Notice of Request for Extension of Approval of an Information Collection; Select Agent Registration, 30092-30093 [2011-12753]
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30092
Federal Register / Vol. 76, No. 100 / Tuesday, May 24, 2011 / Notices
laboratories and private inspection
services) to be accredited by APHIS to
perform specific laboratory testing or
phytosanitary inspections that could
serve as the basis for issuing Federal
phytosanitary certificates, phytosanitary
certificates for reexport, or export
certificates for processed plant products.
The accreditation process requires the
use of several information collection
activities to ensure that nongovernment
facilities applying for accreditation
possess the necessary qualifications.
We are asking the Office of
Management and Budget (OMB) to
approve our use of these 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 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
3.4482758 hours per response.
Respondents: Operators of
nongovernment facilities who wish to
be accredited to perform laboratory
testing or phyosanitary inspection
services in connection with APHIS’
export certification program and certain
employees of such nongovernment
facilities.
Estimated annual number of
respondents: 15.
Estimated annual number of
responses per respondent: 5.8.
Estimated annual number of
responses: 87.
Estimated total annual burden on
respondents: 300 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
VerDate Mar<15>2010
16:47 May 23, 2011
Jkt 223001
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. 2011–12751 Filed 5–23–11; 8:45 am]
BILLING CODE 3410–34–P
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
Animal and Plant Health
Inspection Service, USDA.
ACTION: Extension of approval of an
information collection; comment
request.
AGENCY:
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.
SUMMARY:
You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/fdmspublic/
component/
main?main=DocketDetail&d=APHIS2011&-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
ADDRESSES:
PO 00000
Frm 00005
Fmt 4703
Sfmt 4703
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
https://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
E:\FR\FM\24MYN1.SGM
24MYN1
jlentini on DSK4TPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 100 / Tuesday, May 24, 2011 / Notices
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
VerDate Mar<15>2010
16:47 May 23, 2011
Jkt 223001
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]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2011–0049]
Effectiveness Indications Statements
in Veterinary Biologics Labeling;
Notice of Public Meeting and Request
for Comments
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are issuing this notice to
inform producers and users of
veterinary biological products, as well
as other interested individuals, that we
will be holding a public meeting to
discuss a draft guideline (concept paper)
concerning effectiveness indications
statements in veterinary biologics
labeling. We are also making the
concept paper available for review and
comment.
DATES: The public meeting will be held
on Thursday, June 16, 2011, from 9 a.m.
to 3 p.m. We will consider all comments
that we receive on or before July 25,
2011.
SUMMARY:
The public meeting will be
held at the National Centers for Animal
Health, 1920 Dayton Avenue, Ames, IA.
You may submit comments on the
concept paper by either of the following
methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/fdmspublic/
component/
main?main=DocketDetail&d=APHIS-
ADDRESSES:
PO 00000
Frm 00006
Fmt 4703
Sfmt 4703
30093
2011-0049 to submit or view comments
and to view the concept paper.
• Postal Mail/Commercial Delivery:
Please send one copy of your comment
to Docket No. APHIS–2011–0049,
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–
2011–0049.
Reading Room: You may view the
concept paper and any comments we
receive on the Regulations.gov Web site
(see link above) or 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. 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.
FOR FURTHER INFORMATION CONTACT: Ms.
Dee McVey, Center for Veterinary
Biologics, VS, APHIS, 1920 Dayton
Avenue, Ames, IA 50010; phone (515)
337–6100, fax (515) 337–6120, or e-mail:
dee.mcvey@aphis.usda.gov.
SUPPLEMENTARY INFORMATION: The
Animal and Plant Health Inspection
Service (APHIS) administers and
enforces the Virus-Serum-Toxin Act (the
Act), as amended (21 U.S.C. 151–159).
The regulations issued pursuant to the
Act are intended to ensure that
veterinary biological products are pure,
safe, potent, and effective when used
according to label instructions. The
regulations in 9 CFR part 112 prescribe
requirements for packaging and labeling
veterinary biologics. The regulations in
part 112 ensure that labeling provides
adequate information concerning the
expected effectiveness and safety of the
product. Current APHIS guidelines
(Veterinary Services Memorandum
[VSM] No. 800.202—General Licensing
Considerations: Efficacy Studies)
provide examples of statements that
may be used in labeling to describe the
indications for use of a product,
provided that the product has
demonstrated a specified level of
performance in an efficacy study that
was the basis for issuance of the product
license. VSM 800.202 specifies
performance requirements and
allowable indications statements for
four different levels (tiers) of
effectiveness.
In July 2009, representatives of
veterinary biologics manufacturers and
the American Veterinary Medical
Association met with APHIS to discuss
the Agency’s current labeling guidance
and to explore the possibility of
developing a single indications
E:\FR\FM\24MYN1.SGM
24MYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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]
BILLING CODE 3410-34-P
