INFORMATION: 
    Title: Select Agent Registration.
    OMB Number: 0579-0213.
    Type of Request: Extension of approval of an information 
collection.
    Abstract: The Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 provides for the regulation of certain 
biological agents and toxins by the Department of Agriculture (USDA) 
and the Department of Health and Human Services (HHS). Under section 
212 of the Act, USDA regulates biological agents and toxins that have 
the potential to pose a severe threat to both human and animal health, 
to animal health, to plant health, or to animal and plant products. The 
Animal and Plant Health Inspection Service (APHIS) has the primary 
responsibility for implementing the provisions of the Act within USDA. 
Select agents and toxins that have been determined to pose a severe 
threat to both human and animal health or animal products are subject 
to regulation by both APHIS and the Centers for Disease Control and 
Prevention (CDC), HHS, which has the primary responsibility for 
implementing the provisions of the Act within HHS.
    APHIS regulations are contained in 7 CFR part 331 (plant) and 9 CFR 
part 121 (animal and overlap). They require an individual or entity 
(unless specifically

[[Page 30093]]

exempted under the regulations) to register with APHIS or, for overlap 
agents or toxins, APHIS or CDC, in order to possess, use, or transfer 
biological agents or toxins.
    The registration process is designed to obtain critical information 
concerning individuals or entities in possession of certain agents or 
toxins, as well as the specific characteristics of the agents or 
toxins, including name, strain, and genetic information. These data are 
needed, in part, to allow APHIS to determine the biosafety and 
biocontainment level of an entity as well as the entity's security 
situation. This, in turn, helps APHIS to ensure that appropriate 
safeguard, containment, and disposal requirements commensurate with the 
risk of the agent or toxin are present at the entity, thus preventing 
access to such agents and toxins for use in domestic or international 
terrorism. APHIS will also request information to determine that 
individuals seeking to register have a lawful purpose to possess, use, 
or transfer agents or toxins. Forms PPQ 526, VS 16-3, and VS 16-7 are 
approved under this collection for use in the registration process.
    We are asking the Office of Management and Budget (OMB) to approve 
our use of the information collection activities for an additional 3 
years.
    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 
information collection, 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 information collection 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 1.9544673 hours per response.
    Respondents: Researchers, universities, research and development 
organizations, diagnostic laboratories, and other interested parties 
who possess, use, or transfer select agents or toxins.
    Estimated annual number of respondents: 1,163.
    Estimated annual number of responses per respondent: 1.0008598.
    Estimated annual number of responses: 1,164.
    Estimated total annual burden on respondents: 2,275 hours. (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.)
    All responses to this notice will be summarized and included in the 
request for OMB approval. All comments will also become a matter of 
public record.

    Done in Washington, DC, this 18th day of May 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-12753 Filed 5-23-11; 8:45 am]
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