International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL30); Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms; Availability, 61081-61082 [2014-24152]
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Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Notices
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9048,
CVMAESupport@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2002–D–0268 (formerly
Docket No. 2002D–0005)]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH
GL30); Guidance for Industry on
Pharmacovigilance of Veterinary
Medicinal Products: Controlled List of
Terms; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
(GFI #143) entitled ‘‘Guidance for
Industry on Pharmacovigilance of
Veterinary Medicinal Products:
Controlled List of Terms’’ (VICH GL30).
This guidance has been developed for
veterinary use by the International
Cooperation on Harmonisation of
Technical Requirements for Registration
of Veterinary Medicinal Products
(VICH). The purpose of this VICH
guidance document is to describe the
controlled lists of terms critical to
completing the controlled data fields as
identified in the guidance entitled ‘‘Data
Elements for Submission of Veterinary
Adverse Event Reports to the Center for
Veterinary Medicine’’ (GFI #188),
available on the FDA Web site at:
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/ucm042450.htm.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Margarita Brown, Center for Veterinary
Medicine (HFV–240), Food and Drug
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
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61081
Federation for Animal Health (IFAH).
An IFAH representative also
participates in the VICH Steering
Committee meetings.
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote the
international harmonization of
regulatory requirements. FDA has
participated in efforts to enhance
harmonization and has expressed its
commitment to seek scientifically based,
harmonized technical procedures for the
development of pharmaceutical
products. One of the goals of
harmonization is to identify, and then
reduce, differences in technical
requirements for drug development
among regulatory agencies in different
countries.
FDA has actively participated in the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use for
several years to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products among the European Union,
Japan, and the United States. The VICH
is a parallel initiative for veterinary
medicinal products. The VICH is
concerned with developing harmonized
technical requirements for the approval
of veterinary medicinal products in the
European Union, Japan, and the United
States, and includes input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
from the European Commission,
European Medicines Evaluation Agency,
European Federation of Animal Health,
Committee on Veterinary Medicinal
Products, FDA, the U.S. Department of
Agriculture, the Animal Health
Institute, the Japanese Veterinary
Pharmaceutical Association, the
Japanese Association of Veterinary
Biologics, and the Japanese Ministry of
Agriculture, Forestry and Fisheries.
Six observers are eligible to
participate in the VICH Steering
Committee: One representative from the
governments of Australia/New Zealand,
one representative from the industry in
Australia/New Zealand, one
representative from the government of
Canada, one representative from the
industry of Canada, one representative
from the government of South Africa,
and one representative from the
industry of South Africa. The VICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
II. Guidance on Controlled Lists of
Terms
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
In the Federal Register of June 21,
2007 (72 FR 34261), FDA published a
notice of availability for a revised draft
guidance entitled ‘‘Revised Draft
Guidance for Industry on
Pharmacovigilance of Veterinary
Medicinal Products: Controlled List of
Terms’’ (VICH GL30). Interested persons
were given until July 23, 2007, to
comment on the revised draft guidance.
FDA received a few comments on the
draft revised guidance, and those
comments, as well as those received by
other VICH member regulatory agencies,
were considered as the guidance was
finalized. The guidance announced in
this document finalizes the draft revised
guidance dated June 20, 2007. The final
guidance is a product of the
Pharmacovigilance Expert Working
Group of the VICH.
This VICH guidance document
describes the controlled lists of terms
critical to completing the controlled
data fields as indicated in FDA’s
‘‘Guidance for Industry, Data Elements
for Submission of Veterinary Adverse
Event Reports to the Center for
Veterinary Medicine’’ (GFI #188). To
assess the safety and efficacy of
veterinary medicinal products, the use
of controlled lists of terms is important
in order to assure consistency, as well
as to provide for comparison between
products and across product classes.
This guidance also includes an
appropriate maintenance procedure to
keep the lists of terms up to date.
III. Significance of Guidance
This guidance, developed under the
VICH process, has been revised to
conform to FDA’s good guidance
practices regulation (21 CFR 10.115).
For example, the document has been
designated ‘‘guidance’’ rather than
‘‘guideline.’’ In addition, guidance
documents must not include mandatory
language such as ‘‘shall,’’ ‘‘must,’’
‘‘require,’’ or ‘‘requirement,’’ unless
FDA is using these words to describe a
statutory or regulatory requirement.
The guidance represents the Agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of applicable
statutes and regulations.
E:\FR\FM\09OCN1.SGM
09OCN1
61082
Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Notices
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
this guidance have been approved under
OMB control numbers 0910–0284 and
0910–0645.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
VI. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: October 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–24152 Filed 10–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Science Advisory Board to the
National Center for Toxicological
Research Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Science
Advisory Board (SAB) to the National
Center for Toxicological Research
(NCTR).
General Function of the Committee:
To provide advice and
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17:56 Oct 08, 2014
Jkt 235001
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 6, 2014, from 8:15
a.m. to 4:15 p.m. and on November 7,
2014, from 8 a.m. to 2 p.m.
Location: NCTR SAB, 3900 NCTR Rd.,
Conference Room B–12, Jefferson, AR
72079.
Contact Person: Donna Mendrick,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm.
2208, Silver Spring, MD 20993–0002,
301–796–8892, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://www.fda.
gov/AdvisoryCommittees/default.htm
and scroll down to the appropriate
advisory committee meeting link, or call
the advisory committee information line
to learn about possible modifications
before coming to the meeting.
Agenda: On November 6, 2014, the
NCTR Director will welcome the
participants and provide a Center-wide
update on scientific initiatives and
accomplishments during the past year.
The SAB will be presented with an
overview of the Division of
Microbiology Subcommittee and the
Subcommittee Site Visit Report.
Following the public session, the SAB
will hear an update from each of
NCTR’s research Divisions, the Office of
Science Coordination, followed by an
update on NCTR’s Global Interactions.
On November 7, 2014, the Office of
the Chief Scientist will update the SAB
on their research needs, and discuss
opportunities for collaboration to help
address these needs, followed by a
report from the National Toxicology
Program of the National Institutes of
Environmental Health Sciences on
current and future collaboration.
The Center for Biological Evaluation
and Research, the Center for Drug
Evaluation and Research, the Center for
Devices and Radiological Health, the
Center for Veterinary Medicine, the
Center for Tobacco Products, the Office
of Regulatory Affairs, and the Center for
Food Safety and Applied Nutrition will
each briefly discuss their Center-specific
research strategic needs.
Following an open discussion of all
the information presented, the open
session of the meeting will close so that
SAB members can discuss personnel
issues at NCTR.
PO 00000
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Fmt 4703
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FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 30, 2014.
Oral presentations from the public will
be scheduled between approximately 12
noon to 1 p.m. on November 6, 2014.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 22, 2014. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
October 23, 2014.
Closed Committee Deliberations: On
November 7, 2014, from 12 noon to 2
p.m., the meeting will be closed to
permit discussion where disclosure
would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). This portion of the meeting
will be closed to permit discussion of
information concerning individuals
associated with the research programs at
NCTR.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Donna
E:\FR\FM\09OCN1.SGM
09OCN1
]]>Agencies
[Federal Register Volume 79, Number 196 (Thursday, October 9, 2014)]
[Notices]
[Pages 61081-61082]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24152]
[[Page 61081]]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2002-D-0268 (formerly Docket No. 2002D-0005)]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH
GL30); Guidance for Industry on Pharmacovigilance of Veterinary
Medicinal Products: Controlled List of Terms; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry (GFI #143) entitled ``Guidance
for Industry on Pharmacovigilance of Veterinary Medicinal Products:
Controlled List of Terms'' (VICH GL30). This guidance has been
developed for veterinary use by the International Cooperation on
Harmonisation of Technical Requirements for Registration of Veterinary
Medicinal Products (VICH). The purpose of this VICH guidance document
is to describe the controlled lists of terms critical to completing the
controlled data fields as identified in the guidance entitled ``Data
Elements for Submission of Veterinary Adverse Event Reports to the
Center for Veterinary Medicine'' (GFI #188), available on the FDA Web
site at: https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm042450.htm.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Margarita Brown, Center for Veterinary
Medicine (HFV-240), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9048, CVMAESupport@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote the
international harmonization of regulatory requirements. FDA has
participated in efforts to enhance harmonization and has expressed its
commitment to seek scientifically based, harmonized technical
procedures for the development of pharmaceutical products. One of the
goals of harmonization is to identify, and then reduce, differences in
technical requirements for drug development among regulatory agencies
in different countries.
FDA has actively participated in the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use for several years to develop harmonized
technical requirements for the approval of human pharmaceutical and
biological products among the European Union, Japan, and the United
States. The VICH is a parallel initiative for veterinary medicinal
products. The VICH is concerned with developing harmonized technical
requirements for the approval of veterinary medicinal products in the
European Union, Japan, and the United States, and includes input from
both regulatory and industry representatives.
The VICH Steering Committee is composed of member representatives
from the European Commission, European Medicines Evaluation Agency,
European Federation of Animal Health, Committee on Veterinary Medicinal
Products, FDA, the U.S. Department of Agriculture, the Animal Health
Institute, the Japanese Veterinary Pharmaceutical Association, the
Japanese Association of Veterinary Biologics, and the Japanese Ministry
of Agriculture, Forestry and Fisheries.
Six observers are eligible to participate in the VICH Steering
Committee: One representative from the governments of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of Canada, one representative
from the industry of Canada, one representative from the government of
South Africa, and one representative from the industry of South Africa.
The VICH Secretariat, which coordinates the preparation of
documentation, is provided by the International Federation for Animal
Health (IFAH). An IFAH representative also participates in the VICH
Steering Committee meetings.
II. Guidance on Controlled Lists of Terms
In the Federal Register of June 21, 2007 (72 FR 34261), FDA
published a notice of availability for a revised draft guidance
entitled ``Revised Draft Guidance for Industry on Pharmacovigilance of
Veterinary Medicinal Products: Controlled List of Terms'' (VICH GL30).
Interested persons were given until July 23, 2007, to comment on the
revised draft guidance. FDA received a few comments on the draft
revised guidance, and those comments, as well as those received by
other VICH member regulatory agencies, were considered as the guidance
was finalized. The guidance announced in this document finalizes the
draft revised guidance dated June 20, 2007. The final guidance is a
product of the Pharmacovigilance Expert Working Group of the VICH.
This VICH guidance document describes the controlled lists of terms
critical to completing the controlled data fields as indicated in FDA's
``Guidance for Industry, Data Elements for Submission of Veterinary
Adverse Event Reports to the Center for Veterinary Medicine'' (GFI
#188). To assess the safety and efficacy of veterinary medicinal
products, the use of controlled lists of terms is important in order to
assure consistency, as well as to provide for comparison between
products and across product classes. This guidance also includes an
appropriate maintenance procedure to keep the lists of terms up to
date.
III. Significance of Guidance
This guidance, developed under the VICH process, has been revised
to conform to FDA's good guidance practices regulation (21 CFR 10.115).
For example, the document has been designated ``guidance'' rather than
``guideline.'' In addition, guidance documents must not include
mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
The guidance represents the Agency's current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of applicable
statutes and regulations.
[[Page 61082]]
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance have been approved under
OMB control numbers 0910-0284 and 0910-0645.
V. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
VI. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov.
Dated: October 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24152 Filed 10-8-14; 8:45 am]
BILLING CODE 4164-01-P
