80_FR_69849 80 FR 69632 - Notice of Request for Extension of Approval of an Information Collection; Select Agent Registration

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)

Page Range69632-69633
FR Document2015-28597

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 Issue 217 (Tuesday, November 10, 2015) 
[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

69632 Notices Federal Register Vol. 80, No. 217 Tuesday, November 10, 2015 This section of the FEDERAL REGISTER Departmental Management (OAO, Natural Resources and Environment contains documents other than rules or OBPA, OCIO, OCFO, OHSEC, OHRM, proposed rules that are applicable to the Blazer, Arthur; Bonnie, Robert. OJO, OO, and OPPM) and Staff Offices public. Notices of hearings and investigations, (ASCR, OCE, OC, OCR, OGC, and NA) Forest Service committee meetings, agency decisions and rulings, delegations of authority, filing of Alboum, Jonathan; Bender, Stuart; Bice, Blount, Emilee; Mills, Ann; Rodriguez- petitions and applications and agency Donald; Black, David; Bumbary- Franco, Carlos. statements of organization and functions are Langston, Inga; Grahn, David; Natural Resources Conservation examples of documents appearing in this Holladay, Jon; Jeanquart, Roberta; section. Service Johansson, Robert C.; Jones, Carmen; Jones, Diem-Linh; Leonard, Joe; Berns-Melhus, Kim; Norman-Barry, Parham, Gregory L.; Prieto, Jeffrey; Gayle. DEPARTMENT OF AGRICULTURE Shorter, Malcom; Ware, Joseph A.; Research, Education and Economics Wiggins, Marsha A.; Wilusz, Lisa; Performance Review Board Bartuska, Ann. Young, Michael. Appointments Marketing and Regulatory Programs Agricultural Research Service AGENCY:Office of Human Resource (MRP) Jacobs-Young, Chavonda. Management, Departmental Avalos, Edward. Economic Research Service Management, USDA. Agricultural Marketing Service Bohman, Mary; Pompelli, Gregory K. ACTION: Notice of Appointment. Barnes, Rex; Morris, Erin. National Agricultural Statistics Service SUMMARY: This notice announces the Animal and Plant Health Inspection Hamer, Jr., Hubert; Picanso, Renee; appointment of the members of the Service Reilly, Joseph. Senior Executive Service (SES) and Senior Level (SL) and Scientific or Gregoire, Michael; Shea, A. Kevin. National Institute of Food and Professional (ST) Performance Review Grain Inspection, Packers and Agriculture Boards (PRB) for the U.S. Department of Stockyards Administration Broussard, Meryl; Ramaswamy, Sonny. Agriculture (USDA), as required by 5 Mitchell, Lawrence W. DATES: Effective November 2, 2015. U.S.C. 4314(c)(4). The Performance Review Board assures consistency, Food Safety FOR FURTHER INFORMATION CONTACT: stability, and objectivity in the Roberta Jeanquart, Director, Office of Almanza, Alfred; Ronholm, Brian. Human Resources Management, performance appraisal process. USDA has a total of six PRBs: the Secretary’s Farm and Foreign Agricultural Services telephone: (202) 260–8718, email: PRB; Departmental Management and bobbi.jeanquart@dm.usda.gov.or Scuse, Michael. Staff Offices PRB; Natural Resources Patricia Moore, Director, Executive and Environment PRB; Farm and Foreign Agricultural Service Resources Management Division, Foreign Agricultural Services, Rural Quick, Bryce. telephone: (202) 720–8629, email: Development, and Food, Nutrition, and patty.moore@dm.usda.gov. Consumer Services PRB; Marketing and Farm Service Agency (Authority: 5 U.S.C. 4314(c)(4).) Regulatory Programs, Food Safety PRB; Beyerhelm, Christopher. Dated: November 3, 2015. and Research, Education, and Risk Management Agency Thomas J. Vilsack, Economics PRB. The PRBs are Alston, Michael. Secretary. comprised of career and noncareer [FR Doc. 2015–28417 Filed 11–9–15; 8:45 am] executives and Chairpersons to make Food, Nutrition, and Consumer recommendations on the performance of BILLING CODE P Services executives to the Secretary, including performance ratings and bonuses for Wilson, Kathryn. SES, SL, and ST employees. The boards DEPARTMENT OF AGRICULTURE Food and Nutrition Service meet annually to review and evaluate Dean, Telora; Jackson, Yvette. Animal and Plant Health Inspection performance appraisal documents and Service provide written recommendations to the Rural Development Secretary for final approval of [Docket No. APHIS–2015–0083] Salerno, Lillian. performance ratings and base salary Rural Business Service Notice of Request for Extension of asabaliauskas on DSK5VPTVN1PROD with NOTICES increases. Approval of an Information Collection; Parker, Chadwick O. Select Agent Registration SUPPLEMENTARY INFORMATION: In accordance with 5 U.S.C. 4314(c)(4), the Rural Housing Service AGENCY: Animal and Plant Health following executives may be appointed Glendenning, Roger; Hernandez, Tony; Inspection Service, USDA. by mission areas to the USDA PRBs: Primrose, Edna. ACTION: Extension of approval of an Office of the Secretary Rural Utilities Service information collection; comment request. Christenson, Daniel; Wheelock, Leslie. Adams, Keith. VerDate Sep<11>2014 19:41 Nov 09, 2015 Jkt 238001 PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 E:\FR\FM\10NON1.SGM 10NON1

Federal Register / Vol. 80, No. 217 / Tuesday, November 10, 2015 / Notices 69633 SUMMARY: In accordance with the implementing the provisions of the Act are to respond, through use, as Paperwork Reduction Act of 1995, this within USDA. Select agents and toxins appropriate, of automated, electronic, notice announces the Animal and Plant that have been determined to pose a mechanical, and other collection Health Inspection Service’s intention to severe threat to both human health and technologies, such as electronic request an extension of approval of an to animal health or animal products are submission of responses. information collection associated with subject to regulation by both APHIS and Estimate of burden: The public the regulations for select agent the Centers for Disease Control and reporting burden for this collection of registration. Prevention (CDC), HHS. CDC has the information is estimated to average 2.6 DATES: We will consider all comments primary responsibility for implementing hours per response. that we receive on or before January 11, the provisions of the Act within HHS. Respondents: Researchers, APHIS regulations for select agents universities, research and development 2016. and toxins are contained in 7 CFR part organizations, diagnostic laboratories, ADDRESSES: You may submit comments 331 (plant) and 9 CFR part 121 (animal and other interested parties who by either of the following methods: and overlap 1). They require an possess, use, or transfer select agents or • Federal eRulemaking Portal: Go to individual or entity (unless specifically toxins. http://www.regulations.gov/ exempted under the regulations) to Estimated annual number of #!docketDetail;D=APHIS-2015-0083. register with APHIS or with CDC in respondents: 1,517. • Postal Mail/Commercial Delivery: order to possess, use, or transfer Estimated annual number of Send your comment to Docket No. biological agents or toxins. responses per respondent: 3. APHIS–2015–0083, Regulatory Analysis The registration process is designed to Estimated annual number of and Development, PPD, APHIS, Station obtain critical information concerning responses: 4,754. 3A–03.8, 4700 River Road Unit 118, individuals or entities in possession of Estimated total annual burden on Riverdale, MD 20737–1238. select agents or toxins, as well as the respondents: 12,368 hours. (Due to Supporting documents and any specific characteristics of the agents or averaging, the total annual burden hours comments we receive on this docket toxins, including name, strain, and may not equal the product of the annual may be viewed at http:// genetic information. These data are number of responses multiplied by the www.regulations.gov/ needed, in part, to allow APHIS to reporting burden per response.) #!docketDetail;D=APHIS-2015-0083 or determine the biosafety and All responses to this notice will be in our reading room, which is located in biocontainment level of an entity as summarized and included in the request Room 1141 of the USDA South well as the entity’s security situation. for OMB approval. All comments will Building, 14th Street and Independence This, in turn, helps APHIS to ensure also become a matter of public record. Avenue SW., Washington, DC. Normal that appropriate safeguard, containment, reading room hours are 8 a.m. to 4:30 Done in Washington, DC, this 4th day of and disposal requirements November 2015. p.m., Monday through Friday, except commensurate with the risk of the agent holidays. To be sure someone is there to Kevin Shea, or toxin are present at the entity, thus help you, please call (202) 799–7039 Administrator, Animal and Plant Health preventing access to such agents and Inspection Service. before coming. toxins for use in domestic or FOR FURTHER INFORMATION CONTACT: For [FR Doc. 2015–28597 Filed 11–9–15; 8:45 am] international terrorism. APHIS will also information on the regulations for select request information to determine that BILLING CODE 3410–34–P agent registration, contact Mr. Charles L. individuals seeking to register have a Divan, Operations Director, Agriculture lawful purpose to possess, use, or Select Agent Services, National Import DEPARTMENT OF AGRICULTURE transfer agents or toxins. Export Services, VS, APHIS, 4700 River We are asking the Office of Farm Service Agency Road Unit 2, Riverdale, MD 20737; (301) Management and Budget (OMB) to 851–3300, option 3. For copies of more approve our use of this information Submission for OMB Review; detailed information on the information collection activity for an additional 3 Comment Request collection, contact Ms. Kimberly Hardy, years. APHIS’ Information Collection The purpose of this notice is to solicit November 4, 2015. Coordinator, at (301) 851–2727. comments from the public (as well as The Department of Agriculture has SUPPLEMENTARY INFORMATION: affected agencies) concerning our submitted the following information Title: Select Agent Registration. information collection. These comments collection requirement(s) to OMB for OMB Control Number: 0579–0213. will help us: review and clearance under the Type of Request: Extension of (1) Evaluate whether the collection of Paperwork Reduction Act of 1995, approval of an information collection. information is necessary for the proper Public Law 104–13. Comments Abstract: The Public Health Security performance of the functions of the regarding (a) whether the collection of and Bioterrorism Preparedness and Agency, including whether the information is necessary for the proper Response Act of 2002 (the Act) provides information will have practical utility; performance of the functions of the for the regulation of certain biological (2) Evaluate the accuracy of our agency, including whether the agents and toxins by the U.S. estimate of the burden of the collection information will have practical utility; Department of Agriculture (USDA) and of information, including the validity of (b) the accuracy of the agency’s estimate the Department of Health and Human the methodology and assumptions used; of burden including the validity of the asabaliauskas on DSK5VPTVN1PROD with NOTICES Services (HHS). Under section 212 of (3) Enhance the quality, utility, and methodology and assumptions used; (c) the Act, USDA regulates certain clarity of the information to be ways to enhance the quality, utility and biological agents and toxins that have collected; and clarity of the information to be the potential to pose a severe threat to (4) Minimize the burden of the collected; (d) ways to minimize the animal and plant health or to animal collection of information on those who burden of the collection of information and plant products. The Animal and 1 Overlap select agents and toxins are those that on those who are to respond, including Plant Health Inspection Service (APHIS) have been determined to pose a severe threat to through the use of appropriate has the primary responsibility for human and animal health or animal products. automated, electronic, mechanical, or VerDate Sep<11>2014 19:41 Nov 09, 2015 Jkt 238001 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 E:\FR\FM\10NON1.SGM 10NON1


Document Created: 2018-03-01 11:25:58
Document Modified: 2018-03-01 11:25:58
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionExtension of approval of an information collection; comment request.
DatesWe will consider all comments that we receive on or before January 11, 2016.
ContactFor 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.
FR Citation80 FR 69632 
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