Effectiveness Indications Statements in Veterinary Biologics Labeling; Notice of Public Meeting and Request for Comments, 30093-30094 [2011-12762]
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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
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16:47 May 23, 2011
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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
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jlentini on DSK4TPTVN1PROD with NOTICES
30094
Federal Register / Vol. 76, No. 100 / Tuesday, May 24, 2011 / Notices
statement that would convey clinically
useful information to veterinary
practitioners and other consumers of
veterinary biologics. At that meeting,
the American Veterinary Medical
Association, which represents the single
largest group of consumers of veterinary
biologics, informed APHIS that its
members consider labeling indications
statements that are based on the
guidance provided in VSM 800.202 to
be confusing and expressed a desire for
indications statements that provide
insight into the actual performance of
the product, including summaries of
safety and efficacy data. On the other
hand, representatives of the trade
associations representing veterinary
biologics manufacturers have remarked
that their members expend significant
resources on studies to provide data to
support labeling that includes
indications statements that emphasize
the unique properties of their product
versus that of a competitor. They
expressed concern about any change to
the labeling regulations that would
deemphasize product differences or
require public disclosure of proprietary
information that could compromise
manufacturers’ competitive positions in
the marketplace.
In response to the concerns expressed
by these stakeholders, APHIS has
developed a draft policy guideline
(concept paper) concerning the wording
of indications statements used in
veterinary biologics labeling. The draft
guideline differs from current guidance
regarding label claims in VSM 800.202
in that a single indications statement
(e.g., ‘‘This product has been shown to
be effective for the vaccination of
healthy animals X weeks of age or older
against * * *’’) would replace current
indications statements that may reflect
any of four different levels of
effectiveness. In addition to a
standardized indications statement, the
draft guideline also provides for the
public disclosure of a summary (with
confidential business information
removed) of the efficacy and safety data
submitted to APHIS in support of the
issuance of the product license. The
draft guideline may be viewed on the
Regulations.gov Web site (see
ADDRESSES above) or obtained from the
person listed under FOR FURTHER
INFORMATION CONTACT.
We are holding a public meeting to
solicit input and discussion of any
issues that are pertinent to this concept.
This meeting is scheduled for Thursday,
June 16, 2011. Registration information
and copies of the agenda for the meeting
may be obtained from the person listed
under FOR FURTHER INFORMATON
CONTACT. The public meeting will begin
VerDate Mar<15>2010
16:47 May 23, 2011
Jkt 223001
at 9 a.m. and is scheduled to end at 3
p.m. but may end earlier if all persons
wishing to comment have been heard.
The meeting will be recorded, and
information about obtaining a transcript
will be provided at the meeting. If you
require special accommodations, such
as a sign language interpreter, please
contact the person listed under FOR
FURTHER INFORMATION CONTACT.
You may also submit comments
regarding the concept paper using one
of the methods described under
ADDRESSES above.
Done in Washington, DC, this 18th day of
May 2011.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2011–12762 Filed 5–23–11; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Forest Service
Central Montana Resource Advisory
Committee
Forest Service, USDA.
Notice of meeting.
AGENCY:
ACTION:
The Central Montana
Resource Advisory Committee will meet
in Stanford, MT. The committee is
authorized under the Secure Rural
Schools and Community SelfDetermination Act (Pub. L. 110–343)
(the Act) and operates in compliance
with the Federal Advisory Committee
Act. The purpose of the committee is to
improve collaborative relationships and
to provide advice and recommendations
to the Forest Service concerning projects
and funding consistent with the title II
of the Act. The meeting is open to the
public. This will be the second official
meeting of the Central Montana
Resource Advisory Committee.
DATES: The meeting will be held June 1,
2011, 7 p.m.
ADDRESSES: The meeting will be held at
the Judith Ranger District, 109 Central
Ave. Written comments may be
submitted as described under
SUPPLEMENTARY INFORMATION.
All comments, including names and
addresses when provided, are placed in
the record and are available for public
inspection and copying. The public may
inspect comments received at the Judith
Ranger District. Please call ahead to
(406) 566–2292 to facilitate entry into
the building to view comments.
FOR FURTHER INFORMATION CONTACT: Ron
Wiseman, District Ranger, Lewis and
Clark National Forest, (406) 566–2292,
rwiseman@fs.fed.us.
SUMMARY:
PO 00000
Frm 00007
Fmt 4703
Sfmt 4703
Individuals who use
telecommunication devices for the deaf
(TDD) may call the Federal Information
Relay Service (FIRS) at 1–800–877–8339
between 8 a.m. and 8 p.m., Eastern
Standard Time, Monday through Friday.
Requests for reasonable accommodation
for access to the facility or proceedings
may be made by contacting the person
listed FOR FURTHER INFORMATION.
SUPPLEMENTARY INFORMATION: The
following business will be conducted:
(1) Discussion and approval of RAC
operating guidelines. (2) Discussion of
project development and
recommendation process. (3) Review
and vote on projects. Anyone who
would like to bring related matters to
the attention of the committee may file
written statements with the committee
staff before or after the meeting. The
agenda will include time for people to
make oral statements of three minutes or
less. Individuals wishing to make an
oral statement should request in writing
by May 18 to be scheduled on the
agenda. Written comments and requests
for time for oral comments must be sent
to 109 Central Ave., Stanford, MT
59479, or by e-mail to rwiseman@
fs.fed.us, or via facsimile to (406) 566–
2408.
Dated: May 9, 2011.
Ron B. Wiseman,
District Ranger.
[FR Doc. 2011–12569 Filed 5–23–11; 8:45 am]
BILLING CODE 3410–11–M
DEPARTMENT OF AGRICULTURE
Rural Utilities Service
Announcement of Grant and Loan
Application Deadlines and Funding
Levels
Rural Utilities Service, USDA.
Notice of funding availability
and solicitation of applications.
AGENCY:
ACTION:
The Rural Utilities Service
(RUS) announces its Revolving Fund
Program (RFP) application window for
Fiscal Year (FY) 2011. In addition to
announcing the application window,
RUS announces the available funding of
$496,000 for RFP competitive grants for
the fiscal year.
The RFP is authorized under section
306(a)(2)(B) of the Consolidated Farm
and Rural Development Act (Con Act),
7 U.S.C. 1926(a)(2)(B). Under the RFP,
qualified private, non-profit
organizations receive RFP grant funds to
establish a lending program for eligible
entities. Eligible entities for the
revolving loan fund will be the same
entities eligible, under paragraph 1 or 2
SUMMARY:
E:\FR\FM\24MYN1.SGM
24MYN1
]]>Agencies
[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Notices]
[Pages 30093-30094]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12762]
-----------------------------------------------------------------------
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
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
ADDRESSES: 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-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
[[Page 30094]]
statement that would convey clinically useful information to veterinary
practitioners and other consumers of veterinary biologics. At that
meeting, the American Veterinary Medical Association, which represents
the single largest group of consumers of veterinary biologics, informed
APHIS that its members consider labeling indications statements that
are based on the guidance provided in VSM 800.202 to be confusing and
expressed a desire for indications statements that provide insight into
the actual performance of the product, including summaries of safety
and efficacy data. On the other hand, representatives of the trade
associations representing veterinary biologics manufacturers have
remarked that their members expend significant resources on studies to
provide data to support labeling that includes indications statements
that emphasize the unique properties of their product versus that of a
competitor. They expressed concern about any change to the labeling
regulations that would deemphasize product differences or require
public disclosure of proprietary information that could compromise
manufacturers' competitive positions in the marketplace.
In response to the concerns expressed by these stakeholders, APHIS
has developed a draft policy guideline (concept paper) concerning the
wording of indications statements used in veterinary biologics
labeling. The draft guideline differs from current guidance regarding
label claims in VSM 800.202 in that a single indications statement
(e.g., ``This product has been shown to be effective for the
vaccination of healthy animals X weeks of age or older against * * *'')
would replace current indications statements that may reflect any of
four different levels of effectiveness. In addition to a standardized
indications statement, the draft guideline also provides for the public
disclosure of a summary (with confidential business information
removed) of the efficacy and safety data submitted to APHIS in support
of the issuance of the product license. The draft guideline may be
viewed on the Regulations.gov Web site (see ADDRESSES above) or
obtained from the person listed under FOR FURTHER INFORMATION CONTACT.
We are holding a public meeting to solicit input and discussion of
any issues that are pertinent to this concept. This meeting is
scheduled for Thursday, June 16, 2011. Registration information and
copies of the agenda for the meeting may be obtained from the person
listed under FOR FURTHER INFORMATON CONTACT. The public meeting will
begin at 9 a.m. and is scheduled to end at 3 p.m. but may end earlier
if all persons wishing to comment have been heard. The meeting will be
recorded, and information about obtaining a transcript will be provided
at the meeting. If you require special accommodations, such as a sign
language interpreter, please contact the person listed under FOR
FURTHER INFORMATION CONTACT.
You may also submit comments regarding the concept paper using one
of the methods described under ADDRESSES above.
Done in Washington, DC, this 18th day of May 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-12762 Filed 5-23-11; 8:45 am]
BILLING CODE 3410-34-P
