80 FR 69632 - Notice of Request for Extension of Approval of an Information Collection; Select Agent Registration

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 217 (November 10, 2015)

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with the regulations for select agent registration.

[Federal Register Volume 80, Number 217 (Tuesday, November 10, 2015)]
[Notices]
[Pages 69632-69633]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-28597]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0083]


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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[[Page 69633]]

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this 
notice announces the Animal and Plant Health Inspection Service's 
intention to request an extension of approval of an information 
collection associated with the regulations for select agent 
registration.

DATES: We will consider all comments that we receive on or before 
January 11, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0083.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0083, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-
0083 or in our reading room, which 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) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: For information on the regulations for 
select agent registration, contact Mr. Charles L. Divan, Operations 
Director, Agriculture Select Agent Services, National Import Export 
Services, VS, APHIS, 4700 River Road Unit 2, Riverdale, MD 20737; (301) 
851-3300, option 3. For copies of more detailed information on the 
information collection, contact Ms. Kimberly Hardy, APHIS' Information 
Collection Coordinator, at (301) 851-2727.

SUPPLEMENTARY INFORMATION: 
    Title: Select Agent Registration.
    OMB Control 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 (the Act) provides for the regulation of 
certain biological agents and toxins by the U.S. Department of 
Agriculture (USDA) and the Department of Health and Human Services 
(HHS). Under section 212 of the Act, USDA regulates certain biological 
agents and toxins that have the potential to pose a severe threat to 
animal and 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 health and to animal health or animal products are subject to 
regulation by both APHIS and the Centers for Disease Control and 
Prevention (CDC), HHS. CDC has the primary responsibility for 
implementing the provisions of the Act within HHS.
    APHIS regulations for select agents and toxins are contained in 7 
CFR part 331 (plant) and 9 CFR part 121 (animal and overlap \1\). They 
require an individual or entity (unless specifically exempted under the 
regulations) to register with APHIS or with CDC in order to possess, 
use, or transfer biological agents or toxins.
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    \1\ Overlap select agents and toxins are those that have been 
determined to pose a severe threat to human and animal health or 
animal products.
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    The registration process is designed to obtain critical information 
concerning individuals or entities in possession of select 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.
    We are asking the Office of Management and Budget (OMB) to approve 
our use of this information collection activity 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 
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, such as 
electronic submission of responses.
    Estimate of burden: The public reporting burden for this collection 
of information is estimated to average 2.6 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: 1,517.
    Estimated annual number of responses per respondent: 3.
    Estimated annual number of responses: 4,754.
    Estimated total annual burden on respondents: 12,368 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 4th day of November 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-28597 Filed 11-9-15; 8:45 am]
 BILLING CODE 3410-34-P